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Indications For Use:

• • Urinary Incontinence : Stress, Urge and Mixed Incontinence
• • Neuromuscular Reeducation
• • Fecal Incontinence (EMG use only)

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are EMG OR Stimulation perineometer sensors used to monitor OR stimulate the pelvic floor muscles for the treatment of incontinence. This sensor is connected to a surface EMG device to provide Bio-feedback to the patient. This allows the patient to monitor their pelvic muscle activity which is otherwise difficult due to the anatomical location of the pelvic floor muscles. This sensor is connected to a stimulator device to provide stimulation to the patient. This assists the patient with muscle contractions.
The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are single-user plastic sensors with stainless steel electrode contacts. The patient inserts the sensor into the vagina or rectum and uses a surface EMG instrument to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The patient can instead use a stimulator to electrically stimulate the pelvic floor muscles to assist the contraction. The aim is to improve the strength and control of the pelvic floor muscles.

Here's a summary of the acceptance criteria and the studies performed for the Pathway Vaginal EMG/Stimulation Perineometer Sensor and Pathway Anal EMG/Stimulation Perineometer Sensor, based on the provided text:

Acceptance Criteria and Device Performance

The device aims to accurately measure EMG signals and provide stimulation for pelvic floor muscles, performing similarly to predicate devices. The acceptance criteria used are based on demonstrating equivalence rather than specific performance metrics for novel technology.

Detailed Study Information:

The document describes both non-clinical (bench) and clinical performance testing, along with biocompatibility testing. The studies focus on demonstrating substantial equivalence to existing predicate devices.

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

• Non-Clinical Performance Data (Bench Tests): Not explicitly stated. The tests involved measuring known input signals and comparing them to predicate device readings.
• Clinical Performance Data: "A test subject" was used. This indicates a very small sample size, likely N=1.
• Data Provenance: Not explicitly stated but implied to be internal testing by The Prometheus Group (US company). The data would be prospective, generated specifically for this submission.

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

• No external experts are mentioned for establishing ground truth in the performance studies.
• For the non-clinical tests, the "ground truth" was a "known input signal."
• For the clinical tests, the "ground truth" was likely inferred from the pressure perineometer sensor used in an alternate placement, and visual/qualitative assessment of muscle contractions, all relative to the predicate device, rather than an expert medical diagnosis.

4. Adjudication method for the test set:

• No formal adjudication method (like 2+1, 3+1) is mentioned. The comparison seems to be direct against known inputs (bench tests) or direct comparison against the predicate device's performance (clinical tests).

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:

• No MRMC comparative effectiveness study was done.
• This device is a perineometer sensor for EMG and stimulation, not an AI or imaging diagnostic device where human reader performance with/without AI assistance would be a relevant metric. The focus is on the sensor's ability to accurately measure and stimulate.

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

• The device itself is a standalone sensor that measures EMG signals and provides stimulation. Its performance was evaluated without explicit human interpretation in the loop for the performance metrics shown, though a human would be using the device. The non-clinical tests directly assess the sensor's measurement capabilities.

7. The type of ground truth used:

• Non-Clinical Performance Data: "Known input signal."
• Clinical Performance Data: Comparison to the predicate device, and monitoring of resulting contractions using a pressure perineometer sensor. This acts as a comparative measurement, rather than an independent "gold standard" ground truth like pathology for a diagnostic device.

8. The sample size for the training set:

• Not applicable. This device is a sensor and does not involve AI or machine learning models that require a training set.

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

• Not applicable, as there is no training set for this type of device.

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Peritron is used in assessing the strength of pelvic floor muscles, teaching pelvic floor muscle exercises and for providing feedback during pelvic floor muscles exercises.

The Peritron Perineometer comprises a vaginal or anal Sensor, Readout Unit and interconnecting tube. Peritron incorporates a pressure transducer and microprocessor to interpret the air pressure in the sensor and display it either numerically in cm water column pressure or as an analogue bar graph. Hand-held Peritron weighs 220 gm and is powered by a standard 9 volt battery housed in an integral, user-accessible compartment separated physically from the electronic components. All operating functions are controlled by one push-button. The case of Peritron is of injection moulded plastic.

I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested.

The document is a "Safety and Effectiveness Summary" for the Peritron Perineometer (K983052), which aims to demonstrate substantial equivalence to a predicate device (Contimed II™) for FDA clearance. It discusses the device's design, safety features, and a general statement about manufacturing compliance.

