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Brella-Spec™ Vaginal Speculum is used for visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations.

Brella-Spec™ Vaginal Speculum provides the light necessary to illuminate the field during procedures and examinations.

The Brella-Spec™ Vaginal Speculum is a sterile, single-use device with built-in LED illumination system to provide optimal visualization and access during gynecological and obstetrical procedures. This speculum was designed to provide visualization and exposure of the interior of the vagina by a medical professional during gynecological and obstetrical procedures and examinations. The device is ergonomically designed to maximize the view window using two side blades that are opened by a manually operated ratchet mechanism. The device incorporates a fully enclosed LED illumination system. It is composed of medical grade, biocompatible plastic materials.

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving the device meets them:

The document (K133857) describes the Brella-Spec™ Vaginal Speculum and its substantial equivalence to a predicate device (Depalt Vaginal Speculum 2000 Series and Depalt Lighting System, K072762).

Key Finding: The submission explicitly states: "No clinical studies have been done for the purpose of obtaining safety and effectiveness data." This means the device's acceptance criteria are NOT proven through clinical trials or comparative effectiveness studies with human readers or AI assistance. Instead, acceptance is based on bench testing, biocompatibility testing, sterilization validation, packaging validation, and electrical safety testing to demonstrate substantial equivalence to a predicate device.

Given this, many of the specifics requested (like effect size of AI assistance, number of experts for ground truth, sample sizes for test/training sets, etc.) are not applicable to this submission, as it relies on non-clinical data for clearance.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device in terms of technological characteristics, intended use, and performance, supported by non-clinical testing.

• Dimension: Minimal difference, no safety/effectiveness concerns.
• Blade Configuration: Triple blades (subject) vs. dual blades (predicate). Claimed to be "more effective because it provides larger vagina-contacting surface and view window," without impact on safety.
• Blade Movement: 2 articulating blades move horizontally (subject) vs. 1 articulating blade moves vertically (predicate). Claimed to be "more effective because it provides larger view window," without influencing safety.
• Thumb Paddle: 2 thumb paddles (subject) vs. 1 (predicate). Claimed to have "better control" without safety/effectiveness concerns.
• View Window: Adjustable area (5.8-31 cm²) (subject) vs. fixed (18 cm²) (predicate). Claimed to be "more flexible and effective without safety concerns."
• Illumination System: Same as predicate (built-in LED).
• Materials: Different (Polypropylene and Acrylic Polycarbonate for subject vs. Polystyrene for predicate), but biocompatibility testing ensures safety.
• Sterility: Sterile (subject) vs. non-sterile (predicate). Claimed to make the subject device "safer." |

Study Details (Based on Non-Clinical Data)

1. Sample size used for the test set and the data provenance:
   This information is not specified in the provided text for the bench, biocompatibility, sterilization, packaging, and electrical safety tests. The provenance is internal Proa Medical, Inc. testing, not external patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This is not applicable. Ground truth for non-clinical tests (like material properties, sterilization efficacy, electrical output) is established by adherence to recognized standards (ISO, IEC, FDA Blue Book Memo) and engineering specifications, not by expert consensus in a clinical context.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This is not applicable as it pertains to clinical study adjudication, not non-clinical testing.

4. 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, a clinical MRMC study was not done. The document explicitly states: "No clinical studies have been done for the purpose of obtaining safety and effectiveness data." Therefore, there is no information on the effect size of human readers improving with or without AI assistance.

5. 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 manual medical instrument, not an AI or algorithmic device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical tests, the "ground truth" is defined by regulatory standards, engineering specifications, and validated test methods. For example:

   • Biocompatibility: Compliance with ISO 10993.
   • Sterilization: Compliance with ISO 11137.
   • Electrical Safety: Compliance with IEC 60601-1.
   • Performance: Conformity to Proa Medical's internal design specifications.

7. The sample size for the training set:
   This is not applicable. No training set was used as this is a physical medical device, not a machine learning model.

8. How the ground truth for the training set was established:
   This is not applicable as there was no training set.

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