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The modified E-PACK™ procedure kits are provided with the same indication statements for each component of the kit, identical to the labeling provided with the individually marketed device.

Ethicon, Inc. E-PACK™s are considered convenience kits because two or more separate types of Ethicon finished devices are packaged together for the convenience of the user. Ethicon, Inc. certifies that all components within the E-PACK™ procedural kit are legally marketed devices manufactured by or for Ethicon, Inc. The classification of the kit is based on the highest classification of the devices that are provided in the kit. Ethicon, Inc. E-PACK™ Procedure Kits highest device classification is Class II.

The modified package will consist of individual finished devices, with or without their original primary package, that are placed into a plastic sleeve organizer that is subsequently placed into a blister tray with a Tyvek lid.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the E-PACK™ Procedure Kit. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

It's important to note that this document pertains to a procedure kit consisting of pre-packaged existing medical devices (sutures, clips, etc.) and its packaging design and sterilization, not an AI/ML-driven medical device or a diagnostic device whose performance is measured via metrics like accuracy, sensitivity, or specificity.

Therefore, most of the requested information regarding acceptance criteria and study designs relevant to AI/ML device performance (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.

However, I can extract the information that is relevant to the device described:

1. A table of acceptance criteria and the reported device performance

The document describes performance testing related to product integrity and manufacturing processes, not diagnostic performance. The "acceptance criteria" here relate to meeting existing standards for medical device components and packaging.

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each test (e.g., number of kits tested for stability or transit). It states that testing was "performed," and the results "provide reasonable assurance." The data provenance is internal design verification testing performed by Ethicon, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. The product is a pre-packaged kit of existing devices, and the "testing" relates to physical characteristics, sterility, and packaging integrity, not diagnostic or clinical accuracy requiring expert interpretation of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" here is defined by compliance with established international standards (e.g., ISO 10993-7 for biocompatibility, ISO 11607-1 for packaging, ISO 14971 for risk management) and the confirmed performance of the individual components within the kit, which were already legally marketed and had their own established safety and effectiveness.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable.

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There is no change in the approved intended use of the device when provided in the procedure kit

All components of E-PACK procedural kit are legally marketed devices manufactured by or for ETHICON, Inc. and labeled for approved uses. These products are packaged together in the form of a "kit" for the convenience of the surgeon.

The provided text describes a "510(k) Summary of Safety and Effectiveness" for a medical device called the "E-PACK Procedural Kit." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria and device performance as typically understood for AI/software devices.

Therefore, most of the requested information cannot be extracted from the given text because:

• It is not an AI/software device study: The E-PACK Procedural Kit is described as a kit of legally marketed physical devices packaged together. There is no mention of algorithms, AI, machine learning, or software performance.
• It's a 510(k) submission for substantial equivalence: This type of submission aims to show that a new device is as safe and effective as a legally marketed predicate device, often by demonstrating identical technology, intended use, and performance characteristics, rather than establishing statistical performance against predefined acceptance criteria through a clinical study.

Here's an attempt to address the points based on the lack of relevant information:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Not applicable. This document does not describe a study involving a test set of data (e.g., medical images, physiological signals) for an algorithm. It concerns a physical medical device kit.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There is no test set or ground truth establishment described for an algorithmic performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set or adjudication method is described.

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 is not an AI device, and no MRMC study or human reader improvement with AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm, so a standalone performance study is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. No "ground truth" for algorithmic performance evaluation is relevant to this device submission.

8. The sample size for the training set

• Not applicable. This is not an AI/software device, so there is no training set mentioned.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set for an algorithm, the establishment of its ground truth is not applicable.

Summary of the provided document's focus:

The document concerns a "Modified E-PACK Procedural Kit" and aims to demonstrate substantial equivalence to an existing "Predicate Device E-PACK Procedural Kit" under the Federal Food, Drug, and Cosmetic Act. The key arguments for substantial equivalence are:

• Device Description: All components are legally marketed devices. The modification is in packaging for convenience.
• Intended Use: "There is no change in the approved intended use of the device when provided in the procedure kit."
• Sterilization: Sterilized by ethylene oxide to a minimum sterility level of 10^-6.
• Packaging: Component devices may be packaged individually or in a thermoformed blister tray/flexible pouch.

The "Conclusions" section explicitly states: "Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug, and Cosmetic Act."

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