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The Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit-Qualitative is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Healgen® Immunofluorescence analyzer OG-H180. This in vitro diagnostic device is for prescription use only.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) and Liquid Chromatography-Mass Spectrometry (LC-MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to a Fentanyl test result, particularly when a preliminary positive result is obtained.

The Healgen® Immunofluorescence analyzer OG-H180 is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to detect test results from in vitro diagnostic tests on clinical specimens. This analyzer can be used in a laboratory or point-of-care setting.

The AccuFluor Fentanyl FIA Test Kit-Qualitative is a rapid fluorescence immunoassay based on the principle of competitive binding, which uses fluorescent microspheres-labeled antibody as the indicator marker to qualitatively detect fentanyl in human urine. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

During testing, a urine specimen migrates upward by capillary action. Fentanyl, if present in the urine specimen below 1.0 ng/mL, will not saturate the binding sites of antibody-coated particles in the test device. The antibody coated fluorescence particles will then be captured by immobilized Fentanyl conjugate, and the signal will be detected in the test line (T) region to show a negative result. The signal will not be detected in the test line (T) region if the Fentanyl level exceeds 1.0 ng/mL because all the binding sites for the anti-Fentanyl antibodies will be saturated and the result will show as positive. To serve as a procedural control, a signal will be detected at the control line (C) region indicating the proper volume of specimen has been added and membrane wicking has occurred. The test is interpreted by the Healgen® Immunofluorescence analyzer OG-H180 and the result will be interpreted by the analyzer.

The provided FDA 510(k) clearance letter pertains to the Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA) Test Kit - Qualitative and the Healgen® Immunofluorescence Analyzer (OG-H180). This document outlines the general regulatory approval and provides some performance characteristics, but it is not a comprehensive study report detailing all aspects of the acceptance criteria and the full study that proves the device meets those criteria.

Specifically, the document does not explicitly state "acceptance criteria" as a defined set of metrics and thresholds prior to presenting performance data. Instead, it presents results from various analytical performance studies which are implicitly used to demonstrate equivalence to a predicate device. Similarly, it does not describe "human expert ground truth establishment," "adjudication methods," or "MRMC comparative effectiveness studies" because these are typically relevant for AI/ML-based diagnostic devices utilizing image interpretation or complex decision support, which is not the primary function described for this immunoassay and analyzer.

This device is an in vitro diagnostic (IVD) test for qualitative detection of fentanyl in urine, which relies on a chemical reaction read by an analyzer. Therefore, the "study" described is a series of analytical performance tests, rather than a clinical study with human readers and ground truth established by medical experts in the way that would be done for an AI radiology device, for example.

Despite these limitations in the provided text for certain categories, I will extract and infer information where possible based on the provided document and common IVD device clearance practices.

Acceptance Criteria and Device Performance for Healgen® AccuFluor Fentanyl FIA Test Kit

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not explicitly list pre-defined "acceptance criteria" with specific numerical thresholds for all metrics. However, based on the provided performance data, here's an interpretation of the implied criteria and the reported performance. The "acceptance criteria" inferred here are based on what constitutes successful demonstration of performance for an IVD device of this type, often aiming for high accuracy, precision, and lack of interference, especially around the cutoff concentration.

2. Sample Size Used for the Test Set and Data Provenance

• Analytical Precision: 60 replicates per concentration (6 replicates/day for 10 days) per lot, across 9 concentration levels, for 3 device lots. Total: 60 * 9 * 3 = 1620 individual tests.
• Interference: Samples with various interfering substances were tested, each at both drug-free and ±50% Cut-Off spiked fentanyl concentrations, using three batches of device. (Exact number of tests not specified, but implies a comprehensive set).
• Specificity: Various drug metabolites and other compounds tested, each using three batches of device. (Exact number of tests not specified).
• Effect of Urine Specific Gravity and pH: Samples across the specified ranges were tested at -50% and +50% Cut-Off levels by three different operators using three device lots. (Exact number of tests not specified).
• Method Comparison (Clinical Samples): 80 unaltered clinical samples (40 negative, 40 positive). These samples were run at three different testing sites.
• Data Provenance: The document does not explicitly state the country of origin for the clinical samples. It does state they were "unaltered clinical samples," implying they were retrospective real-world samples collected from patients. It does not indicate if they were prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable in the traditional sense for this device. For this IVD device, the primary ground truth for its performance studies (precision, specificity, method comparison) is established by analytical gold standards, specifically:
  • LC/MS-MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) for confirming fentanyl concentrations in precision studies and as the comparator method in the method comparison study.
  • This is a highly accurate and precise laboratory method for quantifying drug concentrations, and its results are considered the "ground truth" for chemical concentration data.
• There were "three different operators" for the specific gravity/pH study, but these are not "experts" in the sense of medical professionals establishing a clinical diagnosis ground truth. They are laboratory personnel performing the test.

4. Adjudication Method for the Test Set

• Not Applicable in the traditional sense. Given that the ground truth is established by LC-MS/MS, there is no human "adjudication" process like consensus reading by multiple radiologists for image interpretation. The LC-MS/MS results serve as the definitive reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance on complex interpretation tasks) is not applicable to a qualitative immunoassay and analyzer like the Healgen AccuFluor Fentanyl FIA Test Kit, which determines the presence or absence of a substance based on a fluorescent signal. The device performance is assessed on its analytical accuracy against a gold standard method.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, the performance presented is primarily standalone. The Healgen® Immunofluorescence Analyzer (OG-H180) automatically interprets the fluorescent signal from the test kit. The performance data (precision, specificity, interference, method comparison) directly reflects the analytical capability of the device and test kit combination, without any human interpretation or intervention in the final "positive" or "negative" determination. A human loads the sample and the device performs the analysis and provides the result.

