(10 days)
The Autosuture™ Endo GIA™ Staplers with Endo GIA™ Single Use Reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
This 510(k) shall describe a new Reload cartridge with Tri-Staple™ technology for use with the currently marketed Autosuture™ Endo GIA™ Stapler as described in the predicate submission K083519. The black Reload bears the identical design characteristics as the Reloads with Tri-Staple™ Technology described in the predicate submission with the exception that the staples sizes shall be 4.0, 4.5, and 5.0 mm for use in extra thick tissue. The black Reloads shall be made available in 45 mm and 60 mm lengths.
The provided text describes a 510(k) submission for a surgical stapler reload, the "Autosuture™ Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology." The submission focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating AI performance. Therefore, many of the requested elements for AI model evaluation are not present in this document.
However, I can extract information related to the acceptance criteria and the general study type from the provided text for this medical device (not an AI device).
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format common for AI models (e.g., specific sensitivity, specificity, or AUC thresholds). Instead, for this surgical device, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices and acceptable performance in bench and in-vivo evaluations. The primary performance goals are safety and effectiveness when used as intended, and functional equivalence to the predicate.
The table below summarizes the closest information available regarding acceptance aspects and reported performance, framed within the context of a medical device submission:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: The new Reload should exhibit identical design characteristics to predicate Reloads with Tri-Staple™ Technology, with specified staple sizes. | "The black Reload bears the identical design characteristics as the Reloads with Tri-Staple™ Technology described in the predicate submission with the exception that the staples sizes shall be 4.0, 4.5, and 5.0 mm for use in extra thick tissue." "The Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology for use in extra thick tissue is substantially equivalent to the predicate Reload cartridges with regard to the stapling technologies employed." |
| Material Biocompatibility: Materials used should be in accordance with ISO Standard 10993-1. | "All components of the Autosuture™ Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology are comprised of materials that are in accordance with ISO Standard 10993-1." |
| Safety and Effectiveness: When used with the Autosuture™ Endo GIA™ Stapler, the device must be safe and effective and perform as intended. | "Bench and in-vivo performance evaluations were conducted to demonstrate that the new Endo GIA™ Single Use Black Reload with Tri-Staple™ Technology when used with the Autosuture™ Endo GIA™ Stapler is safe and effective and performs as intended." |
Study Information (Based on provided text)
Given that this is a 510(k) summary for a surgical stapler reload and not an AI device, the following points address the requested information as much as possible, or explain why it is not applicable or available in the provided document:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document states "Bench and in-vivo performance evaluations were conducted."
- Bench Test Sample Size: Not specified in the summary document. Bench tests typically involve a controlled number of samples to assess mechanical properties and function.
- In-vivo Test Sample Size: Not specified in the summary document. In-vivo studies typically involve animal models or, less commonly for 510(k)s, human subjects. The details of these studies are not provided.
- Data Provenance: Not specified in the summary document. Such details (country, retrospective/prospective) are not typically included in a 510(k) summary for bench or in-vivo non-human studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. For this type of surgical device performance study, "ground truth" is typically established through direct measurement (e.g., staple formation, tissue integrity) in bench testing and observational outcomes in in-vivo studies, rather than expert consensus on diagnostic images. No information on experts establishing ground truth is provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This concept is primarily relevant for studies involving human interpretation (e.g., radiology reads) where disagreements need resolution. It is not applicable to the bench and in-vivo performance evaluations described for this surgical stapler reload.
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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:
- N/A. This is a medical device, not an AI device. No MRMC study was conducted, as there is no AI component or human reader interpretation involved in its intended use.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical surgical device, not an algorithm. Its performance is inherent to its mechanical function, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Bench Tests: Ground truth would likely be based on engineering specifications, mechanical measurements (e.g., staple leg formation, closure height, bursting pressure for anastomoses), and visual inspection for proper function.
- For In-vivo Tests: Ground truth would include direct observation of surgical outcomes, tissue healing, absence of leaks or bleeding, and potentially histological analysis of stapled tissue, as applicable to animal models.
- The document does not detail the specific ground truth metrics beyond generally stating "safe and effective and performs as intended."
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The sample size for the training set:
- N/A. This is a medical device, not an AI model. There is no concept of a "training set" in the context of this 510(k) submission.
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How the ground truth for the training set was established:
- N/A. Not an AI model; thus, no training set or associated ground truth establishment process for a training set.
§ 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.