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510(k) Data Aggregation
(268 days)
The StringKing Disposable Surgical Gown is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. The StringKing Surgical Gowns meet Level 3 and Level 4 requirements of ANSI/AAMI PB 70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The Disposable Surgical Gown consists of a multi-layer nonwoven spunbond-meltblownspunbond (SMS) polyolefin & Film Lamination in the critical zones and a single layer of lighter, more breathable nonwoven SMS polvolefin in the non-critical zones. The StringKing Disposable Surgical Gown is designed for easy donning and doffing with hook and loop neck tabs, belt ties, removable transfer accessory, and polyester wrist cuffs. The StringKing Disposable Surgical Gown is one gown design that meets both Level 4 requirements of AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The gown will be marketed as a L3 gown as well as a L4 gown. The StringKing Disposable Surgical Gowns are single use, disposable medical devices that will be provided sterile.
Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Standard | Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|---|
| ANSI/AAMI PB70:2012 (Overall classification) | Meets Level 3 and Level 4 Liquid Barrier Requirements | Meets ANSI/AAMI PB 70:2012 Level 3 and Level 4 Liquid Barrier requirements | Pass |
| Water Resistance Hydrostatic Pressure Test - AATCC 127:2017 (cm) | $\ge$ 50 cm | All samples passed at $\ge$ 50 cm | Pass |
| Flammability of Clothing Textiles - 16 CFR Part 1610 (a) | Class 1: $\ge$ 3.5 seconds | All samples passed at $\ge$ 3.5 seconds | Pass |
| Durability ASTM D-5034 | $\ge$ 7 lbf | All samples passed at greater than 7 lbf | Pass |
| Tensile Strength ASTM D-5034 Machine Direction and Cross Direction | $\ge$ 7 lbf | All samples passed at greater than 7 lbf | Pass |
| Trap Tear ASTM D5587-15 Machine Direction and Cross Direction | $\ge$ 2.3 lbf | All samples passed at $\ge$ 2.3 lbf | Pass |
| Water Resistance Impact Penetration Test AATCC 42 | $\le$ 1.0 g | All samples passed at $\le$ 1.0 g | Pass |
| ASTM D1683 Seam Strength | $\ge$ 7 lbf | All samples passed at $\ge$ 7 lbf | Pass |
| ASTM F1671 Viral Penetration | Level 4: No penetration at 2 psi | All samples showed no penetration at 2 psi | Pass |
| Ethylene oxide residuals ISO 10993-7 | EO <4mg, ECH <9mg | EO residuals were not detected ("ND") | Pass |
| Cytotoxicity – ISO 10993-5 | $\le$ Grade 2 (mild) | Grade 0 | Pass |
| Skin Sensitization- ISO 10993-10 | Primary Irritation Index 0-0.4 (Negligible) | 0.0 | Pass |
| Skin Irritation - ISO 10993-23 | $\le$ 1 on Magnusson and Kligman Scale | 0.0 | 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 individual test. It generally uses phrases like "All samples passed," indicating that a sufficient number of samples were tested to meet the requirements of the respective standards.
The data provenance is from non-clinical testing conducted according to recognized international and national standards (e.g., ANSI/AAMI PB70:2012, AATCC, ASTM, ISO, CFR). The testing was for the StringKing Disposable Surgical Gown. The document does not specify the country of origin of the testing facilities, but the standards are international. This is retrospective in the sense that the studies were performed and results collected before this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a physical product (surgical gown) and the "ground truth" for its performance is established through objective, standardized laboratory testing (e.g., measuring forces, penetration, chemical residues) against predefined thresholds, not through expert human interpretation or consensus of observational data.
4. Adjudication method for the test set
This is not applicable for the same reasons as above. Performance is determined by meeting objective criteria in standardized tests, not by human adjudication of qualitative or ambiguous data.
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 is not applicable. The device is a surgical gown, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product and does not involve any algorithms or AI for its function or evaluation.
7. The type of ground truth used
The ground truth for the performance of the surgical gown is established by objective measurements and adherence to predefined thresholds specified in international and national standards (e.g., ANSI/AAMI PB70:2012, ASTM D5034, AATCC 127, ISO 10993, etc.). These standards define what constitutes a "pass" or "fail" for various performance characteristics like liquid barrier, flammability, tensile strength, tear strength, seam strength, viral penetration, and biocompatibility.
8. The sample size for the training set
This is not applicable. The device is a physical medical device and does not involve any machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
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