(172 days)
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.
A reusable surgical gown fabricated from 99% polyester, 1% carbon, chemically treated fabric and designed to provide fluid protection through up to 150 laundry/sterilization cycles.
The provided text describes a medical device, the Rotecno® 2000 Surgical Gown, and its regulatory submission (K982059) to the FDA. It outlines the device's intended use and performance testing summary. However, it does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical trial report or a comprehensive validation study.
Instead, the document primarily functions as an FDA clearance letter, confirming "substantial equivalence" to a predicate device based on material, design, form, fit, and function, rather than providing raw performance data against predefined numerical acceptance criteria. The "Performance Testing Summary" section broadly states that the gown was "found acceptable for its intended use" after testing for various properties, but it does not list the acceptance criteria themselves or the specific results.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred or explicitly stated and indicate where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from testing listed) | Reported Device Performance (Summary statement) |
|---|---|
| Breaking Strength (specific values not provided) | Found acceptable for its intended use |
| Tear Resistance (specific values not provided) | Found acceptable for its intended use |
| Air Permeability (specific values not provided) | Found acceptable for its intended use |
| Water Repellency (specific values not provided) | Found acceptable for its intended use |
| Impact Penetration (specific values not provided) | Found acceptable for its intended use |
| Hydrostatic Head (specific values not provided) | Found acceptable for its intended use |
| Flammability (specific values not provided) | Found acceptable for its intended use |
| Aqueous Bacterial Barrier (specific values not provided) | Found acceptable for its intended use |
| Material toxicity/biocompatibility | Found acceptable for its intended use |
| Durability through 150 laundry/sterilization cycles (implied for fluid protection) | Designed to provide fluid protection through up to 150 laundry/sterilization cycles (testing to confirm this durability is implied by the performance summary but not explicitly detailed with results) |
Missing Information: The document states that the gown was "found acceptable for its intended use" for various performance characteristics. However, it does not provide the specific numerical acceptance criteria for each test (e.g., a minimum breaking strength in newtons, or a maximum tear resistance in grams). It also does not provide the specific measured performance values obtained during testing.
2. Sample size used for the test set and the data provenance
- Sample size used for the test set: Not specified in the provided text.
- Data provenance: Not specified in the provided text. The tests are likely laboratory-based bench tests rather than clinical trials with human subjects. The phrase "Performance Testing Summary" suggests the testing was conducted by the manufacturer (Dowling Textile Company) or a subcontractor, but details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. The validation for this type of device (surgical gown) primarily relies on objective physical and microbiological property testing rather than expert-established ground truth from images or clinical assessments.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable, as detailed in point 3.
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
- MRMC study done: No. This type of study is not relevant for a surgical gown. MRMC studies are typically used to evaluate diagnostic imaging devices or AI algorithms where human interpretation is involved.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study done: No. This device is a physical product (surgical gown), not an algorithm or AI system.
7. The type of ground truth used
- Type of ground truth: The "ground truth" for this device's performance is established by standardized laboratory test methods for material properties (e.g., breaking strength, tear resistance, water repellency, flammability, bacterial barrier). These are objective measurements rather than subjective expert consensus, pathology, or outcomes data in the traditional sense of medical diagnostics. The "intended use" statement also forms a basis for acceptability, ensuring the device performs its protective function.
8. The sample size for the training set
- Sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" here would refer to material development and manufacturing process optimization, which is not described.
9. How the ground truth for the training set was established
- How the ground truth for the training set was established: Not applicable, as detailed in point 8.
§ 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.