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510(k) Data Aggregation
(36 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners.
Private Label - Nitrile Examination Gloves Pre-Powdered, Blue and White Color
The provided document is a 510(k) submission for Nitrile Examination Gloves. It details the product, its intended use, and its technological characteristics and performance data compared to an equivalent device. However, it does not describe a study that uses AI or machine learning models or involves human readers and experts in the context of device performance evaluation.
Instead, the document focuses on the physical and performance attributes of the gloves, referencing ASTM standards and FDA requirements. Therefore, I cannot extract information related to AI performance, human reader studies, ground truth establishment, or sample sizes for AI training/testing from this document.
The acceptance criteria and reported device performance are related to the physical properties and dimensions of the Nitrile Examination Gloves as per ASTM D 3578-95 standards.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM D 3578-95) | Reported Device Performance (Nitrile Exam Gloves) |
|---|---|---|
| Dimensions | ||
| Length (min) mm | Not explicitly stated as "criteria", but 240 mm is consistently reported. | 240 mm |
| Palm width mm | Not explicitly stated as "criteria", but ranges are consistently reported. | Small: 85 ± 10 mm |
| Medium: 95 ± 10 mm | ||
| Large: 111 ± 10 mm | ||
| Thickness (min) | ||
| 1. Cuff (min) | Not explicitly stated as "criteria", but 0.1 mm is consistently reported. | 0.1 mm |
| 2. Palm (min) | Not explicitly stated as "criteria", but 0.1 mm is consistently reported. | 0.1 mm |
| 3. Fingertip (min) | Not explicitly stated as "criteria", but 0.1 mm is consistently reported. | 0.1 mm |
| Physical Properties (Before Aging) | Minimum values required by ASTM D 3578-95 | |
| Tensile Strength (min) | 14 Mpa | 14 Mpa |
| Ultimate Elongation (min) | 700 % (Small) | |
| 700 % (Medium) | ||
| 700 % (Large) | 700 % (Small) | |
| 700 % (Medium) | ||
| 500 % (Large) | ||
| Physical Properties (After Aging at 100° for 22 hrs) | Minimum values required by ASTM D 3578-95 | |
| Tensile Strength (min) | Not explicitly stated as "criteria", but 14 Mpa is consistently reported. | 14 Mpa |
| Ultimate Elongation (min) | Not explicitly stated as "criteria", but 500 % is reported for aged gloves. | 500 % |
| Inspection Related Defects | AQL (Acceptable Quality Level) | |
| Watertightness (Holes) | 2.5 (S-4) | Meets FDA pinholes requirement. |
| Dimension (Width, length, Thickness) | 4 (S-2) | Meets ASTM Standard. |
| Physical Properties (Before & After Aging) | 4 (S-2) | Meets ASTM Standard. |
| Weight of residual powder in medium size gloves: | 150 ± 50 mg | (Reported as a characteristic, no explicit criteria for passing) |
2. Sample size used for the test set and the data provenance:
- The document refers to "Inspection Related Defeats" with AQL (Acceptable Quality Level) values (e.g., S-4 for watertightness, S-2 for dimension and physical properties). These AQL values imply a sampling plan used for quality control, but the specific sample sizes for the test sets are not provided.
- The data provenance is for gloves manufactured by PT. EKA WIRA ASIA in Medan, Indonesia. The data is retrospective, as it describes the characteristics of the manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the document describes performance testing of physical products (gloves) against established ASTM standards, not evaluation by human experts using a ground truth.
4. Adjudication method for the test set:
- This information is not applicable for the same reason as point 3. Testing is against objective physical standards.
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:
- This information is not applicable as the document is about the physical properties of examination gloves, not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable as the document is about the physical properties of examination gloves.
7. The type of ground truth used:
- The "ground truth" for the device's performance is established by ASTM D 3578-95 standards and FDA requirements (e.g., pinholes requirement). These are objective, pre-defined specifications rather than expert consensus, pathology, or outcomes data in a medical diagnostic context.
8. The sample size for the training set:
- This information is not applicable. There is no mention of a "training set" as the device is a physical product (gloves) and not an AI/ML model.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 8.
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