(149 days)
The EEATM 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-sicle anastomoses in both open and laparoscopic surgeries.
The EEA™ circular stapler with Tri-Staple™ technology (Black) places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis as an endto-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. The instrument is activated by squeezing the handle firmly as far as it will go. The subject circular stapler will be offered for an extra thickness range, which is identified by the black staple guide. Staplers with extra thick staple size deploy three height progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples. The subject circular staplers are available in 3 lumen sizes 28, 31. 33mm and 2 shaft lengths a standard 22 cm shaft and an XL 35 cm shaft. The 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 (Black) is manufactured with patient contact materials (stainless steel, titanium) that are utilized within the predicate devices (K172361 and K062850).
The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) is a manual device which 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 devices (K172361 and K062850).
The EEA™ Circular Stapler with Tri-Staple™ Technology (Black) is a single-use device that is packaged and sterilized via ETO (Ethylene Oxide) with a 5-year shelf life, which is the same as the predicate devices (K172361 and K062850).
The provided text describes the 510(k) summary for the EEA™ Circular Stapler with Tri-Staple™ Technology (Black). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study. As such, the information typically found for such a study (like sample sizes for test sets, ground truth establishment, MRMC studies, or training set details) is not present.
However, the document lists various non-clinical performance tests conducted to support substantial equivalence, and for these tests, it states that "The acceptance criteria of each test within the In-Vitro section has been satisfied and results deemed acceptable," and "All units evaluated yielded comparable or better results in accordance with the acceptance criteria for Ex-Vivo test" and "In-Vivo acute test." This implies that internal acceptance criteria were established and met for these non-clinical evaluations.
Here's a breakdown of the available information based on your request, with an emphasis on what is not explicitly stated as well:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of defined acceptance criteria alongside quantitative performance results for the device. Instead, it makes general statements about meeting "acceptance criteria" and yielding "comparable or better results" for the non-clinical tests.
| Test Category | Acceptance Criteria (Not explicitly quantified in the document) | Reported Device Performance |
|---|---|---|
| In-Vitro Tests | - Visual inspection criteria (?) | - Satisfied acceptance criteria for visual inspection, safety lock release |
| - Safety lock release force criteria (?) | force, staple formation, anvil attach/detach force, clamping force, | |
| - Staple formation criteria (?) | unclamping force, and firing force. | |
| - Anvil attach/detach force criteria (?) | ||
| - Clamping/unclamping force criteria (?) | ||
| - Firing force criteria (?) | ||
| Ex-Vivo Tests | - Firings criteria (?) | - All units yielded comparable or better results in accordance with |
| - Knife cut evaluation criteria (?) | acceptance criteria for ex-vivo firings, knife cut evaluation, and | |
| - Leak / Burst test criteria (?) | leak/burst tests. | |
| In-Vivo Studies | - Atraumatic tissue test criteria (?) | - All units yielded comparable or better results in accordance with |
| - Hemostasis test criteria (?) | acceptance criteria for in-vivo acute tests (atraumatic tissue, | |
| - Staple formation on tissues criteria (?) | hemostasis, staple formation on tissues). | |
| - Chronic survival study criteria (?) | - Chronic animal study showed no differences in healing metrics or | |
| anastomotic index compared to predicate. | ||
| Human Factors | - Device performance meets user needs criteria (?) | - Validated device performance, mitigated potential use errors, validated |
| - Mitigated use errors criteria (?) | training and instruction. Demonstrates substantial equivalence. | |
| - Training/Instruction validation criteria (?) | ||
| Biocompatibility | - Followed ISO 10993-1 and FDA guidance (?) | - Results support the subject devices are biocompatible. |
| Sterilization | - Sterility Assurance Level ($\leq 10^{-6}$) | - Achieved minimum SAL of $10^{-6}$. |
| - ETO residual limits (?) | - ETO residual test performed. | |
| Stability/Shelf-life | - Functional test after aging for 5 years (?) | - Results support a 5-year shelf life. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for any of the performance tests.
- Data Provenance: The studies were conducted by Covidien, the manufacturer. The document doesn't specify countries of origin for the data (e.g., for animal studies). The studies are non-clinical, implying they were conducted in a laboratory or animal model setting and are inherently prospective for the device being tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The performance tests described (e.g., force tests, burst tests, tissue evaluations) likely rely on objective measurements and established scientific protocols rather than expert consensus on a "ground truth" as might be seen in diagnostic imaging studies.
4. Adjudication method for the test set
- Not applicable and not provided. The nature of the non-clinical performance tests (e.g., measuring forces, evaluating staple formation) typically involves objective measurements against pre-defined criteria, not adjudication by multiple independent reviewers.
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
- No. This type of study is relevant for AI/diagnostic imaging devices. The EEA™ Circular Stapler is a surgical device, and its evaluation does not involve "human readers" or "AI assistance" in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not applicable to a physical surgical stapler. The device is operated by a human, and its performance is evaluated in conjunction with human use (e.g., human factors/usability testing).
7. The type of ground truth used
- For the non-clinical tests (in-vitro, ex-vivo), the "ground truth" would be the objective measurements compared against pre-defined engineering specifications and performance standards for the device and its predicates. For the in-vivo animal study, the "ground truth" for healing metrics and anastomotic index would be based on pathology and standard clinical assessments of tissue healing and integrity in the animal model.
8. The sample size for the training set
- This information is not applicable and not provided. This device is a physical surgical tool, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
- This information is not applicable and not provided, as there is no AI training set for this device.
§ 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.