(196 days)
The EEA™ Circular Stapler with Tri-Staple™ Technology 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 EEA™ circular stapler with Tri-Staple™ technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. The diameter of the staple line is 33 mm, 31 mm, 28 mm. The EEA™ circular stapler with Tri-Staple™ technology is available in 2 shaft lengths; a standard 22 cm shaft and an XL 35 cm shaft. The staplers are offered in one staple size medium/thick. Staplers with medium/thick staple size (purple) deploy three height progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples. The low profile Tilt-Top™ anvil is available on all staplers. A blunt tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.
The EEA™ Circular Stapler with Tri-Staple™ Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis as an 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 is a manual single-use device that is packaged and sterilized via ETO (Ethylene Oxide) with a 5-year shelf life.
The EEA™ Circular Stapler with Tri-Staple™ Technology is designed for prescription use only per 21 CFR 801 Subpart D. The device is utilized in open and laparoscopic surgical procedures.
The EEA™ Circular Stapler with Tri-Staple™ Technology is manufactured with patient contact materials (stainless Steel, titanium) that are utilized within the predicate device (K062850).
The EEA™ Circular Stapler with Tri-Staple™ Technology is utilized by approximating tissue, instrumentation activation by squeezing the handle firmly as far as it will go, audible and tactile firing indicator upon completion of the staple firing and removal of the device from the surgical field in the same manner as the predicate device (K062850).
This document is a 510(k) premarket notification for the Covidien EEA™ Circular Stapler with Tri-Staple™ Technology (K172361), indicating that it is substantially equivalent to a predicate device (K062850). The FDA's letter and the 510(k) summary provide information on the device's technical characteristics, but do not describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device, which is implied by the detailed questions about ground truth, MRMC studies, and sample sizes for training/test sets.
The nature of the submission (510(k) for a surgical stapler) implies a focus on demonstrating substantial equivalence to a predicate mechanical device, not on AI/ML performance.
Therefore, most of the specific questions about acceptance criteria for an AI/ML device, the study that proves it, sample sizes for training/test sets, ground truth establishment, expert qualifications, and MRMC studies, cannot be answered from the provided text. The text explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." It also states: "This submission does not include data from clinical studies."
However, I can extract information about the performance tests conducted to support substantial equivalence for this mechanical medical device.
Here's a breakdown of what can and cannot be answered based on the provided text:
Preamble: This document refers to the FDA 510(k) submission for a surgical stapler, which is a mechanical device, not an AI/ML device. Therefore, the questions related to AI/ML specific aspects (like ground truth, MRMC, training/test sets, etc.) are not applicable to the content provided.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with explicit "acceptance criteria" alongside "reported device performance" in the quantitative sense typically expected for a medical device study (e.g., specific thresholds for sensitivity, specificity, accuracy). Instead, it lists various performance tests that were successfully completed to demonstrate substantial equivalence. The "reported device performance" is implicitly that the device "conforms to applicable technical design specifications and performance requirements" and achieves "safety and effectiveness."
| Performance Test Category | Test Conducted | Implicit Acceptance (Met requirements) |
|---|---|---|
| Stability Testing | Accelerated aging test for 5 years shelf life | Yes |
| Sterilization Validation | Per ISO 11135-1 and ISO 10993-7 (Overkill method, ETO Residuals) | Yes |
| Biocompatibility Testing | Per ISO 10993-1 and FDA guidance (NRU Cytotoxicity, Guinea Pig Maximization Sensitization, Intracutaneous Irritation, Acute System Toxicity, Pyrogenicity) | Yes |
| Performance Test In Vitro | Staple formation, Anvil attach force, Anvil detach force, Firing force | Yes |
| Performance Test In Vivo | External Atraumatic tissue, Hemostasis, Staple formation, Knife cut, Anastomotic burst pressure, Non-Clinical Chronic Study (colo-colonic and gastro-jejunal anastomoses) | Yes |
| Performance Test Human Factors / Usability | Device performance evaluation per design specifications, Validate potential use error per Risk and Hazard analysis, Validate training and Instructions for Use | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. The document refers to "design verification and validation testing" and "nonclinical testing" but does not give specific sample sizes for these tests.
- Data Provenance: Not specified. The studies are referred to as "design verification and validation activities," "applicable design verification activities," and "nonclinical testing." There is no mention of country of origin for this testing data.
- Retrospective or Prospective: Not specified.
3. 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)
This question is not applicable as this is a mechanical surgical stapler, not an AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as this is a mechanical 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
This question is not applicable as this is a mechanical surgical stapler, not an AI/ML device. The submission explicitly states it "did not rely on the assessment of clinical performance data" and "does not include data from clinical studies."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as this is a mechanical surgical stapler, not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This question is not applicable as this is a mechanical surgical stapler. The "ground truth" for this device would be its ability to consistently perform its mechanical function as specified in the design (e.g., proper staple formation, sufficient burst pressure, appropriate firing force). This is evaluated through the various performance tests listed.
8. The sample size for the training set
This question is not applicable as this is a mechanical surgical stapler and does not involve AI/ML training.
9. How the ground truth for the training set was established
This question is not applicable as this is a mechanical surgical stapler and does not involve AI/ML training.
§ 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.