(98 days)
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination. It is also tested to be used against Chemotherapy Drugs. These gloves were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs is made of natural rubber intended to be worn by operating personnel to protect a surgical wound from contamination.
Here's the analysis of the provided text regarding acceptance criteria and the study:
The provided document is an FDA 510(k) clearance letter for a medical device: "Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs".
The document does not describe a study that uses an AI/ML algorithm, nor does it involve human readers, ground truth establishment through expert consensus or pathology for a diagnostic imaging device. Instead, it describes a physical characteristic test for a surgical glove.
Therefore, many of the requested points are not applicable to this document. I will focus on what is relevant to the provided text.
This document describes the testing performed on a surgical glove to assess its permeation by chemotherapy drugs.
1. A table of acceptance criteria and the reported device performance
Based on the provided information, the acceptance criteria are not explicitly stated as quantitative thresholds for "minimum breakthrough detection time" in a formal table like in a software performance study. Instead, the performance is reported against a specific standard and then followed by a warning. The implication is that a higher breakthrough time is better.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Implicit) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (3.3 mg/ml) | Acceptable for use (prior to warning) | 13.1 |
| Cisplatin (1.0 mg/ml) | Acceptable for use | >240 |
| Cyclophosphamide (20.0 mg/ml) | Acceptable for use | >240 |
| Dacarbazine (10.0 mg/ml) | Acceptable for use | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Acceptable for use | >240 |
| Etoposide (20.0 mg/ml) | Acceptable for use | >240 |
| Fluorouracil (50.0 mg/ml) | Acceptable for use | >240 |
| Methotrexate (25.0 mg/ml) | Acceptable for use | >240 |
| Mitomycin C (0.5 mg/ml) | Acceptable for use | >240 |
| Paclitaxel (6.0 mg/ml) | Acceptable for use | >240 |
| Thiotepa (10.0 mg/ml) | Acceptable for use (prior to warning) | 15.7 |
| Vincristine Sulfate (1.0 mg/ml) | Acceptable for use | >240 |
Note regarding acceptance criteria: The document explicitly states: "Please note that Carmustine and Thiotepa have extremely low permeation times of 13.1 minutes and 15.7 minutes respectively. WARNING: Do Not Use With: Carmustine and Thiotepa." This implies that while the gloves were tested with these drugs, their performance was deemed insufficient for safe use, leading to a "Do Not Use" warning. Therefore, for Carmustine and Thiotepa, the implicitly accepted performance might be "not usable," despite the test results being reported. For other drugs, ">240 minutes" is the reported performance and implicitly acceptable for use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily refers to the "Latex Powder Free Surgical Glove" as a single device type. It does not provide specifics on the sample size (e.g., number of gloves tested) for the chemotherapy drug permeation test.
The testing method referenced is ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This is a standardized, laboratory-based physical test.
The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer's testing to support the 510(k) submission. This is a prospective test in the sense that the testing was performed specifically to evaluate the device against this standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. This is a physical test of a device's barrier properties, not a diagnostic or AI/ML study requiring expert ground truth establishment. The "ground truth" is determined by the objective measurement of breakthrough time according to the ASTM standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are relevant for human-interpreted data, such as medical image analysis, not for standardized physical property testing of a device.
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
This is not applicable. This is a physical product, not an AI/ML algorithm or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm. The "standalone performance" here would be the glove's permeation resistance under the specified test conditions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this test is established by the objective measurement of chemical permeation through the glove material using a standardized laboratory method (ASTM D6978-05). It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This is not applicable. There is no AI/ML algorithm involved, and therefore no training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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).