7. The Type of Ground Truth Used

• Analytical Gold Standard (LC-MS/MS): This is the primary method used to establish the true concentration of fentanyl in samples for precision studies and as the comparative reference for clinical samples.
• Spiked Samples: For analytical performance studies (precision, interference, specificity), known concentrations of fentanyl or interfering substances were added to negative urine samples, establishing a controlled ground truth.

8. The Sample Size for the Training Set

• Not explicitly stated in the document, and likely not applicable in the typical AI/ML sense. This device is an immunoassay, not an AI/ML diagnostic algorithm that undergoes a "training" phase with a large dataset. Immunoassays are based on biochemical principles and do not "learn" from data in the same way. Performance is optimized during development and validated analytically.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable / Not Described. As it's not an AI/ML device relying on a training set, the concept of establishing ground truth for training does not apply here. The analytical performance is characterized through rigorous testing under controlled conditions and comparison to established reference methods (like LC-MS/MS).

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EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XP190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-P190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

EVIS EXERA III BRONCHOVIDEOSCOPES OLYMPUS BF-XT190 is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, Endo Therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

The EVIS EXERA III BRONCHOVIDEOSCOPES (OLYMPUS BF-XP190, OLYMPUS BF-P190, and BF-XT190) and BRONCHOVIDEOSCOPE BF-H1100 and BF-1TH1100 are used for endoscopic diagnosis and treatment within the respiratory organs. These endoscopes consist of three parts: the control section, the insertion section, and the connector section.

The provided FDA 510(k) clearance documentation for the Olympus Bronchovideoscopes (K250862) primarily demonstrates substantial equivalence based on technological characteristics and bench testing. It does not contain information about comparative effectiveness studies (like MRMC studies for AI devices), expert ground truth establishment, or typical performance metrics associated with AI/software-as-a-medical-device (SaMD) clearances.

This submission focuses on:

• Technological Equivalence: Showing that the devices (BF-XP190, BF-P190, BF-XT190, BF-H1100, and BF-1TH1100) are fundamentally the same as their predicates, with the primary change being compatibility with a new video system center (CV-1500) and updated labeling related to laser/high-frequency/APC systems.
• Bench Testing: Verification of physical and imaging performance parameters (e.g., thermal safety, color performance, resolution, noise, video latency) to ensure they meet specifications, particularly when combined with the new video system.
• Animal Testing: To assess the imaging modes (WLI, NBI, TXI, BAI-MAC) with the new video processor.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/software performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) is not present in this document. The document explicitly states that "Software Testing and Cybersecurity" was "not performed" due to "no design, material, sterilization, reprocessing, packaging, shelf life, or software changes" (Page 29). This implies that the device itself is a hardware endoscope, and any software associated with it is considered an intrinsic part of its established functionality, not a new or significantly changed software component requiring a separate performance study with clinical endpoints or AI evaluation.

The "acceptance criteria" here relate to the successful completion of the listed bench (and limited animal) tests, demonstrating that the new combination (endoscope + CV-1500) functions as intended and safely, similar to the predicate combinations.

Below is a table summarizing the "acceptance criteria" and "reported device performance" as derived from the document's comparison tables and performance data section, which are primarily about technical specifications and functional verification, not software/AI performance metrics.

Acceptance Criteria and Reported Device Performance (Summary based on provided text)

Since this 510(k) is for existing endoscopes with a new video system and updated labeling, the "acceptance criteria" are implied by the extensive comparison tables (Tables 1-5) which show the subject devices having nearly identical technical specifications to their predicate devices, and the successful completion of specified bench and animal testing. The performance data section doesn't list specific quantitative acceptance criteria for each test but rather states that tests were conducted to "ensure that the subject device performs as intended and meet design specifications."

Study Details (based on provided text)

The document describes performance testing rather than a comparative clinical study for AI/software-as-a-medical-device.

1. A table of acceptance criteria and the reported device performance:

   • See table above. The acceptance criteria are largely implied by the equivalence to the predicate devices in terms of physical, optical, and functional characteristics, and the successful completion of specified bench and animal tests. Quantitative metrics for these tests are not provided in this summary but would have been part of the full submission.

2. Sample sizes used for the test set and the data provenance:

   • Test set sample size: Not specified. The document mentions "bench testing" and "animal testing." For bench tests, it typically refers to a small number of devices or engineered test setups. For animal testing, the number of animals or studies is not provided.
   • Data provenance: Not specified. It can be inferred that the testing was conducted by or on behalf of Olympus Medical Systems Corp. in Japan, given the manufacturing site and submitter location. It does not state if the data is retrospective or prospective, or from which country/region the "animal" data would originate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable / Not specified. This type of information is typically provided for studies evaluating AI algorithms or diagnostic accuracy, where human experts establish a ground truth for imaging interpretation. The present submission is for a hardware endoscope system, and its performance evaluation relies on engineering specifications and functional testing, not expert interpretation of diagnostic images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable / Not specified. Adjudication methods are relevant for human reader studies or expert ground truth establishment, which are not detailed here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, not performed / Not applicable. This submission is not for an AI companion diagnostic or an AI-software-as-a-medical-device. It's for an endoscope system. The document explicitly lists "Software Testing and Cybersecurity" and "Clinical" as "not performed" because there were no fundamental software changes beyond integration with a new video system, which itself does not constitute an AI component in the context of this 510(k) summary. The NBI, RDI, TXI, and BAI-MAC modes are imaging enhancements, not AI algorithms.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This relates to AI/software performance, which is not the focus of this 510(k).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. For this device (endoscope), ground truth typically relates to engineering specifications (e.g., accurate measurements, clear image quality as determined by reproducible test patterns, proper functionality of mechanical parts). For the animal testing of imaging modes, the "ground truth" would be the direct observation of the animal's internal anatomy via the endoscope itself and comparison to expected/known characteristics, not an independent "pathology" or "outcomes" ground truth in a diagnostic sense.

