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The Cervilenz Measuring Sound is used for measuring the depth and/or length of the uterus, cervix and vagina.

The Cervilenz Measuring Sound is a single use, disposable device used for measuring the depth and/or length of the uterus, cervix and vagina. The operating principle of the Cervilenz Measuring Sound is the same as that of cleared, commercially-available uterine sounds, and is based on insertion of the device into the cervical canal in order to obtain measurements. The Cervilenz Measuring Sound is fabricated from medical grade plastics of known biocompatibility and with a history of human use.

The provided text describes a 510(k) premarket notification for the "Cervilenz Measuring Sound," a single-use, disposable device for measuring the depth and/or length of the uterus, cervix, and vagina.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

Acceptance Criteria and Device Performance:

The document does not explicitly state quantitative acceptance criteria (e.g., "accuracy must be within X mm"). Instead, it states the device was evaluated for its "accuracy and reproducibility of measurements" and found to perform "equivalently to commercially-available uterine sounds."

Study Details:

The provided text offers very limited information about the study itself. It states "Brief summary of nonclinical tests and results: The Cervilenz Measuring Sound was found to perform equivalently to commercially-available uterine sounds when evaluated for accuracy and reproducibility of measurements."

Here's what can be extracted and what is not provided:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable. This device is a physical measuring sound, not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical device, not an algorithm. However, the "nonclinical tests" likely represent a standalone evaluation of the device's physical properties and measurement capabilities.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For a measuring sound, ground truth would likely be established through:

   • Comparison to a highly accurate reference standard measurement tool.
   • Known physical dimensions of objects being measured.

7. The sample size for the training set: Not applicable. This is a physical device, not a machine learning algorithm that requires a "training set."

8. How the ground truth for the training set was established: Not applicable.

Summary of Device Performance Claim:

The core claim is that the Cervilenz Measuring Sound performs equivalently to predicate uterine sounds in terms of accuracy and reproducibility. This equivalence is presented as sufficient proof that the device meets safety and effectiveness requirements, as its technological characteristics (dimensions, materials, operating principle) are also comparable and do not raise new safety or performance concerns. The specific details of the nonclinical tests conducted to support this equivalence are not provided in this summary.

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