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The Urinary Incontinence System with various treatment modalities is intended to be used by males and females for muscle contraction in the treatment of stress incontinence, urge incontinence, and mixed incontinence.

The Finecure Urinary Incontinence System is a non-implanted, electrical, pelvic floor muscle stimulator. It is intended to strengthen the pelvic floor muscles by electrical stimulation in the treatment for urinary incontinence. The system has several preset modes that correspond to different conditions associated with urinary incontinence. The Urinary Incontinence System can be used in the clinical setting and the home care environment. The System is composed of enclosure, display screen, PCB, rotary switch, and other electronic components. The system is to be used with pelvic floor probes and anorectal probes.

The provided document is a 510(k) Summary for a Urinary Incontinence System. It describes the device and its equivalence to predicate devices, but it does not contain details of a clinical study with acceptance criteria for device performance related to urinary incontinence treatment efficacy.

The "Testing Summary" section on page 12 focuses entirely on non-clinical tests (biocompatibility, electrical safety, EMC, home healthcare environment, bench testing, and software verification), confirming the device meets safety and design requirements. There is no mention of a study involving human subjects or clinical outcomes for treating incontinence.

Therefore, many of the requested details cannot be extracted from this document as the type of study implied by the request (a study proving the device meets acceptance criteria for its intended use) was not performed or at least not described within this 510(k) summary.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Study Details (Based on available document)

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

The document does not explicitly state acceptance criteria in terms of clinical performance (e.g., reduction in incontinence episodes) for the Urinary Incontinence System. The acceptance criteria mentioned are related to engineering and safety standards, and the reported "performance" refers to the device passing these tests.

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

This information is not provided as the document does not describe a clinical study with a test set of human subjects. The "test set" refers to the hardware and software units tested against engineering standards.

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)

This information is not applicable/provided as there was no clinical study described that would require expert-established ground truth for patient outcomes. The "ground truth" for the engineering tests would be the specifications and standards themselves, assessed by engineers or testing laboratories.

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

This information is not applicable/provided as there was no clinical study with human readers/assessors described.

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

This information is not applicable/provided. No MRMC or comparative effectiveness study involving human readers or AI assistance is mentioned. The device is a physical therapeutic device, not an AI diagnostic tool.

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

This information is not applicable/provided. The device is a physical medical device for electrical stimulation, not an algorithm, and the safety/performance tests described did not involve evaluating its efficacy in a standalone algorithmic context.

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

For the non-clinical tests, the "ground truth" is adherence to established international and national engineering standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11) and the manufacturer's own design specifications. There is no ground truth related to clinical outcomes or expert consensus on clinical data mentioned in this document.

8. The sample size for the training set

This information is not applicable/provided as no clinical studydata (training or test) is described.

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

This information is not applicable/provided as no clinical study data (training or test) is described.

Summary of Document Focus:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices based on:

1. Similar intended use and indications for use.
2. Comparison of technological characteristics (e.g., power source, output parameters, waveform, pulse rate).
3. Non-clinical testing to ensure the device meets safety (electrical, EMC, biocompatibility) and performance standards for its design, especially in the home healthcare environment.

The document does not include details of clinical performance studies demonstrating the effectiveness of the Urinary Incontinence System in treating stress, urge, or mixed incontinence in human subjects, or any associated acceptance criteria for these clinical outcomes. The FDA generally clears Class II devices, like this one, based on substantial equivalence to existing legally marketed devices, often without requiring new clinical efficacy studies if the technological characteristics and safety profiles are similar.

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The Urinary Incontinence Probe, model PR-51 Vaginal Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

The Urinary Incontinence Probe, model PR-51 Vaginal Probe & PR-52 Anal Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

The Urinary Incontinence Probe, model PR-51 Vaginal Probe & PR-52 Anal Probe are the light weight cylinder consisting of two independent conductive rings that are paired and isolated, physically and electrically. The cylinder is shaped with a handle for comfort positioning in vaginal/anal canal for incontinent treatment as above mentioned and easy for removing after treatment. It is watertight to allow for washing with soap and water between uses. The probe is designed for repeated intermittent use in home or clinic for up to one year by a single user. It does not require sterilization, but does required washing for reuse according to the validated cleaning method as recommended in user manual.

To fit with different type of device connection, the lead wire of device was provided with three different type of wire connection terminals, 2mm pigtail, 3.5mm femelle and 2.35 mm femelle. Either of the PR-51 Vaginal Probe & PR-52 Anal Probe can be connected to any one of three connection terminals.

The provided document describes a 510(k) premarket notification for an "Electrode for Urinary Incontinence" (Models PR-51, PR-52). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study with acceptance criteria.

Therefore, many sections of your request related to acceptance criteria, sample sizes, ground truth, expert adjudication, and clinical study outcomes cannot be directly extracted from this document, as these types of studies were explicitly stated as "Not applicable" (# 9 Brief discussion of clinical tests: Not applicable).

The document primarily addresses non-clinical performance and biological evaluation.

Here's a breakdown of the information that can be extracted or inferred, and what cannot:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. No specific acceptance criteria (e.g., in terms of clinical efficacy, sensitivity, specificity, accuracy) or reported performance metrics are listed because no clinical performance study was conducted or required for this 510(k) submission. The submission focuses on substantial equivalence based on technological characteristics and non-clinical testing.

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

Not applicable/Not provided. No clinical test set. The non-clinical tests (biological evaluation and standards compliance) do not typically refer to "test sets" in the same way clinical studies do. The manufacturer is Guangzhou Finecure Medical Equipment Co., Ltd. from China.

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/Not provided. No clinical test set requiring expert ground truth.

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

Not applicable/Not provided. No clinical test set requiring adjudication.

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 an electrode for urinary incontinence, not an AI diagnostic imaging device. No MRMC study was conducted or is relevant.

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

Not applicable. This device is a medical electrode, not a software algorithm.

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

Not applicable. For the non-clinical tests, the "ground truth" would be compliance with the standards referenced (e.g., biocompatibility testing for ISO 10993).

8. The sample size for the training set

Not applicable/Not provided. No clinical study was conducted.

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

Not applicable/Not provided. No clinical study was conducted.

Summary of what the document does provide regarding device performance and acceptance:

The device's acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device (Everyway Incontinence Stimulation Electrode, K122194) and compliance with specific non-clinical standards.

Acceptance Criteria and Reported Device Performance (as inferred from the 510(k) submission strategy):

Study Proving Device Meets Acceptance Criteria:

The "study" in this context refers to the non-clinical tests and analysis performed to demonstrate substantial equivalence and safety/effectiveness.

• Non-Clinical Testing: The document explicitly states that the "Electrode for Urinary Incontinence conforms to the following standards:" and then lists the three ISO 10993 standards mentioned above. This indicates that appropriate biocompatibility testing was performed and passed, leading to compliance with these standards.
• Comparison to Predicate Device: The 510(k) submission itself is a "study" of comparison, wherein the manufacturer presents arguments and data (including the declaration of compliance with standards) to demonstrate that their device is "substantially equivalent" to an already cleared predicate device. The FDA's review and clearance (K140265) indicate that they agreed with this assessment.

In conclusion, this regulatory document focuses on establishing substantial equivalence for market clearance, rather than reporting on a clinical effectiveness study with defined acceptance criteria for efficacy. The "acceptance criteria" are compliance with relevant safety standards (biocompatibility) and demonstration of similar technological characteristics and intended use as an existing cleared device.

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