(24 days)
The GIA™ stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.
The GIA™ stapler with Tri-Staple™ technology places two triple staggered rows of titanium staples and simultaneously cuts and divides tissue between these two triple rows. The subject GIA™ stapler and cartridges with Tri-Staple™ technology are available in 60 mm and 80 mm staple line length and two staple sizes to accommodate tissue thicknesses: medium/thick and extra thick. Staplers for medium/thick tissue (purple cartridge) deploy three height-progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples on either side of the tissue cut line. Staplers for extra thick tissue (black cartridge) deplov three height-progressive rows of 4.0 mm. 4.5 mm and 5.0 mm titanium staples on either side of the cut line. Each GIA™ staple™ technology may be reloaded with a GIA™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument.
The design modification is to add one contraindication per special control 21 CFR 878.4740(b)(2)(ix)(A), and revises IFUs and labels per new regulation requirements.
Based on the provided text, the device in question is a surgical stapler, not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria, study design for AI/ML validation (e.g., sample sizes for training/test sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this 510(k) submission.
The document describes the GIA™ Stapler with Tri-Staple™ Technology and a special 510(k) submission for adding a new contraindication to its labeling. The manufacturer argues for substantial equivalence to a predicate device (K202701, K192720) based on non-clinical performance data and the consistency of the added contraindication with surgical training and practice.
Here's what can be extracted from the text regarding the device and its assessment:
Device: GIA™ Stapler with Tri-Staple™ Technology
Type: Surgical Stapler (manual, linear stapler)
Function: Places two triple staggered rows of titanium staples and simultaneously cuts and divides tissue between these rows.
Applications: Abdominal and thoracic surgical procedures for resection, transection, and creation of anastomosis.
The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance data and the justification of substantial equivalence for the change introduced (the new contraindication).
Here's how the provided information relates to the request, acknowledging the non-AI/ML nature:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit for this submission): The primary acceptance criterion for this specific 510(k) submission is to demonstrate that the addition of a contraindication does not alter the fundamental operating principle, mechanism of action, intended use, or a new question of safety and effectiveness compared to the predicate device. The device's fundamental performance characteristics (e.g., staple formation, tissue cutting) are presumed to be established by the predicate device's clearance.
- Reported Device Performance (for this submission):
- Technological and Performance Characteristics: The subject device is stated to "not change the fundamental operating principle and mechanism of action when compared to the predicate device."
- Usability Assessment: "Usability assessment was performed for the proposed labeling changes to demonstrate substantial equivalence to the predicate device."
- Contraindication: The added contraindication ("should not be used to staple tissues that are necrotic, friable, or have altered integrity, e.g., ischemic or edematous tissues") is stated to be "consistent with surgical training and practice."
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of AI/ML validation. For a mechanical device like a stapler, "test set" would typically refer to the samples of components or assembled devices used for various mechanical, material, or functional tests (e.g., staple strength, firing force, material biocompatibility). The document only generally states "Non-clinical performance data" and "Usability assessment was performed." Specific sample sizes or provenance for these engineering tests are not detailed in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (no AI/ML ground truth). The "ground truth" concept in AI/ML refers to expert-annotated data. For this device, the "truth" is based on engineering specifications, material properties, and surgical principles. The document mentions the contraindication is "consistent with surgical training and practice," implying a consensus amongst medical professionals or established surgical guidelines, rather than a specific expert panel establishing "ground truth" for a dataset.
4. Adjudication method for the test set:
- Not applicable (no AI/ML ground truth).
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 a mechanical surgical device, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a mechanical surgical device, not an algorithm.
7. The type of ground truth used:
- Not applicable in the AI/ML sense. For this device, the "truth" for its performance is derived from:
- Engineering specifications and testing: Ensuring the stapler performs its mechanical function (stapling, cutting) within predefined tolerances.
- Surgical principles and clinical consensus: The added contraindication is deemed valid because it aligns with established surgical understanding of tissue viability.
- The document explicitly states: "Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies."
8. The sample size for the training set:
- Not applicable (no AI/ML training data).
9. How the ground truth for the training set was established:
- Not applicable (no AI/ML training data).
In summary, this 510(k) pertains to a hardware medical device (a surgical stapler) and its labeling changes, not an AI/ML-driven software product. Therefore, most of the detailed questions regarding AI/ML validation studies are not relevant to this specific FDA submission. The "evidence" provided for this submission focuses on demonstrating that the change (adding a contraindication) does not alter the device's fundamental equivalence to its predicate, primarily through non-clinical testing and alignment with accepted medical practice.
§ 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.