Here's what I can extract and what's missing based on your request:

What's available in the text:

• Device Description: The Peritron Perineometer is described as comprising a vaginal or anal Sensor, Readout Unit, and interconnecting tube, used for diagnosing and treating stress incontinence, assessing pelvic floor muscle strength, and providing exercise feedback.
• Substantial Equivalence Claim: The document explicitly states, "Peritron does not alter the effectiveness compared to substantially equivalent Contimed II™ device as both devices measure the increase in air pressure in a sensor caused by a voluntary contraction of pelvic floor muscles."
• Manufacturing Compliance: "Peritron is tested during manufacture for compliance with the performance criteria set out in the Brochure and Handbook of Appendix five." (However, "Appendix five" and the specific performance criteria are not provided).
• Safety Experience: "Since its inception in 1991, over 1200 units have been put into operation and at no time during the development or usage of the Peritron has there been an incident that in any way threatened the safety of any individual." This is a general safety statement, not a performance study.
• FDA Clearance: The letter from the FDA confirms the device is "substantially equivalent" to legally marketed devices based on the submitted 510(k) notification.

Missing Information (which is what you requested):

1. Table of acceptance criteria and reported device performance: This is not present. The document mentions "performance criteria set out in the Brochure and Handbook of Appendix five," but these criteria and the specific test results against them are not included.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: No such study is described. The document relies on substantial equivalence to a predicate device's general effectiveness.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical device that measures a physiological action, not an algorithm.
7. Type of ground truth used: Not explicitly defined in terms of a study comparing device measurements to a gold standard. The device measures pressure from voluntary muscle contraction, implying real-time physiological response.
8. Sample size for the training set: Not applicable as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for premarket clearance based on substantial equivalence, focusing on safety and general effectiveness relative to an existing device. It does not provide the detailed performance study data, acceptance criteria, or ground truth methodologies typically found in a clinical validation study for a new device's specific performance metrics.

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Indications For Use:

• • Urinary Incontinence : Stress, Urge and Mixed Incontinence
• • Fecal Incontinence
• • Neuromuscular Reeducation

The Pathway Vaginal/Rectal Perineometer Probe is an EMG perineometer probe used to monitor the pelvic floor muscles for the treatment of incontinence. This probe is connected to a surface EMG device to provide Bio-feedback to the patient. This allows the patient to monitor their pelvic muscle activity which is otherwise difficult due to the anatomical location of the pelvic floor muscles.
The Pathway Vaginal/Rectal Perineometer Probe is a single-user plastic probe with three metal electrode contacts. The patient inserts the probe into the vagina or rectum and uses a surface EMG instrument to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The aim is to improve the strength and control of the pelvic floor muscles.

The provided document describes a device called the Pathway Vaginal/Rectal Perineometer Probe and its substantial equivalence to a predicate device. The information requested pertains to the acceptance criteria and the study that proves the device meets those criteria.

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

The document does not explicitly state "acceptance criteria" in a tabular format with defined thresholds. Instead, it presents performance data used to demonstrate substantial equivalence to a predicate device. The implied acceptance criterion is that the Pathway probe performs "similarly" to the predicate device and accurately measures EMG signals.

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

• Non-clinical (Bench Tests): The document states "A series of bench tests were performed" and "A matrix of different frequencies and amplitudes was measured." It does not specify a numerical sample size for these tests (e.g., number of measurements or repetitions).
• Clinical Tests: The document states "A number of Male and Female subjects were instructed to perform a series of contractions and relaxations." It does not specify the exact number of subjects or the sample size of the clinical test set.
• Data Provenance: The document does not explicitly state the country of origin. The submission is from a US company (The Prometheus Group, Portsmouth, NH) to the FDA, suggesting the studies were likely conducted in the US. The studies are prospective in nature, as they involve performing tests and gathering data specifically for the device submission.

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

The document describes tests to measure EMG signals and compare the Pathway probe's performance to a predicate device. These tests involved instrumental measurements (non-clinical) and subject-performed contractions/relaxations (clinical). The "ground truth" here is the physical EMG signal itself and the performance relative to a known predicate device. There is no mention of human experts establishing ground truth in the context of interpretation or diagnosis for the test set. The ground truth for the non-clinical tests was the input signals, and for clinical tests, it was the recorded muscle activity during contractions/relaxations, compared against the predicate device.

