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510(k) Data Aggregation
(63 days)
BIOGREEN YIELDS SDN.BHD
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's for the expected contamination between patient and examiner. This device is for over-the counter use.
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.
Non Sterile Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-05, Standard Specification for Nitrile Examination Gloves for Medical Application.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Non-Sterile, Blue Color Powder Free Nitrile Examination Glove":
This document describes a 510(k) summary for a medical device, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device. For such devices, the "acceptance criteria" are generally compliance with recognized standards and performance specifications, and the "study" is the testing conducted to show this compliance.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Watertight (1000ml) | FDA 1000ml Water Leak Test: AQL = 2.5 | Pass |
| ASTM D6319-05: | ||
| Length (mm) - Size M, L, XL | Min 230 | 240 - 248 |
| Palm width (mm) - Size M | 95 ± 10 | 95 - 98 |
| Finger Thickness (mm) (Single Layer) | Min 0.05 | 0.08 - 0.09 |
| Palm Thickness (mm) (Single Layer) | Min 0.05 | 0.06 - 0.07 |
| Physical Properties (Before Aging): | ||
| Tensile Strength (MPa) | Min 14 | 22 - 32 |
| Ultimate Elongation (%) | Min 500 | 710 - 750 |
| Physical Properties (After Aging): | ||
| Tensile Strength (MPa) | Min 14 | 22 - 29 |
| Ultimate Elongation (%) | Min 400 | 630 - 690 |
| Powder Content | Max 2.0mg/glove | Below 2 mg/glove |
| Moisture Content | Max 2.0% | 0.57% |
| Bio-compatibility (Primary Dermal Irritation Test, Guinea Pig Sensitization) | Pass (implied standard, though not explicitly stated as ASTM) | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes for each test within the "Summary of Performance Data." However, for gloves, industry standards like ASTM D6319-05 typically specify sampling plans (e.g., AQL levels for attributes like watertightness). The "Multiple Normal G1" indicated for the Watertight test likely refers to a sampling plan for inspection level G1.
The data provenance is from Malaysia (BIOGREEN YIELDS SDN. BHD. is located in Sitiawan, Perak, Malaysia). The nature of the tests (physical and chemical properties, bio-compatibility) indicates this data is prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of device (patient examination gloves) does not typically involve human expert interpretation for establishing "ground truth" in the way an AI diagnostic algorithm would. The "ground truth" is established by direct measurement of physical and chemical properties and biological reactions according to standardized protocols (ASTM D6319-05, FDA watertight test, bio-compatibility tests). Therefore, there were no human experts establishing ground truth in the context of interpretation; rather, qualified laboratory personnel would have conducted the tests according to established scientific methods.
4. Adjudication method for the test set
Not applicable for this type of device testing. Adjudication is relevant for subjective interpretations, often in diagnostic imaging, where multiple experts may disagree. Here, the tests are objective 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
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI-assisted diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a physical product (gloves) and does not involve AI or human "readers" in its performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone study (in the context of AI algorithms) was not done. This device is a physical product and its performance is measured directly against established physical and chemical standards, not through an AI algorithm.
7. The type of ground truth used
The ground truth used is based on:
- Performance Standards/Specifications: Established by recognized standards organizations (ASTM D6319-05) and regulatory bodies (FDA 1000ml watertight test).
- Objective Measurements: Direct quantitative and qualitative measurements of physical properties (length, width, thickness, tensile strength, elongation), chemical properties (powder content, moisture content), and biological reactions (bio-compatibility tests).
8. The sample size for the training set
Not applicable. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in the machine learning sense. The manufacturing process itself (which is subject to Good Manufacturing Practices) ensures consistency, but there's no data set used to "train" the product's performance.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this physical device, there is no ground truth established for a training set.
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