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The biofeedback components of the InCare Pelvic Floor Therapy System with Desktop Computer are intended to provide electromyographic or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.

The electrical stimulation component of the InCare Pelvic Floor Therapy System with Desktop Computer provides stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

The InCare Pelvic Floor Therapy System with Desktop Computer is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyographic or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence. The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.

The premarket notification is being submitted to the Agency to include the electrical stimulation parameter of 200 Hz to the existing InCare Pelvic Floor Therapy System with Desktop Computer, K961872.

The provided text is a 510(k) premarket notification for the InCare Pelvic Floor Therapy System with Desktop Computer. It focuses on demonstrating substantial equivalence to a predicate device (Hollister PRS9300 Pelvic Floor Therapy System, K961872), primarily due to the addition of a 200 Hz electrical stimulation parameter.

This type of submission does not typically include detailed acceptance criteria in the sense of performance metrics (like sensitivity, specificity, accuracy) derived from a clinical study, nor does it present the results of such a study with sample sizes, ground truth establishment, or expert adjudication. Instead, the acceptance criteria are met by demonstrating that the new device's technological characteristics are substantially equivalent to a legally marketed predicate device, and that this new parameter does not raise new questions of safety or effectiveness.

Therefore, many of the requested fields cannot be directly extracted from this document as the safety and effectiveness summary relies on substantial equivalence to a predicate device rather than a new clinical performance study with specific acceptance criteria that would be typical for a novel device or a device with new indications.

However, I can extract information related to the device characteristics that are presented to support the claim of substantial equivalence.

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

Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly that the proposed device's characteristics must be comparable to the predicate device, or any differences must not raise new questions of safety or effectiveness. The "reported device performance" is essentially the detailed specifications of the proposed device, shown in comparison to the predicate device.

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

Not applicable. This is a substantial equivalence submission based on device specifications comparison, not a clinical study with a test set of data.

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)

Not applicable. No ground truth was established by experts for a test set in this submission.

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

Not applicable. No test set adjudication method described as no clinical performance study was conducted.

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

Not applicable. This is not an AI-assisted device, and no MRMC study was conducted or described.

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

Not applicable. This is a medical device for treatment/biofeedback, not an algorithm being evaluated for standalone performance.

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

Not applicable. As noted, this submission is driven by substantial equivalence to a predicate device based on technical specifications rather than a clinical study requiring ground truth derived from expert consensus, pathology, or outcomes data. The "ground truth" for this application is the established safety and effectiveness of the predicate device and the demonstration that the new device remains within those bounds.

8. The sample size for the training set

Not applicable. This submission doesn't involve machine learning or a training set.

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

Not applicable. This submission doesn't involve machine learning or a training set.

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The biofeedback components of the InCare Pelvic Floor Therapy System with Desktop Computer are intended to provide electromyographic or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of female urinary incontinence.

The electrical stimulation component of the InCare Pelvic Floor Therapy System with Desktop Computer provides stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of female urinary incontinence.

The InCare Pelvic Floor Therapy System with Desktop Computer is an office based instrument that is intended to be used by physicians, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyographic or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of female urinary incontinence. The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of female urinary incontinence.

The "nucleus" of the system is the combination of an instrumentation unit and a desktop computer. Other peripheral devices such as monitors and printers can be added for convenience or ease of use. There is a clear separation of functional control between the two elements of the system. Features or functions that are "data manipulation and presentation" activities are properly associated with the personal computer. Features and functions that are "patient treatment" actions are controlled by the Instrumentation Unit.

The desktop computer and Instrumentation Unit are physically separate devices "linked" to each other by a communication pathway.

The provided text describes a 510(k) premarket notification for a medical device and, as such, does not contain a study demonstrating novel clinical effectiveness or "acceptance criteria" in the way understood for new efficacy studies.

Instead, the document asserts substantial equivalence to a predicate device (Hollister PRS9300 Pelvic Floor Therapy System, K930530/C). This means the device is considered safe and effective because it is essentially the same as a legally marketed device.

Therefore, the "acceptance criteria" here are essentially the technological characteristics and intended use being substantially equivalent to the predicate device. The "study" is a comparative analysis demonstrating this equivalence.

Here's the information broken down based on the provided text, while acknowledging that a traditional clinical study as you might expect for a new drug or novel device with performance metrics against a clinical endpoint is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding a "Study" to prove the device meets acceptance criteria:

The document describes a comparison analysis rather than a traditional clinical or performance study in the sense of collecting new patient data.

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

• Test Set Sample Size: Not applicable. This document is a predicate comparison for a 510(k) submission, not a new clinical study. There is no "test set" of patients or data in the typical sense.
• Data Provenance: The "data" used is a comparison of the device's technical specifications and intended use against a previously cleared device (the predicate). The provenance is the design specifications of the new device and the known characteristics of the predicate device. This is a retrospective analysis by comparing specifications.

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

• Not applicable. Ground truth, in the context of clinical studies, refers to definitive diagnoses or outcomes. For a 510(k) submission, the "ground truth" for regulatory clearance is that the device is substantially equivalent to a legally marketed predicate. This "truth" is established by the manufacturer's regulatory team and reviewed by the FDA, based on documented technical specifications.

4. Adjudication method for the test set:

• Not applicable. There is no multi-person adjudication of a "test set" in this type of submission. The comparison is made against the clear specifications and intended use of the predicate device.

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:

• Not applicable. This device is a pelvic floor therapy system that provides biofeedback and electrical stimulation. It is not an AI-powered diagnostic imaging device or an AI assistant for human readers. Therefore, an MRMC study is irrelevant to this device.

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

• Not applicable. This is a physical therapy device used by clinicians with patients, not a standalone algorithm.

7. The type of ground truth used:

• The "ground truth" in this context is the design specifications and functional equivalence to the legally marketed predicate device (Hollister PRS9300 Pelvic Floor Therapy System, K930530/C), as defined by FDA 510(k) regulations.

8. The sample size for the training set:

• Not applicable. As this is not an AI/ML device or a de novo clinical study, there is no "training set."

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

• Not applicable for the same reasons as #8.

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