8. The sample size for the training set:

   • Not applicable. This submission is not for an AI system that requires a "training set."

9. How the ground truth for the training set was established:

   • Not applicable. As above, no AI training set is described.

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The HiCardi+ H100 is intended to record symptomatic cardiac events and continuous electrocardiogram (ECG) for 72 hours from ambulatory patients by attaching HiCardi+ H100 SmartPatch to the skin surface. ECG records are stored in SmartPatch for review by the clinician after the recording period (up to 72 hours) is completed. It is indicated for use on 22 years or older who may be symptomatic and/or asymptomatic or suffer from transient symptoms as palpitations, shortness, of breath, dizziness, light-headedness, fatique, or anxiety. The reported ECG metrics include preliminary indications of the irreqular beat and/or rhythm and heart rate measurement based on a single-lead ECG basis. The arrhythmia information addressed in the report does not contain diagnostic interpretation; the reported indication is provided for review by the intended user to make a diagnosis based on clinical judgment and experience.

The HiCardi+ H100 consists of two components:

• . Patient-worn ECG patch (Sensor, SmartPatch);
• . Review & Report Generation Software (LiveStudio).

The SmartPatch is a wearable and reusable patch device intended to measure ECG signals from a patient for 72 hours. The SmartPatch is intended to record ECG signals and automatically indicate the irregular beat and/or rhythm of the recorded ECG data to aid the clinician in finalizing the ECG interpretation. The SmartPatch has an Event Button the patient can press to record symptoms, such as heart palpitations, dizziness, or chest pain, etc.

The LiveStudio is a review software operating on a personal computer (PC). The software visualizes the ECG data and preliminary indications from the SmartPatch for review, editing, and interpretation by the clinician. The LiveStudio provides tools to assist the clinician with their review. The final report includes the summary results of the review and can be documented by PDF formatted documents and printed by a printer connected to the PC.

The provided document details the FDA 510(k) clearance for the HiCardi+ H100 device. However, it does not contain specific acceptance criteria or an analytical study that proves the device meets those criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ZIO® SkyRunner (SR) Electrocardiogram (ECG) Monitoring Service) through various performance data and compliance with standards. It lists various bench tests and clinical data to support substantial equivalence but does not provide details on specific acceptance criteria for a performance study of the arrhythmia detection algorithm or the results of such a study.

Here's a breakdown of what can be extracted and what is missing from your request based on the provided text:

Missing Information:

• A table of acceptance criteria and the reported device performance: This detailed table is not present. While standards are listed (e.g., IEC 60601-2-47, EC57 for validation of heart rate detection and arrhythmia detection algorithm), the specific performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) and their associated acceptance thresholds are not provided, nor are the actual numerical results for these metrics.
• Sample size used for the test set and the data provenance: Not specified for any performance evaluation directly comparing the device's algorithmic performance to a ground truth.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
• Adjudication method: Not specified.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or detailed.
• Standalone (algorithm only without human-in-the-loop performance) study: While "Validation of heart rate detection and development of arrhythmia detection algorithm" is mentioned as a bench test, the specifics of this "validation" are not provided, including the study design, acceptance criteria, methods, or results of a standalone performance evaluation.
• Type of ground truth used: Not explicitly stated for performance validation studies.
• Sample size for the training set: Not specified.
• How the ground truth for the training set was established: Not specified.

What is mentioned that is relevant to performance data for substantial equivalence, but doesn't fully answer your questions:

• Performance Data: The document states that "Verification and validation activities established the safety and performance characteristics of the subject device with respect to the predicate."
• Bench Testing: Several bench tests were conducted, including:
  • "Validation of heart rate detection and development of arrhythmia detection algorithm (IEC 60601-2-47, EC57)"
  • "Disposable ECG electrodes Performance (ANSI/AAMI EC12)"
  • "Software Verification and Validation (IEC 62304)"
• Compliance to Standards: The device complies with various standards, including IEC 60601-2-47 (EC57), which is relevant to ambulatory ECG performance and includes requirements for heart rate detection and arrhythmia detection. However, the specific performance requirements within these standards and how the device met them numerically are not detailed here.

Conclusion based on provided text:

The provided document, an FDA 510(k) clearance letter and summary, confirms that the HiCardi+ H100 device received clearance based on substantial equivalence to a predicate device. It indicates that performance testing, including "Validation of heart rate detection and development of arrhythmia detection algorithm," was conducted in accordance with relevant standards (IEC 60601-2-47, EC57). However, the document does not provide the detailed acceptance criteria or the specific results of such a performance study (e.g., sensitivity, specificity, accuracy values) which would prove the device quantitatively meets those criteria. It notes that "Clinical data was reviewed to demonstrate the substantial equivalence of the subject device," but does not elaborate on the nature or results of this clinical review in terms of a performance study against specific acceptance criteria for its arrhythmia detection capability.

