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Medline Disposable Sterile Surgical Gowns, Zoned Impervious are surgical apparel that is intended to be wom 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.

Medline Disposable Sterile Zoned Impervious Surgical Gowns are manufactured from a non-woven fabric which is laminated to a plastic film. Because the plastic film is made of microporous polyethylene, it provides protection from inward liquid penetration as well as comfort by allowing outward passage of vapor. These products are disposable and intended for single use only. The Sontara Spunlace Fabric is produced by DuPont. It is a hydroentangled (or hydrolaced) fabric made using a Spunlace technology. For medical applications, the content is approximately 55% wood pulp and 45% polyester. The interlaced fibers and surface finish give Sontara outstanding barrier properties while providing the comfort features of re-usable linens. This product has seams which are bound to provide strength and barrier properties. Tape is utilized to cover the drill holes required during manufacturing. There are long stockinet cuffs on the sleeves for added comfort and protection. Both Velcro and snaps are offered as closures. The materials used in Medline's gowns are strong, do not unravel or delaminate and are low in lint.

The provided text describes a 510(k) submission for Medline Disposable Sterile Zoned Impervious Surgical Gowns. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive independent clinical study data to prove the performance against a set of acceptance criteria in the way a diagnostic or therapeutic device might.

However, based on the information provided, we can infer acceptance criteria related to material properties and barrier performance. The "study" described is a set of non-clinical tests.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance Study for Medline Disposable Sterile Zoned Impervious Surgical Gowns

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Johnson & Johnson Medical, Inc.'s Barrier Fabric 450 Surgical Gown, K934608). The "acceptance criteria" are implied by the performance characteristics presented in comparison to the predicate, and the regulatory requirements for surgical gowns. The study conducted comprises non-clinical performance tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on Acceptance Criteria: The "acceptance criteria" here are largely implicit, aiming to demonstrate that the Medline gown performs at least as well as or similarly to the legally marketed predicate device, especially concerning barrier properties and safety.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The document only states that the gowns "have been tested" under the ASTM standards and "meet the requirements" for biocompatibility. The quantity of gowns or material samples used for these tests is not provided.
• Data Provenance: The tests are stated to have been performed by Medline Industries, Inc. (or commissioned by them). The nature of the testing is non-clinical (laboratory testing of material properties/barrier performance). No country of origin for the data is explicitly mentioned beyond the submitter's location (Mundelein, IL). It is inherently retrospective as these tests would have been completed prior to the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This question is not applicable in the context of this 510(k) submission. The "ground truth" for the performance claims (viral penetration, synthetic blood penetration, biocompatibility) is established through standardized laboratory tests (ASTM F1670, F1671, ISO 10993), not expert consensus on clinical cases. The interpretation of these test results would be conducted by qualified laboratory personnel following established protocols, rather than a panel of experts establishing a "ground truth" for each sample.

4. Adjudication Method for the Test Set:

• None. As the "study" involves laboratory testing against objective standards (e.g., pass/fail for penetration, compliance with ISO 10993), there is no human adjudication method like 2+1 or 3+1 typically used for clinical image interpretation or diagnosis. The results are quantitative or qualitative assessments based on standardized methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study was not conducted or described. This type of study is relevant for diagnostic devices where human readers interpret patient data (e.g., medical images) with and without AI assistance. This submission pertains to a surgical gown, which is a physical barrier device, not a diagnostic tool requiring human interpretation of cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• No. This question is not applicable. The device is a surgical gown, not an algorithm or AI system. Its performance is assessed directly through material and barrier property testing, not through algorithmic output.

7. Type of Ground Truth Used:

• The "ground truth" for the performance claims is based on standardized laboratory test results (e.g., meeting the requirements of ASTM F1670 for synthetic blood penetration, ASTM F1671 for viral penetration, and ISO 10993 for biocompatibility). These are objective measurements and assessments against specified scientific standards, not expert consensus on patient outcomes or pathology.

8. Sample Size for the Training Set:

• Not applicable. This submission is for a physical medical device (surgical gown), not a machine learning model or an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there is no training set for an algorithm, this question is not relevant.

In summary, the provided document details a regulatory submission for a surgical gown, demonstrating substantial equivalence through non-clinical testing. The "acceptance criteria" are met by showing performance consistent with regulatory standards and comparable to a predicate device, through standardized laboratory tests rather than complex clinical trials or expert-adjudicated datasets.

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