(203 days)
UNiPACK Barrier Sleeve and Barrier Film and UNiGlide Barrier Envelope are intended to be used as a barrier to cover dental instruments. This device is non-sterile and intended for single patient use only.
The UNIPACK Barrier Sleeve and Barrier Film consist of various sizes and shapes of polyethylene covers which are positioned on various small hand-held dental instruments such as handpieces, 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, etc. The devices are sold non-sterile, prepackaged, and are for single use only.
The provided document is a 510(k) premarket notification for a medical device called the UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Therefore, many of the requested items related to AI/MRMC studies, human-in-the-loop performance, and expert consensus for ground truth are not applicable to this submission. The tests are for material properties and barrier effectiveness, not for diagnostic or therapeutic efficacy involving AI or human interpretation of medical images.
Here's a breakdown of the acceptance criteria and study information available in the document:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM F1670: Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood | Pass=no penetration (per ASTM F1670) | Material could not be penetrated by synthetic blood under study conditions. Meets requirements. |
| ASTM F1671: Resistance of Materials used in Protective Clothing to Penetration by Blood-Borne Pathogens using Phi-X174 Bacteriophage Penetration as a Test System | Acceptance criteria per ASTM F1671 | Material met criteria of test standard under study conditions. Meets requirements. |
| ASTM D882: Standards Test Methods for Tensile Properties of Thin Plastic Sheeting | Per ASTM D882, no acceptance criteria for this test method. | Results are for information only as there is no P/F criteria. |
| ASTM F1342: Standard Test method for protective Clothing Material Resistance to Puncture | Per ASTM F1342, no acceptance criteria for this test method. | Results are for information only as there is no P/F criteria. |
| ASTM D1004: Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting | Per ASTM D1004, no acceptance criteria for this test method. | Results are for information only as there is no P/F criteria. |
| ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Acceptance criteria per ISO 10993-5. | Test article passed test and determined non-cytotoxic. |
| ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Acceptance criteria for both studies per ISO 10993-10. | Study completed and test article considered non-sensitizer. Study completed and test article considered non-irritant. |
| X-Ray Effectiveness: Effectiveness of X-Ray Devices Covered with Barrier Sleeves | Expert X-Ray reader should not be able to observe differences between images of same objects captured with and w/o Barrier Sleeves covering X-Ray source. | Images were deemed to be the same by a trained X-Ray reader. |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each specific test (e.g., how many barrier sleeves were tested for penetration). It generally refers to "study conducted per [standard]" which implies adherence to the sample size requirements of those specific ASTM/ISO standards. The data provenance is not specified beyond being "non-clinical tests" supporting a US FDA 510(k) submission, suggesting the testing was likely conducted in a controlled lab environment. No information on country of origin or retrospective/prospective nature is provided, as these are material property tests rather than clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For the "X-Ray Effectiveness" test:
- Number of experts: Singularly referred to as "a trained X-Ray reader."
- Qualifications of experts: Only stated as "a trained X-Ray reader." No specific years of experience or board certifications are mentioned.
For other tests (ASTM/ISO standards), the "ground truth" is established by the methodology and objective measurements defined by the respective standards (e.g., chemical analysis for cytotoxicity, physical measurement for tear strength, visual observation for penetration). These do not typically involve human experts establishing "ground truth" in the same way an AI diagnostic system would.
4. Adjudication method for the test set
For the "X-Ray Effectiveness" test, the adjudication method appears to be a single "trained X-Ray reader" making a judgment. There is no mention of multiple readers or an adjudication process (e.g., 2+1, 3+1).
For the other non-clinical tests, adjudication is not applicable as the results are based on objective, standardized test methodologies.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic or AI-assisted devices where human interpretation plays a significant role. The device in question is a physical barrier, not a diagnostic tool or AI software.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device is a physical barrier sleeve/film, not an algorithm or software. Therefore, there is no "algorithm only" performance to evaluate. The tests performed are on the physical properties and barrier effectiveness of the material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For ASTM F1670 & F1671 (Penetration): The ground truth is the objective observation of synthetic blood or bacteriophage penetration according to the standard's methodology.
- For ASTM D882, F1342, D1004 (Tensile, Puncture, Tear): The ground truth is the physical measurement obtained according to the standard's methodology.
- For ISO 10993-5 (Cytotoxicity): The ground truth is the biological response (e.g., cell viability) observed in in vitro cell culture, as interpreted by the standard's criteria.
- For ISO 10993-10 (Irritation/Sensitization): The ground truth is the observed biological response in animal models (guinea pigs, rabbits) according to the standard's criteria.
- For X-Ray Effectiveness: The ground truth is the subjective visual assessment by a "trained X-Ray reader" that images of objects with and without the barrier sleeves are the same. This is the closest to an "expert opinion" ground truth, but it's for equivalence in imaging, not for a diagnostic finding.
8. The sample size for the training set
Not applicable. This device is a physical barrier and does not involve AI or machine learning, thus there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this device, a method for establishing its ground truth is irrelevant.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.