(166 days)
The Intimina KegelSmart and Intimina KegelSmart Pearl are intended for independent use by women at home to strengthen pelvic floor muscles to treat stress and/or urge urinary incontinence.
The Intimina KegelSmart and KegelSmart Pearl are pelvic floor muscle exercise devices that provides biofeedback and exercise guidance. Each time the device is used it registers the user's pelvic floor muscle contraction strength and automatically sets a strength level, from 1 to 5, for the following session. Each level has a corresponding exercise routine that is communicated to the user with gentle vibrations.
The provided text is a 510(k) Summary for the Intimina KegelSmart and KegelSmart Pearl devices. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain a specific study proving the device meets acceptance criteria in terms of clinical performance metrics like sensitivity, specificity, accuracy, or effect size for improvement in human readers with AI assistance.
Instead, the document focuses on:
- Substantial Equivalence: Comparing the technological characteristics of the new device to a predicate device (The Reflex Treatment System).
- Safety and Performance Standards: Stating conformity with biological evaluation (ISO 10993) and electrical safety (IEC 60601) standards, and software guidance.
- Functional Performance Testing: A brief mention that functional performance testing was provided to demonstrate the device operates per its Instructions for Use, without detailing the results or acceptance criteria for this testing.
- Literature Review: A general statement about evidence in published literature regarding the effectiveness of pelvic floor muscle training for urinary incontinence.
Therefore, I cannot populate the requested table (1) or address points 2-7, 9 in detail based solely on the provided text, as this information is not present. The document describes a regulatory submission for substantial equivalence based on technological similarity and compliance with general safety/performance standards, not a clinical study demonstrating specific performance metrics against defined acceptance criteria for the new device.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric / Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Equivalence (Implicit Acceptance Criteria for 510(k) substantial equivalence) | |
| * FDA Classification: Class II, perineometer 884.1425 (HIR) | Conforms (Same as predicate) |
| * Intended Use: For the treatment of stress and/or urge urinary incontinence in females | Conforms (Same as predicate) |
| * Target Population: Women experiencing symptoms of pelvic floor muscle weakness and mild incontinence | Conforms (Same as predicate) |
| * Anatomical Site: Probe inserted vaginally | Conforms (Same as predicate) |
| * Method of Function (General): Registers user's pelvic strength, assigns strength level, guides through exercise routines. | Conforms (Similar to predicate, differing in feedback mechanism - vibration vs. visual, and specific exercise routines/levels) |
| * Key safety/materials: Medical grade silicone, 1xAAA battery, cleaned but not sterile, single patient device. | Conforms (Comparable to predicate) |
| * Electrical Safety Standards (e.g., IEC/EN 60601-1, IEC/EN 60601-1-2): Compliance with relevant electrical safety and EMC standards. | Conforms (Stated conformity with IEC/EN 60601-1 3rd ed., IEC/EN 60601-1-2:2007) |
| * Biocompatibility Standards (e.g., ISO 10993-5, ISO 10993-10): Compliance with relevant standards for in vitro cytotoxicity, irritation, and skin sensitization. | Conforms (Stated conformity with ISO 10993-5 and ISO 10993-10) |
| * Software Guidance: In line with FDA guidance for software in medical devices. | Conforms (Stated compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005) |
| * Functional Performance: Operates per its Instructions for Use. | "Functional performance testing was provided... demonstrating that it operates per its Instructions for Use." (No specific metrics or acceptance criteria for this functional performance testing are detailed in the document). |
| Clinical Efficacy (Based on literature, not a specific device study outlined here): Regular pelvic floor muscle training results in a significant increase in pelvic floor muscle strength and is an effective treatment for stress or mixed urinary incontinence. (Implicit expectation for similar devices, not a specific acceptance criterion for this device's clinical trial). | "There is evidence in the published literature that regular pelvic floor muscle training results in a significant increase in pelvic floor muscle strength, is an effective treatment for stress or mixed urinary incontinence." (This refers to the general efficacy of the therapy, not a clinical trial of the specific device meeting its individual performance criteria.) |
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 (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
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, as this is not an AI-assisted diagnostic device, and no MRMC study or AI component in that context is discussed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-only device in the diagnostic sense. The device itself (hardware and embedded software) provides guidance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned for any specific study of the device. The "ground truth" for the device's efficacy is largely derived from the existing medical literature on pelvic floor muscle training.
8. The sample size for the training set: Not applicable; this device is not a machine learning model that requires a training set in the typical sense for image analysis or diagnostics. Its "training" happens internally as it adapts to the user's strength.
9. How the ground truth for the training set was established: Not applicable for the reasons mentioned in point 8.
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).