(58 days)
The AEON™ Endoscopic Powered Stapler has applications in general, abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.
The AEON Endoscopic Powered Stapler system is composed of the AEON Endoscopic Powered Stapler Handle ("Powered Handle") and AEON Endoscopic Stapler Reloads ("Reloads"). The AEON Endoscopic Powered Stapler places two, triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The Powered Handle may be reloaded and fired up to 20 times in a single procedure. The Powered Handle is available in three different lengths (60mm, 160mm and 260mm) and the Reloads are available in multiple staple sizes to accommodate various tissue thicknesses.
The AEON Endoscopic Powered Stapler uses software to control the operation of the stapler and is AC powered. The device is sterile packaged and is labeled for single use.
The provided FDA 510(k) clearance letter and summary for the AEON™ Endoscopic Powered Stapler focuses on demonstrating substantial equivalence to predicate devices, primarily for an expanded indication to include thoracic applications. However, it does not contain the detailed information typically found in a study report proving a device meets specific acceptance criteria, especially for AI/ML-driven devices.
Based on the provided text, here's an analysis of the acceptance criteria and the study that supports it, with the caveat that many details commonly sought for AI/ML device evaluations are not present in this document.
Acceptance Criteria and Study for AEON™ Endoscopic Powered Stapler (Thoracic Applications)
The core "acceptance criteria" discussed in this document revolve around demonstrating substantial equivalence for the expanded indication of "thoracic surgery." This implies that the device, when used for this new application, performs safely and effectively without raising new questions of safety or efficacy. Since the device itself is a mechanical surgical stapler with software control, the criteria are likely related to the mechanical performance and clinical outcomes.
The document explicitly states that the expanded Indications for Use for thoracic applications are supported by real-world evidence data.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) summary for a mechanical device with software control, the "acceptance criteria" are implied by the claim of substantial equivalence and the successful real-world evidence for thoracic applications. Specific quantitative performance metrics typical for AI/ML (e.g., sensitivity, specificity, AUC) are not directly stated. Instead, the acceptance criteria are implicitly that the device is "safe and effective for use for thoracic applications" without adverse events or performance issues that would preclude clearance.
| Acceptance Criterion (Implied) | Reported Device Performance (Summary of Real-world Evidence) |
|---|---|
| Safety for Thoracic Applications | The real-world evidence data concluded that the device is safe for use for thoracic applications. |
| Effectiveness for Thoracic Applications | The real-world evidence data concluded that the device is effective for use for thoracic applications. |
| No new questions of safety/efficacy | The submission aims to demonstrate substantial equivalence, implying no new safety or efficacy concerns compared to the predicate/reference devices for this expanded indication. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size (number of patients, procedures, or stapler uses) used in the real-world evidence data.
- Data Provenance: The data is described as "Real-world evidence data." The document does not specify the country of origin of this data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For a surgical stapler's clinical performance, "ground truth" would typically relate to clinical outcomes assessed by surgeons or other medical professionals.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described. This type of study is typically relevant for diagnostic imaging AI systems where human readers interpret images with or without AI assistance. The AEON™ Endoscopic Powered Stapler is a surgical instrument, not a diagnostic AI. The document states "human factors testing is not applicable to support the expanded Indications for Use," further indicating that comparative studies with human action are not central to this particular clearance process.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
The device is a powered surgical stapler that uses software to control its operation. While the software itself might have undergone standalone validation, the performance described (safety and effectiveness for thoracic applications) would inherently involve the device operating with a human surgeon in the loop. A standalone "algorithm only" performance in the context of surgical stapling would be largely meaningless without the mechanical components and user interaction. The document implies that the device's overall performance, including its software-driven functions, was evaluated in real-world use for thoracic applications.
7. The Type of Ground Truth Used
For "real-world evidence data" supporting the safety and effectiveness of a surgical stapler for thoracic applications, the ground truth would most likely be derived from:
- Clinical Outcomes Data: This would include metrics like incidence of staple line failure, leaks, bleeding, tissue trauma, successful resection/transection, complication rates, and patient recovery within a thoracic surgical context.
- Surgeon Assessments: Evaluations by operating surgeons regarding ease of use, stapler performance, and observed tissue response.
The document does not explicitly state the specific type of ground truth, but these are the most probable types for this device and its application.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of the expanded indications or real-world evidence. This is expected given that the clearance is for a mechanical device with software control, not an AI/ML diagnostic algorithm that typically relies on extensive training data. The software within the stapler likely has deterministic control logic rather than learning algorithms that require large training datasets in the typical AI sense.
9. How the Ground Truth for the Training Set was Established
Since a "training set" is not mentioned or described in the context of the device's software learning or the expanded indications, the method for establishing its ground truth is not applicable here. The software control functions were likely verified and validated through a design control process, not machine learning model training.
§ 878.4740 Surgical stapler.
(a) Surgical stapler for external use.
(1)
Identification. A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.(b) Surgical stapler for internal use.
(1)
Identification. A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.(2)
Classification. Class II (special controls). The special controls for this device are:(i) Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following:
(A) Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type;
(B) For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force;
(C) Measurement of staple line strength;
(D) Confirmation of staple line integrity; and
(E) In vivo confirmation of staple line hemostasis.
(ii) For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device.
(iii) For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed.
(iv) Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) Performance data must demonstrate the sterility of the device.
(vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling.
(viii) Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life.
(ix) Labeling of the device must include the following:
(A) Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity.
(B) Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including:
(
1 ) Avoidance of use of the stapler to staple tissue outside of the labeled limits for maximum and minimum tissue thickness;(
2 ) Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures;(
3 ) Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage;(
4 ) Avoidance of use of the stapler on the aorta;(
5 ) Establishing proximal control of blood vessels prior to stapling where practical and methods of blood vessel control in the event of stapler failure;(
6 ) Ensuring stapler compatibility with staples; and(
7 ) Risks specifically associated with the crossing of staple lines.(C) Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling.
(D) List of staples with which the stapler has been demonstrated to be compatible.
(E) Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device.
(F) Information regarding tissues on which the stapler is intended to be used.
(G) Identification of safety mechanisms of the stapler.
(H) Validated methods and instructions for reprocessing of any reusable device components.
(I) An expiration date/shelf life.
(x) Package labels must include critical information and technical characteristics necessary for proper device selection.