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The Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients requiring respiratory therapy on a prescriptive basis. It may be used at home, in institution, vehicle, train, airplane, boats and other transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

Users should follow their doctor's advice on setting the oxygen flow rate and should not adjust the flow rate without consulting a healthcare professional.

Note: Patients should regularly consult with their physician to evaluate the need for adjustments in their oxygen therapy settings.

The Portable Oxygen Concentrator is a Class II, low-risk medical device designed to provide a high-concentration oxygen supply (87%-95.5%) to adult patients requiring supplemental oxygen therapy as prescribed by a healthcare professional. It is intended for use at home, in institution, vehicle, train, airplane, boats and other transport modalities and complies with FAA regulations for in-flight use. The device is not intended for life-support or life-sustaining purposes.

The Portable Oxygen Concentrator utilizes Pressure Swing Adsorption (PSA) technology, which extracts oxygen from ambient air by selectively adsorbing nitrogen through molecular sieve beds. Oxygen is delivered through a pulse dose mechanism, synchronizing oxygen release with the patient's inhalation cycle to optimize efficiency and minimize waste.

The series consists of four models, each offering different pulse dose settings:

• W-R1 (MAX): 1, 2, 3, 4, 5, 6, S
• W-R1: 1, 2, 3, 4, 5, 6
• W-R2: 1, 2, 3, 4, 5
• W-R2 (Lite): 1, 2, 3, 4

The device operates in pulse flow mode and supports multiple power sources, including 100–240V AC (50–60Hz) and a rechargeable lithium-ion battery (14.4V / 6500mAh). While the hardware supports 13.0–16.8V DC input, DC operation is not currently supported, as no DC accessories are provided or authorized. A single battery charge provides up to 4.5 hours of continuous use, ensuring flexibility across various environments.

Designed for portability and efficiency, the W-R Series features a lightweight build (1.8 kg), low noise operation, and an intuitive LCD display. Its ergonomic and user-friendly design has been internationally recognized with six global design awards, including iF, Red Dot, and IDEA, for its usability, portability, and patient-centered innovation.

The device is suitable for operation within a temperature range of -5°C to 40°C (23°F to 104°F), humidity levels of 5% to 90% (non-condensing), and atmospheric pressure from 54kPa to 106kPa. It can function at altitudes up to 5,000 meters (16,400 feet).

The Portable Oxygen Concentrator consists of a casing, compressor, molecular sieve system, solenoid valve, battery, cooling fan, control board, and display screen.

Note: The device does not include a nasal cannula; patients should purchase one separately. The oxygen outlet follows international standards, and recommended cannula specifications can be found in Section 2.12: Cannula Use of the user manual.

The provided FDA 510(k) clearance letter is for a Portable Oxygen Concentrator. This device is not an AI/ML-enabled device. The information requested in the prompt (acceptance criteria, study details, sample size, ground truth, expert adjudication, MRMC studies, etc.) is typically associated with the rigorous evaluation of AI/ML software as a medical device (SaMD) or AI-enabled medical devices, especially those using diagnostic imaging.

Medical devices like portable oxygen concentrators are evaluated primarily on their physical performance characteristics, safety standards, and conformity to established regulations for mechanical and electrical safety. The clearance letter outlines the non-clinical tests performed (safety and performance testing, biocompatibility testing, electrical safety and EMC testing, battery safety testing, and software verification/validation), but these are not the types of studies that involve expert readers, ground truth consensus, or MRMC comparative effectiveness specific to AI diagnostics.

Therefore, I cannot extract the requested information (acceptance criteria in the context of an AI study, sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML) directly from this document, as it pertains to a different type of medical device evaluation.

To directly answer your request based on the provided document, which is for a Portable Oxygen Concentrator (not an AI/ML diagnostic device):

The FDA 510(k) Clearance Letter for the Portable Oxygen Concentrator focuses on demonstrating substantial equivalence to a predicate device through:

• Same Intended Use: Providing supplemental oxygen to adult patients on a prescriptive basis for respiratory therapy.
• Similar Technological Characteristics: Utilizing breath detection, molecular sieve/pressure swing adsorption, and a pulse dose mechanism.
• Performance Data: Presenting specifications like oxygen concentration, pulse volumes, sound levels, and mechanical/electrical safety.
• Compliance with Recognized Standards: Adhering to various international IEC and ISO standards for medical electrical equipment, biocompatibility, and oxygen concentrators.

The "acceptance criteria" for a device of this type are generally meeting the performance specifications and safety standards outlined in the non-clinical testing section, and demonstrating that any differences from the predicate device do not raise new questions of safety or effectiveness.

