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510(k) Data Aggregation
(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.
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(144 days)
The ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials.
The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, singlepatient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. Together, the ETHICON™ 4000 60 mm Staplers and ETHICONTM 3D Reloads deliver 3D staples in the first, second, fifth and sixth rows of staples. The third and fourth rows (nearest the knife) maintain the traditional 2D B-formed staples.
ETHICON™ 4000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The Subject stapler device is available in three different shaft lengths - Compact, Standard and Long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The device is packaged with a primary lithium Battery Pack that must be installed prior to use. There is embedded software to articulate and initiate firing of the device.
The instruments are packaged without a reload and must be loaded prior to use. The instrument may be reloaded for a maximum of 12 firings during a single procedure. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. The instruments' lockout feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.
The staples are permanent implants that provide tissue closure and apposition from the time of implant through the critical phases of healing. The staples remain in place for the patient's lifetime, unless in the opinion of the treating physician, they require removal.
The Subject stapler and reloads will not be compatible with previous ECHELON™ staplers and reloads. This is a new platform that will work with 3D reloads only.
This 510(k) summary is for the ETHICON™ 4000 60mm Staplers and ETHICON™ 3D 60mm Reloads. It focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list a table of acceptance criteria with corresponding performance metrics for the reasons stated below. Instead, it indicates that the devices either met or improved upon the predicate devices' performance, or passed functional requirements.
| Test Type | Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Staple Performance Bench Testing | Equivalent to or improved compared to predicate devices | Performed staple performance equivalence bench testing compared to the predicate, and performed at least equivalently or showed improved performance. |
| Device Functional Performance | Met functional requirements of the subject device features | Performed device functional performance bench testing and passed the functional requirements. |
| Staple Line Strength | Demonstrated characteristics comparable to predicate devices | Performed staple line strength product characterization of Subject and Predicate devices, implying comparable strength or meeting specified criteria, though specific metrics are not provided. |
| Biocompatibility | Compliant with ISO 10993-1 | Biocompatibility evaluation was performed according to ISO 10993-1. |
| Hemostasis Performance | Acceptable hemostasis performance in pre-clinical models (details not provided) | Pre-clinical data including hemostasis performance was collected in abdominal and thoracic procedures. Result deemed acceptable to demonstrate substantial equivalence, though specific metrics and acceptance levels are not given. |
| Tissue Healing Response | Acceptable tissue healing response in pre-clinical models (details not provided) | Pre-clinical data including tissue healing response was collected in abdominal and thoracic procedures. Result deemed acceptable to demonstrate substantial equivalence, though specific metrics and acceptance levels are not given. |
| Human Factors | Met human factors engineering requirements (details not provided) | Human Factors testing report was included. |
| 3D Staple Design Safety/Efficacy | Safe and effective staple formation with the 3D staple design, as demonstrated by testing vs. reference devices and meeting acceptance criteria. | The same stapling performance tests were conducted on the Subject and reference devices (with 3D staple design), and all met their respective acceptance criteria. This demonstrates safe and effective staple formation with the 3D staple design. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the test sets used in the non-clinical studies (e.g., staple performance, functional performance, staple line strength, hemostasis, tissue healing).
The data provenance is from non-clinical studies, which implies laboratory or animal testing rather than human subject data. Pre-clinical data for hemostasis and tissue healing response were conducted in "Abdominal and Thoracic procedures," indicating animal models.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation relies on non-clinical (bench and pre-clinical animal) testing and not on expert interpretation of human clinical data or images. Ground truth, in this context, would be established by objective measurements and scientific protocols.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation relies on non-clinical testing, not subjective assessments that would require adjudication.
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
An MRMC study was not done. This device is a surgical stapler and reload system, not an AI-assisted diagnostic or interpretive device that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a surgical stapler, which is a physical medical instrument, not an algorithm or software-only device.
7. The type of ground truth used
The ground truth for the non-clinical tests would be established through:
- Objective Measurements: For staple performance, functional performance, and staple line strength, measurements of physical properties (e.g., staple formation, closure force, staple line integrity, burst pressure) would serve as ground truth, compared against pre-defined engineering specifications or predicate performance.
- Histopathology/Pathology and Physiological Measurements: For hemostasis and tissue healing response in pre-clinical animal studies, ground truth would be established through direct observation, macroscopic assessment, histological examination (pathology), and physiological measurements relevant to bleeding control and tissue repair.
- Compliance with Standards: For biocompatibility, ground truth is compliance with the requirements of ISO 10993-1.
8. The sample size for the training set
This information is not applicable. The device is a physical surgical instrument, not an AI/ML algorithm that requires a "training set." The development process would involve extensive engineering design, prototyping, and iterative testing, but not a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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