Search Results

The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.

The proposed device Disposable Surgical Gown is model UM-148, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of polyester. The proposed device is available in sizes: S(120×135cm), M(125×140cm), L(130×145cm) and XL(135×150cm). This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and a blue color.

The provided text describes a 510(k) premarket notification for a medical device, specifically a "Disposable Surgical Gown (UM-148)". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study" described are about showing that the new surgical gown performs comparably to established standards and a predicate device, rather than proving a new clinical claim.

Here's an analysis of the provided information, formatted as requested:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Tearing Strength (ASTM D5587-15): 10 samples.
• Breaking Strength and Elongation (ASTM D5034-09): 10 samples.
• Failure in Sewn Seams (ASTM D1683M-17): 10 samples.
• Water Penetration Resistance (AATCC 42-2013): 3 nonconsecutive batches.
• Evaporative Resistance (ASTM F1868-17): 13 samples.
• Water Resistance: Hydrostatic Pressure Test (AATCC 127-2014): 3 nonconsecutive batches.
• Flammability (CPSC 16 CFR Part 1610-2008): 5 samples.
• Linting (ISO 9073-10:2003(E)): 13 samples.
• Biocompatibility (ISO 10993-10 and ISO 10993-5): Sample sizes for the specific in vitro and in vivo tests are not explicitly stated, but the tests were performed "under the conditions of the study".

The data provenance is from non-clinical tests conducted by or on behalf of Unimax Medical Products Co., Ltd. in China. These are prospective tests performed on the proposed device to demonstrate its performance against recognized industry standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a submission for a physical medical device (surgical gown) where performance is measured against established scientific and engineering standards for materials and protective properties, not based on expert interpretation of observational data. The "ground truth" is defined by the objective metrics specified in the test methodologies (e.g., N for strength, g for water penetration, cm for hydrostatic pressure).

4. Adjudication method for the test set

Not applicable. Performance is measured against quantitative and qualitative criteria defined by the respective standards, and the results are reported directly (e.g., "PASS", "45.5N"). There is no subjective interpretation or adjudication process involved as would be the case for image-based diagnostic AI, for example.

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-enabled diagnostic device. It is a physical product (surgical gown).

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI-enabled diagnostic device.

7. The type of ground truth used

The ground truth is based on established industry standards and objective physical measurements. For example:

• AAMI/ANSI PB70:2012 defines liquid barrier performance levels.
• ASTM standards define methods and acceptance criteria for material strengths (tearing, breaking, seam).
• AATCC standards define methods for water resistance.
• CPSC 16 CFR Part 1610 defines flammability classes.
• ISO 9073-10 defines linting criteria.
• ISO 10993 standards define biocompatibility criteria based on in vitro (cytotoxicity) and in vivo (irritation, sensitization) tests.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The tests are directly measuring the physical properties of the manufactured product.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

Ask a specific question about this device

The Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.

Surgical Face Mask is composed of Nylon and Spandex ear loops, Iron-plastic nose clip, Inner layer Spunbond polypropylene, Middle Melt-blown polypropylene and outer Spun-bond polypropylene. The meltblown polypropylene material acts as the filter that stops microbes from entering or exiting the mask. Surgical Face Masks feature pleats or folds. Three pleats are used to allow the user to expand the mask such that it covers the area from the nose to the chin. The type is ear-loop, where a string-like material is attached to the mask and placed behind the ears. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

The provided document describes the non-clinical testing performed for a Surgical Face Mask (Model: 17.5X9.5CM EAR-LOOP) to demonstrate its substantial equivalence to a legally marketed predicate device. This is not an AI/ML medical device, and therefore, the requested information regarding AI/ML-specific study aspects (like expert ground truth establishment, MRMC studies, training/test set details, etc.) is not applicable to this document.

The document focuses on the physical performance and biocompatibility of the surgical face mask, comparing it to established industry standards for surgical apparel.

Here's the relevant information extracted and presented based on the document:

Device: Surgical Face Mask, Model: 17.5X9.5CM EAR-LOOP
Regulatory Class: Class II
Product Code: FXX
Regulation Number: 21 CFR 878.4040 (Surgical Apparel)
Predicate Device: K203426, Surgical Face Mask (non-sterile)

Study Type: Non-clinical (performance and biocompatibility)
Clinical Test Conclusion: No clinical study was included in this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against ASTM F2100-19 Level 2 performance standards and ISO 10993 for biocompatibility.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size: For each performance test (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability), 3 non-consecutive lots were tested, using a sample size of 32 per lot.
• Data Provenance: The document does not explicitly state the country of origin for the non-clinical test data. Given the applicant and correspondent are based in China, it is highly likely the testing was conducted in China. The data is retrospective in the sense that it was collected and compiled for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

N/A. This is a physical device, and its performance is evaluated against established engineering standards (ASTM, EN, ISO, CFR) through laboratory testing, not through expert consensus on qualitative data or medical imaging.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical evaluations, especially for AI/ML devices where human experts may disagree on interpretations. For physical device testing against quantitative standards, the test results are objective measurements evaluated directly against the predefined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

N/A. MRMC studies are used to evaluate the diagnostic accuracy of AI/ML systems in conjunction with human readers. This document pertains to a physical medical device (surgical face mask) with performance validated via non-clinical laboratory testing.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A. This question is also specific to AI/ML devices. The "standalone" performance here would refer to the mask's inherent physical properties and functionality, which are indeed tested without human intervention in their function, only human operation of the test equipment.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by established engineering and material science standards (e.g., ASTM F2100, ASTM F1862, EN 14683, ISO 10993, 16 CFR 1610). The device's measured properties are directly compared to the quantitative or qualitative requirements specified in these standards.

8. The Sample Size for the Training Set

N/A. This device does not use an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

N/A. (See point 8)

Ask a specific question about this device