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510(k) Data Aggregation
(163 days)
The Stryker Steri-Shield 8 disposables, including all hood and toga models, are components of the Stryker Steri-Shield 8 Personal Protection System and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker Steri-Shield 8 disposables are sterile, disposable, single-use only devices.
The Stryker Steri-Shield 8 Surgical Protective Equipment consist of Stryker Steri-Shield 8 Surgical Hoods and Steri-Shield 8 Surgical Togas.
The Stryker Steri-Shield 8 Surgical Hood is a single piece device that covers the user's head, neck, and shoulder region and is intended to be worn with commercially available sterile surgical gowns. The Steri-Shield 8 Hoods are available with Standard (NPA), Peel Away (PA) and Anti-Reflective (AR) face shield options.
The Stryker Steri-Shield 8 Surgical Togas are a single piece device that covers the user's head, neck, arms, torso, and upper legs region. The Stryker Steri-Shield 8 Surgical Togas is offered in three configurations: Steri-Shield 8 Pullover Togas, Steri-Shield 8 Zippered Togas, and Steri-Shield 8 Tie Back Togas.
The Stryker Steri-Shield 8 Surgical Hoods and Togas is a medical device intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure to infectious bodily fluids, and the transfer of microorganisms and particulate material. The device is sterile, disposable, and for single-use only.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard/Test) | Reported Device Performance |
|---|---|
| Barrier Performance (Gown - Critical Zone Level 4 Protection) | |
| ASTM F1671 testing - BVB & Sleeve Seam | Passes requirements for PB70 Level 4 protection |
| Barrier Performance (Gown - Non-Critical Zone) | |
| AATCC Test Method 42 Per AAMI/ANSI PB70 | Passes AATCC Test Method 42 (< 4.5g) |
| Barrier Performance (Hood - Exempt) | |
| All materials and seams | Non-protective (meets acceptance criteria as intended) |
| Physical Performance | |
| Flammability per 16 CFR Part 1610 (Class 1) | Class 1 requirements met |
| Water Spray Impact per AATCC 42 (Water Penetration ≤ 4.5 g) | Water Penetration ≤ 4.5 g |
| Synthetic Blood per ASTM F1862 (No visible penetration) | No visible penetration |
| Fabric Viral Penetration per ASTM F1671 (no detectable (< 1 PFU/mL)) | No detectable (< 1 PFU/mL) |
| Particulate Filtration Efficiency per ASTM F2299 (≥ 95%) | ≥ 95% |
| Bacterial Filtration Efficiency per ASTM F2101 (≥ 95%) | ≥ 95% |
| Particle Release per ISO 9073-10 (Lint Count ≤ 4.0 (Log10, Upper Quartile)) | Lint Count ≤ 4.0 (Log10, Upper Quartile) |
| Air Permeability per ASTM D737 | Better or equivalent to predicate product |
| Tear Strength per ASTM D5587 (≥ 2.3 lbf) | ≥ 2.3 lbf |
| Tensile Strength per ASTM D5034 (≥ 7.0 lbf) | ≥ 7.0 lbf |
| Seam Strength per ASTM D1683 (≥ 7.0 lbf) | ≥ 7.0 lbf (Predicate was ≥ 6.0 lbf, so this is an improvement or meets threshold) |
| Evaporative Resistance per ASTM F1868 | Better or equivalent to predicate product |
| Light Transmittance and Haze per ASTM D1003 | Better or equivalent to predicate product |
| Perforation Tear Strength Testing (Stryker Internal Testing) (0.15 lbf < Tear Force ≤ 1.5 lbf) | 0.15 lbf < Tear Force ≤ 1.5 lbf |
| Biocompatibility | |
| Human Factors and Usability | Product is found to be safe and effective for the intended users, uses and use environment |
| Noise and Speech Interference Levels | Better or equivalent to predicate product |
| Carbon Dioxide (CO2) Testing (Inhale CO2 ≤ 5000ppm per OSHA Exposure Limits) | Inhale CO2 ≤ 5000ppm |
| ISO 10993-1, -5, -10, -23, -11 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity) | Cytotoxicity – MEM Grade ≤ 2; Sensitization – Sensitization response ≤ 0; Irritation – Intracutaneous Reactivity ≤ 1.0; Acute Systemic Toxicity – No signs of toxicity, no weight loss in excess of 10% (Note: Cytotoxic response in one test article was mitigated by in vivo testing and chemical characterization) |
| ISO 10993-17 (Toxicological risk assessment) | Assessment performed |
| ISO 10993-18 (Chemical characterization of medical device materials) | Characterization performed |
| Sterilization | |
| Finished (Terminal) Product Sterilization Method (SAL 10-6 Terminally sterilized via Ethylene Oxide (EO)) | SAL 10-6 Terminally sterilized via Ethylene Oxide (EO) in accordance with ISO 11135, Half cycle overkill method |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each test mentioned (e.g., number of hoods or togas tested for flammability, water resistance, etc.). The tests are described as "Performance Data (Non-Clinical Tests)," indicating that they were conducted in a laboratory setting on product samples. The data provenance is not specified beyond being generated by Stryker Instruments as part of their 510(k) submission. Given the nature of performance testing for surgical apparel standards, these tests are typically conducted on representative samples of the manufactured devices.
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. The acceptance criteria for the Stryker Steri-Shield 8 Surgical Hoods and Togas are based on recognized industry standards (e.g., ASTM, AATCC, ISO, 16 CFR) for material properties and device performance, not on expert interpretations of outcomes.
4. Adjudication method for the test set:
This information is not applicable as the acceptance criteria are based on objective, quantifiable measurements from recognized standards, not subjective assessments 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:
This information is not applicable. The device is a surgical hood and toga, not an AI-assisted diagnostic or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a physical product (surgical apparel), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on established, quantifiable metrics and pass/fail criteria defined by recognized national and international standards for medical textiles, barrier materials, and biological safety. Examples include:
- Physical properties (e.g., tear strength, tensile strength, air permeability).
- Barrier effectiveness against fluids, synthetic blood, viruses, and particulates.
- Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity).
- Flammability.
- CO2 levels within the hood.
These "ground truths" are objective measurements against defined thresholds in the standards.
8. The sample size for the training set:
This is not applicable as the device is a physical product and not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable as the device is a physical product and not an AI/ML algorithm.
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