(20 days)
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.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| i. Stability | "Confirmed the stability of the E-PACK™ Procedure Kits and the individual products within the E-PACK™ Procedure Kits." |
| ii. Biocompatibility | "Confirmed that E-PACK™ Procedure Kits meet the ISO 10993-7, Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals, requirements." |
| iii. Labeling | "Confirmed the E-PACK™ Procedure Kits meet labeling requirements for convenience kits." |
| iv. Packaging/Transit Testing | "Confirmed E-PACK™ Procedure Kit weight does not exceed the transit test worst case and the E-PACK™ components fit within the limits of the current packaging system. The proposed package configuration passed all transit testing requirements found in ISO 11607-1. Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems." |
| v. Sterilization | "Confirmed that E-PACK™ Procedure Kit products can be sterilized with Ethylene Oxide and can be sterilized two times." |
| Risk Management | "The modified package configuration used for the proposed device meets the requirements ISO 14971:2007 Medical devices -- Application of risk management to medical devices and ISO 11607-1: 2006 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems." |
| Overall Conclusion | "The results of these tests provide reasonable assurance that the modified device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing." |
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.
§ 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.