(238 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate.
Powder Free Nitrile Examination Glove (Grev) Tested for Use with Chemotherapy Drugs and Fentany) Citrate are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Medium, Large, Extra Large, Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978-05(2019). The gloves are single use, disposable, and provided non-sterile.
The document is a US FDA 510(k) premarket notification for "Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate" (K223713). It is not a report on a study proving a device meets acceptance criteria for an AI/ML medical device, but rather a submission for a physical medical device (gloves).
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, including details like "sample size used for the test set," "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone (algorithm only) performance," cannot be extracted from this document, as it discusses the physical properties and chemical permeation resistance of examination gloves.
The tables in the document describe the performance of the gloves against various chemotherapy drugs and Fentanyl Citrate, and their physical properties and biocompatibility.
Here's the closest interpretation of the request using the provided document's context of a physical device:
Acceptance Criteria and Device Performance (for Examination Gloves)
This document describes the testing and acceptance criteria for Powder Free Nitrile Examination Gloves. The "Acceptance Criteria" refer to the performance standards the gloves must meet to be considered safe and effective for their indicated use, especially concerning resistance to chemotherapy drugs and fentanyl citrate. The "Reported Device Performance" shows the results for the applicant's specific glove product.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides these in a combined table under "Summary of Non-Clinical Performance Data" and "Technological Characteristic Comparison Table: Chemotherapy Permeation and Fentanyl Citrate Comparison Claim."
Non-Clinical Performance Data Summary (from page 10):
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL | Pass |
| ASTM D6319-19 | Physical Dimensions Palm Width | XS: 70±10mm, S: 80±10mm, M: 95±10mm, L:110±10mm, XL: 120±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions Thickness | Finger: 0.05mm (min), Palm: 0.05mm (min) | Pass |
| ASTM D6319-19, ASTM D412-16 (2021) | Physical Properties | Tensile Strength (Min 14 MPa), Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319-19, ASTM D5151-19 | Water leak test | G-I, AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19, ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs | Refer to table of specific drug breakthrough times | Pass (See details below for specific drugs) |
| ISO 10993-10:2010 | Irritation and Skin Sensitization | No Skin sensitization and Skin irritation | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | No Cytotoxicity reactivity | showed potential toxicity to L929 cells.* |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity. |
*Note on Cytotoxicity: The document states "showed potential toxicity to L929 cells" for cytotoxicity but then indicates "Cytotoxicity concern was addressed by acute systematic toxicity testing" in the comparison table (page 6), where the Acute Systematic Toxicity test result was "no evidence of systemic toxicity." This implies the potential in vitro toxicity was deemed acceptable given no in vivo systemic toxicity.
Chemotherapy Drug and Fentanyl Citrate Permeation (pages 5 & 6 and 8 & 9):
The acceptance criterion for most drugs is a minimum breakthrough detection time, often stated as ">240 minutes". The reported device performance is presented alongside the predicate and reference devices.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Minutes) (Subject Device K223713) |
|---|---|
| Arsenic Trioxide (1 mg/ml) | >240 |
| Azacitidine (25 mg/ml) | >240 |
| Bendamustine HCL (5 mg/ml) | >240 |
| Bleomycin sulfate (15 mg/ml) | >240 |
| Bortezomib (1 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carboplatin (10 mg/ml) | >240 |
| Carfilzomib (2 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 13.9 |
| ... (many drugs listed as >240 minutes) ... | ... |
| Thiotepa (10 mg/ml) | 44.4 |
| ... (more drugs listed as >240 minutes) ... | ... |
| Fentanyl Citrate Injection (100mcg/2mL) | >240 |
| Simulated Gastric Acid Fluid/Fentanyl Citrate Mix 50/50 | >240 |
Important Note: The document explicitly states: "*Please note that the following drugs have extremely low permeation times: Carmustine: 13.9 minutes, Thio Tepa: 44.4 minutes. Warning: Do not use with Carmustine and Thio Tepa." This indicates that for these two specific drugs, the gloves do not meet a desired long-duration protection, and this is communicated as a warning on the label. For all other listed drugs, the glove achieved a breakthrough time of >240 minutes, meeting the implicit acceptance given the context of other drugs and the "Pass" result in the summary table.
2. Sample size used for the test set and the data provenance:
- The document does not specify the exact sample sizes (number of gloves or individual tests) used for each physical, chemical permeation, or biocompatibility test. It only states "Non-clinical tests were conducted to verify that the proposed device met all design specifications."
- Data Provenance: The tests were conducted to specific ASTM and ISO standards. The manufacturer, Better Care Plastic Technology Co., Ltd, is located in China (Fuqian Xi Road, West district of Shenze, Industrial Base, Shenze County, Hebei, 050000, China). The testing data would originate from their internal testing or third-party labs they commissioned. The document does not specify if the data is retrospective or prospective, but for such device testing, it is typically prospective, meaning the tests were performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the testing of physical gloves. "Ground truth" established by experts (e.g., radiologists) is relevant for diagnostic AI/ML devices where human interpretation is the gold standard. For these gloves, the "ground truth" is established by direct physical and chemical measurements following globally recognized standards (ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for establishing consensus ground truth in medical image interpretation for AI/ML studies. Here, the results are direct measurements.
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. An MRMC study is for evaluating human performance (e.g., radiologists) with and without AI assistance for diagnostic tasks. This document is about the physical properties of medical gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This concept pertains to AI algorithms performing diagnostic tasks independently. The "device" here is a physical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance of the gloves is based on:
- Direct Physical Measurements: e.g., length, palm width, thickness, tensile strength, elongation, water leak rate, powder residue, all conducted according to specified ASTM standards.
- Chemical Permeation Testing: Direct measurement of breakthrough time for specific chemotherapy drugs and fentanyl citrate using ASTM D6978-05 (2019) standard.
- Biocompatibility Testing: In vitro cytotoxicity (ISO 10993-5), dermal irritation and skin sensitization (ISO 10993-10), and acute systemic toxicity (ISO 10993-11), where "ground truth" is determined by the specific biological responses observed as per the standard's criteria.
8. The sample size for the training set:
- Not applicable. There is no AI/ML model or "training set" for physical examination gloves.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical device.
§ 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.