Here's a breakdown of the closest equivalents to your requested categories, given the nature of the device and the document:

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

For a portable oxygen concentrator, acceptance criteria are generally related to its physical and performance specifications like oxygen purity, flow rates, noise levels, and battery life, rather than diagnostic accuracy metrics.

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QMAPP® is intended for use by professional healthcare providers for physiological/hemodynamic monitoring. The system may be used to display and analyze surface ECG (Electrocardiogram), respiration, invasive pressures, pulse oximetry (SpO2), End tidal CO2 (EtCO2), fractional flow reserve (FFR), non-invasive blood pressure (NiBP), surface body temperature, cardiac output and intra-cardiac ECG. QMAPP® provides also clinical data acquisition, medical image/data processing and analytical assessment. QMAPP® is intended for use in the areas of, but not limited to cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology. QMAPP® can be used standalone and in networked environments. The system is intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or send to other devices, such as physiological monitoring system, information management systems, image acquisition/storage devices and other medical devices.

The QMAPP® system offers a complete physiological/hemodynamic monitoring and reporting system. The system is built from three units: an Amplifier, Live Monitoring CPU and Reporting CPU. The Amplifier Unit has various sensors connected with the patient, e.g. ECG, SpO2 and NiBP. The Amplifier Unit is connected to the Live Monitoring CPU via a dedicated Ethernet connection. The acquired patient information can be visualized on a Live Monitoring CPU. Typically located in the technical room. A software application executed on the Live Monitoring CPU can visualize the patient information. Also the Amplifier Unit can be controlled, i.e. most importantly, to set acquisition and filtering parameters for the different sensors, by the Live Monitoring CPU. Optionally the Monitoring unit can be connected via a dedicated Ethernet connection to a Reporting CPU, typically located in the technical room. On the Reporting CPU a database is installed which facilitates data storage and retrieval. A software application executed on the Reporting CPU serves as a patient data management system. It can e.g. be used for analysis, calculation and reporting in various representations of patient information.
The QMAPP® system, can operate standalone or it can be part of a typical hospital network infrastructure. The latter offers the possibility to send or receive information from and to other devices. The software has several communication modules, based on HL7 or DICOM protocols to interface with third party equipment/systems.
• The QMAPP® system works with 3rd party 510(k) cleared SpO2 module (Covidien Nellcor, K083325), NiBP module (CAS Medical Systems, MAXNIBP ND+, e.g. used in FDA cleared device CAS Medical Systems, 740 Select, K150620) and EtCO2 sensors e.g. used in FDA cleared device CLEO Patient Monitor, K142244.

The provided FDA 510(k) Clearance Letter for the QMAPP® System describes the device, its intended use, and a summary of non-clinical tests conducted to support its substantial equivalence. However, the document does not contain the specific details required to fully address your request regarding acceptance criteria and the comprehensive study that proves the device meets them.

Here's a breakdown of what can and cannot be extracted from the provided text, and where the requested information is missing:

Information Present in the Document:

• Overall Device Performance: The "NON-CLINICAL TESTS" section lists various characteristics on which "Bench testing" was carried out, implicitly suggesting these are areas where performance was evaluated. The "Referenced Standards and Performance Testing" section explicitly states that the QMAPP® system "meets the requirements of following performance Standards."
• Study Type: The studies mentioned are "Bench testing," "Usability Testing," and "Software verification and validation testing." The clearance is based on a "Traditional 510(k)" and relies on "non-clinical data."
• Ground Truth Type (for non-clinical testing): For the performance characteristics listed (ECG, Heart rate, SpO2, NiBP, IBP, Cardiac Output, Intra cardiac ECG, Skin Temperature, ECG impedance for Rate of respiratory effort, Measurement accuracy), the "ground truth" would be established by the physical standards and reference systems used during bench testing for each specific measurement. For example, a calibrated heart rate simulator would provide the ground truth for heart rate accuracy.
• Sample Size for Training Set: Not explicitly mentioned, but the document refers to a "software verification and validation testing," implying a dataset (likely synthetic or previously collected) was used.
• How Ground Truth for Training Set was Established: Not explicitly mentioned.

Missing Information (Crucial for your request):

The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and adherence to recognized standards. It does not present a detailed study report with specific acceptance criteria, reported performance against those criteria, or the methodology of how "ground truth" was established for clinical or test datasets in the manner you've requested for an AI/ML context.

The QMAPP® system is a physiological/hemodynamic monitoring system, not specifically an AI/ML device that requires a comparison of algorithmic output against expert consensus on a test set, multi-reader multi-case studies, or standalone algorithm performance. The "clinical data acquisition, medical image/data processing and analytical assessment" mentioned are functions of the system, but the document does not elaborate on an AI/ML component with associated performance metrics.

