(71 days)
The surgeon's gloves are sterile gloves worn by surgeons, healthcare workers or similar personnel during surgical procedures to prevent contamination between the user and the patient.
Surgeon's Gloves or Surgical Gloves. Anatomical in shape. Hand Specific (Left or Right). Available in sizes 6, 6½, 7, 7½, 8, 8½, 9. Made from Natural Rubber Latex, Sulphur, Zinc Oxide, ZDEC, ZDBC, Titanium Dioxide, Antioxidant (Styrenated Phenol), and Absorbable Corn Starch. Designed to comply with the physical measurements of ASTM D 3577.
The provided document describes a 510(k) submission for Surgeon's Gloves (SUR-G GLOV®) and focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI-based device. Therefore, many of the requested elements for an AI device study (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable and not present in this document.
However, the document does contain information regarding the performance characteristics of the gloves, which can be interpreted as acceptance criteria based on the ASTM D 3577 standard.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is compared against the ASTM D 3577 (91) standard. This standard serves as the acceptance criteria for various physical characteristics of surgeon's gloves.
| Characteristics | Acceptance Criteria (ASTM D 3577 (91)) | Reported Device Performance (SUR-G GLOV®) |
|---|---|---|
| Width Size | ||
| 6 | $76 \pm 6$ | $76 \pm 3$ |
| 6½ | $83 \pm 6$ | $83 \pm 3$ |
| 7 | $89 \pm 6$ | $90 \pm 3$ |
| 7½ | $95 \pm 6$ | $95 \pm 3$ |
| 8 | $102 \pm 6$ | $103 \pm 3$ |
| 8½ | $108 \pm 6$ | $109 \pm 3$ |
| 9 | $114 \pm 6$ | $115 \pm 3$ |
| Length (min) | 265 | 280 |
| Thickness | ||
| Palm mm | 0.10 | $0.21 \pm 0.02$ |
| Finger mm | 0.10 | $0.23 \pm 0.02$ |
| Cuff mm | 0.10 | $0.21 \pm 0.02$ |
| Tensile Strength Min | ||
| (Unaged) | 24 Mpa | 27 Mpa |
| (Aged) | 18 Mpa | 24 Mpa |
| Elongation @ break | ||
| (Unaged) | 750% min | 830% |
| (Aged) | 560% min | 800% |
| Modulus @ 500 % elongation (max.) | 5.5 Mpa | 4.0 Mpa |
| External powder level | NA (Not Available in ASTM standard) | $80 \pm 25$ mg |
| Internal powder level | NA (Not Available in ASTM standard) | $90 \pm 25$ mg |
2. Sample sized used for the test set and the data provenance
The document states "A test certificate of the above is in Appendix B." but Appendix B is not provided in the extracted text. Therefore, the specific sample sizes used for testing these performance characteristics are not available. The data provenance (country of origin, retrospective/prospective) is also not available from the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is a physical device (surgical gloves), and its performance is measured against established engineering and material standards (ASTM D 3577), not by expert interpretation or ground truth derived from expert consensus.
4. Adjudication method for the test set
Not Applicable. As per point 3, the assessment is against a standard, not expert 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 is not an AI-based device, and therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is not an AI algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance is adherence to the ASTM D 3577 standard for surgical gloves, which defines acceptable physical properties.
8. The sample size for the training set
Not Applicable. This is not an AI device that requires a training set. The gloves are manufactured and tested against specifications.
9. How the ground truth for the training set was established
Not Applicable. No training set is relevant for this device. The "ground truth" (i.e., the standard specifications) for manufacturing and testing are established by ASTM International.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).