(143 days)
The EEA™ circular stapler with Tri-Staple™ technology has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The EEA™ circular stapler with Tri-Staple™ technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis as an end-to-end, end-to-side or side-to-side anastomosis in both open and laparoscopic surgeries. The instrument is activated by squeezing the handle firmly as far as it will go.
The subject circular stapler will be offered with a medium/thick tissue range which is identified by the purple staple quide and an extra thick tissue range which is identified by the black staple guide. Staplers for medium/thick tissue deploy three height-progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples. Staplers for extra thick tissue, deploy three height-progressive rows of 4.0 mm. 4.5 mm and 5.0 mm titanium staples. The subject circular staplers are available in 25mm lumen size and 2 shaft lengths; a standard 22 cm shaft and an extra (XL) 35 cm shaft. The Tilt-Top™ anvil is available on all staplers. A blunt and a sharp tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.
Both the subject device and the predicate device (K192330 and K172361) are from the same product family Tri-Staple™ EEA™ stapler. The subject device EEA™ Circular Stapler with Tri-Staple™ Technology (lumen size 25mm) provides the surgeons a choice of additional lumen size selections to best suit the target anatomy.
The subject EEA™ Circular Stapler with Tri-Staple™ Technology is manufactured with the same patient contact materials that are utilized within the predicate device (K192330 and 172361).
In the same manner as the predicate device (K192330 and K172361), the subject EEA™ Circular Stapler with Tri-Staple™ Technology is a manual surgical stapling device that places a circular, triple staggered row of titanium staples and resects tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. An audible and tactile firing indicator will provide additional feedback of firing completion.
The subject EEA™ Circular Stapler with Tri-Staple™ Technology is a single-use device that is packaged and sterilized via ETO (Ethylene Oxide) with a 5-year shelf life, which is the same as the predicate device (K192330 and 172361).
This document describes a 510(k) premarket notification for the "EEA Circular Stapler with Tri-Staple Technology." This notification seeks to demonstrate substantial equivalence to previously cleared devices. It primarily focuses on the device's technical and performance characteristics compared to its predicates rather than proving clinical effectiveness through a multi-reader multi-case (MRMC) study or a standalone algorithm performance study.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of quantitative acceptance criteria with corresponding reported device performance metrics in the way one might expect for a diagnostic AI device. Instead, it describes various performance tests conducted. The "acceptance criteria" are implied to be that the subject device performs comparably to the predicate devices and existing reference devices, and that it meets established engineering and functional benchmarks for surgical staplers.
However, the document lists several performance tests that were conducted. For each of these, the implicit acceptance criterion is successful completion and/or performance comparable to the predicate/reference device.
Acceptance Criterion (Implied) Reported Device Performance Performance Test (In-Vitro): Visual/Packaging Inspection: Device meets visual and packaging specifications. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. IFU Walkthrough: Device functions as described in Instructions for Use. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Safety Lock Release Force Test: Safety lock releases within specified force range. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Staple Formation on Test Medium: Staples form correctly and consistently on a test medium. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence; this is a fundamental functional test. Anvil Retention Force Test: Anvil is retained with adequate force. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Anvil Attach Force Test: Anvil attaches correctly with specified force. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Anvil Detach Force Test: Anvil detaches correctly with specified force. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Clamping Force Test: Device applies specified clamping force. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Unclamping Force Test: Device unclamping functions as specified. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Firing Force Test: Device fires within specified force range. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Performance Test (Ex-Vivo): Ex-Vivo Firings: Device fires successfully on ex-vivo tissue. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Knife Cut Evaluation: Knife provides a clean and complete cut. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Leak / Burst Test: Anastomosis created by stapler meets specified leak/burst pressure integrity. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Performance Test (In-Vivo): Atraumatic Tissue Test: Stapler application is atraumatic to tissue. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Hemostasis Test: Stapler application achieves hemostasis. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Staple Formation on Tissues: Staples form correctly on in-vivo tissues. Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence. Chronic animal study: No differences in healing metrics or anastomotic index compared to reference. "The chronic animal study submitted in K172361 to evaluate the performance of the subject device and reference device shows no differences in healing metrics or anastomotic index." (This refers to a study for a predicate device, and the current device is deemed to perform similarly.) -
Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample sizes for each of the non-clinical (in-vitro, ex-vivo, in-vivo) tests. It merely lists the types of tests performed. For the "chronic animal study," it refers to a study submitted in K172361, but doesn't detail the sample size for that study in this document.
- Data Provenance:
- Country of Origin: Not explicitly stated for each test beyond the submitter being in "Min Hang District, Shanghai, China."
- Retrospective or Prospective: These are primarily prospective engineering and performance tests conducted specifically for this submission, simulating device use. The animal study from K172361 would also be prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests described are primarily objective engineering and biological performance tests, not typically subjected to "expert ground truth" in the same way an AI diagnostic model would be. For the animal study, veterinarians or pathologists would assess outcomes, but their number and specific qualifications are not detailed here.
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Adjudication method for the test set:
This information is not provided. Adjudication methods (e.g., 2+1, 3+1) are typically relevant for subjective evaluations or labeling in AI or clinical trial contexts. For engineering performance tests, results are usually based on objective measurements against pre-defined specifications.
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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:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic accuracy or physician performance with AI assistance, which is not applicable to a surgical stapler device. The device is a manual surgical instrument, not an AI or diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. This device is a manual surgical stapler, not an algorithm or an AI-powered system. Therefore, standalone algorithm performance is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance tests would be defined by engineering specifications, physical measurements, and biological outcomes. For example:
- In-vitro tests: Measured forces, dimensions, visual inspection against specification.
- Ex-vivo tests: Measured burst pressure, visual inspection for knife cut completeness, visual assessment of staple formation.
- In-vivo/Animal study: Histopathological analysis (pathology), gross observation of healing, assessment of anastomotic integrity, and physiological outcomes (referred to as "healing metrics or anastomotic index").
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The sample size for the training set:
Not applicable. This device is a mechanical surgical instrument, not an AI or machine learning model that requires a training set.
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How the ground truth for the training set was established:
Not applicable. As above, there is no training set 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.