4. Adjudication method for the test set

Not applicable. The tests measured physical properties (EMG signals, biocompatibility) or compared performance to a predicate device. There was no diagnostic interpretation or subjective assessment that would require an adjudication method.

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 EMG perineometer probe, not an AI-powered diagnostic tool requiring human readers or interpretation of complex cases. Therefore, no MRMC study or AI assistance effect size is relevant or reported.

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

Not applicable. This is a medical device for monitoring physiological signals, not an algorithm. Its performance is inherent to its physical design and sensor capabilities.

7. The type of ground truth used

• Non-clinical (Bench Tests): The ground truth was the known input signals (specific frequencies and amplitudes) generated for the test setup, against which the probe's readings were compared.
• Clinical Tests: The ground truth was the EMG activity generated by subjects' pelvic floor muscle contractions and relaxations, measured by both the Pathway probe and the predicate device. The performance of the predicate device (Perrymeter probe, K911190/A) served as a comparative ground truth for "similar" performance.
• Biocompatibility Tests: The ground truth was established by standardized laboratory test protocols for biocompatibility, using accepted criteria for safety (e.g., 0% sensitization, negative reactions, non-cytotoxic, non-pyrogenic).

8. The sample size for the training set

Not applicable. This device is not an algorithm that requires a training set.

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

Not applicable. As this device is not an algorithm, there is no training set or associated ground truth establishment process.

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INTENDED USE STATEMENT: The Perineometer (Biofeedback monitor) and vaginal probe are intended to be used to assist the patient in exercising her pelvic muscles (referred to Kegal exercises) which may lead to increased bladder control.

The PERINEOMETER & VAGINAL PROBE , is a passive device which will allow the patient to visually monitor their Kegal exercise progress.

The Vaginal probe is a Single patient use only device comprised of a medical grade Silicone shaft with a silicone balloon (Inflatable to enlarge to accomodate various vaginal sizes.) and a oolvurethane connector tube. The silicone balloon is mounted in such a way that when pressure is applied to it, air will be displaced through it's connector tubing. This air displacement is being monitored by the biofeedback monitor will cause the LED lights to turn on in proportion to the pressure exerted. This probe is similar to the legally marketed probe via 510(k) numbers (K902843) and (K913736) except that in this case we are inflating the balloon to provide gentle pressure to the vaginal wall. This will allow the probe to be customized for the patients individual vaqinal size.

The Perineometer (Biofeedback Monitor) is powered by rechargeable batteries. To prevent a potential shock hazard this unit will not function while it is being recharged. The Perineometer is identical to the biofeedback monitor which had been 510(k) approved for use in fecal incontinence (K902843). Thus, in the case of this 510(k) submission, we only seek to expand its use for general Kegal exercises.

SYSTEM DESCRIPTION: The patient inserts the vaginal probe which is connected to the Perineometer. Once the probe is inflated until it provides gentle pressure to the vaginal wall. As the pelvic muscles expand and contract (Kegal exercises) the pressure in the probe changes and these pressure changes are converted into a visual signal on the Perineometer (biofeedback monitor). The visual signal on the Perineometer is a series of LEDs (lights) which provide the patient with a real time representation of pelvic muscle activity.

This submission describes the Biosearch Medical Products, Inc. "PERINEOMETER & VAGINAL PROBE" for assisting patients with pelvic muscle exercises to improve bladder control. The device consists of a Perineometer (biofeedback monitor) and a vaginal probe.

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for the "PERINEOMETER & VAGINAL PROBE" in terms of performance metrics like sensitivity, specificity, or accuracy. Instead, the focus is on demonstrating substantial equivalence to legally marketed predicate devices through material biocompatibility and functional similarity.