Based on the provided text, here is what can be inferred and explicitly stated, with clear indications of missing information for your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the QMAPP® system was tested against and "meets the requirements of following performance Standards." These standards themselves contain detailed acceptance criteria for various parameters. The table below excerpts the performance characteristics mentioned in the "SUBSTANTIAL EQUIVALENCE SUMMARY TABLE" and "NON-CLINICAL TESTS" sections. Crucially, the document does not provide the specific numerical acceptance criteria (e.g., minimum accuracy percentages, maximum deviations) or the actual measured performance values against those criteria in a consolidated table. Instead, it states that the device "meets the requirements" of the listed standards and has "Accuracy" values which are the specifications for the device itself, not acceptance criteria of a study.

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

• Sample Size for Test Set: Not specified. The document only mentions "Bench testing," "Usability Testing," and "Software verification and validation testing." These are typically performed in a lab environment.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. Given it's bench testing, actual patient data provenance is not directly relevant for the stated tests, but the data used for software verification and validation testing (if involving patient data) is not detailed.

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

• Number of Experts & Qualifications: Not applicable/not specified. For bench testing of physiological monitoring devices, the "ground truth" comes from calibrated testing equipment and reference signals, not expert human interpretation in the way, for example, a radiology AI would be evaluated. The "Software verification and validation testing" is also not described as relying on expert review of a patient dataset for ground truth.

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

• Adjudication Method: Not applicable/not specified. This methodology is typically used when comparing an algorithm's output to human expert interpretations, which is not the type of testing described for this physiological monitor.

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

• MRMC Study: Not applicable. The QMAPP® system is described as a physiological/hemodynamic monitoring, data acquisition, and analytical assessment system. It is not presented as an AI-assisted diagnostic tool designed to improve human reader performance in interpreting images or complex clinical scenarios.

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

• Standalone Performance: The described "Bench testing" and "Software verification and validation testing" can be considered "standalone" in the sense that they evaluate the device's inherent measurement and processing capabilities without a human in the loop for interpretation, but for a physiological monitor, the ultimate "human-in-the-loop" is the clinician using the displayed information. The document does not describe an AI algorithm that operates entirely independently to make a diagnosis or prediction in the same way an AI for image analysis might.

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

• Type of Ground Truth: For the "Bench testing" of physiological parameters, the ground truth would be established by calibrated reference standards and simulated physiological signals. For instance, a signal generator provides a known ECG waveform or blood pressure reading, and the device's measurement is compared to this known input.

8. The sample size for the training set

• Sample Size for Training Set: Not specified. The document mentions "Software verification and validation testing," which would involve a dataset, but its size is not detailed. There is no mention of a "training set" in the context of an AI/ML model, as the device is not presented as such.

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

• How Ground Truth for Training Set was Established: Not specified. If a "training set" was used for software validation (e.g., for signal processing algorithms), the ground truth would likely be established through
  • Synthetic data: Ground truth is known by design.
  • Previously validated physiological data: Data collected with highly accurate reference devices, where the "truth" for various physiological parameters is established by the reference device's measurements.

In summary: The FDA 510(k) clearance document for the QMAPP® System confirms that the device meets relevant performance standards through non-clinical bench testing and software validation. However, it does not provide the detailed acceptance criteria and study particulars, particularly those related to expert-adjudicated test sets, MRMC studies, or specific AI/ML training/testing methodologies, because the device is presented as a traditional physiological monitor, not an AI-powered diagnostic system.

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RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

RFMagik Lite is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch. There are two handpieces. RO handpiece and AGNES RF handpiece that delivers RF energy through the disposable electrode in the handpiece.

The provided FDA 510(k) clearance letter for RFMagik Lite does not contain information about specific acceptance criteria or a study that directly proves the device meets such criteria in terms of clinical performance or effectiveness. The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing (electrical, EMC, biocompatibility, sterility, shelf life, and performance bench testing) and an ex vivo study.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria in terms of clinical performance metrics (e.g., success rates, complication rates, or comparative outcomes) are mentioned in the document for the RFMagik Lite. The "performance testing" referenced is primarily bench testing to ensure the device operates safely within design specifications. The acceptance criteria for the non-clinical tests are implicit in the adherence to recognized standards.

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

The document does not specify a "test set" in the context of clinical or human subject data. The testing mentioned is non-clinical (bench, ex vivo). For the ex vivo study, the number of tissue types used was three (liver, skin, and muscle), but the specific number of samples or specimens within each tissue type is not provided.

