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Ask a specific question about this device

Ask a specific question about this device

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.

This 510(k) is for amikacin in the dilution range of 0.25-256 µg/mL for testing non-fastidious gram-negative isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 µg/mL demonstrated acceptable performance with the following organisms:

Acinetobacter spp. (Acinetobacter baumannii)

Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens)

Pseudomonas aeruginosa

Not Found

The provided FDA 510(k) clearance letter pertains to The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin. This device is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates, specifically for amikacin in the dilution range of 0.25-256 µg/mL for testing non-fastidious gram-negative isolates on the system. The indications for use specify its application for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa.

Unfortunately, the provided document does not contain the detailed information required to specifically answer your questions about acceptance criteria, study methodology (sample size, data provenance, expert qualifications, adjudication), MRMC studies, standalone performance, or training set details. This clearance letter is a formal notification of substantial equivalence and outlines the intended use and regulatory classifications, but it does not include the full summary of safety and effectiveness data that would typically contain such study specifics.

To get the information you're looking for, you would generally need to refer to the 510(k) Summary document, which is usually part of the full 510(k) submission and is publicly available through the FDA's 510(k) database. This summary typically provides a more detailed overview of the performance studies conducted to support the clearance.

Therefore, I cannot populate the table or answer most of your specific questions based solely on the provided text.

However, I can extract what is implied about acceptable performance:

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

Based only on the statement "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 µg/mL demonstrated acceptable performance with the following organisms," we can infer that the device met the manufacturer's internal acceptance criteria for performance for these organisms, as the FDA has cleared it. Without the 510(k) summary, specific numeric thresholds for performance metrics (e.g., Essential Agreement, Category Agreement) for in vitro diagnostic susceptibility tests are not provided in this letter.

• Acinetobacter spp. (Acinetobacter baumannii)
• Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens)
• Pseudomonas aeruginosa |

The following questions cannot be answered from the provided document:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance. (Note: This device is an in vitro diagnostic for antimicrobial susceptibility testing, not typically an AI-assisted diagnostic read by a human expert in the context of imaging or pathology. An MRMC study is highly unlikely for this type of device.)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. (The device itself is the "standalone" test; human interpretation is involved in setting up the test and reading the results, although it's an automated or semi-automated system. Performance is typically measured against a reference method.)
7. The type of ground truth used. (For AST devices, the ground truth is typically a reference method like broth microdilution or agar dilution, performed according to CLSI guidelines.)
8. The sample size for the training set. (While there might be "training" in the sense of model development for an automated reader, a primary training set in the AI/ML sense is not typically discussed for this type of in vitro diagnostic device, which relies on chemical reactions and optical detection.)
9. How the ground truth for the training set was established. (Similar to point 8, this question's premise might not directly apply to this type of device.)

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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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The Boston Scientific RFG-X1 (GX1) Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific GX1 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes

The Boston Scientific GX1 Radiofrequency (RF) Generator is a 50W RF lesion generator that supplies electrical power to associated RF Probes. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. The GX1 Generator is a product line extension of the Boston Scientific G4 Radiofrequency Generator which is FDA approved under 510(k) K082051.

The GX1 Generator is a small, portable unit (14.3" W x 10.8" H x 12.5" D, 24lbs) that can accommodate line Voltage between 100 and 240 Volts. The GX1 Generator has advanced functionality and a Graphical User Interface (UI) equivalent to the Boston Scientific RF Generator, its predicate device.

The provided FDA 510(k) clearance letter describes a medical device, the Boston Scientific GX1 Radiofrequency Generator, and its performance testing. However, the document does not contain information related to acceptance criteria, a study proving the device meets those criteria, or details regarding AI/ML components.

The GX1 Radiofrequency Generator is a hardware device used to create radiofrequency lesions, not a software or AI/ML device that would typically have acceptance criteria based on diagnostic performance metrics (like sensitivity, specificity, AUC) and require a clinical study with a test set, ground truth, and expert adjudication.