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The EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500 is intended to be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product is designed to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, provide illumination to the endoscope, supply air through the endoscope while inside the body and control/monitor ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis. The CV-1500 Video System Center is compatible with scopes within the EVIS 190 and 1100 families.

The BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

The BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 is intended to be used with an Olympus video system center, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. This instrument is indicated for use within the airways and tracheobronchial tree.

The CV-1500 video system center is indicated to process electronic signals transmitted from Olympus video endoscopes, output images to monitors, and be used with Olympus ancillary equipment for endoscopic diagnosis, treatment, and video observation. This product also functions as a pump to supply air through the endoscope, a light source to the endoscope, and a controller/monitor of ancillary equipment. NBI (Narrow Band Imaging), RDI (Red Dichromatic Imaging), TXI (TeXture and color enhancement Imaging), and BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast) are adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging. NBI, RDI, TXI and BAI-MAC are not intended to replace histopathological sampling as a means of diagnosis.

RDI (Red Dichromatic Imaging) observation: RDI is optical-digital observation using red dichromatic narrow band light and green illumination light to enhance visibility of bleeding points in the endoscopic image due to the difference in light absorption.

TXI (TeXture and color enhancement Imaging): TXI emphasizes tonal changes, patterns, and image outlines. It also corrects the brightness of dark areas.

BAI-MAC (Brightness Adjustment Imaging with Maintenance of Contrast): BAI-MAC maintains the brightness of the bright part of the endoscopic image and corrects the brightness of the dark part of the endoscopic image.

The BF-H1100 and BF-1TH1100 endoscopes consist of three parts: the control section, the insertion section, and the connector section. The endoscope receives the illumination light from light guide connector connected to the video system center (CV-1500). The illumination light is transferred to the distal end through the optical fiber bundle inside of the endoscope and illuminates the inside of the patient body through the illumination lens at the distal end.

The endoscope receives the reflected light from the inner lumen of a patient by objective lens at the distal end. The built-in charge-coupled device (CCD) at the distal end converts the light to the electrical signal, and the signal is sent to the video system center via the electrical cable and the video connector of the endoscope. The endoscope transfers the image signal and displays the observation image on the screen.

This FDA 510(k) summary focuses on establishing substantial equivalence for the EVIS X1 Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, and Bronchovideoscope Olympus BF-1TH1100 to their predicate devices. The listed performance data describes various bench tests and an animal study conducted. However, this document does not detail specific acceptance criteria or report device performance against those criteria in a tabular format. It also explicitly states that "No clinical study was performed to demonstrate substantial equivalence." Therefore, a comprehensive answer for all your requested points cannot be extracted from this particular document.

Here's what can be inferred and what information is missing:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document in a tabular format. The document states that "The design verification tests and the acceptance criteria were identified and performed as a result of the risk management," and lists various performance tests (e.g., Thermal Safety, Durability, Resolution, Depth of Field, RDI, TXI and BAI-MAC performance). However, it does not provide the specific acceptance thresholds for these tests or the quantitative results achieved by the device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Bench Testing: The document does not specify sample sizes for the bench tests.
• Animal Study: An "animal study" was performed for CV-1500 to confirm WLI, NBI, TXI, and BAI-MAC performance. The document does not specify the sample size (e.g., number of animals) or the country of origin for this study. It is implicitly a prospective study in an animal model.
• Clinical Study: "No clinical study was performed to demonstrate substantial equivalence." Therefore, there is no human test set or associated provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as there was no clinical study involving human readers or expert-established ground truth mentioned in this 510(k) summary for device performance evaluation. For the animal study, the ground truth establishment method and expert involvement are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there was no clinical study involving human readers discussed in this 510(k) summary. For the animal study, the adjudication method is not detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done involving human readers or AI assistance, as explicitly stated: "No clinical study was performed to demonstrate substantial equivalence." The device described is an endoscopic imaging system, not an AI-powered diagnostic tool. The imaging modes (NBI, RDI, TXI, BAI-MAC) are described as "adjunctive tools for endoscopic examination which can be used to supplement Olympus white light imaging" and "are not intended to replace histopathological sampling as a means of diagnosis."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not describe the device as an standalone algorithm. The device is a video system center and bronchoscopes. The performance evaluation focuses on the technical characteristics and imaging capabilities of the hardware and integrated imaging modes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "Performance testing - Bench", the ground truth would be established by controlled experimental conditions and measurements against known physical standards. For the "Performance testing - Animal," the ground truth likely involved direct visual assessment and possibly histopathological examination of tissues within the animal model, though this is not explicitly stated.

8. The sample size for the training set

This is not applicable as the device is a hardware endoscopic system, not a machine learning algorithm that requires a training set in the typical sense. The "training set" concept does not apply to this type of device submission.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

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The Hubly Electric Drill is a single-use, sterile, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.

The Hubly Electric Drill is a battery powered cranial drill. It is single-use disposable and provided ethylene oxide sterilized. The drill is designed to create optimal burr holes, in the emergency room, at the bedside, or in the operating room. The system is designed to streamline bedside intracranial access and facilitate the treatment of emergent conditions in adult patients.

The device is a battery-powered hand drill which can be used one-handed using either hand. The drill is trigger-activated after removal of the battery pull tab. The drill has a single speed and turns off when the trigger is released. The drill bit has depth indicators at 5 and 10mm depth, which the physician may use to visually gauge depth of penetration while drilling.

