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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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Interpreted)	Reported Device Performance
I. Substantial Equivalence to Predicate Device (K193354)
- Same Intended Use and Principle of Operation	The subject device shares the same intended use (temporary relief of minor muscle aches/pains, temporary increase in circulation) and principle of operation (air pressure massage using inflatable garment) as the predicate.
- No New Questions of Safety & Effectiveness	Comparative analysis of technological characteristics concludes that differences do not raise new questions of safety & effectiveness. The safety and performance tests confirm compliance.
II. Compliance with Recognized Consensus Standards
- Biocompatibility (ISO 10993 for intact skin contact)	Conducted and passed Cytotoxicity, Skin Irritation, and Sensitization testing.
- Electrical Safety & EMC (ANSI/AAMI ES60601-1, IEC60601-1-2)	Tested for conformance and complies with ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, A2:2010/(R)2012 and IEC60601-1-2:2014.
- Home Healthcare Environment (IEC 60601-1-11)	Complies with IEC 60601-1-11:2015.
- Usability (IEC60601-1-6)	Complies with IEC60601-1-6: 2013-10.
- Software Verification & Validation (FDA Guidance)	Verification and validation testing conducted as per FDA guidance. "Verification of the Overlapped Compression Therapy was conducted to ensure that the product works as designed. Validations was conducted to check the design and performance of the product."
III. Bench Testing Performance
- Accuracy of Pressure & Time	"Accuracy testing for pressure and time to ensure that the device can achieve the intended maximum pressure and maintain it for the intended treatment time." (Result: Meets specifications)
- Seam Strength	"Seam strength testing to ensure that the seams of the device do not burst if maximum pressure is exceeded in the device." (Result: Meets specifications)
- Failure Mode (Over-pressurization mitigation)	"Failure mode testing to indicate how the device mitigates the risk of over-pressurization if there is a software failure and the device starts to exceed maximum intended pressure." (Result: Device mitigates risk)
IV. Specific Technical Specifications (Comparison to Predicate)
- Pressure Error Range: ±10mmHg	The subject device has a pressure error range of ±10mmHg, which is smaller (better) than the predicate's ±25mmHg. This is noted as "Different, Note 2" and deemed not to affect safety and effectiveness.
- Sleeve Materials: Polyester (Passes Biocompatibility)	The subject device uses Polyester; the predicate uses Nylon with Polyurethane laminate. This is noted as "Different, Note 5" but the subject device complies with biocompatibility standards, so it does not affect safety/effectiveness.
- Number of Air Chambers: 2 Chambers	The subject device has 2 chambers; the predicate has 3. This is noted as "Different, Note 6" but determined not to affect safety/effectiveness as the applicable treatment site and Indications For Use are within the range of the predicate.
- Inflation Time: ≤20s; Deflation Time: 7s	The subject device specifies these times, which are similar to the predicate's range of 3-30s inflation and 1-5s deflation. This is noted as "Similar, Note 7" and considered safe and effective due to compliance with standards, pressure sensor protection, and similar treatment modes/pressures/cycle times to the predicate.

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.)

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.
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.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no clinical "test set" requiring adjudication.
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.
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.
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.
The sample size for the training set:
- Not applicable. The device is not based on machine learning or AI that requires a "training set."
How the ground truth for the training set was established:
- Not applicable. No training set is used.

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