(30 days)
The EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™ transoral circular stapler anvil have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The EEA™ circular stapler with Tri-Staple™ technology and OrVil™ Transoral Circular Stapler Anvil is a manual, single-use device that places a circular, triple staggered row of titanium staples and resects the excess tissue. It has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. The subject device is to add new product models with OrVil™ transoral circular stapler anvil to EEA™ circular stapler with Tri-Staple™ technology 21mm or 25mm XL purple or black stapler.
This document describes the premarket notification (510(k)) for the EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil. It is a medical device, specifically a surgical stapler. The provided text, however, does not contain information about software, AI algorithms, or a study involving human readers' improvement with AI assistance.
Therefore, many of the requested points regarding acceptance criteria and study details for an AI-based device, such as sample sizes for test and training sets, expert qualifications, ground truth establishment for AI models, and MRMC studies, cannot be extracted from this document.
The document primarily focuses on demonstrating the substantial equivalence of this new device to previously cleared predicate devices through non-clinical performance data and usability evaluation.
Here's what can be extracted based on the provided text, while acknowledging the limitations for an AI-related request:
Acceptance Criteria and Reported Device Performance (Non-AI Device)
Given that this is a mechanical surgical stapler and not an AI-driven device, the "acceptance criteria" here refer to the successful completion of various performance and safety tests to demonstrate substantial equivalence to predicate devices, rather than AI performance metrics (e.g., sensitivity, specificity).
| Acceptance Criteria (based on tests performed) | Reported Device Performance (Implied as "passed" for substantial equivalence) |
|---|---|
| Performance Test (In-Vitro): | |
| Visual/Packaging Inspection | Deemed acceptable |
| IFU Walkthrough | Deemed acceptable |
| Firing Force on Red-Skin Foam Test | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Staple Formation on Red-Skin Foam | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Suture Break Test | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Pulling Guide Suture Reel Removal | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Proximal Guide Suture Break Test | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Removing Guide Suture from Anvil Test | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Removal Force with Suture Cut in 1 leq | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Retention Break Force | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Insertion Force of Accessory Tube Fitting | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Retention Force of Accessory Tube Fitting | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Performance Test (Ex-Vivo): | |
| Ex-vivo Rectum Firing | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Knife Cut Evaluation | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Anastomotic Leak/Burst Pressure Test | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Performance Test (In-Vivo): | |
| Leak Evaluation | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Staple Formation | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Hemostasis | Met pre-defined specifications (implied, as substantial equivalence concluded) |
| Sterilization Assessment (ISO 11135) | Compliant |
| Stability Test (for single-use device) | Compliant |
| Biocompatibility Tests (ISO 10993-1) | Compliant |
| Usability Evaluation (IEC 62366-1:2015+AMD1:2020) | Safe and effective for intended users, uses, and use environments (as stated) |
Study Details (Relevant to this non-AI medical device submission)
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Sample size used for the test set and the data provenance:
- The document mentions "non-clinical performance data" and a series of "Performance Test (In-Vitro)", "Performance Test (Ex-Vivo)", and "Performance Test (In-Vivo)". No specific sample sizes for these tests are provided.
- Data provenance (e.g., country of origin, retrospective/prospective) is not specified for these non-clinical tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the submission describes a mechanical device. The "ground truth" for this device would be engineering specifications and functional performance.
- For the usability study, "intended users (surgeons, nurses)" evaluated the device, but the number and qualifications beyond their professional roles are not specified.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of device testing. Performance is measured against physical specifications.
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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:
- No. This is not an AI-enabled device.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI-enabled device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on established engineering specifications, ASTM or ISO standards for medical devices, and successful performance in the described in-vitro, ex-vivo, and in-vivo functional tests. For the usability study, it's based on subjective and objective feedback from intended users against safety and effectiveness criteria.
-
The sample size for the training set:
- Not applicable. This is not an AI device that undergoes training.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI device that undergoes training.
In summary: The provided document is a 510(k) summary for a traditional mechanical surgical stapler. It does not involve AI or any of the detailed study methodologies typically associated with AI/software medical device submissions. Therefore, most of the questions relating to AI performance, data sets, and expert evaluations cannot be answered from this text.
§ 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.