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510(k) Data Aggregation
(268 days)
The Disposable Surgical Isolation Gown is intended to protect patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the disposable surgical isolation gown meets the requirements of a Level 4 barrier protection per ANSI/AAMI PB70:2012 -Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities. The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
The disposable surgical isolation gown consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings,The products are composed of 45g of SMS (spunbond, meltblown, spunbond) non-woven fabric and 20g of PE(Polyethylene) film layer material with the color in blue.Disposable surgical isolation gown have a hook and loop fastener at the back of the neck and a waist ties feature to secure the gown to the body of the user. The material of the collar of the Disposable Surgical Isolation Gown is 35g of white PP (polypropylene). The cuffs are white polyester rib sleeve cloth with a length of 7.5cm. The disposable surgical isolation gown provided in ONE product model in six sizes. The size of disposable surgical isolation gown is divided into six groups: S, M, L, XL, XXXL. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the disposable surgical isolation gown meet the requirements for Level 4 classification.
The disposable surgical isolation gown is a single use, disposable medical device provided non-sterile.
The provided text describes the acceptance criteria and study for a Disposable Surgical Isolation Gown, not an AI device. As such, information regarding AI-specific details like effect size improvement with AI assistance, standalone algorithm performance, or ground truth establishment for AI training sets is not present. Therefore, the response will focus on the details pertinent to the medical device described.
Acceptance Criteria and Device Performance for Disposable Surgical Isolation Gown
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Item | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Weight per square (g) (ASTM D3776) | ≥65g/m² | Lot A: 66.88 g/m²Lot B: 67.86 g/m²Lot C: 66.92g/m² | Pass |
| Flammability (16 CFR Part 1610) | Class 1: Burn time ≥ 3.5 seconds | Class 1 (Results obtained from Three Lots) | Pass |
| Liquid Barrier Performance (AATCC-127) - Hydrostatic Pressure | > 50 cm H₂O | > 50 cm H₂O (3 non-consecutive lots tested, using a sample size of 32/lot) | Pass |
| Liquid Barrier Performance (AATCC-42) - Water Impact | ≤ 1.0 g | ≤ 1.0 g (3 non-consecutive lots tested, using a sample size of 32/lot) | Pass |
| Liquid Barrier Performance (ASTM F1671/F1671M-2013) - Blood-Borne Pathogen | 1. Assay titer (PFU/mL) < 12. 29 out of 32 pass at 13.8 kPa (1 min) | 1. Base Material: Pass2. Seam: Pass3. Sleeve seam: PassAssay titer (PFU/mL): All were < 1 (3 non-consecutive lots tested, using a sample size of 32/lot) | Pass |
| Tensile Strength (ASTM D5034) | ≥ 7 lbf | Lot A: (Length: 42.94 lbf / Width: 30.4 lbf)Lot B: (Length: 43.5 lbf / Width: 29.5 lbf)Lot C: (Length: 42.64 lbf / Width: 30.38 lbf) | Pass |
| Tearing Strength (ASTM D5733) | ≥ 2.3 lbf | Lot A: (Length: 18.82 lbf / Width: 12.2 lbf)Lot B: (Length: 19.94 lbf / Width: 12.98 lbf)Lot C: (Length: 20.32 lbf / Width: 12.3 lbf) | Pass |
| Seam Strength (ASTM D1683) | ≥ 7 lbf | Lot A: 22.14 lbf (FTS)Lot B: 20.6 lbf (FTS)Lot C: 21.4 lbf (FTS) | Pass |
| Linting (EN ISO 9073-10) | Log₁₀ < 4 | Log₁₀ < 4 (Material/Sleeve) (Results obtained from Three Lots) | Pass |
| Air permeability (ASTM D737) | -- (No specific numerical acceptance criterion listed, but "Pass" implies meeting expected performance) | 0.065 cm³/cm²/sec (Results obtained from Three Lots) | Pass |
| Evaporative Resistance of Clothing Materials (ASTM F1868) | -- (No specific numerical acceptance criterion listed, but "Pass" implies meeting expected performance) | Lot A: Evaporative Resistance: 0.08981 kPa.m²/W, Intrinsic: 0.08638 kPa.m²/WLot B: Evaporative Resistance: 0.08666 kPa.m²/W, Intrinsic: 0.08323 kPa.m²/WLot C: Evaporative Resistance: 0.08971 kPa.m²/W, Intrinsic: 0.08628 kPa.m²/W | Pass |
| Cytotoxicity (ISO 10993-5:2009) | Noncytotoxic | Under the conditions of the study, the device is noncytotoxic. | Pass |
| Irritation (ISO 10993-10:2010) | Nonirritating | Under the conditions of the study, the device is nonirritating. | Pass |
| Sensitization (ISO 10993-10:2010) | Nonsensitizing | Under the conditions of the study, the device is nonsensitizing. | Pass |
The reported device performance indicates that the Disposable Surgical Isolation Gown successfully met all stated acceptance criteria for the non-clinical tests conducted.
2. Sample size used for the test set and the data provenance:
- Sample Size: For liquid barrier performance tests (AATCC-127, AATCC-42, ASTM F1671/F1671M-2013), a sample size of 32 per lot was used. For other tests like Weight per square, Flammability, Tensile Strength, Tearing Strength, Seam Strength, Linting, Air Permeability, and Evaporative Resistance, three non-consecutive lots of the device were tested.
- Data Provenance: The document does not explicitly state the country of origin for the test data, nor does it specify if the studies were retrospective or prospective. Given that this is a premarket notification (510(k)) for a physical medical device, the studies are typically conducted by the manufacturer or accredited labs to international and national standards, and are prospective in nature to demonstrate compliance.
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 and not provided in the document. The "ground truth" for this type of medical device (surgical gown) is established through standardized non-clinical laboratory tests and objective measurements against predefined international and national standards (e.g., ASTM, AATCC, ISO, 16 CFR). There's no subjective expert interpretation of results that would require "ground truth" establishment in the context of diagnostic or imaging AI.
4. Adjudication method for the test set:
Not applicable. As noted above, the evaluation relies on objective, standardized laboratory test results, not on expert adjudication of subjective assessments.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI device.
7. The type of ground truth used:
The "ground truth" for this device is established through adherence to standardized test methods and their specified acceptance criteria from organizations like ASTM, AATCC, ISO, and regulatory bodies (16 CFR). These standards define objective, measurable physical and biological properties.
8. The sample size for the training set:
Not applicable. This is not an AI device, so there is no concept of a "training set" in the machine learning sense. The manufacturing process is validated through quality control and adherence to good manufacturing practices.
9. How the ground truth for the training set was established:
Not applicable. As this is not an AI device, there is no "training set" or corresponding ground truth establishment process in that context.
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