Therefore, I cannot fulfill most of your request as the information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as specific numerical targets for performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly "Pass" for compliance with electrical safety standards, electromagnetic compatibility, and various design verification tests.
• Reported Device Performance:

• RF Output Voltage Measurement
• RF Output Current Measurement
• RF Output Impedance Measurement
• RF Ramp Rate Control
• Stimulation Output Voltage
• Stimulation Output Current
• Ablation Temperature Measurement
• Contact Quality Measurement | Pass |
  | Packaging Testing | Conform to ASTM D4169 Standard Practice for performance testing of shipping containers and systems | Pass |
  | Mechanical Testing | - Tamper Resistant screws
• Cleaning Test
• Drop Test
• Impact Test
• Flammability
• Overbalance
• Durable Labels
• Ingress Protection
• Operational conditions (Temperature, Pressure and Humidity) | Pass |
  | Lesion Size Comparison Test | Compare lesions size in homogenous tissue using G4 (Predicate) vs GX1 System | Pass |
  | Dimension and Weight | Meet dimensional and weight specifications per product specification | Pass |
  | Software Verification | - User Workflow and Information Display
• Touch Screen
• Error Display
• Report/Diagnose Logging
• Security
• Language Translation
• Therapy Template | Pass |

Missing Information (Not present in the provided document):

2. Sample size used for the test set and the data provenance: Not applicable for this type of hardware device testing. There isn't a "test set" in the context of clinical data for diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance is typically established through engineering specifications, calibrated measurements, and adherence to international standards.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth used for these technical tests are established engineering specifications, physical measurements, and compliance with recognized industry standards (e.g., IEC standards for electrical safety and EMC, ASTM for packaging).
8. The sample size for the training set: Not applicable, as this is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The Boston Scientific GX1 Radiofrequency Generator underwent a series of non-clinical bench testing to demonstrate its performance, safety, and effectiveness. These tests included:

• Electrical Safety Testing: To ensure compliance with IEC 60601-1 and IEC 60601-2-2.
• Electromagnetic Compatibility (EMC) Testing: To confirm compliance with IEC 60601-1-2.
• Performance Testing: A range of specific tests covering RF power, voltage, current, impedance, temperature measurement/control, stimulation output, contact quality measurement, and lesion size comparison with the predicate device (G4 RF Generator) in "homogenous tissue."
• Packaging Testing: To ensure integrity during shipping.
• Mechanical Testing: Covering various physical durability and environmental factors.
• Software Verification: To confirm user interface, error handling, security, and other software functionalities.

All tests "Passed," indicating that the device met its design input requirements and compliance standards. The study's conclusion was that the GX1 Generator is substantially equivalent to its predicate device (K082051) based on indications for use, technological characteristics, and acceptable results from verification and validation testing.

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Olo is intended for vaporization and photocoagulation of benign vascular and benign pigmented lesions in soft tissues.

Olo is a device which emits laser radiation with a wavelength of 532 nm, which is delivered to the tissue through a transfer fiber and a handpiece or a scanner.

The Olo device electrical specifications are: 100-240V~, 50/60Hz, 600VA.

The provided FDA 510(k) clearance letter for the El.En. S.p.A. Olo Laser Device does not contain information about acceptance criteria or a study proving that the device meets specific performance acceptance criteria for a diagnostic AI/ML device.

The document describes a laser surgical instrument, and its clearance is based on substantial equivalence to an existing predicate device (QuadroStar PRO). The "performance data" section explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data" which refers to electrical safety, EMC, and software validation for the device's operational functions, not its diagnostic or an AI/ML component's performance.

Therefore, I cannot extract the requested information concerning acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or training set specifics from the provided text. The device described appears to be a physical medical device (laser) and not a software as a medical device (SaMD) or an AI/ML-powered diagnostic tool as indicated by the nature of the questions.

If the "Olo Laser Device" does incorporate AI/ML for diagnostic purposes, the provided FDA clearance letter is insufficient to detail how its performance was evaluated against specific diagnostic acceptance criteria. This type of information would typically be found in a separate Premarket Submission for AI/ML-enabled Medical Devices Guidance document or within the full submission details, which are not provided here.

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Strauss Surgical Cystoscopes are intended to illuminate and visualize the male urethra, prostate, and bladder for the purpose of performing diagnostic and surgical procedures.

Strauss Surgical Hysteroscopes are intended to illuminate and visualize the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

The cystoscopes/hysteroscopes described herein are rigid endoscopes for visualizing the urethra, the urinary bladder or uterus, fallopian tube ostium and the cervical canal during the performance of endoscopic procedures in urology or gynecology.

