(26 days)
An examination 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. These gloves were tested for use with chemotherapy drugs with Gastric Acid, Xylazine and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. chemotherapy drugs; Gastric Acid; Xylazine; Fentanyl
Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
This document is a 510(k) clearance letter for a medical device: "Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl". This type of device is a physical barrier and does not involve AI or imaging analysis, which are the typical contexts for the detailed acceptance criteria and study designs you've requested.
Therefore, many of the specific questions you've asked, such as those related to AI algorithm performance (e.g., sample size for training set, number of experts for ground truth, MRMC studies) are not applicable to this device.
However, I can extract the closest analogous information from the provided text about the device's performance against its stated "Indications for Use," which serves as its functional acceptance criteria.
Understanding the Device and its "Acceptance Criteria":
The device is a medical glove. Its primary "acceptance criteria" are related to its ability to prevent permeation by various substances, specifically:
- 60 chemotherapy drugs
- Gastric Acid
- Xylazine
- Fentanyl Citrate
The reported "device performance" is measured by the "Minimum Breakthrough Detection Time (Min.)" when tested according to ASTM D6978-05. The acceptance criterion implied for most tested substances is "no breakthrough detected up to 240 minutes" (i.e., >240 minutes). For two specific drugs, Carmustine and Thiotepa, the breakthrough times are explicitly lower (11 minutes and 39 minutes, respectively), and the label includes a warning that these should not be used with these drugs.
Here's the information parsed from the document, addressing your questions where applicable, and stating "Not Applicable" (N/A) for those that don't fit the context of a physical barrier device or an AI/imaging study:
1. A table of acceptance criteria and the reported device performance
For most substances, the implied acceptance criterion is "no breakthrough detected up to 240 minutes". The reported performance generally meets this, with specific exceptions noted.
| Substance/Chemotherapy Drug | Concentration (mg/ml or other) | Acceptance Criterion (Based on typical performance) | Reported Device Performance (Minimum Breakthrough Detection Time - Min.) |
|---|---|---|---|
| Most Chemotherapy Drugs (58 out of 60 listed) | Varies (e.g., Amethopterin 25.0, Bleomycin Sulfate 15.0) | >240 minutes breakthrough time | >240 |
| Carmustine | 3.3 | N/A (specific warning) | 11.0 |
| Thiotepa | 10.0 | N/A (specific warning) | 39.0 |
| Gastric Acid | Not specified (Simulated) | >240 minutes breakthrough time | >240 (no breakthrough detected up to 240 minutes) |
| Xylazine | 100 mg/ml | >240 minutes breakthrough time | >240 (no breakthrough detected up to 240 minutes) |
| Fentanyl Citrate | 100mcg/2ml | >240 minutes breakthrough time | >240 (no breakthrough detected up to 240 minutes) |
Note: The "acceptance criterion" column for Carmustine and Thiotepa is marked N/A because the device performance is clearly below the general threshold of >240 minutes, and instead, the clearance document acknowledges this lower performance and specifies a warning against their use. This means the device is cleared despite not meeting the >240 min criterion for these two specific chemicals, but with a critical warning to users.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The testing was conducted according to ASTM D6978-05, which would stipulate the required sample sizes for such tests, but the specific number used for this device is not reported.
- Data Provenance: The manufacturer is "GMP Medicare Sdn. Bhd." located in Malaysia. The testing methodology (ASTM D6978-05) is an international standard. Whether the testing was performed in Malaysia or another country is not specified, nor is whether the data is retrospective or prospective, though performance testing for device clearance is typically prospective by nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This device is a physical barrier. "Ground truth" in this context is established by objective laboratory testing (permeation time using analytical methods), not by human expert interpretation (like radiologists for medical images).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used for establishing consensus among human annotators/experts, typically in medical imaging or clinical trials. The "test set" here refers to physical samples of gloves subjected to a standardized chemical permeation test. The results are quantitative and objectively measured.
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
- N/A. This is a physical device, not an AI-assisted diagnostic tool. No human "readers" or AI assistance are involved in its primary function or testing for this clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Objective laboratory measurement/Chemical Permeation Testing: The "ground truth" for this device's performance is the direct measurement of breakthrough time using the standardized ASTM D6978-05 method. This involves analytical detection of the permeating substance on the non-contact side of the glove.
8. The sample size for the training set
- N/A. This is a physical device. There is no "training set" in the context of machine learning. Design and development of the glove material (e.g., nitrile composition) would involve material science and manufacturing processes, but not a machine learning training set.
9. How the ground truth for the training set was established
- N/A. As above, no training set for an algorithm is involved.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.