The drill also has an auto-stop feature which detects when the bit breaks through the inner table of the skull and immediately stops the drill. The device has an LED indicator which indicates to the user (green) when they are applying enough force and (red) when the drill stops.

The drill features mechanical plunge prevention with a tapered stainless steel drill may be reactivated any number of times using the trigger if the physician desires.

The provided text describes performance testing for the Hubly Electric Drill. However, it does not contain specific numerical acceptance criteria or numerical reported device performance in a table format, nor does it detail a study proving the device meets specific acceptance criteria in the way requested.

Instead, the document outlines various tests conducted to demonstrate the device's substantial equivalence to a predicate device and its safety and effectiveness.

Here's an attempt to extract and synthesize the information based on the request, noting where information is not explicitly provided in the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit numerical acceptance criteria and corresponding reported device performance values. It generally states that the device "meets all design specifications and requirements" for bench tests and "all in vivo requirements were met" for the animal study.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a numerical sample size for any of the performance tests (bench testing, animal study).
• Data Provenance:
  • Bench Testing: Conducted by Hubly Inc. (implied, as they are the applicant).
  • Animal Study: Conducted in a GLP (Good Laboratory Practice) compliant setting using a sheep model. The location/country is not specified.
  • Retrospective/Prospective: The tests described (bench, animal) are prospective studies conducted to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• This information is not provided in the document. The studies described are performance tests and an animal study, not studies relying on expert review for ground truth establishment.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. The described tests are instrumental/procedural performance tests and an animal study, not studies involving human reader interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed on human subjects." The studies focused on bench performance and an animal model.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• The Hubly Electric Drill is a physical medical device (a drill), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable. The "software verification testing" was conducted on firmware responsible for the automatic stopping feature, but this is an embedded system, not a standalone AI application. The software implements "additional safety features" and has a "Moderate" level of concern.

7. Type of Ground Truth Used

• Bench Testing: Ground truth was implicitly based on engineering design specifications and requirements (e.g., battery life, depth of penetration, trigger performance).
• Animal Study: Ground truth was based on observational outcomes in the sheep model, specifically demonstrating that "Users (Test Device Evaluators) could safely use the Hubly Electric Drill for intracranial access without damaging the dura or brain tissue."

8. Sample Size for the Training Set

• This information is not applicable/provided. The device is a physical drill with embedded firmware, not a machine learning model that requires a training set in the conventional sense. The "software" mentioned is firmware, which is typically developed through traditional software engineering processes, not trained on data.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable/provided for the reasons stated in point 8.

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The KARL STORZ H1 camera head, in combination with an appropriately indicated camera control unit (CCU), light source, and monitor, and with an appropriately indicated endoscope, or microscope, is used for real-time visualization in diagnostic and surgical procedures.

The camera head consists of an anodized aluminum, stainless steel enclosure containing a CMOS (Complementary metal-oxide-semiconductor) NTSC image sensor that converts light into electrons, the transistors in each pixel then amplify and move the charge using the more traditional wires forming conventional output signals. The camera head is intended to be attached to the proximal end of the endoscopes and is connected via cable to the compatible CCU for power and operational functions. The camera head is designed to be compatible for use with all standard KARL STORZ Endoscopes, Fiberscopes and Microscope for endoscopic observation in general endoscopic procedures.

The provided text describes a 510(k) submission for the KARL STORZ H1 Camera Head, which is an endoscope camera. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

The document lists several performance tests conducted for the subject device to ensure it meets its design specifications and is substantially equivalent to the predicate device. However, it does not explicitly state numerical acceptance criteria for each test or a direct comparison of the subject device's performance against those criteria in a table format. It generally states that the device "met all its design specification" and "performs as well as the predicate device."

Implied Acceptance Criteria Categories (from "Performance Testing" section):

• Color Reproduction and Color Contrast Enhancement
• Illumination
• Detection Uniformity
• Depth of field
• Spatial Resolution
• Dynamic Range & Detection Linearity
• Distortion
• Latency
• Signal-to-Noise Ratio (SNR) & Sensitivity
• Field of View

Reported Device Performance:

The document states, "The bench testing performed verified and validated that the H1 Camera Head has met all its design specification and is substantially equivalent to its predicate devices." It also concludes, "The conclusions drawn from the nonclinical tests demonstrate that the subject devices, the H1 Camera Head performs as well as the predicate device."

Without specific numerical acceptance criteria and performance data, a detailed table cannot be created.

2. Sample size used for the test set and the data provenance

The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications."

Therefore, there was no clinical test set in terms of human subjects or medical images. The testing was entirely non-clinical bench testing. The sample size for this non-clinical testing is not specified. The data provenance is also not applicable in the sense of country of origin for retrospective or prospective data, as it was bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no clinical testing was performed and the ground truth was established through non-clinical bench testing against design specifications, no human experts were used to establish ground truth in the traditional sense of medical image interpretation.

4. Adjudication method for the test set

Since no clinical test set involving human experts was used for ground truth establishment, no adjudication method (like 2+1 or 3+1) was employed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. The device is a camera head, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not directly applicable. The device is a camera head, not an algorithm. The "standalone" performance was essentially the non-clinical bench testing of the device itself (hardware performance), which was done without human-in-the-loop in a clinical diagnostic context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical testing was based on design specifications and objective physical measurements during bench testing, ensuring the camera met its intended performance characteristics (e.g., spatial resolution measurements, color accuracy, brightness control functionality). This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This question is not applicable as the H1 Camera Head is a hardware device and not an AI/machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established

This question is not applicable as the H1 Camera Head is a hardware device and not an AI/machine learning algorithm requiring a training set.

