(48 days)
The Convertors® Spunbonded, Flashspun Polyolefin Gowns are devices intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
Convertors® Spunbonded, Flashspun Polyolefin Gowns, Sterile. Each gown is packaged with a towel.
This document describes a 510(k) submission for Convertors® Spunbonded, Flashspun Polyolefin Gowns. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria for performance metrics. Therefore, a direct response to your request about acceptance criteria and a study proving a device meets them, in the typical sense of a diagnostic or therapeutic device with quantitative outcomes, is not fully applicable.
However, I can extract the relevant information from the provided text regarding how the device's acceptability was established, which can be framed to address aspects of your request where possible.
Here's a breakdown based on the provided text, interpreting "acceptance criteria" and "study" within the context of a 510(k) for surgical gowns:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (Implied) |
|---|---|
| Intended Use | "The intended use is the same" as the predicate device (Convertors® Optima standard, fabric- and poly-reinforced gowns). |
| Performance Attributes | "The performance attributes are the similar" to the predicate device. |
| Biocompatibility | All materials "evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'." |
| Specific Biocompatibility Tests | Sensitization, cytotoxicity, and irritation/intracutaneous reactivity tests were performed. |
| Industry Recognized Test Methods | Materials "were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." |
| Protection (Implied) | Protect both the surgical patient and operating room personnel from transfer of microorganisms, body fluids, and particulate material (same as predicate). |
Note: The document for a surgical gown 510(k) generally focuses on demonstrating substantial equivalence through similar intended use, performance attributes, and material safety rather than a clinical effectiveness study with specific diagnostic accuracy or treatment efficacy endpoints. The "performance attributes" likely refer to properties like barrier effectiveness, fluid resistance, strength, etc., which would have established acceptance ranges but are not explicitly detailed here.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a numerical sample size for "performance attributes." The description states "All materials used in the fabrication of this Convertors® Spunbonded, Flashspun Polyolefin gowns were evaluated..." This implies the materials themselves were the "sample" for biological qualification and other industry-recognized tests.
- Data Provenance: The document does not specify country of origin for the data or whether tests were retrospective or prospective. It only mentions compliance with ISO 10993 Part-1 and "industry recognized test methods."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This type of information (number of experts, qualifications, ground truth establishment) is typically not part of a 510(k) submission for surgical gowns. The "ground truth" here is established via adherence to recognized standards (ISO 10993) and industry-accepted test methods for material properties, rather than expert consensus on clinical outcomes or image interpretations. The "experts" are likely the laboratory personnel performing the standardized biocompatibility and material property tests.
4. Adjudication Method (for the test set)
- Not applicable in the context of this 510(k) submission for a surgical gown. Adjudication methods (like 2+1) are typically used in clinical studies or studies involving expert interpretation (e.g., radiology reads) to resolve discrepancies. The assessment here is based on objective laboratory testing against established material specifications and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or certain therapeutic devices where human readers or clinicians interpret data. Surgical gowns are evaluated for their barrier properties and biocompatibility, not for interpretation-based outcomes.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. The device is a physical surgical gown, not an algorithm or AI system.
7. The Type of Ground Truth Used
- The "ground truth" for the material evaluation relies on established international standards (ISO 10993 Part-1 for biocompatibility) and industry-recognized test methods for material performance attributes. This includes objective measurements for sensitization, cytotoxicity, irritation/intracutaneous reactivity, and implied physical properties (e.g., barrier effectiveness, durability) that are not detailed in this summary.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI or machine learning model that requires a "training set." The "training" in the context of a 510(k) for a physical device would refer to manufacturing processes and quality control, not data training.
9. How the Ground Truth for the Training Set was Established
- Not applicable for the same reasons as 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.