The provenance of this ex vivo data would be laboratory-based, focusing on tissue samples rather than human subjects. The country of origin for the ex vivo study is not explicitly stated, but the submission is from a South Korean company.

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

Since there is no mention of a clinical "test set" or human subject data, there is no information about experts establishing ground truth for such a set. The ex vivo study would likely involve experts in histology or pathology for evaluating thermal effects, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable, as there is no described clinical "test set" requiring adjudication.

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. The RFMagik Lite is an electrosurgical device for cutting and coagulation, not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study comparing human reader performance with or without AI assistance.

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

Not applicable. The RFMagik Lite is a physical electrosurgical device, not a standalone algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is defined by the adherence to and successful completion of recognized consensus standards (e.g., AAMI ES60601-1, IEC60601-2-2 for electrical safety, ISO 10993 for biocompatibility). For the ex vivo study, the "ground truth" would likely be the observed thermal effects on the tested tissues, assessed against predetermined safety or efficacy thresholds (though these thresholds are not explicitly stated in the document).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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Endo Motor with E-LITE MAX, E-LITE PRO and ELITE-INO is cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the position of the file tip inside the canal.

E-LITE MAX & ELITE-INO:

The Endo Motor with E-LITE MAX and ELITE-INO is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. It is designed to enlarge the root canal, facilitate dentin filling, or measuring the root canal length. The product is a portable device consist of a cordless hand-piece and a charge base, it is powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, file system, Apex etc. Users can also set and modify by keys, and provide design of factory initialization, and calibration of the apex location. It can be used as a low-speed motorized handpiece and device for measuring canal length. The rotary speed and torque range are adjustable.

There are three function features for E-LIT MAX and ELITE-INO:

• Root Canal enlargement: Prepare the root canal with apex locator function.
• Apex Location: Measure the length of the root canal.
• Multi-function: Measuring the length while root canal preparation.

The device can save 9 programs, each program can set different parameters according to the user.

E-LITE PRO:

The Endo Motor with E-LITE PRO is a low-speed rotating oral equipment mainly used for root canal preparation. It is designed to enlarge the root canal or facilitate dentin filling. The product is a portable device having a cordless hand-piece with a charging adapter, it is powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, file system, Apex etc. Users can also set and modify by keys, and provide design of factory initialization, and calibration of the apex location. It can be used as a low-speed motorized handpiece and device for measuring canal length. The rotary speed and torque range are adjustable.

There is only one function features for E-LITE PRO:

• Root Canal enlargement: Prepare the root canal, without apex locator function.

The device can save 9 programs, each program can set different parameters according to the user.

The Endo Motor must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The Endo Motor is intended to be sterilized prior to use.

The compatible device can be used with Endo Motor is rotary instruments such as rotary root canal files, the working part of rotary instruments normally made of Nickel titanium (NiTi). These files are not included in the submission.

The provided FDA 510(k) clearance letter and summary for the "Endo Motor" (K242514) indicate that this is a dental handpiece and accessories, specifically an endodontic motor with root canal measurement capabilities. This type of device is not an AI/ML-enabled medical device and therefore the provided document does not contain the information typically found in an FDA submission for AI/ML devices regarding acceptance criteria, training data, ground truth establishment, or clinical study design (e.g., MRMC studies).

The document states: "No clinical test data was used to support the decision of substantial equivalence." This further confirms that a study validating an AI/ML component was not part of this clearance.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance of a traditional medical device (an endomotor) against established electrical safety, EMC, usability, and functional standards, as opposed to the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information related to AI/ML device validation because it is not present in the provided document. The document describes compliance with recognized standards for traditional medical devices (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility).

However, I can extract the general "acceptance criteria" and "device performance" as understood for this type of non-AI device from the provided tables, focusing on the comparative aspects:

Acceptance Criteria and Device Performance (Based on traditional device comparison):

The acceptance criteria for the Endo Motor (E-LITE MAX, E-LITE PRO, ELITE-INO) are primarily established through a direct comparison to a predicate device (Guilin Woodpecker Medical Instrument Co., Ltd.'s Endo Motor, K203320) and compliance with relevant international standards for medical devices. The objective is to demonstrate that the proposed device is "substantially equivalent" in terms of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a "test set" in the context of an AI/ML model's performance on a dataset of patient cases. Instead, "tests" refer to engineering and biocompatibility validations of the physical device. Therefore, typical sample size metrics for AI/ML validation are not applicable here. The data provenance is implied by the testing standards (e.g., in-house testing by the manufacturer based on international standards). The nature of this submission indicates a retrospective comparison to an already cleared predicate device, rather than a prospective clinical trial.

