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510(k) Data Aggregation
(230 days)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs
This document is an FDA 510(k) clearance letter for "Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs" (K182176). It does not describe a study that uses artificial intelligence (AI) or machine learning, nor does it contain the specific types of information requested in your prompt regarding AI/ML device performance.
The document focuses on the device performance of surgical gloves in terms of their resistance to chemotherapy drug permeation. Based on the provided text, here’s an attempt to extract relevant information, but please note it does not align with the requested structure for AI/ML device studies:
1. A table of acceptance criteria and the reported device performance
The document presents the "Breakthrough Detection Time (Minutes)" for various chemotherapy drugs, which can be interpreted as the device's reported performance against a specified test. There isn't an explicit "acceptance criteria" listed in the way one might find for an AI algorithm's metric thresholds. However, regulatory bodies like the FDA typically have guidance or standards for what constitutes acceptable barrier protection for medical gloves against hazardous chemicals. For the purpose of this response, the reported breakthrough times are the "device performance."
| Test Chemotherapy Drug and Concentration | Reported Device Performance (Breakthrough Detection Time - Minutes) |
|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 37.5 (47.8, 38.3, 37.5) |
| Cisplatin 1.0 mg/ml (1,000ppm) | >240 min |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | >240 min |
| Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | >240 min |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | >240 min |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | >240 min |
| Methotrexate 25 mg/ml (25, 000 ppm) | >240 min |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 min |
| Melphalan 5 mg/ml (5,000 ppm) | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 min |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 58.3 (69.8, 68.6, 58.3) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 min |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the testing, nor the data provenance in terms of country of origin or retrospective/prospective nature. This information would typically be in a detailed test report, not the summary 510(k) clearance letter.
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 is not applicable to the type of device and testing described. The "ground truth" for glove permeation testing is established through standardized laboratory methods as defined by organizations like ASTM, not by expert human interpretation in the way AI/ML ground truth is established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept relates to human consensus in medical image interpretation, which is not relevant to chemical permeation testing of gloves.
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 AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is the measured breakthrough time of the chemotherapy drugs through the glove material, determined by quantitative laboratory testing using established standards (e.g., ASTM D6978, which is a common standard for this type of testing). This is a direct physical measurement.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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(192 days)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
This surgeon's glove is a device made of synthetic rubber.
The provided text is a 510(k) premarket notification for "Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs." This submission focuses on the performance of surgical gloves in resisting permeation by chemotherapy drugs.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the "Breakthrough Detection Time" specifications for various chemotherapy drugs. The reported device performance is the actual breakthrough time measured for each drug.
| Test Chemotherapy Drug and Concentration | Acceptance Criteria (Breakthrough Detection Time - Minutes) | Reported Device Performance (Minutes) |
|---|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | Implied: Minimum acceptable time | 37.5 (47.8, 38.3, 37.5) |
| Cisplatin 1.0 mg/ml (1,000ppm) | Implied: Minimum acceptable time | >240 min |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20.000 ppm) | Implied: Minimum acceptable time | >240 min |
| Fluorouracil 50.0 mg/ml (50.000 ppm) | Implied: Minimum acceptable time | >240 min |
| Ifosfamide 50.0 mg/ml (50.000 ppm) | Implied: Minimum acceptable time | >240 min |
| Methotrexate 25 mg/ml (25, 000 ppm) | Implied: Minimum acceptable time | >240 min |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Melphalan 5 mg/ml (5,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | Implied: Minimum acceptable time | >240 min |
| Thiotepa 10.0 mg/ml (10,000 ppm) | Implied: Minimum acceptable time | 58.3 (69.8, 68.6, 58.3) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | Implied: Minimum acceptable time | >240 min |
Note on Acceptance Criteria: The document directly presents the performance data rather than explicit numerical acceptance criteria for each drug from a regulatory body. However, for devices of this nature, the general "acceptance" is that the glove performs adequately for its intended use, typically implying that longer breakthrough times are better. The explicit mention of Carmustine and ThioTEPA's breakthrough times as a "Caution" implies that their performance, while reported, is at the lower end of the acceptable spectrum compared to the others that exceed 240 minutes.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size (number of gloves or tests performed for each drug). For Carmustine and Thiotepa, three individual values are listed in parentheses (e.g., 47.8, 38.3, 37.5 for Carmustine), suggesting at least three tests were performed for these specific drugs, and an average was calculated. For other drugs, only ">240 min" is reported, so the exact number of tests is not discernible from the text.
- Data Provenance: Not specified in the document. It's likely from laboratory testing conducted by or for the manufacturer (Pt. Medisafe Technologies) to assess the glove's barrier properties against chemotherapy drugs. The country of origin of the data is not mentioned, nor whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of testing (chemotherapy drug permeation) does not typically involve human experts to establish "ground truth." The ground truth is established through standardized laboratory testing methods that measure the chemical permeation. Therefore, information about experts and their qualifications in this context is not applicable. The "ground truth" for permeation resistance is determined by the output of the testing apparatus using recognized analytical techniques.
4. Adjudication Method for the Test Set
Not applicable. As this is chemical permeation testing, there is no expert adjudication process in the traditional sense. The results are derived directly from the laboratory measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an imaging or diagnostic device that involves human readers interpreting cases. It's a medical device (surgical glove) whose performance is evaluated through material science and chemical permeation tests, not through human interpretation or comparative effectiveness studies with AI assistance.
6. Standalone Performance
Yes, the study describes the standalone (algorithm or device-only) performance. The reported breakthrough detection times are purely reflective of the glove's material properties and its resistance to chemical permeation, without any human-in-the-loop interaction during the performance measurement.
7. Type of Ground Truth Used
The ground truth used is laboratory measurement/chemical assay results. Specifically, it's the time until a chemotherapy drug is detected on the inner surface of the glove, as determined by appropriate analytical methods (e.g., spectroscopy, chromatography) following standardized test procedures (likely ASTM or similar international standards for chemical permeation of protective clothing).
8. Sample Size for the Training Set
Not applicable. This device is a physical product (surgical glove) whose performance is determined by its material composition and manufacturing process. There is no "training set" in the context of machine learning or AI algorithms for this type of product. The manufacturing process is validated, and the product is tested to meet specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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