(242 days)
The surgeon's glove is a disposable device made of synthetic rubber latex intended to be worn by surgeon's and or operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The surgeon's glove is a disposable device made of synthetic rubber latex.
This document describes the FDA clearance for the "SensiCare PI Ortho LT Surgical Glove." The primary study referenced is for the glove's permeation resistance to chemotherapy drugs.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, which the device was tested against. While specific thresholds for "acceptance" are not explicitly stated in this document (e.g., minimum acceptable breakthrough time), the results report the breakthrough detection time for each drug. The interpretation is that a longer breakthrough time indicates better performance.
| Chemotherapy Drug (Concentration) | Acceptance Criteria (Implicit from ASTM D6978) | Reported Device Performance (Breakthrough Detection Time) |
|---|---|---|
| Bleomycin (15 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Busulfan (6 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Carboplatin (10.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Carmustine (BCNU) (3.3 mg/ml) | Tested per ASTM D6978 | 25.8 minutes (25.8, 34.1, 35.4) |
| Cisplatin (1.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Cytarabine (100 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Epirubicin (Ellence) (2 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Fludarabine (25.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Fluorouracil (50.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Idarubicin (1.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Ifosfamide (50.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Mechlorethamine HCl (1.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Melphalan (5 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Methotrexate (25 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Mitomycin C (0.5mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Paraplatin (10 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Rituximab (10 mg/ml) | Tested per ASTM D6978 | >240 minutes |
| Thiotepa (10.0 mg/ml) | Tested per ASTM D6978 | 34.6 minutes (37.5, 37.8, 34.6) |
| Vincristine Sulfate (1.0 mg/ml) | Tested per ASTM D6978 | >240 minutes |
Note: The document includes a "Warning: Do not use with Carmustine" and "Caution: Testing showed a minimum breakthrough time of 34.6 minutes with Thiotepa," indicating that for these specific drugs, the performance may not meet an assumed universal acceptance criterion for all chemotherapy drugs, or at least warrants specific precautions.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The exact sample size (number of gloves or individual test replicates for each drug) is not explicitly stated in the provided text. However, for Carmustine and Thiotepa, three individual breakthrough times are listed, suggesting at least three replicates for these specific drug tests (e.g., 25.8, 34.1, 35.4 minutes for Carmustine; 37.5, 37.8, 34.6 minutes for Thiotepa). For drugs with ">240 minutes", it's implied that the test continued for at least 240 minutes without breakthrough for all tested samples.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a report on device testing results.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This study involves material testing (chemical permeation through a glove), not interpretation of medical images or patient data that would require expert consensus for ground truth. The "ground truth" here is the physical breakthrough detection time measured by laboratory equipment.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a material science test, not a subjective assessment requiring adjudication. The method is likely standardized within ASTM D6978.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, this was not an MRMC comparative effectiveness study. This type of study is for evaluating diagnostic or screening performance of an AI system, often involving human readers. The current study is an objective material property test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, this is a "standalone" performance test, but not in the context of an AI algorithm. It's a test of the physical characteristics of the surgical glove itself, without human intervention in the measurement of permeation. The device (glove) functions independently of human interpretation regarding its barrier properties.
7. The Type of Ground Truth Used
The ground truth used is objective laboratory measurement (breakthrough detection time) in accordance with the specified standard (ASTM D6978). This is analogous to pathology or outcomes data in a clinical context, as it's a definitive, measurable characteristic of the device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set" in the conventional sense. The glove's design and manufacturing process would be informed by material science and engineering principles, not an algorithmic training process on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
§ 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).