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POWER-Q2300 is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER-Q2300 simulates kneading of tissues by using an inflatable garment (cuff).

POWER-Q2300 is comprised of a main body, a power cord, cuffs, and hoses for connecting the device to the cuffs. The device is AC-powered. There are four cuffs to apply to different body areas, such as leg, arm, hip, and half-leg. The cuffs have 4-chambers. The cuff inflates and deflates sequentially to apply the pressure on the target body areas which are controlled by the main body. Double hose is to connect main body and leg cuff. Single hose is to connect main body and arm cuff (or hip cuff or half-leg cuff). Extension zipper is for bigger leg. Blocked jack is to block an air outlet that will not be used. The colors of the cuffs and extension zipper are available in pink or gray.

The provided document is a 510(k) summary for the "Compressible Limb and Circulation Therapy System, Model POWER-Q2300". This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Based on the information provided in this 510(k) summary, the device under review is a physical medical device (a massager) aiming for "temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation". It is NOT an AI/ML-enabled diagnostic or therapeutic device. Therefore, many of the typical acceptance criteria and study components requested in the prompt (such as accuracy metrics for an AI model, ground truth establishment by experts, MRMC studies, training/test set sample sizes for AI, etc.) are not applicable to this type of device.

The "study that proves the device meets the acceptance criteria" for a physical device like this primarily involves non-clinical performance testing to ensure it adheres to recognized standards for safety and essential performance, and a comparison to a predicate device to demonstrate substantial equivalence.

Here's an attempt to answer the prompt based only on the provided document, highlighting which aspects are applicable and which are not:

Acceptance Criteria and Device Performance for POWER-Q2300

As this is a physical medical device and not an AI/ML model, the acceptance criteria are based on meeting recognized medical electrical equipment standards and demonstrating comparable performance to a predicate device for its intended physical function.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable in the context of AI/ML testing. For this physical device, "testing" refers to non-clinical laboratory verification against engineering standards. The document states: "Performance testing for pressure accuracy, seam strength, and fail mode testing has been performed." It does not specify sample sizes for these tests, as they would typically involve engineering samples tested to specific physical and electrical standards, not a "test set" of patient data.

Data provenance: Not applicable. There is no patient data or clinical data used for regulatory submission, as explicitly stated: "No clinical testing was performed."

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

Not Applicable. As there was no clinical testing performed and no AI/ML component, there was no need for expert ground truth establishment using patient data.

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

Not Applicable. This is relevant for clinical studies or AI algorithm validation with uncertain ground truth. For this physical device, regulatory clearance relied on non-clinical engineering tests and comparison to a predicate device.

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 physical massager, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies are not relevant.

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

Not Applicable. There is no AI algorithm to evaluate in standalone mode.

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

Not Applicable for clinical ground truth. The "ground truth" for this device's performance validation is its adherence to recognized engineering standards (IEC, ANSI/AAMI) for electrical safety, EMC, usability, and specific physical performance parameters (pressure accuracy, seam strength, fail mode). There is no "patient-specific" ground truth required for this type of device clearance by FDA.

8. The sample size for the training set

Not Applicable. This device does not use an AI or machine learning model, and therefore has no "training set."

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

Not Applicable. As there is no AI model or training set, there is no ground truth establishment for a training set.

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POWER RECOVERY is intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER RECOVERY simulates kneading and stroking of tissues by using an inflatable garment (cuff).

Compressible Limb and Circulation Therapy System Model POWER RECOVERY is a powered inflatable tube massager, and comprised of a main body, an AC-DC adapter, cuffs with hose, and a hose adapter and a main hose for connecting the device to the cuffs. The device is powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery. There are three cuffs to apply to different body areas, such as leg, arm, and hip. Leg cuff and arm cuff have 6-chambers and hip cuff has 5-chambers. The cuffs can be inflating and deflating sequentially to apply the pressure on the target body areas which are controlled by the main body. The device simulates kneading and stroking of tissues by using an inflatable garment (cuff) to temporarily relieve minor muscle aches and pains and to temporarily increase blood circulation to the tested areas in people who are in good health.

The provided text describes a 510(k) premarket notification for the "Compressible Limb and Circulation Therapy System, Model POWER RECOVERY" and its comparison to a predicate device, the "Rapid Reboot Compression Therapy System."

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics. It does not present a table of specific acceptance criteria (e.g., minimum sensitivity/specificity thresholds) or quantitative performance metrics typically seen in studies evaluating the diagnostic or predictive accuracy of a device.

Instead, the "acceptance criteria" here are implicitly related to meeting safety and performance standards for a powered inflatable tube massager and having indications for use and technological features that are substantially equivalent to a legally marketed predicate device.

