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510(k) Data Aggregation
(212 days)
"Skypro. Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single use, disposable, and provided sterile.
"Skypro, Surgical Gown 6021" are sterile, disposable, and intended for single use. They are fundamentally made of blue non-woven spunbond-meltblown-spunbond (SMS) polypropylene fabrics, and come in a variety of sizes (XS, S, M, L, XL, and XXL). The gown features white elastic cuffs, a hook-and-loop tap for closing the neck, and four waist belts for closing the back.
"Skypro, Surgical Gown 6021" is constructed in accordance with AAMI PB70 Level 3 specifications. The major raw material of the surgical gown is non-woven SMS polypropylene fabric, which is a trilaminate non-woven fabric with a densely packed structure (i.e., small micron pore sizes) to provide tortuous paths to block the penetration of particulate matter. The hydrophobic nature of the fabric can effectively prevent the absorption and penetration of liquids and body fluids. The joints and seam regions of the surgical gown are sealed via ultrasonic vibration- assisted welding to avoid the penetration of liquids through joints and seam stitching. The whole of the surgical gown exhibits a barrier performance of Level 3.
The provided text describes the 510(k) submission for the "Skypro, Surgical Gown 6021" and compares it to a predicate device. This document is a regulatory submission for a medical device (surgical gown), not a software-based AI/ML device. Therefore, the bulk of the questions, specifically those related to AI/ML device performance (like "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "number of experts for ground truth," or "sample size for training set"), are not applicable.
However, I can extract information related to the acceptance criteria and study proving the device meets those criteria, as well as the types of testing performed for this non-AI medical device.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document details various non-clinical tests and their criteria, which serve as the acceptance criteria for the surgical gown.
| Test Performed | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM F2407-20, Section 7.2 Tensile Strength (ASTM D5034-09(R17)) | To evaluate the tensile strength of the gown material | ≥ 30N | Pass (Warp yarns torn (MD): 179.7 N, Weft yarns torn (CD): 103.7 N) |
| ASTM F2407-20, Section 7.2 Seam Strength (ASTM D1683/D1683M-22) | To evaluate the tensile strength of the gown seam | ≥ 30N | Pass (Sleeve seam: 113.3 N, Armhole seam: 73.2 N, Shoulder seam: 111.1 N) |
| ASTM F2407-20, Section 7.2 Tearing Strength (ASTM D5733-99) | To evaluate the tear strength of the gown material | ≥ 10N | Pass (Warp yarns torn (MD): 53.9 N, Weft yarns torn (CD): 29.2 N) |
| ASTM F2407-20, Section 7.3 Lint Generation (ISO 9073-10:2003) | To evaluate the potential for linting of the gown | Documentation only | Pass (Side A (face): Total linting: 140.9, Coefficient of linting: 2.15; Side B (back): Total linting: 242.2, Coefficient of linting: 2.38) |
| ASTM F2407-20, Section 7.3 Evaporative Resistance (ASTM F1868-17) | To evaluate the evaporative resistance of the gown | Documentation only | Pass (0.00215 kPa·m²/W) |
| Water Resistance: Hydrostatic Pressure (AATCC 42:2017) | To evaluate the hydrostatic water resistance of the gown | ≥ 50cmH20 | Pass (Base material: > 50 cmH₂O, Sleeve Seam: > 50 cmH2O, Tie attachment with/without film: > 50 cmH₂O) |
| Water Resistance: Impact Penetration (AATCC 127:2018e) | To evaluate the water spray resistance of the gown | ≤ 1.0g | Pass (Base material: 0 g, Sleeve Seam: 0 g, Tie attachment with/without film: 0 g; No penetration can be observed) |
| ASTM F2407-20, Section 6.3 Flame Spread (16 CFR 1610) | To evaluate the flame resistance of the gown | Class 1 | Pass (Class 1) |
| Cytotoxicity Test: MEM Elution (ISO 10993-5:2009) | To evaluate the cytotoxic potential of the gown | Under conditions of the testing, non-cytotoxic | Pass (Under conditions of the testing, non-cytotoxic) |
| Sensitization Test: Kligman Maximization Test (ISO 10993-10:2021) | To evaluate the sensitization potential of the gown | Under conditions of the testing, not a sensitizer | Pass (Under conditions of the testing, not a sensitizer) |
| Primary Skin Irritation Test: Intracutaneous Injection Test (ISO 10993-10:2021) | To evaluate the skin irritation potential of the gown | Under conditions of the testing, not an irritant | Pass (Under conditions of the testing, not an irritant) |
| Sterilant Gas Residue Analysis (ISO 10993-7) | To verify low levels of residual ethylene oxide and ethylene chlorohydrin | EO: < 4 mg /device; ECh: < 9 mg / device | Pass (EO: < 4 mg /device, ECh: < 9 mg / device) |
| Seal Peel Test (ASTM F88) | To evaluate the force necessary to open the sterile barrier seals | 0.375 lbf (average) | Pass (0.375 lbf (average)) |
| Dye Migration Test (ASTM F1929) | To verify the integrity of the sterile barrier | No leakage | Pass (No leakage) |
| Simulated Aging Test (ASTM F1980) | To verify the ability of the sterile barrier to maintain integrity during its shelf life | Meets performance specifications after accelerated aging, no visually apparent change | Pass (Meets performance specifications after accelerated aging, no visually apparent change) |
| AAMI PB 70 Classification | To classify the gown's barrier performance | Level 3 | Level 3 |
| Sterility Assurance Level | To ensure microbial sterility | 10^-6 | 10^-6 |
| Shelf Life | To define the time during which the product remains safe and effective | Stated Shelf Life (e.g., 2 years) | 2 years |
2. Sample sizes used for the test set and the data provenance
The document does not specify the exact sample sizes for each non-clinical test. It refers to standard ASTM and ISO methods, which typically dictate sample sizes. The data provenance is not explicitly stated in terms of country of origin, nor is it specified as retrospective or prospective; these are standard laboratory tests on the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is for a physical medical device (surgical gown), not an AI/ML device relying on expert interpretation for ground truth. The "ground truth" here is objective physical and chemical properties measured by standardized test methods.
4. Adjudication method for the test set
Not applicable. This is for a physical medical device. The results are from standardized laboratory testing, not subjective human-reviewed data requiring adjudication.
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. No MRMC study was performed.
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.
7. The type of ground truth used
The ground truth is established through adherence to recognized international (ISO) and national (ASTM, AATCC, 16 CFR) standards and test methods for material properties, barrier performance, biocompatibility, and sterility. These are objective, measurable outcomes.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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