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Air compression therapy system FO3002 is intended for home to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Air compression therapy system FO3002 is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.

Air compression therapy system FO3002, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve circulation to the treated areas. Clothing should be worn between the device and the patient's skin.

This document is a 510(k) Premarket Notification from the FDA for an "Air compression therapy system FO3002". It demonstrates the device's substantial equivalence to a legally marketed predicate device (NormaTec Pulse and NormaTec Pulse Pro, K160608).

Based on the provided text, the device does not involve an AI algorithm or performance criteria that would require a study as described in the prompt. The "acceptance criteria" discussed are related to technical specifications and safety standards, rather than diagnostic accuracy or human performance with AI assistance.

Therefore, many of the requested sections (2-9) are not applicable to this document as it pertains to a physical medical device (an air compression therapy system) that does not incorporate AI or require assessment of its diagnostic performance through a test set and ground truth.

However, I can extract the acceptance criteria in terms of the device's characteristics and how it compares to the predicate, which serves as its "performance" in the context of this 510(k) submission.

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

In a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. This is primarily shown through a comparison of technological characteristics and indications for use. The "reported device performance" in this context refers to how closely the subject device's characteristics match or are explained in relation to the predicate.

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

This information is Not Applicable (N/A). The device is an air compression therapy system, not an AI/software device that processes data for diagnostic purposes requiring a test set for performance evaluation. The submission relies on technical and safety testing to demonstrate equivalence, not clinical performance data from a patient population.

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)

N/A. No diagnostic "ground truth" or expert review of patient data was necessary for this device type.

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

N/A. No test set or adjudication process as described for AI/diagnostic devices was performed.

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

N/A. This is not an AI-assisted diagnostic device.

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

N/A. Not an algorithm-based device.

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

N/A. No ground truth of this nature was established. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device, against which the subject device's technical specifications and safety profile are compared for substantial equivalence.

8. The sample size for the training set

N/A. No training set was used as this is not a machine learning/AI device.

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

N/A. No training set or associated ground truth was established.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the "acceptance criteria" (i.e., is substantially equivalent to a legally marketed predicate) is presented as a comparative analysis of technical specifications and safety standards compliance.

• Evidence Type: The submission relies on non-clinical performance testing (compliance with electrical safety, EMC, biocompatibility standards like IEC 60601-1-11, IEC 60601-1-2, ANSI AAMI ES60601-1, ISO 10993-5, ISO 10993-10, IEC 62133-2) and a direct comparison of the subject device's features to those of the predicate device.
• Methodology: The manufacturer states "Performance Testing - Clinical" and "Performance Testing - Animal" are "Not Applicable". This indicates that no human or animal studies were conducted to prove performance for this 510(k) submission. Instead, the demonstration of substantial equivalence is built upon:
  • Identical Indications for Use.
  • Similar (or identical) technological characteristics: as detailed in the comparison table (e.g., pressure range, mode of compression, power source, materials, safety features). Any differences are argued not to raise new questions of safety or effectiveness.
  • Compliance with recognized electrical safety and biocompatibility standards.
• Conclusion of the Study (FDA's Determination): The FDA's letter (K212169) signifies that based on the provided information, the device is considered "substantially equivalent" to predicate devices, meaning it is "as safe, as effective, and performs as well as the legally marketed predicate devices." This substantial equivalence is the ultimate "proof" required for market clearance under the 510(k) pathway for this type of device.

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Air compression therapy system Models FO-3001 and FO-3008: Intended for home to temporarily relieve minor muscle aches and/or pains, promote blood circulation in the treated areas.

Air Pressure Therapy System is consist of air pressure sensor, air pump, sleeves etc working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses. The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The sleeve works under the action of sensor and microprocessor.

Air Pressure Therapy System, in medical market, it has a sequential squeezing from distal to proximal, thus help to improve the circulation of blood.

The provided FDA 510(k) summary (K201982) indicates that the Air compression therapy system FO-3001 and FO-3008 are substantially equivalent to the NormaTec Pulse and NormaTec Pulse Pro (K160608) predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, quantified list with pass/fail thresholds. Instead, the substantial equivalence is established by comparing the subject device's characteristics against those of the predicate device (K160608). The underlying assumption is that if the subject device's performance, safety features, technological characteristics, and intended use are similar or equivalent to a legally marketed predicate, it meets the necessary criteria for market clearance.

The "acceptance criteria" are implicitly derived from the characteristics of the predicate device and the recognized consensus standards. The "reported device performance" is then the subject device's characteristics as described.

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

The document states "Performance Testing - Clinical: Not Applicable" and "Performance Testing - Animal: Not Applicable" (Page 4). This indicates that no clinical or animal studies were conducted for this 510(k) submission to demonstrate performance. The clearance is based on substantial equivalence to the predicate device through technological comparison and adherence to recognized consensus standards.

Therefore, there is no test set, sample size, or data provenance information provided in this document as it was not required for this type of submission.

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

As no clinical or animal performance testing was conducted, there was no test set, and therefore no experts were used to establish ground truth in the context of device performance. The evaluation was primarily engineering and regulatory.

4. Adjudication method for the test set

Not applicable, as no dedicated test set or clinical performance study was conducted.

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. This device is an air compression therapy system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

Not applicable. This device is hardware-based for physical therapy, not an algorithm or software. No standalone performance study was conducted.

7. The type of ground truth used

Not applicable, as no performance studies with a ground truth component were conducted. The "ground truth" for this 510(k) is effectively the established safety and effectiveness of the legally marketed predicate device (K160608), supported by the subject device's adherence to relevant technical standards.

8. The sample size for the training set

Not applicable, as this device does not involve machine learning or AI models with training sets.

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

Not applicable, as this device does not involve machine learning or AI models with training sets.

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