(339 days)
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
| Performance Parameter | Acceptance Criteria (for AAMI Level 3 Gown, where applicable & standards listed) | Reported Device Performance (AMD Ritmed AssureWear™ VersaGown) |
|---|---|---|
| Level of barrier protection (AAMI PB70) | Level 3 | Level 3 |
| Basic weight (ASTM D3776) | Predicate: 41 g/m² (1.21 oz/yd²) | 39.97 ± 1.61 g/m² (1.17 oz/yd²±0.05) |
| Liquid barrier performance | ||
| - Hydrostatic Pressure (AATCC 127) | Predicate: Body/sleeve mean: 69 cmH2O | Chest: 109.34 ± 0.34 cmH2O |
| Sleeve seams: 110.67 ± 3.84 cmH2O | ||
| Belt attachments: 104 ± 5.19 cmH2O | ||
| Body/sleeve/belt mean: 108 ± 3.1 cm H₂O | ||
| - Impact penetration (AATCC 42) | Predicate: Body/sleeve mean: 0.08 g | Chest: 0.3: 2.07; >0.5: 1.97 |
| Index for Particulate Matter (IPM): 1.50 | ||
| Inside: Total linting >0.3: 2.16; >0.5: 2.00 | ||
| Index for Particulate Matter (IPM): 1.35 | ||
| Biocompatibility | Non-cytotoxic, non-irritant, non-sensitizing | Irritation (ISO 10993-10): Under the condition of the study, not an irritant. |
| Sensitization (ISO 10993-10): Under the condition of the study, not a sensitizer. | ||
| Cytotoxicity (ISO 10993-5): Under the condition of the study, non-cytotoxic. |
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.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.