The device has been tested and met the requirements of these standards. |
| Indications for Use | Indications for use must be substantially equivalent to the predicate device. | POWER RECOVERY: "intended for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. POWER RECOVERY simulates kneading and stroking of tissues by using an inflatable garment (cuff).
Predicate Device: "indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Rapid Reboot Compression Therapy System simulates kneading and stroking of tissues by using an inflatable garment."

Reported as "Identical." |
| Technological Characteristics | Key technological characteristics (operation mode, pressure range, cuffs, etc.) should not raise new questions of safety or effectiveness compared to the predicate. | Operation Mode: 5 modes (SEQUENTIAL, ADDITION, MASSAGE) vs. 2 (Sequential, Peristaltic). Massage mode of subject device is a combination of SEQUENTIAL and Addition modes, which are similar to predicate modes.
Pressure Range: 60-150 mmHg vs. 0-200 mmHg. Subject device has a smaller pressure range.
Number of Inflatable Appliance Segments: 6 or less for leg/arm, 5 or less for hip vs. 4. Subject device has more segments.
Sleeve and Chamber: Leg: 6-chambers, Arm: 6-chambers, Hip: 5-chambers vs. Leg: 4-chambers, Arm: 4-chambers, Hip: 4-chambers. Subject device has more chambers.
Power Source(s): 15 VDC via IEC 60601-1 compliant power supply (100-240 VAC input), Optional integrated rechargeable battery vs. 110VAC, 60Hz. Minor difference.
Weight: 2 kg including battery vs. 2.63 kg (5.8 pounds). Minor difference.
Dimensions: 114 x 141 x 245 mm vs. 25.4 x 16.51 x 12.7 cm (10" x 6.5" x 5"). Minor difference.
Treatment Time: User can select 10, 20, and 30 minutes vs. User determines therapy time, choose from 10, 20, or 30 minute session time, with option to add additional 10 minutes. Reported as "Identical."
Anatomical site: Identical.
Prescriptive or OTC: Identical (OTC).
Environment of Use: Identical. |

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

The document explicitly states: "No clinical testing was performed." Therefore, there is no test set in the sense of a clinical trial or a dataset of patient cases. The evaluation relies entirely on non-clinical testing for standards compliance and a comparison of technical specifications to a predicate device.

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

Not applicable as no clinical testing or test set involving expert ground truth existed.

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

Not applicable as no clinical testing or test set involving expert ground truth existed.

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. The device is a physical therapeutic device (powered inflatable tube massager), not an AI-based diagnostic or imaging interpretation system. No MRMC study was conducted.

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

Not applicable. The device is a physical therapeutic device, not an algorithm, and does not operate in a standalone algorithmic capacity as would be understood in the context of AI or diagnostic software.

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

Not applicable. For this type of device (a massager), ground truth related to diagnostic accuracy is irrelevant. The "ground truth" for its safety and claimed physiological effects (e.g., temporary increase in blood circulation) would typically come from well-controlled clinical studies demonstrating these effects, but the document states "No clinical testing was performed." Instead, compliance with safety and performance standards and substantial equivalence to a predicate device with established safety and efficacy (for its limited indications) forms the basis of its clearance.

8. The sample size for the training set

Not applicable. The device is a physical therapeutic device, not a machine learning model, so there is no "training set."

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

Not applicable for the reason stated above.

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WIC -2008S is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

WIC-2008S is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.

This document describes a medical device, the Compressible Limb Therapy System WIC-2008S, which is a "Powered inflatable tube massager." The submission is for a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy through extensive clinical trials.

Therefore, the provided text does not contain information about acceptance criteria, detailed device performance metrics, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth for training sets was established.

The document focuses on:

• Device Description: It's a system that uses four-chamber garments for full legs and has variable duration, pressure, cycle time, and gradient settings.
• Intended Use: To treat conditions like primary lymphedema, edema following trauma and sports injuries, post-immobilization edema, venous insufficiencies, and lymphedema.
• Substantial Equivalence: The primary argument is that the WIC-2008S is substantially equivalent to a previously cleared device (WIC-2008, K102319) in terms of intended use, technological, and performance characteristics, without raising new safety or effectiveness concerns.
• Performance Characteristics (Standards Applied): Instead of reporting specific device performance against acceptance criteria, the document lists a series of national and international standards the device has conducted and applied, which are common for medical devices to ensure safety, quality, and regulatory compliance. These standards include:
  • Council Directive 93/42/EEC (Medical Devices)
  • IEC 980:2008 (Graphical symbols for use in labeling)
  • IEC 1041:2008 (Information supplied by manufacturer)
  • ISO 13485:2003 (Quality management systems)
  • ISO 14155-1:2003 (Clinical investigation of medical devices for human subjects - General requirements)
  • ISO 14971:2007 (Application of risk management)
  • IEC 60601-1 (General requirements for safety of medical electrical equipment)
  • IEC 60601-2-10 (Particular requirements for safety of nerve and muscle stimulators)
  • IEC 60601-1-2 (Electromagnetic compatibility)

Conclusion:

Based on the provided text, it's not possible to populate the requested table or answer most of the questions, as this is a 510(k) submission focused on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria often seen for novel devices that require efficacy data.

