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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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