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510(k) Data Aggregation
(387 days)
The Inner Peace™ pelvic exercise device is recommended for the strengthening of perineal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.
Inner Peace™ is a one-piece, silicone intravaginal pelvic-floor exercise device that squeezes down to be easily inserted, only to spring back to its original shape to fit comfortably and snugly against the vaginal walls. The enclosed spring provides resistance as the User performs kegel exercises to strengthen and tone the pelvic floor muscles
The provided text describes Kamabry, Inc.'s "Inner Peace™" pelvic floor exerciser and its 510(k) submission, K122800. The device is a Class II perineometer intended "for the strengthening of perineal pelvic floor muscles by offering resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women."
The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a standalone study. The primary method of demonstrating acceptance is through biocompatibility testing and mechanical performance testing, combined with a comparison to legally marketed predicate devices.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Tested in accordance with ISO 10993 Recognized Standards, found to be safe for intended use, biocompatible, non-toxic, and well-tolerated by mucosal membranes. |
| Mechanical Safety | Various mechanical tests performed to establish safe use. (Specific criteria/results not detailed) |
| Material | Polydimethylsiloxane (silicone) for the device body, similar to predicate devices. |
| Operating Principle | Resistive pelvic floor strengthener (embedded spring), similar to predicate devices. |
| Indications for Use | Strengthens pelvic floor muscles, corrects urinary incontinence in women. Identical to predicate devices. |
| Sterility | Clean, but not sterile. Similar to predicate devices. |
| Target Population | Women with mild incontinence. Similar to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility Testing: The document states "ISO 10993 testing results indicated material is biocompatible." However, it does not specify the sample size used for this testing or the provenance of the data (e.g., whether it was animal studies, in-vitro, or human clinical data).
- Mechanical Performance Testing: The document states "Various mechanical tests were performed to establish safe use." Again, no sample size or data provenance is provided for these tests.
- Clinical Efficacy/Effectiveness: No clinical test set or human subject data is mentioned or appears to have been used to prove the device's ability to "correct urinary incontinence in women." The submission relies on substantial equivalence to predicates that claim this indication.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The submission does not describe clinical testing or the establishment of a ground truth through expert consensus for a test set. The claim of efficacy ("correct urinary incontinence") is made based on similarity to predicate devices, not on a study with ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation (e.g., radiologists reading images), which is not relevant to this pelvic floor exerciser.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, a "standalone" assessment of the device's physical properties and biocompatibility was performed. The biocompatibility and mechanical performance tests were done on the device itself, without human interaction measuring its performance in a clinical setting for efficacy. However, this is not the typical context of a "standalone" study for AI algorithms.
7. The Type of Ground Truth Used
- Biocompatibility: The "ground truth" was established by recognized standards (ISO 10993). Compliance with these standards served as the basis for concluding biocompatibility.
- Mechanical Safety: The "ground truth" was likely established against engineering specifications or validated internal test methods to ensure safe operation.
- Clinical Efficacy (for incontinence): No specific ground truth was established by this submission for clinical efficacy in correcting incontinence. Instead, the device relies on the "ground truth" of the predicate devices' established efficacy when claiming substantial equivalence for this indication.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI or algorithm-based product that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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