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510(k) Data Aggregation
(99 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided text is a 510(k) Summary for a medical device, "Disposable Vinyl Nitrile Synthetic Gloves Powder Free" (K211516). This document details the device's characteristics and its equivalence to a predicate device, as submitted to the FDA.
Based on the nature of the device (disposable patient examination gloves) and the content of the summary, the "device" in question is not an AI/ML-driven diagnostic or assistive technology. Instead, it is a physical medical device. Therefore, the questions related to AI/ML device performance metrics (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, training set size, etc.) are not applicable to this document.
The acceptance criteria and performance are related to the physical properties, safety, and regulatory compliance of the gloves.
Here's the information that can be extracted from the provided text, related to the device's acceptance criteria and how it meets them:
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D5250 | Physical Dimensions | Length: ≥230 mm Width (S): 85±5 mm Width (M): 95±5 mm Width (L): 105±5 mm Width (XL): 115±5 mm Thickness (Finger): ≥0.08 mm Thickness (Palm): ≥0.08 mm | Length: >230 mm Width (S): 88-90 mm Width (M): 95-97 mm Width (L): 106-108 mm Width (XL): 113-116 mm Finger Thickness: 0.08-0.10 mm Palm Thickness: 0.09 mm | Pass |
| ASTM D5151 | Watertightness | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks | Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | 0.11 mg/glove | Pass |
| ASTM D412 | Physical properties (Before Aging) | Tensile Strength: ≥11 MPa Ultimate Elongation: ≥300% | Tensile Strength: 15.2-17.8 MPa Ultimate Elongation: 417-606% | Pass |
| ASTM D412 | Physical properties (After Aging) | Tensile Strength: ≥11 MPa Ultimate Elongation: ≥300% | Tensile Strength: 12.4-16.9 MPa Ultimate Elongation: 370-568% | Pass |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. | Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. | Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size for Physical/Performance Tests: The specific sample sizes for each physical test (e.g., number of gloves tested for dimensions, powder content, or tensile strength) are not explicitly stated for all tests. For the watertightness test (ASTM D5151), the result "0/125 leaks" implies a sample size of 125 units were tested.
- Data Provenance: The document does not specify the country of origin for the test data for the subject device beyond the manufacturer being in China. The tests are "non-clinical" (laboratory-based physical and biocompatibility testing), not human clinical studies. The data would be prospective as it's generated specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device requiring expert adjudication/ground truth for image interpretation or diagnosis. The "ground truth" for these physical and biocompatibility tests is based on established laboratory testing methodologies and international standards (ASTM, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for human interpretation of data in studies, not for standardized physical/chemical/biocompatibility testing of a physical product.
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. Performance is of the physical glove itself, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on established international standards and laboratory testing protocols (ASTM D5250, ASTM D6124, ASTM D5151, ASTM D412, ISO 10993-5, ISO 10993-10). These standards define the methodologies and acceptance criteria for physical, chemical, and biological properties of examination gloves.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable.
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(89 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free vinyl synthetic patient examination gloves. The subject device is blue. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.
The provided document is a 510(k) summary for a medical device: "Disposable Vinyl Nitrile Synthetic Gloves Powder Free". This document describes the device's characteristics, its comparison to a predicate device, and the results of non-clinical tests conducted to demonstrate its safety and effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5250 | Physical Dimensions Test | Length (mm): ≥230 Width (mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5 Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length: >230 Width: S: 84-89; M: 93-97; L: 105-107; XL: 115-116 Finger Thickness: 0.08-0.2 Palm Thickness: 0.07-0.08 Result: Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks Result: Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.07 mg Result: Pass |
| ASTM D412 | Physical Properties - Before Aging | Tensile Strength: ≥11MPa Ultimate Elongation: ≥300% | Tensile Strength: 11.6-16.2 Ultimate Elongation: 308-391 Result: Pass |
| ASTM D412 | Physical Properties - After Aging | Tensile Strength: ≥11MPa Ultimate Elongation: ≥300% | Tensile Strength: 11.0-14.0 Ultimate Elongation: 323-337 Result: Pass |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. Result: Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. Result: Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. Result: Pass |
2. Sample Size Used for the Test Set and Data Provenance
- ASTM D5151 (Watertightness): The test result states "0/125 leaks", indicating a sample size of 125 gloves for this particular test.
- Other tests (ASTM D5250, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10): The specific sample sizes for these tests are not explicitly stated in the provided summary. However, these are generally performed on a sufficient number of samples to meet the requirements of the respective ISO/ASTM standards.
- Data Provenance: The device manufacturer (Tangshan Hongyun Healthcare Products Co., Ltd.) is located in China. The non-clinical tests were conducted to verify the device met design specifications. The document does not specify if the data is retrospective or prospective, but given the nature of product testing for regulatory submission, it is typically prospective for the specific batch/samples used for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This document describes physical, chemical, and biological testing of a medical device (gloves) against established standards. It does not involve interpretation of medical images or patient data that would require "experts" in the sense of clinicians establishing ground truth on a test set. The "ground truth" for these tests is defined by the acceptance criteria within the international and national standards (ASTM, ISO) themselves.
4. Adjudication Method for the Test Set
- Not applicable. The tests performed are objective measurements against predefined criteria as per established standards (ASTM, ISO), not subjective assessments requiring adjudication by multiple readers or experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or AI algorithms that require human interpretation and comparison with and without AI assistance to measure reader improvement. The device in question is a physical glove, and its performance is evaluated through standardized physical, chemical, and biological tests, not through human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Yes, the testing described is effectively "standalone" performance in the sense that the device's characteristics are measured objectively against standards without human-in-the-loop performance in a clinical scenario being assessed for regulatory purposes. The device itself is not an algorithm, so the term "algorithm only" isn't directly applicable, but the performance evaluation is solely based on the device's intrinsic properties.
7. The Type of Ground Truth Used
- The "ground truth" is defined by the acceptance criteria established in recognized international and national standards (ASTM D5250, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10). These standards specify objective physical, chemical, and biological parameters that the gloves must meet to be deemed safe and effective for their intended medical purpose.
8. The Sample Size for the Training Set
- Not applicable. A "training set" is relevant for machine learning or AI algorithms. This document describes the non-clinical testing of a physical medical device (gloves), which does not involve machine learning models and therefore has no "training set."
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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