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The PS-1 is indicated for use as an adjunct in the treatment of high and low anorectal malformations. The PS-1 is used to identify striated muscles to be used in anal reconstructions.

The PS-1 Peña Muscle Stimulator, addressed in this premarket notification, has the same technological characteristics as the commercially available Radionics Model 433-A General Hospital Stimulator and the P. B. Services Model A-200 Constant Current Peripheral Nerve Stimulator. Like these devices, the PS-1 is intended to be used as a stimulator.

The provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria.

Instead, the document is a 510(k) premarket notification for the Model PS-1 Peña Muscle Stimulator, demonstrating its substantial equivalence to existing predicate devices (Radionics Model 433-A General Hospital Stimulator and P.B. Services Model A-200 Constant Current Peripheral Nerve Stimulator).

Here's a breakdown of what can be extracted and what is missing based on your request:

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

• Missing. The document states "The system and unit testing results provided in this premarket notification verify that the Model PS-1 Peña Muscle Stimulator is safe and reliable." However, it does not specify what those "testing results" were, what the acceptance criteria for "safe and reliable" were, or the quantitative performance metrics achieved. The basis for substantial equivalence is primarily technological characteristics being similar to predicate devices, not specific performance against defined criteria.

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

• Missing. No information on sample size or data provenance is provided. The document focuses on technological equivalence with predicate devices.

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)

• Missing. This type of information is not relevant to a substantial equivalence determination based on technological characteristics and safety/reliability claims without explicit performance studies.

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

• Missing. See point 3.

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

• Missing. This device is a muscle stimulator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not applicable.

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

• Missing. This device is a physical muscle stimulator, not an algorithm. Standalone algorithm performance is not applicable.

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

• Missing. No ground truth establishment is described because no specific performance study against a "truth" is detailed. The assessment revolves around the device's design, safety features (audio indicators, battery test), and similarity to predicate devices.

8. The sample size for the training set

• Missing. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

• Missing. See point 8.

Summary of available information related to "acceptance criteria" and "study":

The document primarily relies on the concept of substantial equivalence to predicate devices.

• "Acceptance Criteria" (Implied): The implied "acceptance criteria" for this 510(k) submission are that the device shares the same technological characteristics as the predicate devices and that its design raises no new safety or effectiveness concerns. Specific, quantifiable performance criteria are not explicitly stated. Safety is highlighted through intrinsic features like audio indicators and a battery test function.
• "Study" (Implied Verification): The document mentions "The system and unit testing results provided in this premarket notification verify that the Model PS-1 Peña Muscle Stimulator is safe and reliable." However, the details of this verification ("study") are not provided. It seems to refer to internal testing performed by the manufacturer to ensure basic functionality and safety features are working as intended, rather than a formal clinical or comparative performance study against pre-defined statistical endpoints. The basis for safety and effectiveness is largely similarity to already approved devices.

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