(469 days)
Their intended use is to prevent an interchange of body fluids via the hands of the wearer and the person (patient) being examined. Specifically, they are designed to prevent blood or other body fluids from the hands of the wearer from being transferred to the examinee. Also they are designed to prevent body fluids from the examinee from being transferred to the wearer via the wearer's hands.
Oak Carolina examination gloves are made from poly vinyl chloride (vinyl). They are to be marketed under the trade name Sensi-tex.
The provided text describes a medical device, specifically Oak Carolina Examination Gloves, and outlines its specifications and some testing results. However, it does not describe an AI/ML powered device or a study involving such a device, and therefore the specific questions you've asked about acceptance criteria and a study proving an AI device meets them are largely not applicable.
The document focuses on the physical properties and basic performance of examination gloves as per FDA requirements in 1996 for a 510(k) submission.
Here's an attempt to answer your questions based on the provided text, flagging where the information is not present or not applicable to an AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material | Poly vinyl chloride (vinyl) |
| Trade Name | Sensi-tex |
| Width | |
| Small | $92 \pm 5mm$ |
| Medium | $105 \pm 5mm$ |
| Large | $114 \pm 5mm$ |
| X-Large | $124 \pm 5mm$ |
| Length (minimum) | 230mm (for all sizes) |
| Tensile (minimum) | 1310 PSI (for all sizes) |
| Elongation (minimum) | 300% (for all sizes) |
| Thickness (range) | |
| Finger | 4-6 mils (for all sizes) |
| Palm | 9-13 mils (for all sizes) |
| Water Leak Requirements (ASTM D5151-92) | Meets 1000 ml water test leak requirements |
| Biocompatibility | Not a primary irritant to the skin |
| Accelerated Aging | Meets physical requirements before and after accelerated aging at 158 ±4.5ºF |
| Additives | No color or flavor additives, no dusting or donning powder |
Regarding AI-specific acceptance criteria (Sensitivity, Specificity, AUC, etc.): Not applicable. This document is for a medical glove, not an AI device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions physical requirements tested "before and after accelerated aging" and "when tested in accordance with ASTM D5151-92" and "Biocompatibility studies." However, specific sample sizes for these tests are not provided.
- Data Provenance: The document is dated April 26, 1996, and relates to a submission to the FDA in the USA. The manufacturer is "Oak Carolina Inc. 100 Roe Road Travelers Rest, S.C. 29690" in the USA. The data would therefore be assumed to be from tests performed in the USA by the manufacturer. It is a report on testing, so it can be considered a retrospective summary of completed tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This pertains to a physical product's performance against pre-defined engineering and safety standards, not an AI model's diagnostic accuracy where expert ground truth is typically used. The "ground truth" here is the pass/fail result of physical and chemical tests against established standards (e.g., ASTM standards).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This concept typically applies to discrepancies in expert annotations for AI model ground truth. The tests described are objective measurements (e.g., width, length, tensile strength, water leak) against a standard, not subjective interpretations requiring adjudication.
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 document describes a physical medical device (examination gloves), not an AI algorithm designed to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a physical medical device (examination gloves), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the glove's performance is based on objective measurements against established industry standards (e.g., ASTM D5250, ASTM D5151-92) and biocompatibility testing. This is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device (examination gloves), not an AI algorithm that undergoes training.
9. How the ground truth for the training set was established
- Not applicable. This document describes a physical medical device (examination gloves), not an AI algorithm.
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AUG 12 1996
Image /page/0/Picture/2 description: The image shows the logo for OAK CAROLINA INC. The word "OAK" is in a stylized font and is surrounded by an oval shape. The words "CAROLINA INC." are to the right of the logo in a bold, sans-serif font.
April 26, 1996
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
Attention: To whom it may concern
Subject: Summary of Safety and Effectiveness Information for Oak Carolina Examination Gloves.
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Oak Carolina Inc. 100 Roe Road Travelers Rest, S.C. 29690
Oak Carolina examination gloves are made from poly vinyl chloride (vinyl). They are to be marketed under the trade name Sensi-tex. Their intended use is to prevent an interchange of body fluids via the hands of the wearer and the person (patient) being examined. Specifically, they are designed to prevent blood or other body fluids from the hands of the wearer from being transferred to the examinee. Also they are designed to prevent body fluids from the examinee from being transferred to the wearer via the wearer's hands.
This product is donned or placed on the hands. Care should be taken to prevent rips and tears during donning and use.
The specifications for the gloves are as follows:
| Style Number | 96-160 | 96-260 | 96-360 | 96-460 |
|---|---|---|---|---|
| Size | Small | Medium | Large | X-Large |
| Width | $92\pm5mm$ | $105\pm5mm$ | $114\pm5mm$ | $124 \pm 5mm$ |
| Length(minimum) | 230mm | 230mm | 230mm | 230mm |
| Tensile(minimum) | 1310 PSI | 1310 PSI | 1310 PSI | 1310 PSI |
| Elongation(minimum) | 300% | 300% | 300% | 300% |
| *Thickness(range) | ||||
| Finger | 4-6 mils | 4-6 mils | 4-6 mils | 4-6 mils |
| Palm | 9-13 mils | 9-13 mils | 9-13 mils | 9-13 mils |
The product meets the physical requirements specified above both before and after accelerated aging at 158 ±4.5ºF.
*Measured per ASTM D5250 Fig. 1
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This product when tested in accordance with ASTM D5151-92 meets the 1000 ml water test leak requirements.
This product contains no color or flavor additives. No dusting powder or donning powder is used in the manufacture of this product.
Biocompatibility studies demonstrate that this product is not a primary irritant to the skin.
This product, a vinyl examination glove is substantially equivalent in composition and function to other vinyl examination gloves.
Sincerely,
Guy Dempsey
Greg Dempsey Quality Assurance Manager
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.