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Tidi brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment.

Available in numerous sizes, CSR wrap is a single-use product intended for use in steam and ethylene oxide sterilization applications. The wraps maintain their wrapped integrity after sterilization to maintain contents' sterility before use.

CSR Wraps can also be used for many needs that do not require sterilization, such as draping a tray and acting as a protective sheet between a surface and instruments.

The Banta Healthcare Group Tidi Brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment. The Sterilization/CSR Wrap is made from a blue, wet formed nonwoven fabric comprised of natural wood pulp fibers bonded with a synthetic resin binder and is available in numerous sheet sizes. Sterilization/CSR Wrap is a single-use product intended for use in steam and ethylene oxide sterilization applications.

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets them. Instead, it focuses on demonstrating substantial equivalence to a predicate device. Therefore, I cannot generate the requested table and study details.

Here's why and what information is available:

1. Acceptance Criteria and Device Performance:

• Not provided. The document does not define specific acceptance criteria for the Tidi Brand Sterilization/CSR Wrap's performance (e.g., burst strength, microbial barrier effectiveness after sterilization).
• Instead, it states: "The differences between the Banta Healthcare Group Tidi Brand Sterilization/CSR Wrap specifications and the predicate device specifications do not result in different performance or raise new questions regarding safety and effectiveness." This implies that the 'acceptance criterion' is essentially meeting the performance level of the predicate device, but no quantitative metrics are given.

2. Sample Size and Data Provenance:

• Not applicable / Not provided. Since no new performance studies are detailed, there's no mention of sample sizes, test sets, or data provenance. The submission relies on the established safety and effectiveness of the predicate device.

3. Number of Experts and Qualifications:

• Not applicable / Not provided. Ground truth establishment by experts is relevant for studies involving subjective assessment (e.g., image interpretation). This submission is for a physical device, and its safety and effectiveness are being assessed through comparison to an existing device, not through expert review of data.

4. Adjudication Method:

• Not applicable / Not provided.

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

• Not applicable / Not provided. MRMC studies are typically used for diagnostic or interpretive devices where human performance with and without AI assistance is being evaluated. This is a sterilization wrap, not a diagnostic tool.

6. Standalone (Algorithm Only) Performance:

• Not applicable / Not provided. This concept applies to AI algorithms. The Tidi Brand Sterilization/CSR Wrap is a physical product.

7. Type of Ground Truth Used:

• Not applicable / Not provided (in the context of new studies). The "ground truth" for this submission is effectively the established performance and safety profile of the predicate device, Ahlstrom Dexter - Dextex II Sterilization Wrap (K800123). The argument is that the new device is functionally identical, and therefore, its "ground truth" performance should align with the predicate.

8. Sample Size for Training Set:

• Not applicable / Not provided. Training sets are used for machine learning.

9. How Ground Truth for Training Set Was Established:

• Not applicable / Not provided.

In summary: The provided text is a 510(k) summary that emphasizes substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria for a new, independent evaluation. This means it leverages the regulatory clearance of an existing device by demonstrating that the new device is essentially the same in terms of intended use and technological characteristics, or that any differences do not raise new questions of safety or effectiveness.

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These devices are indicated for use as a barrier that is used as an accessory to oral or rectal, digital or mercury thermometers. These sheaths are non-sterile and are intended for single patient use only.

SaniTherm Disposable Thermometer Sheaths are plastic coverings used for either oral or rectal, mercury or digital thermometers. Digital Thermometer Sheaths may not be suitable for use with all clinical thermometers. Example - Clinical thermometers which employ rigid plastic sheaths. Banta Thermometer Sheaths are made from ethylene methyl acrylate copolymer film.

The provided document is a 510(k) premarket notification for "SaniTherm Disposable Thermometer Sheaths". This document outlines the general information about the device and its substantial equivalence to other devices already on the market.

Crucially, this document does not describe specific acceptance criteria and a study demonstrating the device meets those criteria, as it focuses on establishing substantial equivalence rather than reporting on a specific performance study with defined metrics.

Therefore, I cannot provide the requested information in the format specified because the source material does not contain it. The document affirms the device's substantial equivalence to existing predicate devices (Abco Dealers, K871465 and Mediine Industries, Inc., K772385) in terms of materials, construction, and manufacturing process. It also states its intended use as a barrier for thermometers.

Based on the provided text, the following information is either not present or not applicable in the context of a performance study:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on substantial equivalence to existing devices, not unique performance claims with specific metrics.
2. Sample size used for the test set and the data provenance: Not provided. No specific performance study is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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 thermometer sheath, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

Summary of what is available in the document related to the device:

• Device Name: SaniTherm Disposable Thermometer Sheaths
• Proprietary Name: SaniTherm Themometer Sheaths, Oral and Rectal, Digital and Mercury
• Common Name: Thermometer Sheaths
• Intended Use/Indications for Use: These devices are indicated for use as a barrier that is used as an accessory to oral or rectal, digital or mercury themometers. These sheaths are non-sterile and are intended for single patient use only.
• Material: Ethylene methyl acrylate copolymer film.
• Sterilization: Not sold sterile.
• Latex Content: Latex-free.
• Substantial Equivalence: To Abco Dealers, K871465 and Mediine Industries, Inc., K772385. Identical in materials, construction, and manufacturing process. Size may vary for different thermometer types.

For a device like a thermometer sheath, the "acceptance criteria" and "performance study" would typically relate to physical properties (e.g., tear strength, barrier effectiveness against liquids/pathogens, compatibility with thermometers) rather than diagnostic accuracy or AI performance. This 510(k) document indicates that such performance characteristics are implicitly met because the device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness.

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