(90 days)
The PeriCoach is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.
The PeriCoach® device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of contraction of the user's pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device to be supplied under prescription only.
The provided text appears to be a 510(k) summary for the PeriCoach device, which is a perineometer. This document is primarily focused on demonstrating "substantial equivalence" to a predicate device (Neen Healthcare Periform K002617) to obtain FDA clearance, rather than detailing a study that establishes explicit acceptance criteria and corresponding device performance in clinical use. Thus, much of the requested information regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample sizes," "expert ground truth," "adjudication methods," and "MRMC comparative effectiveness studies" is not explicitly present.
However, based on the information provided, we can infer some aspects related to non-clinical testing and the basis for substantial equivalence.
Here's an attempt to answer your questions based on the provided text, with many fields being marked as "Not explicit in text" where the information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to a legally marketed predicate device. The document summarizes the non-clinical testing performed to establish this. Explicit acceptance criteria with quantitative thresholds for performance metrics (e.g., sensitivity, specificity, accuracy) are not provided in this summary.
| Acceptance Criteria (Implied/Inferred for Substantial Equivalence) | Reported Device Performance (Non-Clinical Test Results) |
|---|---|
| Biocompatibility (ISO 10993 compliance) | Pass: Tested for Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Vaginal Irritation (ISO 10993-10), and Systemic Toxicity (ISO 10993-11). Found to be safe for the intended purpose. |
| Electrical Safety (IEC 60601-1 compliance) | Pass: Conducted in accordance with IEC 60601-1:2005. |
| Electromagnetic Compatibility (IEC 60601-1-2 compliance) | Pass: Conducted in accordance with IEC 60601-1-2:2007. |
| Home Healthcare Environment Electrical Safety (IEC 60601-1-11) | Pass: Conducted in accordance with IEC 60601-1-11:2010. |
| Software Verification & Validation (IEC 62304 compliance) | Pass: Conducted in accordance with IEC 62304:2006. |
| Mechanical Durability | Pass: Various mechanical tests conducted, including drop testing, durability testing, immersion/long term cleaning exposure, and sensor behavior testing. Results indicate device is effective for intended use. (Specific values or thresholds not provided). |
| Chemical Safety | Pass: Probe outer surface constructed of chemically inert materials and tested in accordance with ISO10993 standards. |
| Functional Equivalence (Principle of Operation) | Substantially Equivalent: Both devices use a probe inserted into the vagina to determine strength of pelvic floor muscles and encourage/assist with Kegel exercises via feedback. PeriCoach uses force sensing resistors (wireless) vs. predicate's sEMG biofeedback (wired). Changes are not new safety/efficacy concerns. |
| Anatomical Sites & Target Population | Substantially Equivalent: Female Pubococcygeus muscle area; Adult female urinary incontinence. |
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: Not explicit in the text. The document refers to non-clinical testing (biocompatibility, electrical safety, mechanical tests, software V&V) of the device itself, rather than a clinical human subject test set.
- Data Provenance: Not explicit in the text. The company is based in Australia. The non-clinical tests were conducted according to international standards (ISO, IEC).
- Retrospective or Prospective: Not applicable as no clinical study on human subjects is described for proving performance against acceptance criteria in the context of efficacy for the indication. The tests were primarily device characterization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not explicit in the text. This document does not describe a clinical study where expert ground truth was established for a test set. The non-clinical tests rely on compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not explicit in the text. No clinical test set requiring adjudication is described.
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 is mentioned. This device is a biofeedback perineometer, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not an "algorithm only" device in the typical AI sense. Its primary function is a measurement and biofeedback device. The non-clinical testing establishes the standalone performance of the device's components (sensors, software, electrical safety, etc.) as detailed in Q1. The device itself (the probe and its communication to the smartphone app) constitutes the "standalone" element being tested for safety and basic function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For Non-Clinical Testing: The "ground truth" for the non-clinical tests referred to here is compliance with established international standards (ISO 10993, IEC 60601 series, IEC 62304) and manufacturer specifications for mechanical performance. There isn't a "clinical ground truth" like pathology or outcomes data presented in this summary for the purpose of demonstrating efficacy.
8. The sample size for the training set
- Not applicable/Not explicit in the text. This document does not pertain to an AI model that would require a "training set." The software verification and validation are for the device's operational software, not for training a predictive model.
9. How the ground truth for the training set was established
- Not applicable/Not explicit in the text. Not relevant for this type of device and submission.
Summary Interpretation:
The provided document, a 510(k) summary, is intended to demonstrate that the PeriCoach device is "substantially equivalent" to a previously cleared predicate device. This is achieved by showing that:
- It has the same intended use.
- It has similar technological characteristics (or that any differences do not raise new questions of safety and efficacy).
- Non-clinical testing (biocompatibility, electrical safety, mechanical durability, software V&V) confirms its safety and performance in alignment with relevant standards, thereby addressing any potential new safety or efficacy concerns arising from the differences (e.g., wireless feedback, different materials).
The document does not present results from a clinical trial or study designed to establish quantitative efficacy or performance metrics for the device's ability to "treat stress, mild-moderate urge and mixed urinary incontinence" in human subjects. The approval is based on the idea that if it's substantially equivalent in terms of safety and how it works, and the predicate device is already cleared for that indication, then this device can also be cleared.
§ 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).