(76 days)
THIS DEVICE IS A DISPASABLE DEVICE INTENDED for MEDICAL PURPOSES THAT IS WERN ON THE EXAMINER'S Official T AND HAND TO PREVENT CONTAMINATION SETWEEN EXAMINER
SATARI® latex patient examination glove, is a powder glove single side polymer coated, non sterile, 200 ug or less of total water extractable protein per gram, 10 mg/dm- or less of residual powder
The provided text is a 510(k) summary for the SATARI® latex patient examination glove. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria through performance evaluation.
Therefore, many of the requested sections about study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness simply cannot be answered from the provided document. The document does not describe such a study.
However, I can extract the acceptance criteria that are implied through the device description and the "identical" or "similar" comparisons.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the description of the device and the comparison to the predicate device. Since the device claims substantial equivalence, the "acceptance criteria" are essentially matching the characteristics of the predicate device and meeting regulatory standards for examination gloves.
| Acceptance Criterion | Reported Device Performance (as stated in document) |
|---|---|
| Total water extractable protein | "200 µg or less of total water extractable protein per gram" |
| Residual powder | "10 mg/dm² or less of residual powder" |
| Intended Use | "Identical" to predicate: "A disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." |
| Target Population | "Identical" to predicate |
| Design | "Similar" to predicate |
| Materials | "Identical" to predicate |
| Performance | "Identical" to predicate (Implies meeting the same physical performance standards like tensile strength, puncture resistance, etc., but specific values are not provided in this summary) |
| Sterility | "Identical" to predicate (Non-sterile) |
| Biocompatibility | "Identical" to predicate |
| Mechanical Safety | "Identical" to predicate |
| Chemical Safety | "Identical" to predicate |
| Anatomical Sites | "Identical" to predicate |
| Human Factors | "Identical" to predicate |
| Where Used | "Identical" to predicate |
| Standards Met | "Identical" to predicate (Implies meeting relevant ASTM or ISO standards for examination gloves, but specific standards are not listed in the provided text). |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. The document does not detail a specific performance study with a test set. It relies on a comparison to a predicate device and states "Technical comparison of specific elements is attached in the main submission."
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is described as there is no specific test set study detailed.
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 medical glove, not an AI diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical glove, not an algorithm.
7. The type of ground truth used:
- Not applicable in the sense of a diagnostic or imaging study. The "ground truth" for this device's performance would be adherence to established material specifications, manufacturing standards, and regulatory requirements for patient examination gloves. The document implies compliance through comparison to its predicate device and adherence to listed protein and powder limits.
8. The sample size for the training set:
- Not applicable. This document does not describe a training set as it's not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. This document does not describe a training set.
§ 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.