(132 days)
The ETHICON ™ Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues.
The ETHICON™ Linear Stapler delivers two staggered rows of titanium staples in order to approximate internal tissues. The Subject device is sterile, single patient, disposable device used in conjunction with reloadable ETHICON™ Linear Stapler 3D Reloads to staple tissue in one firing stroke. The Subject device is a next generation Linear Stapler to be used in open procedures requiring a surgical stapler. The Subject device incorporates proven Gripping Surface Technology (GST) Reload Technology, leveraged from Ethicon Endocutters, along with a 3-D staples developed for other Ethicon Endocutters and open mechanical devices.
The ETHICON™ Linear Stapler 30 mm, 60 mm and 90 mm Staplers are sterile, single- patient-use instruments that staple tissue. There are two staggered rows of staples, on either side of the staple line. This device may be used on the general population for routine wound closure via stapling. The 30 mm reload creates a 30 mm staple line. The 60 mm reload creates a 60 mm staple line. The 90 mm reload creates a 90 mm staple line.
The 90mm device and compatible reloads have also been developed. The 90mm device can be used by surgeons who prefer to use a 90mm device when transecting wider tissue such as completing the closure of a side-to-side anastomosis or when performing a sleeve gastrectomy. The Predicate device does not currently offer a 90mm size but the principles of operation are the 30mm and 60mm devices. Design verification testing demonstrates that the 90mm device and compatible reloads do not raise new types of safety or effectiveness questions.
The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instrument may be loaded eight times for a maximum of eight firings per instrument during a single procedure. There are blue and green reload options for each device size.
The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.
The provided text does not contain information about acceptance criteria or a study proving a device meets them in the context of an AI/ML powered medical device. Instead, the document is an FDA 510(k) clearance letter and summary for a surgical stapler and its reloads.
The information in the document details the substantial equivalence of the ETHICON™ Linear Stapler to a predicate device, focusing on bench performance testing and animal testing for mechanical, functional, and biological properties of the stapler itself, NOT an AI/ML algorithm.
Therefore, I cannot provide the requested information, such as:
- Acceptance criteria and reported device performance for an AI/ML product: The document outlines engineering specifications and performance evaluations for a mechanical device.
- Sample size for the test set and data provenance: No test set for an AI/ML algorithm is mentioned.
- Number of experts used to establish ground truth and their qualifications: Ground truth for AI/ML is not relevant here.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted as it's not an AI-assisted device.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable for an AI/ML algorithms ground truth, but for the mechanical stapler, the "ground truth" would be successful stapling outcomes and tissue integrity observed in bench and animal tests.
- Sample size for the training set: No training set for an AI/ML algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable.
The document focuses on:
- Bench Performance Testing:
- Formed Staple Height (FSH)
- Staple Form Quality (SFQ)
- Staple Line Integrity (SLI)
- Force to Close
- Force to Fire
- Jaw Aperture
- No Spent Reload/Lockout
- Human Factor Report/Usability Testing
- Staple line Strength Test
- Animal Testing (In-vivo):
- Acute Hemostasis evaluation study
- Tissue Healing response, Survival Study
- Biocompatibility: Based on ISO 10993-1.
All of these tests "passed the criteria for success," indicating the device met the pre-defined performance requirements for a mechanical surgical stapler.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.