(261 days)
The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.
The Tri-Staple™ 2.0 black circular reloads place a circular triple staggered row of titanium staples. After staple formation, the knife blade resects the excess tissue, creating a circular anastomosis such as endto-end, end-to-side, or side-to-side anastomosis as the user sees fit. The new circular reloads will be offered for an extra thick tissue thick is identified by the black staple quide. The circular reloads deploy three height-progressive rows of 4.0 mm. 4.5 mm staples. The Tri-Staple™ technology incorporated in the black reload is essentially the same as the legally-marketed K192330 in terms of reload design. The Tri-Staple™ 2.0 black circular reloads are provided sterile for single use, and available in three lumen sizes: 28, 31, and 33 mm. The Tilt-Top™ anvil is available with all circular reloads.
The Tri-Staple™ 2.0 black reloads are for use with the previously-marketed Signia™ Circular Adapter. as part of the Signia™ stapler. The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads.
The provided text discusses the Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters). Based on the information present, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a tabulated format with specific functional thresholds directly next to "reported device performance." Instead, it highlights various performance tests and evaluations conducted to demonstrate substantial equivalence to predicate devices, inferring that meeting these study outcomes signifies acceptable performance.
However, based on the "Summary of Studies" and the "Substantial Equivalence" table, we can infer some key performance aspects and their assessment:
| Feature/Aspect | Acceptance Criteria (Inferred from Predicate and Study Mentions) | Reported Device Performance (Summary of Studies) |
|---|---|---|
| Mechanical/Functional Performance | Equivalent to or better than predicate devices in stapling strength, hemostasis, anastomosis quality, and tissue resection. | Demonstrated through: |
- Bench top testing
- Ex-vivo testing
- In-vivo pre-clinical testing
- Chronic GLP study (healing metrics, anastomotic index) |
| Shelf-Life/Stability | Device maintains intended performance over its specified shelf-life. | Stability/Shelf-Life study for single-use devices. |
| Biocompatibility | Meets ISO 10993 series and FDA 2016/2020 guidance. | Biocompatibility evaluation conducted in accordance with FDA 2020 guidance and ISO 10993-1. |
| Usability | Meets usability requirements as per FDA guidance and IEC 62366-1. | Usability study performed following FDA's 2016 guidance as well as IEC 62366-1. |
| Software Functionality | Software performs as intended, verified and validated. | Software verification & validation activities completed following FDA's guidance documents and IEC 62304. |
| Sterilization | Achieves minimum Sterility Assurance Level (SAL) of 10-6. | Ethylene oxide (EO) sterilization validation for single-use devices with a minimum SAL of 10-6. Previously demonstrated compliance remains unimpacted. |
| Disinfection | Device can be effectively disinfected. | Disinfection validation performed per FDA 2015 reprocessing guidance. |
| Reliability | Reusable components maintain performance over their extended life. | Reliability data supporting the extended end of life of the reusable devices. |
| Electrical Safety & EMC | Meets relevant ANSI/AAMI ES 60601-1, IEC 60601-1, and IEC 60601-1-2 standards. | Electrical safety testing repeated per ANSI/AAMI ES 60601-1 & IEC 60601-1 and electromagnetic compatibility (EMC) testing per IEC 60601-1-2. |
| MR Safety | MR characteristics are maintained. | Testing repeated per the latest applicable standards, previously cleared via K182475. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for the various tests (bench top, ex-vivo, in-vivo, usability, etc.). It also does not explicitly state the country of origin or whether the data was retrospective or prospective for these non-clinical studies. Given it's a 510(k) submission, the studies are typically conducted by the manufacturer (Covidien/Medtronic) and are usually prospective engineering, preclinical, or human factors studies designed for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide information on the number of experts or their qualifications for establishing ground truth for any of the studies mentioned. For pre-clinical animal studies (GLP), typically veterinarians and pathologists would be involved, and for usability, medical professionals, but specifics are not given.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The document does not describe any adjudication method for establishing ground truth in its studies. This type of detail is more common for clinical trials involving human interpretation of medical images or outcomes, which is not the primary focus of these non-clinical performance studies for a surgical stapler.
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:
The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is relevant for AI-powered diagnostic or interpretive devices involving human readers (e.g., radiologists interpreting images), which is not the nature of this surgical stapler reload. The device is a mechanical stapling device with a "powered stapling technology" and "software-controlled tissue compression," not an AI diagnostic assistant for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
While the device has "software-controlled tissue compression," it is a surgical instrument used by a human surgeon. Therefore, a "standalone algorithm only" performance, in the sense of a diagnostic AI device, is not applicable or discussed. However, the software verification and validation activities essentially represent the "standalone" performance assessment of the integrated software components within the device's operational context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the various non-clinical studies would likely be established as follows:
- Bench top/Ex-vivo: Engineering specifications, physical measurements (e.g., staple height, tissue gap, burst pressure, leak tests), and defined experimental outcomes.
- In-vivo/Chronic GLP study: Histopathological analysis (pathology records), clinical observation of healing progress, measurements of anastomotic integrity, and gross examination performed by trained veterinary professionals and pathologists.
- Usability: Observation of user interaction, task completion rates, error rates, and user feedback against predefined usability goals and safety criteria.
- Biocompatibility: Laboratory testing against ISO standards for material toxicity, sensitization, etc.
8. The sample size for the training set:
The document does not mention a "training set" in the context of machine learning, as this is a mechanical surgical device with integrated software for control, not an AI model that requires a training dataset for learning. The software is developed and validated through traditional software engineering V&V processes.
9. How the ground truth for the training set was established:
As no "training set" in the AI/ML sense is indicated, the concept of establishing ground truth for it is not applicable to this device. The software's correct functioning is established through design specifications, verification, and validation against intended logic and operational parameters.
§ 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.