Search Results

The leva Pelvic Floor Trainer is intended for the purpose of rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mildmoderate urge incontinence in women. This device interacts with the user via smart phone technology.

The leva Rehabilitative Positional Device is a device specifically designed to facilitate Kegel exercise training of women with urinary incontinence by physicians and associated therapists. The device is designed to be discreet and simple to use. Each leva is intended to be used repeatedly by a single patient. The device is designed to be used vaginally.

The RPD hardware consists of the training device itself and an associated battery powered electronics box. The training device has a biocompatible, colored silicone covering which isolates the motion electronics from the environment. The patient inserts the training device in her vagina before commencing Kegel exercises and wirelessly connect the RPD to the smartphone. The training device remains in place during the Kegel exercises. This device can be washed before and after exercise by the patient.

A smartphone, with the appropriate app, is used to connect wirelessly to the RPD and shows the angle of the pelvic floor and the relative motion. This enables the user to visualize the Keqel exercise she is being trained on. The app will carry the information recorded by the patient on her smartphone or tablet. Such information will then connect to a website for the patient or health care provider to store information and retrieve information related to the use of the RPD.

A website is provided for access by the patient, health care provider and insurance company. This website provides utilities for the patient, the health care provider and the insurance company. For the patient the website provides ongoinq tracking of performance—showing improvement in the patient's Keqel exercises when using the RPD. The health care provider shall have access for monitoring their patients' performance.

One RPD is intended for only one patient per device and there is no applicable shelf life for this device.

The provided document describes the Remendium Labs, LLC "Ieva Rehabilitative Positional Device" (K133990), a pelvic floor trainer for women with urinary incontinence. The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than providing a new clinical study with acceptance criteria. No specific acceptance criteria are defined for the device's performance in the document.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them cannot be entirely provided from this document. However, I can extract information about the testing performed and the general conclusions regarding safety and effectiveness, which are implicit acceptance criteria for a 510(k) submission.

Here's a breakdown of the available information:

1. Table of acceptance criteria and reported device performance:

The document does not specify quantitative acceptance criteria in terms of accuracy, sensitivity, or specificity for the device's ability to measure or improve pelvic floor muscle strength. Instead, the "acceptance criteria" are implied by successful completion of various engineering, safety, and usability tests to demonstrate safety and effectiveness for its intended use and substantial equivalence to a 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):

• Sample Size for Test Set:
  • For hardware verification (life flex testing), specific numbers of cycles (1,460) are mentioned, but no "sample size" of individual devices for these tests is specified, typically it would be a small number of engineering samples.
  • For usability testing, "lay volunteers" were used, but the exact number is not specified.
  • For biocompatibility, "All patient contacting materials have been tested," implying material samples rather than a cohort of patients.
• Data Provenance: The document does not specify the country of origin for the internal testing data. It is internal testing conducted by Remendium Labs, LLC, which is based in Baton Rouge, LA, USA. The testing appears to be prospective (studies designed and executed to test the device under development).

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

This information is not applicable or not provided in the document. The testing described primarily involves engineering and usability benchmarks, not clinical ground truth established by medical experts for a diagnostic or screening application. The "ground truth" for these engineering tests would be instrument readings or defined pass/fail criteria for physical and software functions.

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

No multi-reader/adjudication method is mentioned. The tests described are primarily bench tests and usability tests, not clinical evaluations requiring adjudication of subjective assessments.

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 performed or described. The device is a "Rehabilitative Positional Device" and a "Pelvic Floor Trainer," which aids the user in performing Kegel exercises. It does not involve "human readers" or AI assistance in the context of interpretation or diagnosis that would be evaluated in a typical MRMC study. Its "interactive" smartphone technology provides visualization and feedback, but not a diagnostic outcome that would be compared with human readers.

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

The device's core function is to provide objective feedback on pelvic floor muscle contraction to the user via a smartphone app. While the "algorithm" inside the device measures the relative position/bending, its performance is inherently human-in-the-loop because it trains the user. The document details "hardware verification testing," "software validation testing," and "usability testing" as forms of standalone performance evaluation for its components and overall function, but not as a diagnostic algorithm.

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

The "ground truth" for the various tests was based on:

• Engineering Specifications: For hardware and software performance (e.g., ability to withstand a certain number of cycles, accurate sensor readings within defined tolerances, secure communication).
• Regulatory Standards: For safety (IEC 60601 series) and biocompatibility (ISO 10993-1).
• Test Protocols: For packaging (ISTA 2A-2011).
• User Performance: For usability, based on whether volunteers could correctly use and understand the device's interface.

There is no mention of ground truth established by expert consensus, pathology, or clinical outcomes data for the device's primary efficacy in improving incontinence, as this is a 510(k) supporting substantial equivalence, not a premarket approval (PMA) requiring extensive clinical efficacy data. The device's effectiveness for its intended use is asserted based on these engineering and usability tests, and its similarity to a predicate device.

8. The sample size for the training set:

Not applicable. The document does not describe the use of machine learning algorithms that would require a "training set" in the traditional sense. The device's operational principle is based on physical sensor measurements (accelerometers tracking bending) rather than learned patterns from a data set.

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

Not applicable, as there is no "training set" described for machine learning.

Ask a specific question about this device