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510(k) Data Aggregation
(259 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Patient Examination Glove (Non-Sterile) is a patient examination glove available in S, M, L, XL. The glove is provided non-sterile and meets the entire requirement of ASTM standard D 5250-06.
The provided text is a 510(k) premarket notification for a medical device: "Powder Free Vinyl Patient Examination Glove (Non-Sterile)". The document outlines the device description, intended use, and a comparison to a predicate device.
However, the information requested in the prompt, specifically regarding acceptance criteria and the study that proves the device meets the acceptance criteria, is presented in a different context than typically found in AI/ML performance studies. This document pertains to the regulatory clearance of a physical medical device (examination gloves), not an algorithmic or AI-powered one.
Therefore, many of the requested fields are not applicable in this context. I will extract the relevant information regarding performance criteria and how the device meets them from the provided text.
Here's the breakdown of the acceptance criteria and the supporting information:
1. A table of acceptance criteria and the reported device performance
| Characteristics | Acceptance Criteria (Subject Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| Dimension | Length: $\geq$ 230mm | Meets ASTM D5250-06. |
| Width: S size=85mm ± 5mm; M size=95mm ± 5mm; L size=105mm ± 5mm; XL size=115mm ± 5mm | Meets ASTM D5250-06. | |
| Thickness | Finger thickness $\geq$ 0.05mm | Meets ASTM D5250-06. (Implied, as the general statement "Meets ASTM D5250-06" covers these physical properties. The table formatting makes it seem like these are separate rows but they fall under the 'Dimension' and 'Physical Properties' characteristics for the subject device.) |
| Palm thickness $\geq$ 0.08mm | Meets ASTM D5250-06. (Implied) | |
| Physical Properties | Tensile strength $\geq$ 11MPa; Elongation $\geq$ 300% | Meets ASTM D 5250-06. |
| Freedom from pinholes | No leaks; AQL requirement: 2.5 with an accept/reject criteria of 2/3, sample size of 32 (Meets ASTM D5250-06) | Meets ASTM D5250-06. |
| Powder Residual | Powder residue $\leq$ 1.1; Meets ASTM D5250-06 and D6124-06 | Meets ASTM D5250-06 and D6124-06. |
| Cytotoxicity | Not cytotoxic (ISO 10993-5: 2009) | Under the conditions of the study, not cytotoxic. The device passed all biocompatibility testing. |
| Biocompatibility | Not an irritant (Primary Dermal Irritation in rabbits, ISO 10993-10: 2010); Not a sensitizer (Dermal Sensitization in the guinea pig, ISO 10993-10: 2010) | Under the conditions of the study, not an irritant. Under conditions of the study, not a sensitizer. The device passed all biocompatibility testing. (Note: Only ISO 10993-10: 2010 is explicitly cited for irritation/sensitization in the table, but the text mentions ISO 10993-1 for overall biocompatibility evaluation, including irritation and skin sensitization tests.) |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set:
- For "Freedom from pinholes," the sample size is explicitly stated as 32.
- For other physical and material properties (dimension, tensile strength, elongation, powder residual), the sample sizes are not specified in the provided text, but it's implied that testing was conducted according to the respective ASTM standards.
- For biocompatibility tests, the sample sizes for animal tests (rabbits, guinea pigs) are not specified.
- Data Provenance: The testing was conducted by or for LPL (HUI ZHOU) GLOVE CO., LTD in China, as stated by their address in the submitter information. The text does not specify whether the data is retrospective or prospective, but testing for regulatory submission typically involves prospective testing of manufacturing lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the evaluation of a physical medical device like examination gloves. "Ground truth" and "experts" in this context don't align with the AI/ML paradigm. The acceptance criteria are based on established international standards (ASTM, ISO) for physical and material properties and biological safety. Compliance is measured quantitatively.
4. Adjudication method for the test set
Not applicable. The evaluation is against objective, quantitative standards (e.g., specific dimensions, tensile strength values, AQL levels). There's no human "adjudication" in the sense of reconciling differing expert opinions.
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
Not applicable. This is a physical medical device, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is defined by:
- International Standards: Specifically, ASTM D5250-06 (Standard Specification for Vinyl Patient Examination Gloves for Medical Application), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), and ASTM 5151-06 (likely D5151, Standard Test Method for Detection of Holes in Medical Gloves).
- Biocompatibility Standards: ISO 10993-5: 2009 (Cytotoxicity), ISO 10993-10: 2010 (Irritation and Skin Sensitization), and the general framework of ISO 10993-1.
These standards provide the quantitative and qualitative benchmarks against which the device's performance is measured.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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