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

Not applicable. This is not an AI/ML device and does not involve human expert adjudication of medical image data for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This type of study is specifically relevant to AI/ML devices where the goal is to show the impact of the AI on human reviewer performance.

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

Not applicable. This is a physical endodontic handpiece, not a software algorithm.

7. The type of ground truth used

For this conventional medical device, "ground truth" refers to the established performance requirements defined by recognized standards (e.g., IEC, ISO) and the functional specifications of the predicate device. Compliance is demonstrated through laboratory testing of the physical device, rather than through expert consensus on medical data or pathology results.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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1. The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are indicated for use to restore blood flow in the neurovasculature by removing thrombus for the ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received thrombolytic therapy. Endovascular therapy with the device should be started within 6 hours of symptom onset.

2. The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for thrombolytic therapy or who fail thrombolytic therapy are candidates for treatment.

The pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device are designed to restore blood flow in the neurovasculature by mechanical removal of thrombus in patients experiencing acute ischemic stroke due to large vessel occlusion with thrombus. The designed for use in large vessels of the neurovasculature such as the internal carotid artery (ICA) and middle cerebral artery (MCA). The device is supplied sterile and intended for single use only.

This document is a 510(k) Summary for a medical device (pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device) and focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable or not provided in this document because the submission relies on non-clinical performance data (bench testing) to demonstrate substantial equivalence, not clinical effectiveness or performance with human-in-the-loop.

Here's a breakdown of the available information based on your request, highlighting what is provided and what is absent:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)

The document primarily discusses acceptance criteria in the context of bench testing. The general acceptance criterion for all non-clinical performance tests is that the device "met acceptance criteria" and "demonstrated compliance to all the design attributes and that the device performs as intended." Specific quantitative acceptance criteria for each test are not explicitly detailed beyond general descriptions.

1. Table of Acceptance Criteria and Reported Device Performance

Information Not Applicable or Not Provided for a Substantial Equivalence (510k) Submission based solely on Non-Clinical Data:

This 510(k) submission states "No clinical testing was required to support substantial equivalence." Therefore, the following points regarding clinical studies, human readers, and ground truth for clinical data are not applicable in this context.

2. Sample sizes used for the test set and the data provenance: Not applicable given "No clinical testing was required." The "test set" here refers to non-clinical bench test samples (e.g., number of devices tested for kink resistance or clot retrieval). The document does not specify the exact number of devices tested for each bench test, but implies sufficient testing to support "Pass" conclusions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth typically refers to clinical diagnosis or outcome, which was not established in this non-clinical submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 is a medical device for mechanical thrombectomy, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" or standard for comparison is defined by engineering specifications, validated test methods (e.g., ASTM standards), and comparability to the predicate device's performance. For instance, in Simulated Clot Retrieval, the ground truth is successful retrieval of synthetic clots under defined conditions.

8. The sample size for the training set: Not applicable. This refers to training data for AI/ML models, which is not relevant for this mechanical device submission.

9. How the ground truth for the training set was established: Not applicable.

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Prescription Use:
LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to fullthickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.

OTC Use:
LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor scrapes, minor scalds and minor burns.

LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a sterile, single-use dressing. The device has a multi-layer structure, and its foam layer contains 0.40mg/cm² maximum content of ionic silver. According to the different compositions of product structure, the device provides four models: Bordered, Bordered Lite, Non-Bordered, and Transfer.

• (a). The first model, Bordered, consists of a Polyurethane (hereinafter referred to as PU) Film layer, a Super Absorbent Fibre Pad layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a Polyethylene (hereinafter referred to as PE) Release Film covered on the Perforated Silicone.
• (b). The second model, Bordered Lite, consists of a PU Film layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
• (c). The third model, Non-Bordered, consists of a PU Film layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
• (d). The fourth model, Transfer, consists of a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.

The Non-Bordered model can be freely cut as needed. The Transfer model also can be freely cut and allow using together with a secondary absorbent dressing.

Silver in the dressing is intended to provide antibacterial effectiveness within the dressing for up to 7 days, as demonstrated via in vitro testing. The Bordered, Bordered Lite, and Non-Bordered model dressings are equipped with a PU film that offers waterproofing. The self-adhesive Perforated Silicone wound contact layer plays a role in minimizing the trauma on removal.

The provided text is a 510(k) Summary for a medical device (LUOFUCON® Silicone Ag+ Foam Dressing). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI/software component, which is what your request implies about typical 'acceptance criteria' and 'study' information.

