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510(k) Data Aggregation
(88 days)
The polyisoprene powder free, black colour surgical gloves are radiation attenuating and intended to be worn by operating room personal to protect a surgical wound from contamination
The Polyisoprene Powder Free Black Color Radiation Attenuating Surgical Glove is a disposable sterile powder-free medical device made of polyisoprene that is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove contains radiation-attenuating particles to reduce the exposure from harmful ionizing scattered or secondary radiation on the operator's hand during fluoroscopic procedures. The glove is proposed in two (2) options. The Model 2 are made with exactly the same material and composition and differ only by their thicknesses and therefore their attenuation properties.
The provided text describes the acceptance criteria and results of non-clinical performance testing for a medical device, specifically Polyisoprene Powder Free Black Colour Radiation Attenuating Surgical Gloves. It does not describe a study involving AI or human readers for diagnostic purposes. Therefore, most of the requested fields related to AI performance, human reader studies, and training data are not applicable based on the provided document.
Here's a summary of the available information:
1. A table of acceptance criteria and the reported device performance:
| Test Method | Test Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D5151 | Freedom from holes | AQL 1.5 | PASS (AQL=0.65) |
| ASTM D3577 | Physical Dimensions - Length (Size 6-9) | ≥265mm (Predicate) / ≥285mm (Manufacturer) | PASS (All sizes ≥285mm, range: 298-301mm) |
| ASTM D3577 | Physical Dimensions - Width (various sizes) | Size 6.0: 76 ± 6mmSize 6.5: 83 ± 6mmSize 7: 89 ± 6mmSize 7.5: 95 ± 6mmSize 8: 102 ± 6mmSize 8.5: 108 ± 6mmSize 9: 114 ± 6mm | PASS (83-84mm (size 6.5)90-91mm (size 7)96-97mm (size 7.5)106-107mm (size 8)110-113mm (size 8.5)112-115mm (size 9)) |
| ASTM D3577 | Physical Dimensions - Thickness | Min. 0.1mm | PASS (Model 1: Finger: 0.27-0.29mm, Palm: 0.24-0.25mm, Cuff: 0.23-0.24mm; Model 2: Finger: 0.33-0.39mm, Palm: 0.33-0.35mm, Cuff: 0.31-0.33mm) |
| ASTM D3577 | Physical Properties - Tensile Strength (Before accelerated aging) | 17 MPa min | PASS (18.7-19.6MPa) |
| ASTM D3577 | Physical Properties - Tensile Strength (After accelerated aging) | 12 MPa min | PASS (18.2-18.5MPa) |
| ASTM D3577 | Physical Properties - Strength at 500% | 7.0 MPa max | PASS (4.1-4.9MPa) |
| ASTM D3577 | Physical Properties - Ultimate Elongation (Before aging) | 650 % min | PASS (700-720%) |
| ASTM D3577 | Physical Properties - Ultimate Elongation (After aging) | 490 % min | PASS (620-645%) |
| ASTM D6124 | Residual powder | <2mg / glove | PASS (0.05-0.18mg/glove) |
| ASTM D7866 | Attenuation Requirements (at cuff) | 60 kVp: 29%80 kVp: 22%100 kVp: 18%120 kVp: 15% | PASS (Model 1: 60kVp: 42.0-43.0%, 80kVp: 34.4-35.0%, 100kVp: 28.9-29.4%, 120kVp: 25.1-25.4%; Model 2: 60kVp: 50.5-51.3%, 80kVp: 42.0-42.7%, 100kVp: 36.2-36.7%, 120kVp: 31.2-31.6) |
| ISO 10993-10, Skin Irritation | Determine if an extract produces skin irritation | No skin irritation | PASS (Negligible skin irritation observed) |
| ISO 10993-10, Dermal Sensitization | Determine if an extract produces Dermal Sensitization | No skin sensitization | PASS (No skin sensitization produced in guinea pigs) |
| ISO 10993-11, Acute Systemic Toxicity | Determine if an extract causes systemic toxicity in vivo | Meet systemic toxicity test | PASS (Meet the requirement of acute systemic toxicity test) |
| ISO 10993-5, Cytotoxicity | In vitro cytotoxicity on extract | Comparable cytotoxicity to predicate device | PASS (Both devices exhibited slight reactivity at 50x dilution concentration) |
| ASTM D7102-22, Endotoxin | Determination of bacterial endotoxin on gloves | Endotoxin level < 20 EU/device on 3 production batches | PASS (12.9, 12.8, and 15.4 EU/device reported) |
| ISO 21582-21, Pyrogenicity | Pyrogen testing | Non pyrogenic | PASS (Non pyrogenic and meets US Pharmacopeia requirements) |
2. Sample size used for the test set and the data provenance:
- The document primarily references standards (ASTM, ISO) for testing. These standards define the sampling plans for various tests (e.g., AQL for freedom from holes).
- For the Endotoxin determination (ASTM D7102-22), it explicitly states that the test was performed on 3 production batches. No specific sample size (number of gloves) per batch is given.
- For Biocompatibility tests (ISO 10993-10, -11, -5), the tests were performed on "an extract of the product" and involved "rabbit," "guinea pigs," and "in vitro." Specific sample sizes of animals or in vitro repetitions are not provided.
- Data provenance (country of origin, retrospective/prospective): Not specified in the provided text. The submission is from Ineo Tech Sdn Bhd in Malaysia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a medical glove requiring physical, chemical, and biological performance testing against established standards, not a diagnostic device requiring expert opinion for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 3. Testing is based on objective measurements against predefined criteria in 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:
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is defined by the acceptance criteria specified in internationally recognized standards (ASTM, ISO) for medical gloves. These standards define measurable physical, chemical, and biological properties.
8. The sample size for the training set:
- Not applicable. This is a manufactured product, not a machine learning model requiring a "training set."
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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