A rigid endoscope consists of a fiber optic cable and sensitive image transmission system with eyepiece. The fiber optic cable is used to illuminate the site inside the body. The connector for connecting the light guide to the light source is situated at the proximal end of the endoscope. The adapters required to connect the light guide are included in the scope of delivery.

The distal end of the endoscope features an objective lens that captures the image from inside the body. The image is sent through the image transmission system to the eyepiece.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Strauss Surgical Cystoscopes & Hysteroscopes." This type of document primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for the newly cleared device itself.

Crucially, the document explicitly states under the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section that:

"The subject and predicate devices have identical technological characteristics. Therefore, no performance testing was necessary to demonstrate that the subject device is equivalent to the predicate device in terms of safety and performance."

This means that a study proving the device meets individual acceptance criteria, as typically understood for new device performance validation, was not performed or not deemed necessary by the FDA for this 510(k) clearance due to the identical technological characteristics with a previously cleared predicate device.

Therefore, I cannot provide the requested information regarding specific acceptance criteria and the study that proves the device meets them because the document clearly states such testing was not performed for this clearance.

However, I can still address some of your points based on the information provided, even if it's to state the absence of the requested detail:

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

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

• Sample Size for Test Set: Not applicable, as no performance testing was conducted.
• Data Provenance: Not applicable, as no performance testing was conducted.

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)

• Not applicable, as no performance testing was conducted.

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

• Not applicable, as no performance testing was conducted.

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. This device is a rigid endoscope for visualization, not an AI-powered diagnostic tool. Furthermore, no performance testing was conducted.

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

• Not applicable. This device is a rigid endoscope, not an algorithm. Furthermore, no performance testing was conducted.

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

• Not applicable, as no performance testing was conducted.

8. The sample size for the training set

• Not applicable, as no performance testing was conducted (and this is not an AI device that would typically have a training set).

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

• Not applicable, as no performance testing was conducted (and this is not an AI device that would typically have a training set).

Summary of Document's Key Information regarding Performance:

The FDA clearance for the Strauss Surgical Cystoscopes & Hysteroscopes (K251652) was based on substantial equivalence to existing predicate devices (K150158 Schoelly Cystoscopes/Hysteroscopes and accessories). The manufacturer asserted, and the FDA accepted, that the subject device and the predicate device have identical technological characteristics. Therefore, no new performance testing (non-clinical or clinical) was deemed necessary or performed to demonstrate safety and effectiveness for this specific 510(k) submission. The clearance relies on the established safety and performance of the predicate device.

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The AtriCure Isolator Synergy EnCompass Clamp and Guide System is intended to ablate cardiac tissue during surgery.

The Isolator Synergy EnCompass Clamp and Guide System (OLH, OSH, GPM100) is a single-use electrosurgical instrument offered in two configurations: standard length jaws (OSH), and long length jaws (OLH), each with an accessory Glidepath Magnetic Guide (GPM100). All Isolator devices are configured as vascular clamps and feature clamping jaws of various lengths and curvatures. The clamp features two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanism. When activated, the generator delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the device. The Operator controls the application of this RF energy by pressing the Footswitch connected to the generator. The Guide is a single-use surgical accessory designed to facilitate the guidance of surgical instruments through tissue during cardiothoracic surgical procedures. The guide has a flexible, malleable shaft, and magnetic attachment ends that connect to the metal tip of the clamp jaws inside the jaw magnet cups.

The provided FDA 510(k) clearance letter and summary for the AtriCure Isolator® Synergy™ EnCompass Clamp and Guide System (K252056) describe modifications to an existing device, rather than a novel device requiring extensive clinical or AI-based performance studies. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to a predicate device through bench testing and non-clinical performance evaluations, rather than establishing performance against specific diagnostic accuracy or clinical outcome metrics.

The document primarily focuses on ensuring the device modifications do not negatively impact the safety and effectiveness compared to the predicate device. As such, there is no mention of AI integration, MRMC studies, or extensive human reader performance evaluations typically associated with AI/CADe devices.

