(88 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. The document describes a "procedural kit" consisting of existing, legally marketed physical devices. There are no performance metrics (e.g., sensitivity, specificity, accuracy) or acceptance criteria established for an AI/software component, as this is not an AI/software device. | Not applicable. The document states: "All components of E-PACK procedural kit are legally marketed devices manufactured by or for ETHICON, Inc. and labeled for approved uses." The performance is implied to be equivalent to the predicate device due to identical components and intended use. |
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."
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.