(137 days)
The surgeons glove is a disposable device made of synthetic rubber intended to be worn by 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 surgeons glove is a disposable device made of synthetic rubber.
The provided document is a 510(k) clearance letter for SensiCare PI and SensiCare PI Micro Surgical Gloves. It details the device classification, regulatory information, and, importantly, the "Indications for Use" which includes a section on chemotherapy drug permeation. This section contains the acceptance criteria and the results of the study proving the device meets these criteria.
Here's an analysis of the provided information:
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the standard ASTM D6978, which is a "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." The performance is measured by the "Breakthrough Detection Time" in minutes. While the document does not explicitly state a minimum breakthrough time as an acceptance criterion for all chemotherapy drugs, it presents the breakthrough times for each drug. The fact that the gloves are indicated for use with these drugs (except where warnings are given) implies that the reported breakthrough times meet an acceptable threshold within the context of the ASTM D6978 standard for medical gloves.
For drugs with reported breakthrough times of 240 minutes, this indicates that no permeation was detected within the 240-minute test period. For drugs with shorter breakthrough times, the specific times are given. The warnings for Carmustine and Thiotepa for both glove types due to shorter breakthrough times also imply that extended permeation resistance is an implicit acceptance criterion for safe use with these drugs.
| Chemotherapy Drug (Concentration) | SensiCare PI Breakthrough Detection Time (minutes) | SensiCare PI Micro Breakthrough Detection Time (minutes) | Acceptance Criteria (Implicit from ASTM D6978 & Warning) |
|---|---|---|---|
| Bleomycin (15 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Busulfan (6 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Carboplatin (10.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Carmustine (3.3 mg/ml) | 12.4 (12.4, 14.4, 12.4) | 12.4 (13.1, 13.8, 12.4) | Warning: Do not use (Low resistance) |
| Cisplatin (1.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Cyclophosphamide (20 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Dacarbazine (10.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Doxorubicin HCl (2.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Epirubicin (2 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Etoposide (20.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Fludarabine (25.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Fluorouracil (50.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Idarubicin (1.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Ifosfamide (50.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Mechlorethamine HCl (1.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Melphalan (5 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Methotrexate (25 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Mitomycin (0.5 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Mitoxantrone (2.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Paclitaxel (6.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Paraplatin (10 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Rituximab (10 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
| Thiotepa (10.0 mg/ml) | 12.4 (12.4, 13.4, 13.2) | 22.3 (22.3, 23.9, 23.2) | Warning: Do not use (Low resistance) |
| Vincristine Sulfate (1.0 mg/ml) | 240 | 240 | Acceptable resistance to permeation |
Study Details
The document refers to a specific study type: "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." This indicates that the study adhered to this established standard.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document provides breakthrough times, and for Carmustine and Thiotepa, it explicitly lists three individual breakthrough times (e.g., 12.4, 14.4, 12.4). This suggests that at least three samples were tested for these specific drugs for each glove type. For the drugs with a 240-minute breakthrough time, the document does not specify the number of samples, but ASTM D6978 generally requires testing of multiple specimens (e.g., typically at least three) to ensure representative results.
- Data Provenance: The document does not specify the country of origin of the data. The study appears to be a prospective evaluation of the glove's performance against the specified standard, as it's a test performed on the device to prove its properties.
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 type of study (chemical permeation testing) does not typically involve human experts in the way that image interpretation or clinical outcomes studies do. The "ground truth" is established by the standardized laboratory methodology and instrumentation used to detect chemical permeation as defined by ASTM D6978. There are no human expert readers or clinicians involved in establishing the ground truth for chemical breakthrough time.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this study is a laboratory-based chemical permeation test, not a subjective assessment requiring adjudication among experts. The results are objective measurements of breakthrough time. When multiple values are provided (e.g., for Carmustine and Thiotepa), they represent individual test replicates, not adjudicated interpretations.
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 not an MRMC study. It's a laboratory test of a physical device's chemical resistance properties, not an evaluation of human reader performance or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device being tested in a laboratory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is defined by the objective measurement of chemical permeation according to the ASTM D6978 standard. This involves analytical techniques to detect the breakthrough of chemotherapy drugs through the glove material over time. It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. Since there is no training set, this question is not relevant.
§ 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).