Here's the breakdown of the information as requested, tailored to what is provided in this specific 510(k) summary:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the AtriCure Isolator® Synergy™ EnCompass Clamp and Guide System (K252056)

The acceptance criteria and supporting studies for this device are designed to demonstrate substantial equivalence to its predicate device (Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide (GPM100) System, K210477) following minor design and manufacturing changes. The focus is on ensuring the updated device maintains the same safety and effectiveness profile.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for minor modifications, the "acceptance criteria" are implied by the specific performance tests conducted to show that the modified device performs similarly to the predicate and meets relevant safety standards. The reported device performance indicates that the device met these implicit criteria.

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

• Sample Size: The document does not specify exact numerical sample sizes for each test (e.g., number of clamps tested for mechanical properties, number of cadavers for usability). It refers to "bovine tissue" for ex vivo ablation and "cadaver lab" for usability. Given the nature of a 510(k) for minor device modifications, this level of detail regarding sample size for bench testing is typical.
• Data Provenance: The studies are primarily bench testing and laboratory-based non-clinical performance studies.
  • Ex vivo ablation: "bovine tissue"
  • Usability testing: "cadaver lab"
  • Biocompatibility: In vitro and some in vivo tests (implied by ISO 10993 standards, typically not human data unless specified).
  • Sterilization: Tests conducted at Steris Isomedix Operation (Spartanburg, SC).
  • Retrospective/Prospective: Not applicable as these are laboratory and bench studies for device changes, not clinical data from patients.
  • Country of Origin of Data: Not explicitly stated for all tests, but given the manufacturer (AtriCure, Inc., Ohio, USA) and sterilization vendor location (Spartanburg, SC, USA), the direct tests were likely conducted in the USA.

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

This type of information is generally not applicable to a 510(k) submission for minor device modifications based on bench and non-clinical testing. "Ground truth" in this context refers to established scientific and engineering principles, and performance standards (e.g., ISO, IEC). For the usability study, "participants" are mentioned, implying a group of users (likely surgeons or clinical personnel) who operated the device in a simulated environment, but their number and specific qualifications beyond being "users" are not detailed.

4. Adjudication Method for the Test Set

Not applicable. As these are technical, mechanical, and biological tests, "adjudication" in the sense of expert review for ambiguous cases (like in diagnostic image interpretation studies) is not relevant. The results are objective measurements against predefined acceptance criteria.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically designed for evaluating the impact of a diagnostic aid (e.g., AI in image interpretation) on human reader performance. The Isolator® Synergy™ EnCompass Clamp and Guide System is an electrosurgical instrument, not a diagnostic device, and the modifications are minor, so such a study would not be relevant or required.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device does not incorporate an AI algorithm or software that operates independently to produce a diagnostic or analytical output. All testing pertains to the physical and functional performance of the medical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted is based on:

• Regulatory Standards: Compliance with recognized standards like ISO 10993 (Biocompatibility), IEC 60601 (Electrical Safety), and ANSI/AAMI/ISO 11135 (Sterilization).
• Engineering Specifications: Predetermined design life, mechanical limits (e.g., force, jaw aperture), and functional requirements for the device.
• Established Medical Practice: The ability to create "transmural lesions" in tissue (ex vivo), reflecting the intended therapeutic effect.
• Predicate Device Performance: The underlying "ground truth" for demonstrating substantial equivalence is often the proven safety and effectiveness of the legally marketed predicate device. The new device must perform in a "substantially equivalent manner" in relevant aspects.

8. The Sample Size for the Training Set

Not applicable. This device is a physical electrosurgical clamp and guide system, not an AI/ML-driven software device that requires a "training set" of data.

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

Not applicable, for the same reason as point 8.

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The Respond OC Conserving Regulator (130-0800) is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use. It may also be used to deliver a constant flow of oxygen to the patient.

The Respond OC Conserving Regulator (130-0800) is a dual mode high pressure oxygen regulator and conserving device that allows for either a continuous or conserve flow of medical grade oxygen to the patient. The device is designed with a CGA 870 style yoke for use with ambulatory oxygen cylinders. The integrated regulator reduces cylinder pressure to 22psig (+/-3psi) to the sensing diaphragm which allows the Respond OC to sense the start of inhalation by the patient and release a controlled amount of oxygen by pneumatic timing in short bursts into the lungs via an oxygen cannula. The Respond OC supports a delivered oxygen equivalency of 1 to 5 LPM in the conserve mode, which extends the ambulatory time of cylinders up to 6:1 based on the cylinder pressure and selected setting. The continuous flow mode offers settings of 2, 3 and 4 LPM if the patient requires a constant flow of oxygen.

