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The Overlapped Compression Therapy is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in pood health. The Overlapped Compression Therapy simulates kneading and stroking of tissues by using an inflatable garment.

The Overlapped Compression Therapy consists of leg sleeve and control device working together as one unit. The Overlapped Compression Therapy mainly forms the circulating pressure on the limbs and tissues by repeatedly inflating and deflating the multi cavity chambers in sequence, and evenly, orderly and properly extrudes the distal end of the limbs to the proximal end of the limbs.

The provided text describes a 510(k) premarket notification for a medical device called "YY-A02-B Overlapped Compression Therapy." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on comparative analyses and bench testing against established standards, rather than clinical efficacy studies with acceptance criteria in the typical sense of a diagnostic or therapeutic AI device.

Below is an attempt to address your request based on the provided document, acknowledging that most of the requested categories are not applicable to this specific type of submission.

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the format of specific sensitivity, specificity, or similar performance metrics that would be typical for an AI/diagnostic device. Instead, acceptance is based on demonstrating substantial equivalence to a predicate device and adherence to recognized safety and performance standards. The "device performance" is reported as compliance with these standards and successful completion of bench tests.

To structure this for your table, I will interpret "acceptance criteria" as meeting regulatory standards and demonstrating comparable performance to the predicate in key technical specifications.

Study Details (Addressing specific points for AI/Diagnostic Devices)

(Note: This device is a physical therapy device, not an AI/Diagnostic device. Therefore, many of these points are explicitly stated as "Not Applicable" or are inherently not part of this type of submission.)

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

   • Test Set Sample Size: Not applicable. The document describes bench testing, biocompatibility testing, electrical safety, and software verification rather than a "test set" of patient data for evaluating diagnostic or predictive performance.
   • Data Provenance: Not applicable. No patient data or clinical imagery is mentioned. The testing involves the device itself.

2. 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. No ground truth based on expert consensus for clinical interpretation is established or reported for this device. The evaluation is based on engineering tests and compliance with recognized standards.

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

   • Not applicable. There is no clinical "test set" requiring adjudication.

4. 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 not an AI-assisted diagnostic or interpretation device that would involve human readers.

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

   • Not applicable. This is a physical therapy device and does not involve a standalone algorithm for diagnostic or predictive performance. The "software verification and validation" focused on ensuring the embedded software controls the device as designed.

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

   • Not applicable. For the engineering and safety tests, the "ground truth" would be the specifications and requirements defined by the consensus standards (e.g., IEC, ISO, ANSI/AAMI) and the device's own design specifications.

7. The sample size for the training set:

   • Not applicable. The device is not based on machine learning or AI that requires a "training set."

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

   • Not applicable. No training set is used.

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The Compression Therapy Device is intended to be an easy to use portable by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to:

• · Aid in the prevention of DVT;
• · Enhance blood circulation;
• · Diminish post-operative pain and swelling;
• · Reduce wound healing time;
• · Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
  The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Compression Therapy Device

Based on the provided text, the document is an FDA 510(k) clearance letter for a "Compression Therapy Device." This letter does not contain the type of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would be required to answer your request.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and lists its indications for use. It discusses regulatory compliance, labeling, and other administrative aspects. It does not provide a technical report of device performance or the study design and results validating its functionality against specific acceptance criteria.

Therefore, I cannot provide the requested information based on the given text.

To answer your request, you would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or a comprehensive technical submission to the FDA.

Ask a specific question about this device