(471 days)
Cardinal Health™ Protexis™ PI Blue with Neu-Thera™ Surgical Gloves are powder-free surgeon's gloves that are disposable devices made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
powder-free surgeon's gloves that are disposable devices made of synthetic rubber
The provided text describes the 510(k) clearance for "Cardinal Health™ Protexis™ PI Blue with Neu-Thera™ Surgical Gloves". This document primarily focuses on the regulatory clearance for a physical medical device (surgical gloves) and its resistance to chemotherapy drug permeation. It does NOT describe an AI/ML-driven medical device, an algorithm's performance, or any associated clinical study involving human readers or expert ground truth establishment for such an algorithm.
Therefore, I cannot fulfill your request for information related to acceptance criteria and studies for an AI device. The questions you've asked are specifically tailored for AI/ML device evaluations (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance).
Based on the provided document, the "acceptance criteria" and "study" are related to the physical properties of the surgical gloves as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria and reported performance for these surgical gloves, as detailed in the "Indications for Use" section, relate to their resistance to permeation by various chemotherapy drugs. This is assessed by reporting the minimum breakthrough detection time.
| Chemotherapy Drug | Acceptance Criteria (Conceptual) | Reported Device Performance (min. breakthrough detection time in minutes, 0.01 µg/cm²/min) |
|---|---|---|
| Carmustine (3.3 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | 18.5 |
| Cisplatin (1 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Cyclophosphamide (20 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Doxorubicin HCl (2 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Etoposide (20 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| 5-Fluorouracil (50 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Methotrexate (25 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Mitomycin C (0.5 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Paclitaxel (6 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
| Thiotepa (10 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | 24.4 |
| Vincristine Sulfate (1 mg/mL) | (Not explicitly stated as a pass/fail threshold, but higher is better) | >240 |
Explanation of the Study:
The study proving the device meets its performance claims is referenced as testing "per ASTM D6978, 'Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.'" This is a standardized laboratory test protocol aimed at evaluating the barrier properties of medical gloves against hazardous drugs.
I cannot answer the following questions because the document pertains to a physical medical device (gloves) and not an AI/ML-driven device:
- 2. Sample sized used for the test set and the data provenance: Not applicable to a physical glove's chemical resistance test in the context of AI.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves is defined by the chemical testing method.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is not an AI.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for glove performance is established through standardized chemical permeation testing, not expert consensus or medical outcomes.
- 8. The sample size for the training set: Not applicable. This is a manufactured product, not an AI model.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document clearly indicates a regulatory submission for surgical gloves, with performance claims related to their chemical resistance. It does not contain any information about an AI/ML device or its associated clinical and technical studies related to AI model evaluation.
§ 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).