The provided FDA 510(k) clearance letter and summary for the Respond OC Conserving Regulator (K250322) outlines the device, its intended use, and its substantial equivalence to a predicate device. However, this documentation does not contain the detailed information typically found in a clinical study report or a comprehensive test report regarding acceptance criteria and the study that proves the device meets them, especially in the context of AI/ML-based medical devices or diagnostic tools.

The device described (an oxygen conserving regulator) is a mechanical device, not an AI/ML-driven diagnostic or treatment device. Therefore, many of the typical requirements for AI/ML device studies (such as MRMC, expert consensus for ground truth, training set details, and specific performance metrics like sensitivity/specificity/AUC) are not applicable here.

The document primarily focuses on bench testing and biocompatibility to demonstrate substantial equivalence to a predicate mechanical device.

Here's an analysis based on the provided document, highlighting what is and is not present concerning "acceptance criteria" and "study proof":

Analysis of Acceptance Criteria and Study Proof for Respond OC Conserving Regulator (K250322)

Based on the provided FDA 510(k) Summary, the device is a mechanical oxygen conserving regulator. The "acceptance criteria" and "study proof" are framed in the context of demonstrating substantial equivalence to a predicate mechanical device through non-clinical (bench) testing and biocompatibility assessments, rather than clinical efficacy studies or AI/ML performance evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the types of tests conducted and states that the device "met its acceptance criteria" and "performs similarly to the predicate device." However, it does not explicitly list the specific quantitative acceptance criteria for each test (e.g., a specific tolerance for oxygen flow, a defined pass/fail for impact resistance) nor does it present the raw, quantitative reported performance results against these criteria. Instead, it provides qualitative statements of compliance.

2. Sample Size for the Test Set and Data Provenance

Given this is a physical device, the "test set" refers to the manufactured units subjected to bench testing. The document does not specify the sample size (number of devices) used for each of the non-clinical tests (e.g., how many units were subjected to accelerated aging, or impact testing).

Data Provenance: The data provenance is from non-clinical bench testing conducted by the manufacturer, Responsive Respiratory, Inc. It's not clinical data or retrospective/prospective human data. The country of origin for the testing itself is not explicitly stated but would typically be where the manufacturer's testing facilities are located.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is not applicable as the device is a mechanical oxygen regulator, not an AI/ML-driven diagnostic or classification device requiring expert-established ground truth from medical images or patient data. Ground truth for its performance would be established through calibrated laboratory equipment measuring physical parameters (flow, pressure, timing, etc.) against engineering specifications.

4. Adjudication Method for the Test Set

This question is not applicable for a mechanical device undergoing bench testing. Adjudication typically refers to resolving discrepancies between human readers or between AI and human readings. Test results for mechanical parameters are either within specification or not, based on objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI/ML) where human readers (e.g., radiologists) interpret cases, and the effectiveness of AI assistance on their performance is evaluated. The Respond OC Conserving Regulator is a therapeutic/delivery device, not a diagnostic one.

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

This question is not applicable in the typical sense for this device. There is no "algorithm" in the way an AI/ML device would have one. The device's "performance" is its mechanical function. The "bench testing" described in the summary is the standalone performance assessment of the device's mechanical and pneumatic operation (e.g., flow rates, bolus timing, pressure regulation) without human intervention beyond setting the controls for the test.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would be physical measurements against engineering specifications and industry standards. For example:

• Flow rates: Measured by calibrated flow meters against specified LPM settings.
• Pressure: Measured by calibrated pressure gauges against specified PSI output.
• Timing of bolus delivery: Measured by sensors and timers to confirm delivery within the specified inspiratory cycle.
• Biocompatibility: Confirmed by laboratory analysis against ISO standards.
• Ignition Sensitivity: Confirmed by testing against ASTM standards.

It is not expert consensus, pathology, or outcomes data, as these are related to clinical diagnosis or patient outcomes, not the performance of a mechanical oxygen delivery device.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is not an AI/ML device that requires data for model training.

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

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

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