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SonoMe and SONOFINDER are indicated for examining the adult, pregnant woman, and children. These products are intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. An appropriately trained healthcare professionals can have operator qualifications. The device use settings are intended in hospital clinic, and medical office settings. The general clinical applications include fetal/ obstetrics(OB), gynecology(GYN), abdominal, small organ and peripheral vessel imaging.

The SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25) are a wireless ultrasound system that uses pulsed-echo technology to transmit ultrasound images via wireless communication to a Tablet PC or Mobile Phone that utilizes the iOS, Android OS or Windows System.

The SonoMe Wireless Probe Type Ultrasound Scanner and SONOFINDER Wireless Probe Type Ultrasound Scanner are a portable, general-purpose, software-controlled, hand-held diagnostic ultrasound system that consists of (i) a commercial off-the-shelf iOS, Android OS or Windows System, (ii) the Wireless Probe Type Ultrasound Scanner software that runs as an app on the mobile device, (iii) the battery-operated, hand-held Wireless Probe Type Ultrasound Scanner transducer that communicates wirelessly with Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and (iv) User Manual, USB charging cable and Wireless Charger (H5C10L only).

The Wireless Probe Type Ultrasound Scanner software can be downloaded to Tablet PC or Mobile Phone which supports by iOS, Android OS or Windows System and utilizes an icon touch-based user interface.

The provided document is a 510(k) summary for the SonoMe and SONOFINDER Wireless Probe Type Ultrasound Scanners, indicating their clearance by the FDA based on substantial equivalence to predicate devices. It primarily focuses on demonstrating that the new devices meet established safety and performance standards through non-clinical testing and comparison with current ultrasound systems.

Crucially, the document explicitly states in Section 9. "Summary of Clinical Tests":

"The subject of this premarket submission, SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SONOFINDER Wireless Probe Type Ultrasound Scanner (Model: SF14L25), did not require clinical studies to support substantial equivalence."

Therefore, the following information regarding acceptance criteria, study design, and performance metrics for an AI-enabled device's clinical performance, as requested in the prompt, cannot be extracted from this document, because no clinical studies were performed or required for the 510(k) clearance of this ultrasound device. The device is purely a hardware ultrasound scanner, not an AI/ML software.

The document focuses on the equivalence of the device's technical specifications and safety standards (electrical, EMC, biocompatibility, acoustic output) to predicate devices, rather than on the performance of a diagnostic algorithm.

Despite the lack of clinical study information in the provided text, I will answer the questions based on the closest relevant information available regarding the device's characteristics and the general principles of medical device clearance, noting where specific details are not provided.

Acceptance Criteria and Device Performance (Based on provided information)

The acceptance criteria for this device are not framed as specific diagnostic performance metrics (e.g., sensitivity, specificity) derived from a clinical study for an AI algorithm. Instead, they are defined by compliance with recognized electrical, safety, and biocompatibility standards, and substantial equivalence in technical characteristics and intended use to legally marketed predicate ultrasound devices.

The "reported device performance" is implicitly that it successfully passed these non-clinical tests and was found substantially equivalent.

1. Table of acceptance criteria and the reported device performance

Regarding an AI-enabled device's clinical performance, the following answers reflect the absence of such information in this specific 510(k) summary, as it explicitly states clinical studies were not required.

2. Sample size used for the test set and the data provenance:

• Not Applicable. No clinical test set or diagnostic study was performed. The evaluation was based on non-clinical engineering and bench testing, and comparison to predicate devices' specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No clinical ground truth was established as no clinical study was performed for this device's clearance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No clinical test set requiring adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. No MRMC study was conducted, as the device is an ultrasound scanner itself, not an AI-assisted diagnostic software affecting human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a hardware ultrasound device, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable. No clinical ground truth was used or established for this submission, as per Section 9. The "ground truth" for the device's clearance pertains to its adherence to established electrical, performance, and biocompatibility standards.

8. The sample size for the training set:

• Not Applicable. This is a hardware device; thus, it does not have a "training set" in the context of an AI/ML algorithm.

9. How the ground truth for the training set was established:

• Not Applicable. As above, this is a hardware device, so there is no training set or ground truth in the AI/ML sense.

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EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I
This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor. EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The EVIS EXERA III COLONOVIDEOSCOPE PCF-H190TL/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190L/I
This instrument is intended to be used with an Olympus video system center, endoscope position detecting unit, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The EVIS EXERA III COLONOVIDEOSCOPE PCF-HO190L/I is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

The EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I are intended to be used with an Olympus video system center, light source, endoscope position detecting unit (for PCF-HQ190L/I only), documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery. The PCF-H190TL/I and PCF-HQ190L/I are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve).

The EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL/I and PCF-HQ190L/I consist of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the PCF-H190TL/I and PCF-HQ190L/I are identical to that of the predicate devices.

Available imaging modes are listed below:
WLI
NBI

This document pertains to the clearance of the EVIS EXERA III Colonovideoscope, specifically the PCF-H190TL/I and PCF-HQ190L/I models. It is a 510(k) premarket notification, which demonstrates substantial equivalence to previously cleared devices rather than requiring a full demonstration of safety and effectiveness as in a PMA. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not in the context of an AI/ML device evaluating specific metrics like sensitivity/specificity for a diagnostic claim, but rather demonstrating that the new colonoscopies are as safe and effective as existing ones, with the added adjunctive feature of Narrow Band Imaging (NBI).

