(142 days)
The ECHELON FLEX™, ECHELON™ 3000, and ECHELON ENDOPATH™ families of staplers and reloads are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The ECHELONTM 3000 45 mm and 60 mm Staplers are sterile, single-patient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line.
The ECHELON™ 3000 45 mm Staplers have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long.
The ECHELON™ 3000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long.
The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.
The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack. Refer to the Battery Pack Disposal section.
The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.
The provided text is a 510(k) summary for the ECHELON™ 3000 Surgical Stapler. It outlines the device description, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence. However, it does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria and the specifics of a study proving the device meets those criteria for an AI/algorithm-based medical device.
The document discusses performance data for a surgical stapler, which is a mechanical device, not an AI/algorithm-based diagnostic or therapeutic tool. Therefore, the types of "acceptance criteria" and "studies" will differ significantly from those for an AI system.
Here's how the information provided relates to your request, and where there are gaps due to the nature of the device:
Regarding the Surgical Stapler (as described in the document):
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Acceptance Criteria and Reported Performance: The document lists various bench testing criteria (Formed Staple Height (FSH), Staple Line Integrity (SLI), Force to Close, Staple Line Visual Analysis, Staple Line Strength) and animal testing (Acute Hemostasis evaluation, Tissue Healing response, Survival Study). For a 510(k), the "acceptance criteria" are generally that the device performs comparably to a predicate device and does not raise new questions of safety or effectiveness. The reported performance is that these tests "demonstrate that the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness." However, specific numerical acceptance criteria (e.g., FSH must be within X range) and the exact numerical performance results are not provided in this summary. This level of detail is typically found in the full 510(k) submission, not the public summary.
Given that this is a mechanical device, not an AI, a table like you requested would list mechanical properties and their measured values against predefined acceptable ranges derived from the predicate device or engineering specifications.
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Sample Size: The document mentions "bench testing" and "animal testing" but does not specify the sample sizes used for these tests.
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Data Provenance: Not specified for the bench or animal testing.
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Number of Experts/Qualifications/Adjudication Method for Test Set: Not applicable in the context of this device's testing. These are relevant for AI systems relying on expert ground truth.
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MRMC Comparative Effectiveness Study: Not applicable. This is a study design for evaluating the impact of AI on human reader performance. This device is a mechanical stapler.
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Standalone Performance: The "bench testing" and "animal testing" can be considered "standalone" performance testing for a mechanical device, as it evaluates the device's physical properties and function without human intervention beyond operation.
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Type of Ground Truth: For a mechanical device like a stapler, "ground truth" equates to established engineering specifications, mechanical properties (e.g., staple height, tensile strength), and biological outcomes (e.g., hemostasis, healing) validated through standard scientific and engineering practices. It's not "expert consensus" on an image, but rather measurable physical and biological parameters.
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Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that undergoes a "training set" process.
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How Ground Truth for Training Set was Established: Not applicable for the same reason.
If the request was hypothetically for an AI-based medical device, and we were to invent the details based on common FDA expectations for AI/ML:
Let's imagine this document was for an AI-powered diagnostic tool. Here's what such a response would include, creating hypothetical details where the provided document has gaps:
Hypothetical Acceptance Criteria and Study for an AI-Powered Diagnostic Device (e.g., for detecting a specific condition in medical images):
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (e.g., for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Standalone Performance | ||
| Sensitivity (AI only) | ≥ 85% | 87.2% |
| Specificity (AI only) | ≥ 75% | 78.5% |
| AUC (AI only) | ≥ 0.85 | 0.89 |
| Human-in-the-Loop Performance (Reader Study) | ||
| Reader Sensitivity (AI-assisted) | ≥ Reader Sensitivity (unaided) + 5% | +6.1% |
| Reader Specificity (AI-assisted) | No significant decrease compared to unaided | +0.5% (not significant) |
| Reader Efficiency (Time per case) | ≤ Time per case (unaided) | -15% (faster) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 500 cases (e.g., 250 positive, 250 negative for the condition).
- Data Provenance:
- Country of Origin: Multi-site, primarily from hospitals in the United States and Europe.
- Retrospective/Prospective: Primarily retrospective data collected from institutional archives. A small subset (50 cases) was prospectively collected to ensure generalizability.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: 3 independent expert readers.
- Qualifications: All were board-certified radiologists with at least 10 years of experience in diagnosing the target condition. Two had fellowship training in the relevant sub-specialty.
4. Adjudication Method for the Test Set
- Method: 2+1 adjudication. Initial reads by two independent expert radiologists. In cases of disagreement, a third, senior-level radiologist (the "tie-breaker") reviewed the case and the initial reads to make a final ground truth determination.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Yes, an MRMC study was performed.
- Effect Size: The study demonstrated a statistically significant improvement in human reader performance when assisted by the AI.
- Sensitivity: Human readers' sensitivity improved by an average of 6.1 percentage points (e.g., from 82% unaided to 88.1% AI-assisted, p
§ 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.