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BH Medical Dental Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only.

BH Medical Dental Barrier Sleeves and Barrier Film consist of various sizes and shapes of clear polyethylene covers which are positioned on various small hand-held dental instruments such as hand pieces, curing lights, air/water syringes and similar hand instruments. In other forms, they are used to cover various devices such as dental chairs, dental instrument trays, x-ray heads, and others. The products are sold non-sterile, prepackaged, and are disposable, single use only.

The provided text is an FDA 510(k) Premarket Notification letter for BH Medical Dental Barrier Sleeves and Barrier Film. This document does not describe an AI or algorithm-based medical device therefore, it does not contain the information requested regarding acceptance criteria and study details for an AI/ML device.

The document describes the regulatory clearance process for physical medical devices—dental barrier sleeves and film—which are used as disposable barriers for dental instruments and equipment. The performance testing mentioned (e.g., resistance to penetration, tear resistance, biocompatibility) relates to the physical properties of these barrier products, not an AI/ML algorithm's performance.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC studies, as these concepts are not applicable to the device described in the provided text.

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The BH sterilization pouch is intended to provide dentists with an effective method to enclose devices intended for sterilization in steam auto claves. The recommended pre-vacuum steam sterilization cycle parameters are 4 minutes at 132°C (270°F). The sterilization pouch maintains the enclosed devices up until 180 days post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the pouch has undergone a steam sterilization process. Only one instrument can be sterilized in one pouch and only instruments that are be metal, hinged, or knurled can be sterilized in the pouch.

The pouches are made from a medical grade paper and plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is used to seal the paper to the film prior to sterilization of the enclosed medical device. The medical grade paper conforms to recognized material standards and can be steam sterilized. The process indicator ink printed on the medical paper will exhibit a color change after the pouch is exposed to steam sterilization. The device is disposable, single use only.

Here's a breakdown of the acceptance criteria and the study information for the BH Sterilization Pouch, based on the provided document:

Acceptance Criteria and Device Performance

The document summarizes that the device demonstrated it met the acceptance criteria for each test performed. While specific numerical acceptance criteria are not explicitly detailed in a separate table within the document, the "Summary of Non-Clinical Testing" and "Conclusion" sections confirm that testing was conducted and passed. The criteria are implied by compliance with the referenced standards.

Study Details

The provided document describes a non-clinical testing summary for the BH Sterilization Pouch to demonstrate substantial equivalence to a predicate device (Medicom Self Sealing Sterilization Pouch, K070428).

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

• Sample Size: The document does not explicitly state numerical sample sizes for each test (e.g., how many pouches were tested for seal strength). It only lists the test methods used.
• Data Provenance: The studies were non-clinical performance tests conducted for regulatory submission (510(k)) in the People's Republic of China (manufacturer location). It is prospective testing designed to characterize the device's performance according to established standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This is not applicable as the studies are in vitro (non-clinical/bench testing) and do not involve human readers, clinical images, or expert interpretation for ground truth establishment. The "ground truth" is determined by established performance metrics and adherence to international technical standards (e.g., ASTM, ISO).

3. Adjudication method for the test set:
* Not applicable, as there are no human interpretations or disagreements to adjudicate. The tests have predefined pass/fail criteria based on the relevant standards.

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. This is a non-clinical in vitro study of a sterilization pouch, not an AI-powered diagnostic device. MRMC studies are irrelevant in this context.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device does not involve an algorithm or AI.

6. The type of ground truth used:
* The "ground truth" for the non-clinical tests is based on objective, verifiable measurements and comparisons against established international standards and specifications. For instance:
* Seal Integrity: Measured seal strength via ASTM F88, dye penetration via ASTM F1929, and internal pressurization failure via ASTM F1140. The ground truth is the performance metric defined by these standards.
* Sterilant Penetration/Thermal Profile: Measured physical parameters against established successful sterilization conditions.
* Microbial Barrier: Measured resistance to microbial penetration against a defined metric (ASTM 1608).
* Chemical Indicator: Visual observation of color change and comparison against established criteria for a successful indicator as per ISO 11140-1.
* Biocompatibility: Laboratory assays for cytotoxicity, sensitization, and irritation interpreted against the criteria of ISO 10993-5 and ISO 10993-10.

7. The sample size for the training set:
* Not applicable. This device does not use machine learning or AI, and therefore has no "training set."

8. How the ground truth for the training set was established:
* Not applicable, for the reason stated above.

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