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510(k) Data Aggregation
(111 days)
The Stryker Flyte Hybrid Hoods are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.
The devices are provided sterile and for single use only.
The Stryker Flyte Hybrid Hoods are intended to be worn over a Flyte Helmet to provide protection to the user's face and head region during surgery. Hoods are worn in conjunction with surgical gowns where the hood material extends beyond the user's upper back and shoulders, while the surgical gown covers the lower portion of the hood up to the user's neck.
The Stryker Flyte Hybrid Hood is comprised of 3 main parts: Hood, Filter and Lens. Stryker Flyte Hybrid Hoods are available with either a standard or peel away lens.
The devices are prescription devices, provided sterile and single use only.
This document describes the acceptance criteria and performance data for the Stryker Flyte Hybrid Hoods.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| CO₂ Level Inside the Hood (Internal test) | CO₂ Level < 5000 ppm | Pass |
| Flammability (16 CFR Part 1610) | No burn time or burn time ≥ 3.5 s | Pass |
| Linting (ISO 9073-10) | ≤ 4.0 CL | Pass |
| Tensile Strength (BS EN 29073-3:1992) | ≥ 20 N | Pass |
| Water Spray Impact Penetration (AATCC Test Method 42-2007) | ≤ 4.5 g | Pass |
| Tear Resistance (ASTM D5587-08) | Hood ≥ 2.50 lbfFilter ≥ 2.00 lbf | Pass |
| Evaporative Resistance (ASTM F1868-12 Part B) | Hood ≤ 25.22 Pa·m²/W | Pass |
| Seam Strength Testing (ASTM D1683/D1683M – 11a) | Lens to Hood peel ≥ 2.00 lbfLens to Hood shear ≥ 6.00 lbfAll other seams ≥ 4.00 lbf | Pass |
| Biocompatibility (in vitro cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (primary skin irritation) | Not an irritant | Not an irritant |
| Biocompatibility (skin sensitization) | Not a sensitizer | Not a sensitizer |
| Bacterial Filtration Efficiency (per ASTM F2101-07) | Compliant - Pass | Compliant - Pass |
| Particulate Filtration Efficiency (per ASTM F2299-03) | Compliant - Pass | Compliant - Pass |
| Water Resistance: Impact Penetration (per AATCC 42) Level 1 Critical Zone | Pass AAMI/ANSI PB70 Requirements for Level 1 Protection. | Pass AAMI/ANSI PB70 Requirements for Level 1 Protection. |
| Flammability (16 CFR Part 1610) | No Flame Spread per 16 CFR Part 1610 | No Flame Spread per 16 CFR Part 1610 |
| Finished (Terminal) Product Sterilization Method | SAL 10-6 | SAL 10-6 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes for each performance test. The data provenance is not specified, but the tests were performed by Stryker Instruments, indicating internal testing. The tests are prospective in nature, demonstrating the device's performance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The tests performed are objective physical, chemical, and biological characterizations of the device material, evaluated against established industry and regulatory standards. Expert consensus for test results is not typically required in this context.
4. Adjudication method for the test set:
Not applicable. The tests involve objective measurements and comparisons to predefined acceptance criteria within established 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 a medical device (surgical apparel) and not an AI-driven diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (surgical apparel) and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance tests outlined is defined by established industry standards, regulatory guidelines (e.g., 16 CFR Part 1610, AAMI/ANSI PB70), and ISO standards (e.g., ISO 9073-10, ISO 11135-1, ISO 10993-1). These standards provide objective criteria for evaluating the physical, mechanical, and biological properties of the surgical hood material.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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