Therefore, I cannot extract the information you requested about AI/software performance, such as:

• Table of acceptance criteria and reported device performance (for AI/software): The document reports performance testing for the physical dressing (e.g., adhesive property, water absorbency, pH value, MVTR, waterproofness, antibacterial effectiveness, sterility), but not for any AI/software components.
• Sample size for the test set and data provenance: Not applicable as there's no AI/software test set.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, I can provide the acceptance criteria and performance data for the physical medical device as reported in the document:

The document describes various performance tests conducted to ensure the subject device is substantially equivalent to the predicate device. It doesn't present these as strict "acceptance criteria" with numerical targets in a table, but rather lists the tests performed and implies that the device "met all design specifications" and was "Substantially Equivalent (SE)" to the predicate with identical performance specifications.

Here's a summary of the performance tests mentioned for the physical device:

Performance Testing for LUOFUCON® Silicone Ag+ Foam Dressing

Additional Context from the document:

• Study Design/Purpose: The overall study described in the 510(k) submission is to demonstrate substantial equivalence of the LUOFUCON® Silicone Ag+ Foam Dressing to a legally marketed predicate device (K223360), not to establish novel performance criteria for an AI/software component.
• Modifications: The only modification to the predicate device was the addition of a new, larger size to the Non-Bordered and Transfer models. The document states, "the material properties of the subject device and predicate device remain the same and the performance specifications are also identical, the difference in size does not affect the effectiveness of the product."
• Clinical Study: No clinical studies were conducted for the subject device.
• Biocompatibility Testing: No additional biocompatibility tests were conducted for this submission. All biocompatibility data were leveraged from the predicate device (K223360) and included tests according to ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, and USP 41-N36.
• Ground Truth (for the physical device): The "ground truth" for the physical device performance is established by adherence to recognized international and national standards (ASTM, BS EN, USP, ISO). The reported performance indicates that the device met the requirements of these standards and, by extension, is substantially equivalent to a predicate device that also meets these standards.

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ERI Portable X-ray System is a portable x-ray source with a fixed tube current and voltage for producing x-ray images of extremities using computed radiography (CR) detection plate or digital radiography (DR) detector, and the applicable objects are adults. This product is for use by qualified personnel.

It is not intended to replace a radiographic system with variable tube current and voltage (kVp) which may be required for full optimization of image quality and radiation exposure for different exam types.

ERI Portable X-ray System generates and controls X-ray with a fixed tube current and voltage (kV). It uses X light source to produce X-ray images of human anatomical structures for diagnosis, and the applicable objects are adults. It operates on 14.4VDC supplied by a rechargeable Lithium-Ion Polymer battery pack.

The ERI Portable X-ray System, is a portable x-ray device that comes in three models: CVX-air, CVX-lite and CVX-E. The differences is as follows:
X-ray tube voltage: CVX-air 70kV, CVX-lite 67 kV, CVX-E 60 kV
X-ray tube current: CVX-air 1mA, CVX-lite 0.8mA, CVX-E 0.6mA
Power Consumption: CVX-air 70 W, CVX-lite 53.6 W, CVX-E 36W
Others are the same as CVX-air
The main model and series models have the same internal and external appearance, only the X-ray irradiation parameter settings are different

The X-ray tube head, X-ray controls and power source are assembled in a portable case. The ERI Portable X-ray System is comprised of the following components:

• (1) X-ray module
• (2) Oscillating circuit board
• (3) Control board
• (4) Beam limiting device
• (5) LCD screen
• (6) Extension wire control
• (7) rechargeable battery.

The provided text details the FDA 510(k) clearance for the ERI Portable X-ray System and includes information about non-clinical testing and comparison to a predicate device. However, it does not contain the specific acceptance criteria for a study or a detailed description of a study that explicitly proves the device meets those criteria with quantitative outcomes like sensitivity, specificity, or improvement effect sizes. The document focuses on demonstrating substantial equivalence to a predicate device through technological comparisons and adherence to relevant standards.

Here's a breakdown of the information that is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document. The document states "The results confirm that the device's design is appropriate and effective for its intended use" and "clinical trials were conducted to compare the imaging results of the ERI Portable X-ray System with those obtained from commercially available X-ray devices. These trials demonstrated that the image quality produced by the ERI system is on par with that of the comparison devices, supporting its substantial equivalence as a portable X-ray system."

However, neither specific numerical acceptance criteria (e.g., minimum diagnostic accuracy, image quality scores) nor quantifiable performance metrics (e.g., sensitivity, specificity, observer agreement, SNR, CNR values) are reported in the text for the subject device or the predicate.

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

Not explicitly provided. The document vaguely states "clinical trials were conducted" but does not give the sample size (number of images, number of patients) of the test set, nor the country of origin of the data, or whether it was retrospective or prospective.