The "performance characteristics" listed are the standards applied (bench and laboratory testing to applicable standards), not specific performance metrics like sensitivity, specificity, accuracy, or effect sizes from clinical studies. The FDA's letter explicitly states that they "have determined the device is substantially equivalent... to legally marketed predicate devices," which means they accepted the manufacturer's argument based on design, materials, and engineering testing to relevant safety standards, rather than new clinical outcome studies.

Therefore, the requested information (performance acceptance criteria, sample sizes, ground truth, expert qualifications, MRMC studies, etc.) is not present in the provided 510(k) summary.

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MK300L is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

MK300L is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.

The provided text is a 510(k) summary for the Compressible Limb Therapy System MK300L, which is a medical device and not an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, such as sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies or acceptance criteria in the context of AI/ML evaluation.

However, based on the provided text, I can extract information relevant to the device's regulatory review and intended use:

1. Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that it meets the safety and effectiveness standards comparable to the predicate devices.

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

The document mentions "bench as well as laboratory testing to applicable standards" but does not specify sample sizes for any test sets in terms of patient data or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically not included in a 510(k) summary focused on substantial equivalence for a non-AI/ML device.

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

Not applicable. This question pertains to AI/ML device evaluation where expert consensus is often used for ground truth. For a physical medical device like a massager, ground truth would typically relate to physical measurements, engineering standards, or clinical outcomes, not expert interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable. This question is relevant to AI/ML evaluations where disagreements between experts need to be resolved. For a non-AI device, adjudication methods in this context are not described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described. MRMC studies are specific to evaluating how human readers' performance changes with or without AI assistance, which is not applicable to this device.

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

Not applicable. This device is a physical massager and does not involve an algorithm or AI component in the sense of a software-as-a-medical-device (SaMD) evaluated for standalone performance.

7. The Type of Ground Truth Used:

The "ground truth" for this device's evaluation is based on compliance with established medical device standards (e.g., electrical safety, quality management, risk management, clinical investigation general requirements) and demonstrating that its performance is comparable to legally marketed predicate devices through "bench as well as laboratory testing." Clinical outcomes data might be inferred from the predicate devices' long-standing safety and effectiveness, but it's not explicitly stated as the ground truth for this specific device's evaluation.

8. The Sample Size for the Training Set:

Not applicable. This device does not use a training set as it is not an AI/ML device.

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

Not applicable. This device does not have a training set.

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LX7(V7) is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

LX7(V7) is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.

The provided text describes a 510(k) premarket notification for a medical device called the "Compressible Limb Therapy System LX7(V7)". This submission focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with statistical endpoints. Therefore, a direct table of acceptance criteria and reported device performance, as typically seen in efficacy studies, is not applicable or present in this document.

The core of this submission is a comparison of the new device (LX7(V7)) to two predicate devices (Lympha Press Plus and WHF-324 (POWER-Q1000 Plus)) to demonstrate that it is "as safe and effective". The "Performance Characteristics" section lists various standards the device applied and conducted tests to, which are related to safety and quality management, but it does not detail specific performance metrics or their acceptance thresholds.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, the document does not present quantitative acceptance criteria or numerical performance data of the LX7(V7) in the way one would expect from an efficacy study. Instead, substantial equivalence is established by comparing the new device's features, intended use, and adherence to safety standards with those of legally marketed predicate devices.

The table below summarizes the comparison between the LX7(V7) and its predicate devices, which serves as the basis for the substantial equivalence determination rather than a direct performance acceptance criteria table.

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

The document does not describe a clinical study with a "test set" in the context of evaluating diagnostic or predictive performance. Instead, it relies on bench and laboratory testing against established safety and quality standards to demonstrate the device's characteristics. Therefore, information on sample size and data provenance for a test set in a performance study is not applicable. The data provenance for the device is from Korea (manufacturer Daesung Maref Co., Ltd.). The study described is a premarket notification for substantial equivalence, not a clinical trial.

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

This information is not provided because the submission is not based on a clinical study where expert-established ground truth would be necessary for a test set.

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

Not applicable, as no test set data requiring adjudication is presented.

