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510(k) Data Aggregation
(200 days)
The Caya® contoured diaphragm is indicated for the prevention of pregnancy in women who elect to use diaphragms as a method of contraception. It is recommended for use with a contraceptive gel.
The Caya® contoured diaphragm is a contoured, flexible, single-sized, silicone elastomer cup for covering the cervix that is circumscribed by a rim encapsulating a nylon spring. The Caya contoured diaphragm has an anatomically shaped spring that has been designed to fit women representing a range of traditional diaphragm sizes.
The document describes the Caya® contoured diaphragm and its clinical study to demonstrate substantial equivalence to a predicate device, the ORTHO® ALL-FLEX® Diaphragm.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" but rather describes a non-inferiority finding compared to a historical control group using the predicate device. The primary performance metric is the 6-month Kaplan-Meier cumulative typical-use pregnancy probability.
| Acceptance Criterion (Implicit) | Reported Device Performance (Caya® contoured diaphragm) |
|---|---|
| Non-inferiority in 6-month typical-use cumulative pregnancy probability compared to the ORTHO® ALL-FLEX® Diaphragm (historical control). | The 6-month Kaplan-Meier cumulative typical-use pregnancy probability for all Caya users was 10.4 per 100 women (95% CI: 6.9, 14.0). The document explicitly states: "The rate for all SILCS users was non-inferior to the rate for all users of the ORTHO® ALL-FLEX® Diaphragm, using data from the historical control groups." |
| Clinical safety profile similar to the predicate device. | The document states: "The single-sized Caya diaphragm has a similar clinical safety profile as the predicate device." (No specific quantitative metrics provided in this summary, but this was an outcome of the study.) |
| Acceptability and ease of use (no specific quantitative acceptance criteria mentioned, but these were study outcomes). | These were study outcomes, but specific acceptance criteria or performance metrics are not detailed in this summary. |
| Biocompatibility testing in accordance with ISO 10993 (passed). | Device passed. |
| Performance testing in accordance with ISO 8009 (passed). | Device passed. |
| Cleaning validation (passed). | Device passed. |
| Barrier effectiveness (pre-pivotal study finding). | Reduced average number of progressively motile sperm per high powered field from 12.5 to 0 in a Phase I post-coital study. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Pivotal Study): 450 couples recruited.
- 300 couples randomized to Caya® contoured diaphragm (referred to as SILCS diaphragm) with BufferGel.
- 150 couples randomized to Caya® contoured diaphragm with N-9 spermicide gel.
- Data Provenance: The pivotal study for the Caya® contoured diaphragm was conducted at six sites in the United States. It was a prospective study. The historical control data for the predicate device was from a multi-center contraceptive study conducted by the National Institute for Child Health and Human Development (NICHD), likely also from the US.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a contraceptive device's effectiveness study, the "ground truth" of pregnancy is typically established by medical diagnosis (e.g., urine/blood tests in a clinical setting by trained medical staff), not typically by "experts" in the way an imaging study would use radiologists. The document mentions "Study outcomes included pregnancy probability, safety, acceptability, diaphragm fit, and ease of use." Medical professionals at the study sites would have been responsible for diagnosing pregnancy and assessing other outcomes.
4. Adjudication Method for the Test Set
This information is not provided beyond the general design of a randomized controlled trial. For pregnancy, the outcome is relatively clear. For safety or device fit/ease of use, the document doesn't detail any specific adjudication committee or method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. This device is a physical contraceptive diaphragm, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The primary ground truth for the pivotal study was pregnancy outcomes. This would have been established through clinical diagnosis by medical professionals at the study sites. Other outcomes included safety (e.g., adverse events diagnosed by medical staff), acceptability, diaphragm fit, and ease of use (likely assessed via patient questionnaires and clinician evaluations).
8. The Sample Size for the Training Set
This information is not applicable as the Caya® contoured diaphragm is a physical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device underwent design, development, and evaluation, which involved iterative testing, but not a "training set" of data for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. Design and development involved various engineering, biocompatibility, and preliminary clinical tests (like the Phase I post-coital study), but these are part of product development and validation, not "training an algorithm."
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