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510(k) Data Aggregation
(64 days)
Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
in addition, these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection time inMinutes, 0.01 ug/cm2/minute | |
|---|---|---|
| 1 | Cisplatin, 1.0 mg/ml (1,000ppm) | >240 |
| 2 | Cyclophosphamide (Cytoxan),20.0mg/ml (20,000ppm) | >240 |
| 3 | Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) | >240 |
| 4 | Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 |
| 5 | Etoposide (Toposar), 20.0 mg/ml (20,000)ppm | >240 |
| 6 | Fluorouracil, 50.0 mg/ml (50,000ppm) | >240 |
| 7 | Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) | >240 |
| 8 | Carmustine (BCNU)3.3mg/ml(3,300ppm) | 0.9 |
| 9 | Thiotepa, 10.0mg/ml (10,000ppm) | 0.05 |
The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes
Carmustine (BCNU)3.3mg/ml(3,300ppm) Thiotepa, 10.0mg/ml ( 10,000ppm)
Not Found
This document details the acceptance criteria and performance for "Blue Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs" in the context of their ability to prevent permeation by chemotherapy drugs.
1. Table of Acceptance Criteria and Reported Device Performance
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection time in Minutes, >0.01 ug/cm²/minute) | Reported Device Performance (Breakthrough Detection time in Minutes, 0.01 ug/cm²/minute) |
|---|---|---|
| Cisplatin, 1.0 mg/ml (1,000ppm) | >240 | >240 |
| Cyclophosphamide (Cytoxan), 20.0mg/ml (20,000ppm) | >240 | >240 |
| Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) | >240 | >240 |
| Doxorubicin Hydrochloride, 2.0mg/ml (2,000ppm) | >240 | >240 |
| Etoposide (Toposar), 20.0 mg/ml (20,000ppm) | >240 | >240 |
| Fluorouracil, 50.0 mg/ml (50,000ppm) | >240 | >240 |
| Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) | >240 | >240 |
| Carmustine (BCNU) 3.3mg/ml (3,300ppm) | Not explicitly stated as acceptance criteria (note indicates "extremely low permeation time") | 0.9 |
| Thiotepa, 10.0mg/ml (10,000ppm) | Not explicitly stated as acceptance criteria (note indicates "extremely low permeation time") | 0.05 |
Note: The document specifies that the maximum testing time is 240 minutes. For Carmustine and Thiotepa, while specific acceptance criteria in the ">X" format are not given, the note highlights their extremely low permeation times, which can be interpreted as a disclosure rather than a failure of an acceptance criterion that requires >240 minutes.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in the provided document. The study refers to testing in accordance with ASTM D6978-05. The sample size would be dictated by the requirements of this standard.
- Data Provenance: Not explicitly stated. The testing was performed in accordance with ASTM D6978-05, which is an international standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes a physical performance test for medical gloves against chemotherapy drugs, not a diagnostic or clinical AI study. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense does not apply here. The "ground truth" is the objective measurement of breakthrough time, determined by standardized laboratory procedures.
4. Adjudication method for the test set
Not applicable. This is a laboratory performance test based on a standardized methodology (ASTM D6978-05), not a situation requiring expert adjudication of subjective assessments.
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 document pertains to the physical performance of a medical device (gloves), not an AI-assisted diagnostic or imaging system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical performance test of a medical device (gloves), not an algorithm.
7. The type of ground truth used
The ground truth used is the objective measurement of chemotherapy drug permeation breakthrough time, determined by a standardized laboratory method, specifically ASTM D6978-05. This is a quantitative, empirical measurement.
8. The sample size for the training set
Not applicable. This is a physical performance test for a medical device (gloves), not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this is not an AI model, there is no training set or ground truth for a training set in this context.
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(99 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.
Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, Blue (SG).
The provided document is a 510(k) premarket notification letter from the FDA for "Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs, Blue (SG)". This document describes the regulatory approval of a medical device (gloves) and not an AI or software device. Therefore, the requested information regarding acceptance criteria and studies for an AI/software device cannot be extracted from this document.
The document mainly focuses on:
- The device being substantially equivalent to legally marketed predicate devices.
- The regulation number, product code, and regulatory class of the device.
- General controls provisions of the Act applicable to the device.
- A list of chemotherapy drugs and the gloves' permeation (breakthrough detection time) for each.
There is no information about:
- AI acceptance criteria or device performance.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone (algorithm-only) performance.
- Type of ground truth used for AI.
- Training set sample size.
- Ground truth establishment for the training set.
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(52 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.
Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue)
The provided document describes the FDA clearance (K101293) for "Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue)". This document is a 510(k) clearance letter and an accompanying "Indications for Use" form. It is not a study report for an AI device.
Therefore, most of the requested information regarding acceptance criteria and studies for an "AI device" cannot be extracted from this document, as it pertains to a physical medical device (examination gloves) and not software or an AI algorithm.
However, I can extract the "performance" data that was submitted to support the claim that the gloves provide "protection against exposure to certain chemotherapy drugs." This is presented as "Breakthrough detection time in minutes" for various chemotherapy drugs.
Here's the closest representation of the requested information based on the provided document:
Acceptance Criteria and Device Performance (for Nitrile Examination Gloves)
This document does not specify "acceptance criteria" in a typical numerical threshold format as would be expected for an AI algorithm. Instead, it presents the "Breakthrough detection time" as the performance metric for each listed chemotherapy drug. While the specific acceptance criterion is not explicitly stated as a minimal breakthrough time, the implication is that longer breakthrough times are better, and certain drugs exceeded 240 minutes, indicating strong protection. The critical warning for Carmustine indicates that its breakthrough time of 1.21 minutes is unacceptable for protection against that specific drug.
| Acceptance Criterion (Implicit) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|
| Sufficient protection against chemotherapy drugs (longer time is better, > 240 min appears desirable, < ~1.21 min is unacceptable) | |
| Chemotherapy Drug | Breakthrough Detection Time (minutes) |
| Carmustine (BCNU) (3.3 mg / ml) | 1.21 |
| Thiotepa (10.0 mg / ml) | 90.7 |
| Fluorouracil (50.0 mg / ml) | > 240 |
| Etoposide (Toposar) (20.0 mg / ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg / ml) | > 240 |
| Mitomycin C (0.5 mg / ml) | > 240 |
| Methotrexate (25.0 mg / ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg / ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg / ml) | > 240 |
| Dacarbazine (DTIC) (10.0 mg / ml) | > 240 |
| Cisplatin (1.0 mg / ml) | > 240 |
| Mitoxantrone (2.0 mg / ml) | > 240 |
| Ifosfamide (50.0 mg / ml) | > 240 |
| Vincristine Sulfate (1.0mg / ml) | > 240 |
| Warning: Do Not Use with Carmustine | Indicates failure to meet protective needs |
Information Not Applicable or Not Provided in the Document (as it's not an AI device study):
- Sample sized used for the test set and the data provenance: Not applicable to a physical glove. The testing methodology for chemotherapy drug permeation is not detailed beyond the results.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for chemotherapy permeation is established through laboratory testing (e.g., using a permeation cell, as per ASTM standards).
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. For the gloves, the "ground truth" is the empirically measured breakthrough time of the drug through the glove material in a controlled laboratory setting.
- The sample size for the training set: Not applicable (no AI training set).
- How the ground truth for the training set was established: Not applicable (no AI training set).
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