(139 days)
Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Gammex Non Latex Pl White Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and ling chemotherapy agents
This document is a 510(k) Premarket Notification from the FDA for a medical device: Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs. The document details the substantial equivalence determination for the device.
Based on the provided text, the device in question is surgical gloves, not an AI/algorithm-based diagnostic or assistive device. Therefore, many of the requested elements of the prompt (ground truth establishment for training/test sets, expert adjudication, MRMC studies, AI effect size, etc.) are not applicable to this type of medical device submission.
The "acceptance criteria" for a physical device like a glove are typically performance specifications based on established standards (e.g., ASTM standards for dimensions, physical properties, lack of holes, chemical permeation). The "study that proves the device meets the acceptance criteria" refers to non-clinical laboratory testing.
Here's an attempt to answer the prompt using the available information, noting where AI-specific questions are not relevant:
Device: Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs
Type of Study: Non-clinical laboratory testing to assess the physical properties, chemical permeation resistance, and biocompatibility of the surgical gloves, demonstrating substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from ASTM standards/device specifications) | Reported Device Performance (Result Summary) |
|---|---|
| Dimensions (ASTM D3577) | Meets ASTM D3577 requirements for length, width, and thickness. |
| - Length: Minimum 265mm | Average 301mm |
| - Palm Width (per size): e.g., 5.5 (70±6mm), 6.0 (76±6mm) etc. | Average values: 5.5 (74mm), 6.0 (80mm), 6.5 (86mm), 7.0 (92mm), 7.5 (97mm), 8.0 (103mm), 8.5 (111mm), 9.0 (119mm) |
| - Thickness (Finger): Minimum 0.10mm | 0.233mm |
| - Thickness (Palm): Minimum 0.10mm | 0.172mm |
| - Thickness (Cuff): Minimum 0.10mm | 0.212mm |
| Physical Properties (ASTM D3577-09) | Meets ASTM D3577-09 requirements for tensile strength, ultimate elongation, and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves. |
| Freedom from holes (ASTM D3577-09, ASTM D5151-06) | Meets ASTM D3577-09 and ASTM D5151-06 requirements of AQL 1.5. (Note: Comparison table implies a stricter AQL for subject device at 0.65 vs. predicate's 1.5, suggesting better performance). |
| Powder-Free (ASTM D3577-09, ASTM D6124-06) | Meets Applicable requirement for Powder Free; ≤ 2 mg per glove. Average residual powder content for the glove during process validation is 0.16mg per glove. |
| Sterility (ANSI/AAMI/ISO 11137-1:2006) | Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL. |
| Biocompatibility: | |
| - ISO in vitro cytotoxicity (ISO 10993-5:2009) | Under the conditions of the study, the device was found to be cytotoxic and therefore the device extracts were evaluated by ISO 10993-11 - Test for systemic toxicity. From Acute Systemic Toxicity device extracts, the device extracts did not elicit a systemic response in the animal model. (Note: Follow-up systemic toxicity test showed no systemic effect, addressing initial in vitro cytotox result) |
| - ISO Skin Irritation Study (ISO 10993-10:2010) | Under the conditions of the study, not an irritant. |
| - ISO Maximization Sensitization Study (ISO 10993-10:2010) | Under the conditions of the study, not a sensitizer. |
| - ISO Systemic Toxicity Study (ISO 10993-11:2006) | Under the conditions of the study, there was no mortality or evidence of systemic toxicity. |
| Chemotherapy Permeation Standard (ASTM D6978-05(2013)) | Under the conditions of the study, the permeation is acceptable for most tested drugs (>240 minutes breakthrough time for most). Specific low breakthrough times noted for Carmustine (10.2 minutes) and Thiotepa (11.5 minutes), leading to a warning not to use with these drugs. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Testing: The document does not explicitly state the total number of gloves or samples tested for each criterion. It mentions "Minimum Breakthrough Detection Time (Sample 1,2,3)" in one table (page 5), implying at least 3 samples were used for chemotherapy permeation testing for each chemical. Standard testing protocols (like ASTM) would dictate specific sample sizes for each test.
- Data Provenance: The testing was "independent laboratory testing" performed by Ansell. The country of origin of the data is not specified, but the submission is to the U.S. FDA by an LLC based in Reno, Nevada, USA. The data is retrospective in the sense that it was collected prior to this submission for regulatory review.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical device like surgical gloves, "ground truth" is established by adherence to recognized national and international testing standards (e.g., ASTM, ISO). These standards define the methodologies and acceptance limits for physical, chemical, and biological performance. Experts involved would be laboratory technicians and engineers specializing in materials testing and biocompatibility, but not in the sense of clinical "expert readers" for diagnostic images.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing consensus "ground truth" in subjective assessments, such as radiology interpretations or clinical diagnoses. For physical device testing, results are typically quantitative measurementsagainst predefined criteria.
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 physical medical device (surgical gloves), not an AI-based diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm. Standalone performance is assessed through the non-clinical laboratory tests showing the glove's inherent properties and resistance.
7. The type of ground truth used:
- Standard-based performance metrics and established laboratory methods. The "ground truth" for this device is based on meeting the performance requirements outlined in:
- ASTM D3577 (Standard Specification for Rubber Surgical Gloves)
- ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ANSI/AAMI/ISO 11137-1:2006 (Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)
- ISO 10993 (Biological evaluation of medical devices), specifically Parts 5 (cytotoxicity), 10 (irritation and sensitization), and 11 (systemic toxicity).
- ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs).
8. The sample size for the training set:
- Not Applicable. There is no "training set" in the context of an AI algorithm for this type of device submission. The device itself is manufactured; it does not "learn" from data.
9. How the ground truth for the training set was established:
- Not Applicable. See 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).