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. The device is a 'Powered Inflatable Tube Massager' without AI components or diagnostic capabilities that would involve human readers interpreting images or data.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

The "ground truth" in this context refers to compliance with recognized international and national standards for medical device safety and quality. The device demonstrated conformance to standards such as:

• Council Directive 93/42/EEC (medical devices)
• IEC 980:2003 (graphical symbols)
• IEC1041:1998 (information supplied by manufacturer)
• ISO 13485:2003 (quality management systems)
• ISO 14155-1:2003 (clinical investigation, Part 1: General requirements - this standard specifies requirements for the design, conduct, recording, and reporting of clinical investigations performed on human subjects to assess the clinical performance or safety of medical devices. Its mention here suggests the potential for clinical investigations, but the document itself doesn't detail one.)
• ISO 14971:2007 (risk management)
• IEC 60601-1 (general requirements for safety)
• IEC 60601-2-10 (safety of nerve and muscle stimulators)
• IEC 60601-1-2 (electromagnetic compatibility)

The "ground truth" for the substantial equivalence claim is that the device's characteristics and performance are comparable to (i.e., "as safe and effective as") the predicate devices, which have already been cleared by the FDA.

8. The sample size for the training set

Not applicable, as there is no mention of an algorithm or machine learning model that would require a training set.

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

Not applicable for the same reason as above.

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WIC-2008 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

WIC-2008 is used with four chamber garments for full leg, and period has its own variable duration,pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.

The provided text from K102319 is a 510(k) summary for a medical device called "Compressible Limb Therapy System WIC-2008." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way one would for a novel algorithm or diagnostic device.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not applicable or not present in this type of regulatory submission.

The document indicates that the device's performance was assessed through bench and laboratory testing to applicable standards and concluded that it is "as safe and effective as the predicate devices, has few technological differences, but there are no new indications for use and without raising any new safety and/or effectiveness concerns." This suggests performance was demonstrated against engineering and safety standards, not against clinical accuracy metrics for an AI algorithm.

Here's a breakdown of what can be extracted and what is not applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. The document does not specify quantitative acceptance criteria or clinical performance metrics in the way requested for an AI/diagnostic device. The performance assessment was against regulatory and safety standards, not clinical accuracy with a "ground truth" as typically understood for AI.

The study concluded: "Compressible Limb Therapy System WIC-2008 has substantial equivalent intended use as the-market-cleared WHF-324 (POWER-Q1000 PLUS) and has substantial equivalent technological and performance characteristics. After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of WON INDUSTRY Co Ltd. that Compressible Limb Therapy System WIC-2008 is as safe and effective as the predicate devices, has few technological differences, but there are no new indications for use and without raising any new safety and/or effectiveness concerns."

This is a statement of equivalence based on meeting general safety and performance standards for a physical medical device, not a data-driven performance report.

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

Not Applicable. This is not a study involving a "test set" of patient data for an algorithm. It's about a physical medical device. The "testing" involved bench and laboratory testing against electrical and safety standards.

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

Not Applicable. No "ground truth" in the context of expert consensus on patient data was established, as this is not an AI or diagnostic device that interprets medical images/data.

4. Adjudication Method for the Test Set:

Not Applicable. See point 3.

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

No. This is not an MRMC study. The device is a massager, not an image interpretation or diagnostic aid.

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

No. This device does not involve an algorithm with standalone performance.

7. The Type of Ground Truth Used:

Not Applicable. The concept of "ground truth" in the sense of clinical diagnoses, pathology, or outcomes data is not relevant to this type of device and its substantial equivalence submission. The "ground truth" for this device's safety and effectiveness would be adherence to the cited international and electrical safety standards (e.g., IEC 60601-1).

8. The Sample Size for the Training Set:

Not Applicable. This device does not use a "training set" in the context of machine learning.

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

Not Applicable. See point 8.

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The WHF-314 (POWER Q1000) device is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as Primary lymphedema, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphedema

WHF-314 (POWER Q1000) is Used with four chamber garments for full leg, and period has its own variable duration, pressure, cycle time and gradient setting Power unit features visual operation status and fault indicators

The provided 510(k) summary for the WONJIN MULSAN Co., Ltd. WHF-314 (POWER Q1000) device does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a submission for substantial equivalence to a predicate device, focusing on regulatory information, intended use, device description, and a comparison with the predicate. There is no mention of a performance study, clinical trial, or any data presented to establish device performance against predefined acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
4. Adjudication method: This information is not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not present.
7. The type of ground truth used: This information is not present.
8. The sample size for the training set: This information is not present.
9. How the ground truth for the training set was established: This information is not present.

The document primarily focuses on establishing substantial equivalence based on the device's design, intended use, and comparison to existing devices, rather than presenting new performance data. The section "Performance Characteristics (If/when applicable)" explicitly states "See the Exhibits," but these exhibits are not included in the provided text.

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