Therefore, the "acceptance criteria" can be inferred as meeting the safety and material requirements of similar devices and demonstrating comparable functionality.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific clinical "test set" in the way typically expected for performance claims (e.g., a cohort of patients randomized to use the device). The device's performance is primarily established through:

• Substantial Equivalence: Comparison to existing, legally marketed predicate devices.
• Material Biocompatibility Testing: Conducted on components (e.g., Anorectal Probe Assembly, Silicone, Polyurethane Tubing). The "sample size" for these tests would refer to the number of material samples tested, but this detail is not provided.
• Data Provenance: The biocompatibility tests are listed with "Test Date" (e.g., 11/11/91 for Anorectal Probe Assembly) or "Vendor Provided." This indicates the data is from laboratory testing of materials and components, likely retrospective given the dates. There is no information about the country of origin for the data or whether it was prospective or retrospective in a clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts establishing a "ground truth" in a clinical context for a test set. The submission relies on:

• Regulatory Standards: USP Class VI for plastics, ANSI/HIMA MD 70.1, British BS 5081,176 for check valve.
• Previous Approvals: The Perineometer's equivalence to existing 510(k)-approved devices (K902843, K913736).
• Expertise in Biocompatibility: The "Nontoxic" and "Meets requirements" results imply assessment by experts in material science and biocompatibility testing, but their specific qualifications or number are not detailed.

4. Adjudication Method for the Test Set

As there is no described clinical "test set" or human assessment of device performance for the purpose of establishing clinical efficacy or accuracy in this submission, there is no adjudication method mentioned. The primary "adjudication" is the FDA's review of the substantial equivalence claim based on the provided material and functional comparisons.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No MRMC comparative effectiveness study was done or reported in this submission. The effectiveness of the device is inferred from its similarity to predicate devices already on the market and the general understanding that pelvic muscle exercises improve bladder control. There is no mention of human readers or AI assistance, let alone an effect size.

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

This device, the "PERINEOMETER & VAGINAL PROBE," is a biofeedback system that provides a visual signal (LED lights) in proportion to pressure exerted by pelvic muscles. It is an interactive device used by the patient (human-in-the-loop) to guide their exercises. Therefore, the concept of a "standalone (algorithm only)" performance assessment does not apply to this type of medical device. Its function is to facilitate human action, not to perform an automated diagnostic or therapeutic task independently.

7. The Type of Ground Truth Used

The "ground truth" in this submission is primarily based on:

• Established Biocompatibility Standards: USP Class VI, ISO standards, and previous FDA approvals for material safety.
• Functional Similarity to Legally Marketed Predicate Devices: The reference to previous 510(k) clearances (K902843, K913736, K945611, K862410, K891774) indicates that the performance of these devices in assisting pelvic muscle exercises and improving bladder control is the benchmark.
• Scientific Consensus: The statement "Presently many Orologists of the country are recommending pelvic muscle exercises to their female patients since the exercises improve urinary continence" implies a general medical consensus on the efficacy of the underlying therapy (Kegal exercises).

8. The Sample Size for the Training Set

There is no "training set" in the context of machine learning or AI models described in this document. The device is a mechanical/electronic biofeedback tool, not an AI or algorithm-based system that requires training data.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

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The Contimed Pressure Biofeedback device is intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.

The Contimed Pressure Biofeedback device is a battery powered machine which registers the force with which a patient contracts their pelvic floor muscles. The force is measured by using an anatomically shaped, inflatable pressure probe that is connected to the Contimed device. The latex probe (anal or vaginal) is inflated with air by using a syringe and is introduced into either the vagina or anus. The voluntary muscle contractions of the exercises compress the air inside the probe and register a reading on the display panel of the Contimed device. The visual display of contraction force gives the patient the ability to see and hear progress in the exercise session. The Contimed has a vertical column of lights. The number of the lights illuminated increases or decreases with an increase of contraction force. To reinforce the effect of the visual signal there is also an audible signal that can be turned on or off. The intensity of the tone increases or decreases in intensity depending on the contraction's force. Over time the exercise program will help the patient to improve the ability to control the pelvic floor muscles.

Three different duty cycles are preset to allow the caregiver the ability to choose a program that will help to strengthen the pelvic floor muscles. They can be set by using the slide switch on the control panel of the device. Three sensitivity levels are available to accommodate different contraction strengths of the pelvic floor muscles. They can be set by using the slide switch on the control panel of the device, there is also a slide switch for zero adjustment.

The provided text does not contain acceptance criteria or a study proving the device meets those criteria.

Instead, the document is a premarket notification (510(k)) summary for the Hollister Contimed Pressure Biofeedback device. This type of document aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, not to prove clinical effectiveness through a study with acceptance criteria.

The document focuses on comparing the technological characteristics of the new device to a predicate device (InCare Contimed II Pressure Biofeedback device, K891774) and a general device type (Perineometer as described in 21 CFR 884.1425).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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