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510(k) Data Aggregation
(88 days)
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, 35g Standard SMMS Surgical Gown met the requirements for Level 2 classification; 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown met the requirements for Level 3 classification; BVB Surgical gown met the requirements for Level 4 classification. Non-sterile gowns are to be sold to repackager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization to ISO 11135-1.
The proposed devices are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and are provided in sterile and non-sterile. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.
The proposed devices are available in two materials, SMMS and BVB. SMMS surgical gowns are available in three gram weights, 35g/m², 43g/m², while BVB surgical gown is available only in 64g/m². All SMMS surgical gowns are provided in two types, standard and reinforced. And all types of SMMS surgical gown and BVB surgical gown are available in six product sizes, including M, L, LL, XL, XLL and XXL.
The barrier protection level for 35g Standard SMMS Surgical Gown meet AAMI Level 2; The barrier protection level for 35g Reinforced SMMS Surgical Gown, 43g Standard SMMS Surgical Gown, 43g Reinforced SMMS Surgical Gown, 50g Standard SMMS Surgical Gown and 50g Reinforced SMMS Surgical Gown meet AAMI Level 3; The barrier protection level for BVB Surgical gown meet AAMI Level 4.
The provided text describes the non-clinical testing of surgical gowns to demonstrate their substantial equivalence to predicate devices, rather than a study for an AI/ML device. Therefore, the requested information regarding AI/ML device acceptance criteria, performance, ground truth, experts, and training/test set details cannot be extracted from this document.
However, I can provide the acceptance criteria and performance results for the physical properties and biocompatibility of the surgical gowns based on the provided tables.
1. A table of acceptance criteria and the reported device performance
| Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flammability | Meets Class 1 requirements | Class 1 |
| Hydrostatic pressure | Level 2 Surgical Gown: >20 cm H2O; Level 3 Surgical Gown: >50 cm H2O; Level 4 Surgical Gown: >50 cm H2O | 35g Standard SMMS Surgical Gown: (Non-sterile): Average 40.57cm; (Sterile): Average 40.21cm (Meets Level 2) 35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 83.53cm; (Sterile): Average 83.57cm (Meets Level 3) 43g Standard SMMS Surgical Gown: (Non-sterile): Average 60.50 cm; (Sterile): Average 60.48 cm (Meets Level 3) 43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 99.59 cm; (Sterile): Average 98.90 cm (Meets Level 3) 50g Standard SMMS Surgical Gown: (Non-sterile): Average 83.19 cm; (Sterile): Average 83.02 cm (Meets Level 3) 50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 108.37 cm; (Sterile): Average 108.37 cm (Meets Level 3) BVB Surgical Gown: (Non-sterile): Average 161.71 cm; (Sterile): Average 162.11 cm (Meets Level 4) |
| Water impact | ≤1.0 g | 35g Standard SMMS Surgical Gown: (Non-sterile): Average 0.041g; (Sterile): Average 0.03g 35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 0.03g; (Sterile): Average 0.029g 43g Standard SMMS Surgical Gown: (Non-sterile): Average 0.036g; (Sterile): Average 0.033g 43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 0.032g; (Sterile): Average 0.032g 50g Standard SMMS Surgical Gown: (Non-sterile): Average 0.031g; (Sterile): Average 0.034g 50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 0.033g; (Sterile): Average 0.031g BVB Surgical Gown: (Non-sterile): Average 0.078g; (Sterile): Average 0.079g (All meet criteria) |
| Breaking strength | ≥30N | 35g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 108.37N; Longitude: 161.87N; (Sterile): Latitude: 108.37N; Longitude: 161.87N 35g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 108.72N; Longitude: 161.19N; (Sterile): Latitude: 108.53N; Longitude: 161.31N 43g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 113.34N; Longitude: 182.30N; (Sterile): Latitude: 113.01N; Longitude: 181.05N 43g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 113.72N; Longitude: 181.14N; (Sterile): Latitude: 112.60N; Longitude: 181.26N 50g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 137.58N; Longitude: 190.87N; (Sterile): Latitude: 137.77N; Longitude: 188.30N 50g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 138.02N; Longitude: 191.32N; (Sterile): Latitude: 138.39N; Longitude: 190.07N BVB Surgical Gown: (Non-sterile): Latitude: 148.44N; Longitude: 236.60N; (Sterile): Latitude: 148.93N; Longitude: 237.72N (All values significantly greater than 30N) |
| Tearing strength | ≥10N | 35g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 32.49N; Longitude: 39.67N; (Sterile): Latitude: 32.31N; Longitude: 39.81N 35g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 32.44N; Longitude: 39.67N; (Sterile): Latitude: 32.55N; Longitude: 39.92N 43g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 33.99N; Longitude: 41.40N; (Sterile): Latitude: 33.92N; Longitude: 41.75N 43g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 34.09N; Longitude: 41.51N; (Sterile): Latitude: 34.01N; Longitude: 41.18N 50g Standard SMMS Surgical Gown: (Non-sterile): Latitude: 44.02N; Longitude: 54.18N; (Sterile): Latitude: 44.36N; Longitude: 54.07N 50g Reinforced SMMS Surgical Gown: (Non-sterile): Latitude: 43.93N; Longitude: 53.96N; (Sterile): Latitude: 44.30N; Longitude: 54.25N BVB Surgical Gown: (Non-sterile): Latitude: 49.76N; Longitude: 53.97N; (Sterile): Latitude: 49.23N; Longitude: 53.98N (All values significantly greater than 10N) |