The clinical performance section largely focuses on the NBI feature. Here's a breakdown of the information provided, specifically addressing the points related to performance data:

The document does not detail specific acceptance criteria for a "device performance" metric in the typical sense of a diagnostic algorithm (e.g., a specific sensitivity or specificity target). Instead, the performance testing is focused on demonstrating that the new device models perform as intended and meet design specifications, and that the NBI feature is an acceptable adjunctive tool. The "acceptance criteria" can be inferred as successful completion of the listed tests in accordance with relevant standards and guidance documents.

Device Performance Summary:

The document does not present a table of acceptance criteria and reported device performance with specific quantitative metrics directly comparable to an AI/ML algorithm's diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, the performance data provided are primarily non-clinical and relate to the safety and functionality of the physical endoscope, along with clinical evidence for the adjunctive NBI feature.

The "acceptance" in this context is the FDA's determination of substantial equivalence (SE) based on these tests, which implies the device's acceptable performance for its intended use.

Inferred "Acceptance Criteria" for Substantial Equivalence:

• Reprocessing Validation: Compliance with guidance for reprocessing medical devices.
• Biocompatibility: Compliance with ISO 10993-1 and FDA guidance.
• Software Verification and Validation: Compliance with FDA guidance for software in medical devices and cybersecurity.
• Electrical Safety & EMC: Compliance with ANSVAAMI ES 60601-1, IEC 60601-2-18, and IEC 60601-1-2.
• Bench Testing: Device performs as intended and meets design specifications for thermal safety, composite durability, photobiological safety, and retroflexed withdrawal/detection of hidden polyps.
• Clinical Performance (for NBI): Real-time predictions of diminutive polyp histology using NBI provide "reasonable certainty" of neoplastic vs. non-neoplastic identity, and the NICE classification helps achieve similar performance. This is presented as an adjunctive tool, not a standalone diagnostic.

Reported Device Performance (from the document):

• Reprocessing Validation: Conducted and documentation provided as recommended. (Meets inferred criteria)
• Biocompatibility Testing: Conducted in accordance with guidance, including Cytotoxicity, Intracutaneous, and Guinea Pig Maximization Sensitization Tests. (Meets inferred criteria)
• Software V&V: Conducted and documentation provided as recommended. (Meets inferred criteria)
• Electrical Safety & EMC: System complies with relevant standards. (Meets inferred criteria)
• Bench Testing: Conducted to ensure the device performs as intended and meets design specifications. (Meets inferred criteria)
• Clinical Performance (Meta-analysis for NBI): Pooled data from NBI-experienced and inexperienced endoscopists making high-confidence predictions of diminutive polyp histology in real-time show "reasonable certainty" of neoplastic vs. non-neoplastic identity. The NICE classification helps achieve similar performance.

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, specific quantitative acceptance criteria and reported performance metrics (like sensitivity/specificity targets) for a diagnostic AI are not provided in this 510(k) for a colonoscope. The "acceptance criteria" are implied by compliance with various testing standards and guidance, and the "reported performance" is that these tests were conducted and the device complied.

For the NBI feature, which is the closest to an "AI-assisted" clinical claim, the performance is described qualitatively:

2. Sample size used for the test set and the data provenance

The document specifies the clinical performance data for the NBI feature came from a meta-analysis of independent studies, with the exception of two Olympus-sponsored studies. It does not provide a specific sample size for a "test set" in the context of an algorithm evaluation, nor does it specify the country of origin of the data or whether the studies were retrospective or prospective. A meta-analysis implies aggregation of various study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable in the typical sense for this submission. The clinical data reviewed is a meta-analysis on NBI, where the "ground truth" for polyps (neoplastic vs. non-neoplastic) would typically be established by histopathology, which is the gold standard, not by expert consensus on imaging. The document states: "This application does not seek to show superiority or non-inferiority of NBI to the gold standard histopathology." This confirms histopathology as the ground truth.

The meta-analysis included "NBI-experienced and inexperienced endoscopists," but their role was in making the predictions themselves, not establishing the ground truth from pathology.

4. Adjudication method for the test set

Not applicable in the typical sense for a meta-analysis focused on a medical device. The "ground truth" for the NBI feature's performance in differentiating polyps is histopathology, which does not require an adjudication method among experts on test set images.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not explicitly described in the document as a primary method for this 510(k) submission. The clinical performance data relies on a meta-analysis of existing clinical literature regarding NBI. The description of the meta-analysis does not focus on an "AI vs. without AI assistance" paradigm, but rather on the predictive accuracy of endoscopists utilizing NBI. NBI itself is an imaging mode, not an AI, though it aids human interpretation. The application is for NBI as an "adjunctive tool," suggesting human-in-the-loop performance is inherently assumed. No specific effect size of improvement is quantified in the provided text.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No standalone performance data was provided because NBI is an imaging mode used by an endoscopist, not an autonomous AI algorithm. The device itself (the colonovideoscope) is a medical instrument requiring human operation.

7. The type of ground truth used

For the clinical meta-analysis on NBI, the type of ground truth used for polyp differentiation was histopathology. This is explicitly stated: "This application does not seek to show superiority or non-inferiority of NBI to the gold standard histopathology."

8. The sample size for the training set

This information is not applicable as this is not an AI/ML algorithm that undergoes a "training" phase. The clinical data comes from independent studies and Olympus-sponsored studies for a meta-analysis of the NBI feature.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" in the context of an AI/ML algorithm being cleared via this 510(k) notification. The ground truth for the meta-analysis of NBI's clinical performance was histopathology.

