(69 days)
The surgeon's glove is a disposable device made of synthetic rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
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The document provided is a 510(k) clearance letter from the FDA for a surgical glove, specifically the SensiCare PI Evolution Surgical Glove, which has been tested for use with chemotherapy drugs.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The core acceptance criterion for the "use with chemotherapy drugs" indication is based on the breakthrough detection time of various chemotherapy drugs when permeating the glove. The device's performance is measured by how long it can withstand permeation by these drugs according to ASTM D6978.
Table of Acceptance Criteria and Reported Device Performance:
| Chemotherapy Drug (Concentration) | Acceptance Criteria (Implied / Regulatory Standard) | Reported Device Performance (Breakthrough Detection Time) |
|---|---|---|
| Bleomycin (15mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Busulfan (6 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Carboplatin (10.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Carmustine (3.3 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | 24.3 minutes (average of 24.3, 24.6, 25.5 minutes) |
| Cisplatin (1.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Epirubicin (Ellence) (2 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Fludarabine (25.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Fluorouracil (50.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Idarubicin (1.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Ifosfamide (50.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Mechlorethamine HCl (1.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Melphalan (5 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Methotrexate (25 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Mitomycin C (0.5 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Paraplatin (10 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Rituximab (10 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
| Thiotepa (10.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | 32.6 minutes (average of 32.6, 34.7, 45.4 minutes) |
| Vincristine Sulfate (1.0 mg/ml) | Not explicitly stated, but common industry expectation is high resistance | >240 minutes |
Note on Acceptance Criteria: The document implies that "approved for use with chemotherapy drugs" is the acceptance. The specific quantitative acceptance criteria for each drug (e.g., minimum breakthrough time required for "safe" use) are not explicitly stated in this FDA letter. However, the data provided indicates the device's performance against a standard test method (ASTM D6978), and the FDA's clearance implies that this performance is deemed acceptable for the stated indications. The warnings for Carmustine and Thiotepa suggest that lower breakthrough times lead to specific usage precautions or contraindications, effectively defining the de facto acceptance threshold for these chemicals where performance below a certain time necessitates a warning.
Study Details from the Provided Content:
The information provided in the FDA letter and particularly the "Indications for Use" section focuses on the results of the testing. It does not contain specific details about the study design, sample sizes, expert involvement, or adjudication methods typically associated with clinical trials or AI/ML model performance studies. The study mentioned is a laboratory test:
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Sample size for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated in the document. The breakthrough times for Carmustine and Thiotepa show three individual readings (e.g., (24.3, 24.6, 25.5) for Carmustine), suggesting at least three samples were tested for these specific drugs. The general "gt;240 minutes" for others does not detail the number of tests.
- Data Provenance: The testing was done "in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This indicates a laboratory-based, prospective testing method. The country of origin of the data is not specified, but it would presumably be from a testing lab associated with Medline Industries, Inc. or a contracted facility.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the study described is a laboratory performance test against chemical permeation, not a clinical study involving experts to establish ground truth for diagnostics or outcomes. The "ground truth" here is the physical breakthrough of the chemotherapy drugs, measured by scientific instruments.
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Adjudication method for the test set:
- Not applicable for a laboratory material permeation test. The measurements are objective physical data.
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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 device is a surgical glove, a medical product, not an AI/ML-driven diagnostic or treatment assistance tool. Therefore, MRMC studies and human reader improvement with AI are irrelevant to this submission.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an algorithm or AI device. The "standalone" performance refers to the intrinsic barrier properties of the glove material.
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The type of ground truth used:
- The ground truth is based on objective physical measurement of chemical permeation through the glove material according to a standardized analytical method (ASTM D6978).
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The sample size for the training set:
- Not applicable. This is a manufactured product (glove) whose performance is characterized, not an AI/ML model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model. The glove's performance characteristics are inherent to its manufacturing and material composition.
In summary, the provided document details the results of laboratory testing demonstrating the surgical glove's resistance to various chemotherapy drugs, which forms the basis for its intended use with these agents. It does not involve AI or human expert assessments in the way requested in some of the questions, as it is a physical product rather than a diagnostic or AI-enabled tool.
§ 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).