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

Not explicitly provided. The document refers to "clinical trials" and "image quality produced by the ERI system is on par with that of the comparison devices," which implies some form of assessment, likely by experts. However, the number and qualifications of these experts are not specified.

4. Adjudication Method for the Test Set

Not explicitly provided. Due to the lack of detail on how the "clinical trials" and "image quality" assessments were performed, the adjudication method (e.g., 2+1, 3+1 consensus, or independent review) is not mentioned.

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

Not explicitly mentioned as an MRMC study. The document states "clinical trials were conducted to compare the imaging results of the ERI Portable X-ray System with those obtained from commercially available X-ray devices." While this implies a comparison, it doesn't specify if it was a formal MRMC study or if it measured an effect size of human readers improving with AI vs. without AI assistance. The device described is an X-ray source and system, not an AI-assisted diagnostic tool, so an MRMC study related to AI might not be applicable here.

6. Standalone (Algorithm Only) Performance Study

Not applicable/Not provided. The ERI Portable X-ray System is an X-ray hardware system, not a software algorithm that performs standalone diagnostic tasks without human interaction. Therefore, a standalone algorithm performance study, as typically done for AI/CAD devices, is not relevant to this submission and is not described.

7. Type of Ground Truth Used for the Test Set

Not explicitly provided with specifics. The statement "image quality produced by the ERI system is on par with that of the comparison devices" suggests that the ground truth for image quality was likely established by expert assessment or comparison against an accepted standard for diagnostic image quality. However, the exact nature (e.g., expert consensus on diagnostic usability, specific phantoms, or clinical outcomes) is not detailed.

8. Sample Size for the Training Set

Not applicable/Not provided. As this is a hardware device for X-ray imaging, there isn't a "training set" in the context of machine learning. The device's performance is validated through engineering tests and clinical evaluations, not by training a model on a dataset.

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

Not applicable/Not provided. See the explanation for point 8.

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This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

The TEX20/TEX20 Pro/TEX20S/TEX20 Exp/TEX20 Elite/TEX10 Pro/TEX10S/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX201/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11T/Eagus TEX11T/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional), Thoracic/Pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).

The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/Eagus TEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).

The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/Eagus TEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance. The document describes a general purpose diagnostic ultrasound system and its substantial equivalence to predicate devices, focusing on technical specifications, safety standards, and intended use rather than AI/ML performance metrics.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information. The document explicitly states "Not applicable" for clinical studies to support substantial equivalence.

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AquaBplus: The AquaBplus is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and may need to be followed by post-treatment devices as well, to meet current AAMI /ANSI/ISO and Federal (U.S.) standards.

AquaB LITE: The AquaB LITE is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices, and mav need to be followed by posttreatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards.

The AquaBplus and AquaB LITE are reverse osmosis (RO) water purification systems that use pretreated soft water to produce dialysis water for hemodialysis (HD) devices and for the preparation of dialysis concentrates.

The AquaBplus system is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaBplus is the base module. AquaBplus B2 is a second RO unit that can be added to increase the quality of dialysis water. AquaBplus HF is a flow heater unit that can be added to provide heat disinfection for the RingMain. The AquaBplus HF module can also supply hot product water to connected HD devices.

The AquaB LITE system is a basic version of the AquaBplus system. Like the AquaBplus, it is a modular system consisting of a base module that can be used on its own or in conjunction with other modules. AquaB LITE is the base module and B2 LITE is a second RO unit that can be added to increase the quality of dialysis water. AquaBplus HF is a flow heater unit that can be added to provide heat disinfection for the RingMain. The AquaBplus HF module can also supply hot product water to connected HD devices.

This document is a 510(k) Premarket Notification letter for the AquaBplus and AquaB LITE water purification systems, which are used for hemodialysis. The document summarizes the device, its intended use, and the performance data that supports its substantial equivalence to a predicate device.

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

Important Note: The provided document is an FDA 510(k) clearance letter and its associated summary. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed results from a clinical or AI-driven study with specific acceptance criteria in the manner an AI/ML medical device might. The "performance data" sections focus on safety, general functionality, and adherence to relevant standards rather than a comparative effectiveness study with human readers or standalone AI performance. Therefore, many of the requested points regarding AI/ML study design (e.g., sample size for test/training sets, expert ground truth, MRMC studies) are not applicable or detailed in this type of submission.

The "device" in this context is a water purification system, not an AI/ML algorithm for image analysis or diagnosis.

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

The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one might for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC thresholds). Instead, the performance data section outlines the types of tests conducted to demonstrate that the device functions as intended and meets relevant standards to be deemed substantially equivalent. The acceptance criteria are implicitly meeting the specified standards and ensuring safety and effectiveness compared to the predicate.

