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Starly pad is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The Starly pad is for OTC (Over-The-Counter) or Prescription use. The Starly pad is for adults only.

The Starly pad consists of Insulation backing layer, Adhesive layer, Conducting film, Gel layer, Protective film and Snap fastener.

This document details the FDA 510(k) clearance for the Starly pad, a cutaneous electrode. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than a detailed "study that proves the device meets the acceptance criteria" in the context of an AI/ML-based medical device.

Therefore, many of the requested elements for an AI/ML study (like sample size for test set, number of experts, MRMC studies, ground truth establishment for AI training) are not applicable or not present in this document, which pertains to a Class II physical medical device.

However, I can extract the relevant acceptance criteria and performance data for this physical device as described in the provided text.

Device Name: Starly pad
Device Type: Cutaneous Electrode
Regulation Number: 21 CFR 882.1320 (Cutaneous Electrode)
Product Code: GXY

Acceptance Criteria and Reported Device Performance

Study Details (Applicable to a physical medical device, not AI/ML model validation):

1. Sample size used for the test set and the data provenance:
   The document does not specify exact sample sizes for each performance test (e.g., how many pads were tested for impedance or adhesion). The data provenance is implied to be from internal testing by Shenzhen Xingyuanli Technology Co., Ltd. (031_Performance test report mentioned and Starly Pad Performance Test Report). The testing is retrospective, conducted prior to the 510(k) submission. No specific country of origin for the data is mentioned beyond the company's location in China.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. This is a physical device, and the "ground truth" for its performance (e.g., impedance value, number of adhesion cycles) is established through standardized engineering and biological evaluation tests, not through expert consensus on interpretation.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods are typically used in clinical studies, particularly for diagnostic imaging, where human readers consensus is required. This document refers to laboratory-based performance testing.

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 device is a cutaneous electrode, not an AI/ML-driven diagnostic tool. No human reader studies are mentioned.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an algorithm or software-driven device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For physical and biocompatibility performance, the "ground truth" is based on:

   • Direct measurements: For dimensions, impedance, current dispersion.
   • Defined test protocols: For skin adhesion performance (e.g., number of cycles before failure).
   • Standardized biological tests: For biocompatibility (Cytotoxicity, Sensitization, Irritation) in accordance with ISO 10993 standards, where the "truth" is the pass/fail outcome based on predefined acceptance criteria for cellular reactions.

7. The sample size for the training set:
   Not applicable. This device does not use an AI/ML model, and therefore has no "training set."

8. How the ground truth for the training set was established:
   Not applicable. See point 7.

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