(168 days)
The GIA™ stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.
The subject 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 GIA™ stapler and cartridges with Tri-Staple™ technology are available in 80 mm staple line length and two staple sizes to accommodate various tissue thicknesses: medium/thick and extra thick. Staplers with medium/thick staple size (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 with extra thick staple size (black cartridge) deploy 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™ stapler with Tri-Staple™ technology may be reloaded with GIA™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument.
The subject device GIA™ Stapler with Tri-Staple™ Technology is manufactured with the same patient contact materials that are utilized within the predicate device (K111825).
The subject device GIA™ stapler™ technology has the same principle operation as the predicate device. The GIA™ Stapler with Tri-Staple™ Technology is a manual single-use device. It is provided sterile (ethylene oxide) with 5-year shelf life, and intended for multiple use during a single procedure, which is the same as the predicate device (K111825).
The provided document is a 510(k) summary for the GIA™ Stapler with Tri-Staple™ Technology, a surgical stapler. It describes the device, its intended use, and its substantial equivalence to a predicate device.
However, the request asks for information regarding acceptance criteria and a "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-driven device. This document does not describe an AI/algorithm-driven device. It describes a mechanical surgical stapler. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size, ground truth for training set) are entirely not applicable to a mechanical device submission like this one.
The document discusses performance tests for the surgical stapler, which are traditional engineering and biological tests, not AI model evaluations.
Given the nature of the provided document, I cannot fulfill the request as it pertains to an AI/algorithm-driven device.
What I can extract from the provided document, interpreting "acceptance criteria" as performance tests for a mechanical surgical stapler, is:
1. A table of acceptance criteria and the reported device performance:
The document lists "Tests performed to evaluate and compare technological and performance characteristics," which essentially serve as acceptance criteria for this mechanical device. No specific quantitative "reported device performance" values are given in this summary; rather, it states that these tests were performed to "demonstrate substantial equivalence."
| Acceptance Criteria (Performance Test Type) | Reported Device Performance (as stated in document) |
|---|---|
| In-Vitro Performance Tests | Conducted to demonstrate substantial equivalence to predicate devices. |
| Visual inspection on product, packaging and instruction for use | (Implicitly met for substantial equivalence) |
| Staple formation on test media | (Implicitly met for substantial equivalence) |
| Firing force test | (Implicitly met for substantial equivalence) |
| Multi-Fire Evaluation | (Implicitly met for substantial equivalence) |
| Ex-Vivo Performance Tests | Conducted to demonstrate substantial equivalence to predicate devices. |
| Burst Pressure | (Implicitly met for substantial equivalence) |
| Pneumostasis | (Implicitly met for substantial equivalence) |
| Across Staple Line Evaluation | (Implicitly met for substantial equivalence) |
| In-Vivo Performance Tests | Conducted to demonstrate substantial equivalence to predicate devices. |
| In vivo safety and efficacy | (Implicitly met for substantial equivalence) |
| Tissue Abrasion | (Implicitly met for substantial equivalence) |
| Hemostasis test | (Implicitly met for substantial equivalence) |
| Staple formation on tissues | (Implicitly met for substantial equivalence) |
| Chronic survival testing | (Implicitly met for substantial equivalence) |
| Human Factors/Usability Tests | Found to be safe and effective for intended users, uses, and use environments. |
| Human factors evaluation per IEC 62366 and FDA Guidance | (Results implicitly support safety and effectiveness) |
| Biocompatibility Testing | Requirements met per ISO 10993-1 and FDA Guidance. |
| Cytotoxicity test | (Implicitly met) |
| Sensitization | (Implicitly met) |
| Intracutaneous irritation | (Implicitly met) |
| Acute system toxicity | (Implicitly met) |
| Pyrogenicity | (Implicitly met) |
| Sterilization Assessment | Validated via Overkill method, ETO residual test performed. |
| Sterilization per ISO 11135 | (Implicitly met) |
| Stability/Shelf-life studies | Accelerated aging test performed for 5 years shelf life. |
| Product and packaging functional test | (Implicitly met) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided 510(k) summary for any of the performance tests.
- Data Provenance: Not specified (e.g., country of origin). The tests are described as "non-clinical performance data." Some are in-vitro, ex-vivo, and in-vivo. These would typically be lab or animal studies for a mechanical device. The document explicitly states "No clinical study is deemed necessary."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device, not one requiring expert human interpretation of images or signals for ground truth. The "ground truth" for these tests would be the physical properties and performance measurements of the stapler itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. This concept is relevant for reconciling discrepancies in human expert labeling/interpretation, not for mechanical device testing.
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 explicitly an evaluation of an AI-driven device, which this is not. The document states "No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For mechanical devices, "ground truth" is established through direct measurement against predefined specifications, material properties, and functional performance benchmarks (e.g., burst pressure measurements, visual inspection, firing force data, staple formation analysis). It is not based on expert consensus of medical images or pathology.
8. The sample size for the training set:
- Not Applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This device is not an AI/ML algorithm.
§ 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.