(137 days)
TriMax Surgical Gown are intended to be worn by operating room personnel during surgical Procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
TriMax Surgical Gown will function as surgical gowns when processed according to instructions. The TriMax Surgical Gown are reusable through 75 wash, dry and sterilization cycles. They are manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
All fabric components used in TriMax Surgical Gowns are made from 100% polyester. TriMax Surgical Gown will function as surgical gowns when processed according to instructions through 75 complete wash, dry and sterilization cycles. These products will be manufactured and distributed as non-sterile surgical gowns that are intended to be sterilized and processed by health care facilities and/or contract sterilization/laundry companies.
The provided text is a 510(k) summary for the TriMax Surgical Gown. It outlines the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness. However, it does not describe acceptance criteria in quantifiable terms or a comparative study as typically performed for diagnostic or AI-driven medical devices.
The document focuses on claiming substantial equivalence to a predicate device (ComPel XTR® Surgical Gowns #K922753) based on the performance of the gown materials and the gown itself after undergoing a specified number of processing cycles. The "acceptance criteria" here are implied through successful completion of standardized material and product performance tests.
Here's an attempt to extract the requested information, acknowledging that some fields may not be directly applicable or fully detailed given the nature of a 510(k) for a surgical gown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implied by success) | Reported Device Performance |
|---|---|---|---|
| Barrier Performance | Viral Resistance ASTM #1671-97b | Pass | Successfully completed |
| Suter Hydrostatic Testing AATCC #127-1989 | Pass | Successfully completed | |
| Mullens Hydrostatic Testing ASTM D751-95 Procedure A | Pass | Successfully completed | |
| Flammability | 16 CFR Part 1610 | Pass | Successfully completed |
| Strength | ASTM #D-1682-87 | Pass | Successfully completed |
| Lint | EDANA 220.0-96 | Pass | Successfully completed |
| Toxicity | Cytotoxicity MEM Elution (MG023) | Non-cytotoxic | Successfully completed |
| Acute Systemic Toxicity (ISO 10993) | Non-toxic | Successfully completed | |
| Primary Skin Irritation (ISO 10993) | Non-irritating | Successfully completed | |
| Sterilization | Prevacuum steam cycles (for non-sterile gown) | Compatible with sterilization | Successfully completed (product sold non-sterile, compatible with prevacuum steam cycles) |
| Durability | Through 75 processing (wash, dry, sterilization) | Maintain performance | Successfully completed (functions as surgical gown through 75 cycles) |
| Colorfastness | To Commercial Laundering AATCC #61-1993(4A) | Pass | Successfully completed |
| Overall Function | Function as surgical gown | Functions as intended | Performed as intended when used as labeled |
Explanation of "Acceptance Criteria (Implied by success)": For a 510(k) of this nature, the demonstration of "success" in meeting the requirements of recognized standards is the primary form of acceptance criterion. The document states "The tests that have been successfully completed include:", indicating that the device met the performance thresholds defined by each respective standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual test (e.g., number of gowns tested for viral resistance or durability). It broadly states that the gown "will function as surgical gowns... through 75 complete wash, dry and sterilization cycles," implying a test sample was put through this process, but the number of units is not quantified.
- Data Provenance: Not specified. However, the tests are against international (ISO) and US (ASTM, AATCC, CFR) standards, suggesting the testing was performed in compliance with these regulations. It does not mention country of origin for the data or if it was retrospective or prospective, as these are typically not relevant for material performance tests of this type.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This type of information (experts establishing ground truth) is typically relevant for diagnostic devices where human interpretation is involved. For a surgical gown, the "ground truth" is based on objective, standardized physical and material performance tests. The standards themselves are generally developed by expert committees, but there isn't a "ground truth" established by individual experts for this specific test set.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in human expert interpretations, typically in diagnostic or imaging studies. For objective material performance tests, the outcome is determined by the test protocol and measurement, not by expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for evaluating the impact of a system (often AI) on human reader performance in tasks like diagnosis or detection. This is not applicable to a surgical gown, which is a physical barrier device. The document does not describe any human reader involvement.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
- Yes, in spirit, but not in the context of an algorithm. The tests described are "standalone" in the sense that they evaluate the gown's material properties and performance objectively, without human intervention in the outcome assessment (beyond conducting the test and recording results). There is no "algorithm" involved, as this is a physical medical device, not a software or AI product.
7. The Type of Ground Truth Used
- The ground truth used is primarily objective physical and chemical testing against established industry and regulatory standards. This includes:
- Material properties: Flammability, strength, lint.
- Barrier performance: Viral resistance, hydrostatic pressure.
- Biocompatibility: Cytotoxicity, systemic toxicity, skin irritation.
- Durability and integrity: Performance after repeated processing cycles.
- The "ground truth" is defined by the passing criteria of the specific ASTM, AATCC, EDANA, ISO, and CFR standards cited.
8. The Sample Size for the Training Set
- Not Applicable. This device is a physical product, not an AI/ML algorithm or software. Therefore, there is no "training set" in the computational sense. The product's design and manufacturing processes are refined through engineering and material science, not through machine learning.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set for an algorithm, there is no ground truth established for it. The performance of the gown itself is proven through the testing detailed in Section 7.
§ 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.