• ISO 23500-1 (Preparation and quality management of fluids for haemodialysis and related therapies – Part 1: General requirements)
• ISO 23500-2 (Preparation and quality management of fluids for haemodialysis and related therapies – Part 2: Water treatment equipment for haemodialysis applications and related therapies)
• ISO 23500-3 (Preparation and quality management of fluids for haemodialysis and related therapies – Part 3: Water for haemodialysis and related therapies) | "Testing to demonstrate that the device meets the... standards." (Implicitly, the device did meet them to receive clearance.) |
  | Software | Conformance with IEC 62304 Edition 1.1 (Medical device software – Software life cycle processes) | "Software verification within this submission is provided in accordance with IEC 62304..." (Implicitly met requirements). |
  | Disinfection Validation| Validation of chemical and heat disinfection labeling in accordance with FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff" (17 March 2015). (Acceptance: Disinfection processes are effective as labeled.) | "Validation of chemical and heat disinfection labeling..." (Implicitly, the validation was successful). |
  | Functional Verification| Complete system testing to verify the performance (e.g., conductivity and temperature) and functional (e.g., operating modes and generated alarms) requirements of the device. (Acceptance: Device operates as per design specifications for various parameters and modes.) | "Complete system testing to verify the performance... and functional... requirements of the device." (Implicitly, the device performed as required.) |
  | Packaging | Packaging and transport verification according to ASTM D4169-16. (Acceptance: Packaging adequately protects the device during transport.) | "Packaging and transport verification according to ASTM D4169-16." (Implicitly, the packaging was found adequate.) |
  | Biocompatibility | Testing conducted in accordance with ISO 10993-1:2020 and FDA guidance. Endpoints evaluated: Chemical Characterization, Toxicological Risk Assessment, Cytotoxicity, Sensitization, Irritation, Material-Mediated Pyrogenicity, Hemocompatibility. (Acceptance: Materials in contact with dialysis water are biologically safe.) | "Biocompatibility testing was conducted... The following endpoints were evaluated to support the biological safety..." (Implicitly, the testing supported biological safety.) |
  | Electrical Safety & EMC| Electrical safety testing in accordance with ANSI/AAMI ES 60601-1:2005. Electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2 Edition 4.0. (Acceptance: Device meets electrical safety and EMC requirements.) | "Electrical safety testing was conducted... EMC was conducted..." (Implicitly, the testing demonstrated compliance.) |
  | Software V&V | System software verification testing to demonstrate effectiveness and confirm operation, in accordance with IEC 62304 and various FDA guidance documents on software functions, OTS software, and cybersecurity. (Acceptance: Software performs effectively and reliably, and meets regulatory guidelines for medical device software.) | "System software verification testing was performed to demonstrate the effectiveness of the software and to confirm the operation of the device." (Implicitly, positive results, leading to clearance.) |

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: Not applicable in the context of this device's testing. There is no "test set" of patient data or images as would be seen for an AI diagnostic algorithm. The testing described is hardware and software functional testing, validation against standards, and biocompatibility testing. These are typically performed on a limited number of physical units or material samples.
• Data Provenance: Not applicable. The "data" here refers to test results from engineering and laboratory evaluations, not patient data.

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. The ground truth for a water purification system is defined by engineering specifications, international standards (e.g., AAMI/ANSI/ISO), and validated chemical/microbiological testing methods, not by expert medical interpretation of images or patient outcomes.

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

• Not applicable. This concept pertains to resolving discrepancies in expert labeling of data for AI/ML models.

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, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI-assisted diagnostic tools that interact with human readers (e.g., radiologists interpreting images). The AquaBplus/AquaB LITE are water purification systems; they do not involve human diagnostic interpretation.

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

• Not applicable. This device is not an AI algorithm. Its "performance" is its ability to purify water according to specified parameters and standards, which is assessed through direct measurement and functional testing, not an isolated algorithm.

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

• The "ground truth" for this device's performance is established by:
  • International and Federal Standards: ISO 23500 series, AAMI/ANSI. These define the acceptable parameters for water quality for hemodialysis.
  • Engineering Specifications: Designed conductivity, temperature, flow rates, and failure modes.
  • Validated Test Methods: Biocompatibility tests (e.g., ISO 10993), disinfection validation protocols, electrical safety, and EMC standards.
  • Predicate Device Performance: The predicate device serves as a benchmark for substantial equivalence.

8. The sample size for the training set

• Not applicable. There is no "training set" as this device does not use machine learning.

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

• Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.

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