(105 days)
The Pure Advantage Nitrile Surgical Glove, Hypoallergenic is "a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination" (21CFR 878.4460).
The Pure Advantage Nitrile Hypoallergenic Surgical glove is a nitrile rubber product manufactured in accordance with the requirements of ASTM D3577 (Typell) and ASTM D5151 requirements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Pure Advantage Nitrile Hypoallergenic Surgical Glove.
The document describes a 510(k) submission for a new surgical glove, comparing it to an existing predicate device. The studies described are primarily non-clinical and aim to demonstrate substantial equivalence, particularly regarding performance standards and safety for hypoallergenic claims.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Standards) | Proposed Device Performance (Pure Advantage Nitrile Surgical Hypoallergenic) | Predicate Device Performance (Pure Advantage Nitrile Surgical) |
|---|---|---|---|
| Performance | ASTM D 3577 [Type 2] | Meets ASTM D 3577 [Type 2] | Meets ASTM D 3577 [Type 2] |
| Water Tightness | ASTM D 5151 | Meets ASTM D 5151 | Meets ASTM D 5151 |
| Safety | Passing Rabbit Irritation Test | Passes | Passes |
| Guinea Pig Maximization | Passing Guinea Pig Maximization | Passes | Passes |
| Modified Draize Repeat Insult Patch Test (for Hypoallergenic Claim) | Passing (No sensitization in 200 human subjects) | Passes | Passes |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the Modified Draize Repeat Insult Patch Test, 200 human subjects were used.
- Data Provenance: The document does not explicitly state the country of origin for the human subjects in the Modified Draize test, but given the submitter and FDA context, it's likely U.S.-based. The study is prospective for the purpose of this submission, though the method itself is a standard clinical evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (Modified Draize Repeat Insult Patch Test) does not typically involve "experts" establishing a ground truth in the same way an imaging study would. The ground truth is the objective physiological response of the human subjects to the glove material (i.e., whether sensitization occurs). The test is conducted and evaluated by trained personnel in a clinical setting, but the document does not specify the number or qualifications of these personnel. The assessment of "Passes" implies a qualified professional interpretation against established dermatological criteria for irritation and sensitization.
4. Adjudication Method for the Test Set
Not applicable for this type of test. The Modified Draize test involves direct observation of skin reactions by trained clinical personnel, not a consensus or adjudication process among multiple independent reviewers as seen in, for example, medical image interpretation studies.
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, an MRMC comparative effectiveness study was not done. This device is a surgical glove, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not an AI algorithm. The performance evaluation is for a physical medical device.
7. The Type of Ground Truth Used
The ground truth for the safety tests (like the Modified Draize) is based on direct physiological responses observed in human subjects (or animal models for pre-clinical tests) according to established dermatological and toxicological protocols. For performance, the ground truth is established by objective measurements against recognized ASTM standards.
8. The Sample Size for the Training Set
There is no explicit "training set" mentioned in the context of machine learning, as this is a physical device submission. However, if interpreting "training set" as the data used to validate the product design and manufacturing process before the final testing for the submission, the document doesn't provide this detail. The safety studies explicitly mentioned for the submission used 200 human subjects for the patch test.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI sense, this question is not applicable. The design and manufacturing of the glove would be informed by general material science, engineering principles, and previous experience with similar products, all aiming to meet the specified ASTM standards and safety profiles. The objective "ground truth" for these ongoing processes would be adherence to the physical and chemical properties and safety profiles defined by scientific understanding and regulatory requirements.
§ 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).