Search Results

AMD Ritmed AssureWear™ VersaGown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). AMD Ritmed AssureWear™ VersaGown is a single use, non-sterile disposable medical device and not intended for use in operating rooms. The medical device will be available in 18 models in large and Xlarge sizes.

AMD Ritmed AssureWear™ VersaGown isolation gown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AMD Ritmed AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown ger ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).

AMD Ritmed AssureWear™ VersaGown is a single use, disposable medical device provided nonsterile and non-intended for use in operating rooms and is constructed of polypropylene Spunbond--Meltblown-Spunbond Nonwovens (SMS), non-woven and coated with polyethylene. The isolation gown consists of one critical zone throughout the entire gown including the seams and belt attachments but excluding cuffs, hems and bindings.

The provided document is a 510(k) Premarket Notification for the AMD Ritmed AssureWear™ VersaGown. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI/human-in-the-loop diagnostic device.

Therefore, many of the requested criteria regarding AI device performance, clinical studies, expert consensus, and ground truth establishment are not applicable to this document. The document describes the acceptance criteria and performance of a physical medical device (isolation gown) based on non-clinical performance testing against established industry standards.

Here's the information as it can be extracted from the document:

Acceptance Criteria and Device Performance for AMD Ritmed AssureWear™ VersaGown

The device is an isolation gown intended to provide barrier protection. The "acceptance criteria" are essentially the performance requirements for an AAMI Level 3 barrier protection gown, as defined by ANSI/AAMI PB70:2012, along with other physical and biological safety standards. The "reported device performance" is the result of the tests conducted on the VersaGown.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For several physical properties (e.g., basic weight, breaking strength, tearing strength), the "acceptance criteria" are implicitly set by comparing to the performance of the legally marketed predicate device. The values for the predicate device are listed in the table if available for comparison.

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

The document does not specify the exact sample sizes for each non-clinical performance test. The results are presented as means and standard deviations, which implies multiple measurements were taken for each test. Data provenance is not described in terms of country of origin or retrospective/prospective, as this is laboratory testing of a manufactured product, not human-subject data.

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

Not applicable. This is for a physical medical device (isolation gown), not a diagnostic algorithm requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" here is determined by the results of standardized physical and biological tests.

4. Adjudication method for the test set

Not applicable. No human adjudication is involved in the performance testing of a physical medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No. This type of study is typically done for diagnostic imaging AI devices, not for physical medical devices like isolation gowns.

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

Not applicable. This is not an AI algorithm. The performance stated is intrinsic to the physical device.

7. The type of ground truth used

The ground truth for this device's performance is established by standardized laboratory testing protocols (e.g., AATCC 127, AATCC 42, ASTM D3776, ISO 9073-10, ISO 10993 series) against the requirements for AAMI Level 3 barrier protection. It is a physical/chemical ground truth rather than an expert consensus, pathology, or outcomes data ground truth in the context of diagnostic AI.

8. The sample size for the training set

Not applicable. This is not an AI device that involves training data.

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

Not applicable. No training set is involved.

Ask a specific question about this device

Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask, Medicom SafeMask Premier Procedure Earloop Face Mask (ASTM Level 1) and Medicom SafeMask Premier Pediatic Procedure Earloop Face Mask are intended to be worn by the patient/ child (recommended 4-12 years of age). The face mask is to be placed on nose and mouth as a protective barrier to provide respiratory protection in procedures or situations where there is a risk of microorganism, body fluid and particulate aerosol transfer. It is a single use, non-sterile disposable device that is recommended for use in healthcare settings with appropriate adult supervision.

Medicom Pediatric/Child's Face Mask is a manufactured pleated three-layer mask construction utilizing ultrasonic bonding. The patterned (ink printed) outer layer is composed of spunbound polypropylene (SBPP) material. The filter media is composed of meltblown polypropylene (MBPP). The inner is either tissue/ cellulose or a spunbound polypropylene (SBPP) layer. Bindings are composed of nonwoven polyester and earloops are made of flat elastic knitted polyester band. A malleable polypropylene nosepiece (made of plastic covered iron wire or 100% aluminum piece) is placed within the bindings for comfort and individualized fit around the wearer's nose. Medicom Pediatric/Child's Face Mask is a non-sterile single use disposable device. The device safety of effectiveness is not affected by storage conditions with no shelf life.

The provided text describes the acceptance criteria and performance data for AMD Medicom's pediatric procedure earloop face masks.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual performance test (PFE, BFE, differential pressure, blood penetration). It only provides the performance range for a "range of performance based on design variations" for the subject device.

For the anthropometry study, the subject device's evaluation involved participants aged 4-12 years old, ranging from 84.8 cm (33.4 inches) to 170.2 cm (67 inches) in height and 16.3 kg (35.94 pounds) to 76.7 kg (169.1 pounds) in weight. The sample size for this study is not explicitly stated, but it refers to a study on children based on the given age, height, and weight ranges.
The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin of the data provided. However, the manufacturer is in Canada, and the predicate device's anthropometric study refers to the "current US population."

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

This information is not provided in the document. The tests performed are laboratory-based and do not involve expert interpretation or ground truth establishment in the context of medical image analysis or similar fields.

4. Adjudication method for the test set

This information is not applicable as the tests are laboratory measurements of physical and biological properties.

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 medical face mask, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant.

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

This information is not applicable as the device is a medical face mask, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance tests (PFE, BFE, differential pressure, etc.) is established by the specifications defined in the referenced ASTM, Mil, and EN standards. These standards dictate the methodology and expected outcomes for measuring the specific properties of the face masks. For biocompatibility and product safety tests, the "ground truth" is defined by meeting the specified criteria (e.g., "Criteria met," "≤20 ppm," "Class 1") according to the referenced ISO and CPSC standards.

8. The sample size for the training set

This information is not applicable. The device is a physical product (face mask), not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device