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The Multicavity Holmium laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

The subject device is derived from the legally marketed (unmodified) device Litho 60 (K172025). This Special 510(k) is submitted due to Device Modifications of the already cleared device Litho 60 (K172025) due to hardware and software change, together with a broadening of the range of some laser emission parameters such as power and frequency.

This document describes the FDA clearance (K180922) for the Quanta System SPA's Holmium laser systems (Empower H100, Cyber Ho 100, Litho 100). However, the provided text does not contain any information regarding clinical studies, acceptance criteria for device performance related to diagnostic accuracy, or human reader performance with or without AI assistance.

The submission is specifically a Special 510(k) for "Device modifications" to an already cleared device (Litho 60, K172025). This type of submission generally relies on demonstrating that the modified device remains substantially equivalent to the predicate device, primarily through engineering, performance, safety, and software testing, rather than new clinical efficacy studies.

Therefore, I cannot provide an answer that includes:

• A table of acceptance criteria and reported device performance related to clinical outcomes.
• Sample sizes for test sets where clinical performance (e.g., diagnostic accuracy) would be evaluated.
• Number of experts for ground truth establishment.
• Adjudication methods.
• MRMC studies or effect sizes of human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used for clinical performance.
• Training set sample size or ground truth establishment for a training set (as this is not an AI/ML device where such details would be relevant to the submission type).

Based on the provided text, the acceptance criteria and study proving the device meets them are focused on engineering performance, safety, and software validation.

Here's what can be extracted from the document regarding acceptance criteria and performance testing for these modifications:

1. Acceptance Criteria and Reported Device Performance (as per a Special 510(k) for device modifications):

2. Sample Size and Data Provenance:
This document indicates that the tests conducted were primarily engineering/bench testing and software verification/validation. These types of tests do not typically use "patient data" or "test sets" in the context of clinical performance evaluation. The data provenance would be laboratory results from the manufacturer.

3. Number of Experts and Qualifications for Ground Truth:
Not applicable for this type of submission. Ground truth for engineering tests is based on established scientific principles, physical measurements, and standard compliance.

4. Adjudication Method for Test Set:
Not applicable. These are objective engineering and software tests, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document does not mention any clinical studies, MRMC studies, or AI assistance for human readers. This is a laser surgical instrument, and the modifications are related to its hardware, software, and emission parameters, not an AI diagnostic component.

6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device (laser), not a standalone algorithm.

7. Type of Ground Truth Used:
For the various tests conducted (electrical safety, EMC, laser safety, software), the "ground truth" is adherence to recognized consensus standards (e.g., IEC 60601 series, IEC 60825-1) and internal design specifications, verified through objective measurements and checks.

8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning model development.

9. How the Ground Truth for the Training Set Was Established:
Not applicable.

In summary, the provided FDA clearance letter and summary for K180922 focuses on demonstrating substantial equivalence through non-clinical testing for hardware and software modifications to an existing device, rather than new clinical efficacy studies or performance evaluation of an AI-driven system.

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The GlucoVitaal H1A Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, thigh, or calf. The GlucoVitaal H1A Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GlucoVitaal H A Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes controls. The Gluco Vitaal H1 A Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The GlucoVitaal H1A Blood Glucose Test Strips are for use with the Glood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf.

The GlucoVitaal H1A Glucose Control Solution is for use with the GlucoVitaal H1A Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

The GlucoVitaal H1A Blood Glucose Monitoring System consists of GlucoVitaal H1A Blood Glucose Test Meter, GlucoVitaal H1A Blood Glucose Test Strips, GlucoVitaal H1A Glucose Control Solution 1 and Control Solution 2, a Lancing device. Control Solution 1 and Control Solution 2 are required but not included with the meter. Control Solution 1 and Control Solution 2 are always provided as a set.

The provided text describes a 510(k) premarket notification for the GlucoVitaal H1A Blood Glucose Monitoring System, seeking substantial equivalence to a predicate device (CERA-CHEK 1070 Blood Glucose Monitoring System).

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a regulated performance standard. Instead, it aims to demonstrate substantial equivalence to a predicate device by comparing various specifications. The "reported device performance" is not given as numerical results against predefined criteria, but rather as statements of identical or similar specifications to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size used for any test set or the data provenance. It focuses on comparing specifications and features for substantial equivalence, rather than presenting a performance study with detailed results from a specific test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The submission is for a blood glucose monitoring system, which typically relies on laboratory reference methods (e.g., YSI analyzer) for ground truth, not expert human readers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the document given the nature of the device and the substantial equivalence claim. Adjudication methods are typically relevant for image-based diagnostic systems where human interpretation can vary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not applicable and not mentioned in the document. This type of study is relevant for AI-assisted diagnostic tools involving human interpretation, which is not the case for a blood glucose monitoring system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

While the device itself operates "standalone" in measuring glucose, the document does not describe a specific performance study in terms of an algorithm-only evaluation. Instead, it asserts that the modification of code setting (from code key to no code) would have "no effect on the performance test," implying that prior performance data (likely from the predicate device) is considered relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth used for any performance evaluation. However, for blood glucose monitoring systems, the ground truth is typically established using a highly accurate laboratory reference method, such as a YSI glucose analyzer.

8. The sample size for the training set

The document does not mention a training set or its sample size. This is a 510(k) submission focused on substantial equivalence to an existing device, not the development and training of a novel algorithm from scratch.

9. How the ground truth for the training set was established

Since no training set is mentioned, the method for establishing its ground truth is not provided.

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