(162 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 subject circular stapler is available in 21mm lumen size and 2 shaft lengths; a standard 22 cm shaft and an XL 35 cm shaft. The staplers are offered in 2 staple sizes, medium/thick and extra 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. Staplers with extra thick staple size (black) deploy three heightprogressive rows of 4.0 mm. 4.5 mm and 5.0 mm titanium staples. The low profile Tilt-Top™ anvil is available on all staplers. A blunt and a sharp tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.
The provided document is a 510(k) summary for a surgical stapler. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain the specific acceptance criteria or the detailed results of a study proving the device meets those criteria, particularly in the context of device performance metrics like accuracy, sensitivity, or specificity.
The document states that a "Chronic animal study performed to evaluate the performance of the subject device and the reference device shows no differences in healing metrics or anastomotic index, and the results demonstrate that the acceptance criteria were met." However, it does not explicitly list these acceptance criteria or the detailed reported device performance. It also mentions "Performance Test (In-Vitro)", "Performance Test (Ex-Vivo)", and "Performance Test (In-Vivo)", but again, it does not provide the acceptance criteria for these tests nor the quantitative results demonstrating compliance.
Therefore, many of the requested details cannot be extracted directly from this document.
Here's what can be gathered, with caveats for missing information:
1. Table of Acceptance Criteria and Reported Device Performance
- The document mentions that acceptance criteria were met for a chronic animal study, but it does not explicitly state what those acceptance criteria are nor does it provide a quantitative report of the device's performance against them.
- For the in-vitro and ex-vivo performance tests, it lists the types of tests performed (e.g., Safety Lock Release Force Test, Leak/Burst Test, Staple Formation on Test Medium) but does not provide specific acceptance criteria values (e.g., "Force must be X N to Y N") or the measured performance values for the device.
2. Sample size used for the test set and the data provenance
- Chronic Animal Study (In-Vivo): The document states a "Chronic animal study" was performed. It implies the performance of the subject device (EEA™ Circular Stapler with Tri-Staple™ Technology, 21mm lumen size) was compared to a reference device (EEA™ Circular Stapler with DST Series™ Technology, K062850, 21mm lumen size).
- Sample Size: Not explicitly stated for either the animal study or other performance tests.
- Data Provenance: The studies were performed to support a 510(k) submission by Covidien (part of Medtronic). Given Covidien's global operations, the country of origin for the data is not specified. The animal study would be prospective, as it involves evaluating a device's performance. The in-vitro and ex-vivo tests would also be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the document describes performance testing of a mechanical device, not an AI/diagnostic device where expert interpretation of data is typically a ground truth component. In this context, "ground truth" would be objective measurements from tests.
4. Adjudication method for the test set
- This information is not provided as it's not relevant for mechanical device performance testing where objective measurements are taken rather than subjective interpretations needing adjudication.
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 is not relevant. The device is a surgical stapler, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a surgical stapler, not an algorithm.
7. The type of ground truth used
- For mechanical performance tests, the "ground truth" would be established by:
- Objective measurements: e.g., force measurements (Safety Lock Release Force, Clamping Force, Firing Force), visual inspections against defined criteria (Visual/Packaging Inspection, Staple Formation), and functional tests (Leak/Burst Test, Knife Cut Evaluation).
- Healing metrics and anastomotic index: For the chronic animal study, these would be the observed outcomes measured by qualified personnel (e.g., veterinary pathologists, surgeons) according to defined protocols.
8. The sample size for the training set
- Not applicable. The device is a mechanical surgical stapler. There is no AI component that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI model.
Summary of Missing Information:
The most crucial missing information, according to your request, is a detailed table showing:
- Specific quantitative acceptance criteria for each performance test (e.g., minimum/maximum force values, leak rates, staple formation dimensions, healing scores).
- The actual quantitative results obtained from the subject device during these tests, demonstrating that it met those criteria.
Without these specifics, we can only state that the document asserts "acceptance criteria were met" without revealing what those criteria were or how the device performed against them numerically.
§ 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.