| Linting | Log10(particle count) < 4 | 35g Standard SMMS Surgical Gown: (Non-sterile): Average 2.89; (Sterile): Average 2.89 35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 2.89; (Sterile): Average 2.90 43g Standard SMMS Surgical Gown: (Non-sterile): Average 2.50; (Sterile): Average 2.47 43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 2.47; (Sterile): Average 2.54 50g Standard SMMS Surgical Gown: (Non-sterile): Average 2.50; (Sterile): Average 2.51 50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 2.47; (Sterile): Average 2.48 BVB Surgical Gown: (Non-sterile): Average 2.54; (Sterile): 2.52 (All meet criteria) |
| Seam strength | ≥30N | 35g Standard SMMS Surgical Gown: (Non-sterile): Average 41.90N; (Sterile): Average 42.21N 35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 41.75N; (Sterile): Average 41.74N 43g Standard SMMS Surgical Gown: (Non-sterile): Average 44.51N; (Sterile): Average 44.56N 43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 44.55N; (Sterile): Average 44.34N 50g Standard SMMS Surgical Gown: (Non-sterile): Average 50.52N; (Sterile): Average 50.45N 50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 50.45N; (Sterile): Average 50.57N BVB Surgical Gown: (Non-sterile): 70.27N; (Sterile): 70.35N (All values significantly greater than 30N) |
| Air permeability | ≥30 ft³/min/ft² | 35g Standard SMMS Surgical Gown: (Non-sterile): Average 70.65 ft³/min/ft²; (Sterile): Average 68.89 ft³/min/ft² 35g Reinforced SMMS Surgical Gown: (Non-sterile): Average 70.67 ft³/min/ft²; (Sterile): Average 69.94 ft³/min/ft² 43g Standard SMMS Surgical Gown: (Non-sterile): Average 65.05 ft³/min/ft²; (Sterile): Average 65.51 ft³/min/ft² 43g Reinforced SMMS Surgical Gown: (Non-sterile): Average 65.76 ft³/min/ft²; (Sterile): Average 66.56 ft³/min/ft² 50g Standard SMMS Surgical Gown: (Non-sterile): Average 62.03 ft³/min/ft²; (Sterile): Average 62.15 ft³/min/ft² 50g Reinforced SMMS Surgical Gown: (Non-sterile): Average 62.12 ft³/min/ft²; (Sterile): Average 62.06 ft³/min/ft² (All meet criteria) |
| Viral barrier (resistance to bacteriophage Phi-X174) | No bacteriophage penetration | For BVB Surgical Gowns only: No bacteriophage penetration (Meets criteria) |
| Ethylene Oxide Residuals | EO:<4mg/device; ECH:<9mg/device | EO Residue: 0.84 mg/device; ECH Residue: 1.18 mg/device (Both meet criteria) |
| Cytotoxicity | Viability $\ge$ 70% of the blank; 50% extract of test sample should have at least same or higher viability than 100% extract | The viability was $\ge$ 70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract. Under the conditions of the study, the proposed device was non-cytotoxic. (Meets criteria) |
| Sensitization | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. (Meets criteria) |
| Irritation | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. (Meets criteria) |
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 used for each test. Instead, it reports average values. It does not provide information on the country of origin of the data or whether the tests were retrospective or prospective, beyond stating that "Non clinical tests were conducted to verify that the proposed device met all design specifications".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as this document pertains to physical and biocompatibility testing of a medical device (surgical gowns), not an AI/ML diagnostic or assistive device that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., imaging reads) to establish ground truth. The tests described here are laboratory-based objective measurements.
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 section is not applicable, as this document is about physical product testing of surgical gowns, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable, as this document is about physical product testing of surgical gowns, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the physical and biocompatibility tests are the established international and national standards and methodologies (e.g., 16 CFR Part 1610, AATCC 127, ASTM D5034, ISO 10993-5, etc.) against which the device's performance is measured. For instance, flammability "ground truth" is meeting Class 1 requirements, hydrostatic pressure "ground truth" is a minimum cm H2O value, and cytotoxicity "ground truth" is cell viability $\ge$ 70% of the blank.
8. The sample size for the training set
This section is not applicable, as this document is about physical product testing of surgical gowns, not an AI/ML device.
9. How the ground truth for the training set was established
This section is not applicable, as this document is about physical product testing of surgical gowns, not an AI/ML device.
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