(257 days)
The Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) is a sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) is a Class II medical device regulated under FDA product code FYA, General & Plastic Surgery Panel, and regulation 21 CFR 878.4040. The device description of the Medline Level 4 Surgical Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993.
The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) is a single-use, sterile, disposable medical device that is provided in a variety of sizes and styles. The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) constructed from nonwoven SMS (spubound, meltblown, spunbond), a poly-fabric reinforcement on the chest front panel and on both sleeves. Each gown is designed with a hook and loop closure at the neck, ties at the waist, knitted cuffs at the end of the sleeves as well as a transfer tab for ease in donning. The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) has been tested according to ANSI/AAMI PB70:2012 and meets AAMI Level 4 barrier level protection for a surgical gown.
The provided text is a 510(k) Premarket Notification from Medline Industries, Inc. for their Level 4 Surgical Gowns. This document describes the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than the acceptance criteria and study proving a device meets acceptance criteria in a clinical setting with human interaction or AI.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance in a clinical or AI context.
- Sample size used for the test set and data provenance (since it's non-clinical, likely material samples, not patient data).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth (as it relates to clinical diagnosis or outcomes).
- Sample size for training set.
- How ground truth for the training set was established.
However, I can provide information based on the non-clinical testing detailed in the document, framed as demonstrating "acceptance criteria" for material performance:
Based on the provided Medline Industries, Inc. 510(k) Premarket Notification for the Medline Level 4 Surgical Gowns (Sirus, Eclipse, Aurora), the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" refer to non-clinical performance testing of the gown's material properties and barrier effectiveness. This document does not pertain to the clinical performance of a diagnostic device or an AI/human-in-the-loop system.
1. A table of acceptance criteria and the reported device performance (for non-clinical material testing):
The acceptance criteria are generally implied by meeting the specified industry standards and guidance documents. The "reported device performance" is that the device meets these requirements. No specific numerical performance values are explicitly tabulated against acceptance criteria in the provided text, but the document states the gown "meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities."
| Acceptance Criteria Category | Standard/Test Method (Implied Criteria) | Reported Device Performance |
|---|---|---|
| Liquid Barrier Performance (Primary) | ANSI/AAMI PB70:2012 Level 4 | Meets Level 4 requirements |
| Material Strength (Breaking) | ASTM D5034-09 (2013) | Tested and presumably met |
| Material Strength (Tearing) | ASTM D5587-15 | Tested and presumably met |
| Material Weight | ASTM D3776/D3776M-09a | Tested and presumably met |
| Material Strength (Bursting) | ASTM D3786/D3786M-13 | Tested and presumably met |
| Flammability | 16 CFR 1610 | Meets requirements of Flame Resistant CPSC 1610 Class 1 |
| Seal Leaks | ASTM F1929-15 | Tested and presumably met (Detecting Seal Leaks by Dye Penetration) |
| Blood-Borne Pathogen Penetration | ASTM F1671 | Tested and presumably met (Resistance of Materials to Penetration by Blood-Borne Pathogens) |
| Water Resistance | AATCC 42 | Tested and presumably met (Water Resistance: Impact Penetration Test) |
| Biocompatibility (Cytotoxicity) | ISO 10993-5 | Met requirements |
| Biocompatibility (Irritation) | ISO 10993-10 | Met requirements |
| Biocompatibility (Sensitization) | ISO 10993-10 | Met requirements |
| Sterilization Residuals | ANSI/AAMI/ISO 10993-7:2008(R)2012 | Tested and presumably met (Ethylene oxide sterilization residuals) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of gown samples or material specimens used for each non-clinical test (e.g., how many gowns were tested for barrier performance or how many material swatches for tensile strength).
- Data Provenance: The tests are explicitly stated as "Non-Clinical Testing" and appear to be laboratory-based tests of the physical gown materials and design. No country of origin for data is stated, implying the testing was performed by or for the manufacturer according to international standards. The data is retrospective in the sense that it was gathered from completed tests to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for this device is established by objective engineering and material performance standards (e.g., a material either resists liquid penetration to a certain level as defined by a standard, or it doesn't). It does not involve human expert interpretation of clinical data or images.
4. Adjudication method for the test set:
- Not applicable. The tests are quantitative and objective measurements against predefined standards, not subjective interpretations requiring adjudication.
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:
- Not applicable. This device is a surgical gown, not an AI-assisted diagnostic or clinical decision support system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The "standalone" performance refers to the physical gown's barrier and material properties.
7. The type of ground truth used:
- The "ground truth" for this device is based on objective engineering standards and test methods (e.g., ANSI/AAMI PB70:2012, ASTM standards, ISO standards). It relates to the physical and barrier properties of the surgical gown material, not clinical outcomes or expert consensus on a diagnosis.
8. The sample size for the training set:
- Not applicable. This device does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.