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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.

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The circular stapler with DST Series™ Technology has application throughout the alimentary tract for the creation of endto-end, end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

The Autosuture™ EEA™ Stapler is a manual, single-use device that places a circular. double staggered row of titanium staples and resects 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.

Here's an analysis of the provided FDA 510(k) submission regarding the acceptance criteria and study information for the Autosuture™ EEA™ Stapler.

It's important to note that this document is a 510(k) summary, which often does not include detailed study results or raw data. Instead, it summarizes the equivalence claims based on testing.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing Summary)

The provided document does not explicitly list quantitative acceptance criteria in a table format with corresponding reported performance values for each criterion. The non-clinical testing section lists various tests performed to demonstrate substantial equivalence, implying that the device met the internal acceptance criteria for these tests.

Implied Acceptance Criteria and Performance (Extracted from Non-Clinical Testing List):

Study Proving Acceptance Criteria:

The studies proving the device meets these implied acceptance criteria are the non-clinical tests listed, which were performed by Covidien. The document states:
"Testing demonstrated that the subject device, Autosuture™ EEA™ Stapler, is substantially equivalent to the predicate devices..."

Detailed Study Information:

1. Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • The document does not specify sample sizes or data provenance (country of origin, retrospective/prospective) for the non-clinical tests conducted. These details are typically found in the full test reports, not the 510(k) summary. Given the nature of these engineering and materials tests, they are inherently "prospective" as new tests were conducted on the subject device.

2. 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 to the type of non-clinical testing described. These tests involve engineering measurements (e.g., force, material properties, sterility, biocompatibility) rather than expert interpretation of medical data (like radiology images). The "ground truth" for these types of tests is established by industry standards (ASTM, ISO, IEC) and the test methodologies themselves.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • This question is not applicable to the non-clinical testing described. Adjudication methods like 2+1 are used for expert consensus on subjective medical assessments, which is not the nature of these engineering tests.

4. 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, an MRMC comparative effectiveness study was not done. This device is a manual surgical stapler, not an AI-powered diagnostic or assistive tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • No, a standalone algorithm performance study was not done. This device is a mechanical surgical stapler and does not involve an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • For the non-clinical tests, the "ground truth" is defined by established engineering and biological standards and specifications (e.g., ASTM F2182-19 for RF heating, ISO 10993-1 for biocompatibility). The device performance is measured against these objective, predefined criteria.

7. The sample size for the training set

   • This question is not applicable. There is no "training set" as this is a mechanical medical device, not a machine learning or AI model.

8. How the ground truth for the training set was established

   • This question is not applicable for the same reason as above; there is no training set for this type of device.

Summary of Device and Evidence Strategy:

The Autosuture™ EEA™ Stapler is a traditional mechanical surgical device. The submission strategy for its 510(k) clearance is based on substantial equivalence to previously cleared predicate devices (Autosuture™ Circular EEA Surgical Stapler K062850 and EEA Circular Stapler with Tri-Staple Technology K221005).

The primary evidence provided focuses on non-clinical performance testing to demonstrate that the subject device performs as safely and effectively as the predicate devices and meets relevant engineering, material, and safety standards. The document explicitly states, "This submission does not require clinical testing," reinforcing that the equivalence is established through physical and mechanical characteristic comparisons and associated test results, rather than clinical trials comparing patient outcomes.

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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 as an end-to-end, end-to-side or side-to-side anastomosis 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 with a medium/thick tissue range which is identified by the purple staple quide and an extra thick tissue range which is identified by the black staple guide. Staplers for medium/thick tissue deploy three height-progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples. Staplers for extra thick tissue, 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 25mm lumen size and 2 shaft lengths; a standard 22 cm shaft and an extra (XL) 35 cm shaft. The 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.

Both the subject device and the predicate device (K192330 and K172361) are from the same product family Tri-Staple™ EEA™ stapler. The subject device EEA™ Circular Stapler with Tri-Staple™ Technology (lumen size 25mm) provides the surgeons a choice of additional lumen size selections to best suit the target anatomy.

The subject EEA™ Circular Stapler with Tri-Staple™ Technology is manufactured with the same patient contact materials that are utilized within the predicate device (K192330 and 172361).

In the same manner as the predicate device (K192330 and K172361), the subject EEA™ Circular Stapler with Tri-Staple™ Technology is a manual surgical stapling device that places a circular, triple staggered row of titanium staples and resects tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. An audible and tactile firing indicator will provide additional feedback of firing completion.

The subject EEA™ Circular Stapler with Tri-Staple™ Technology 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 device (K192330 and 172361).

This document describes a 510(k) premarket notification for the "EEA Circular Stapler with Tri-Staple Technology." This notification seeks to demonstrate substantial equivalence to previously cleared devices. It primarily focuses on the device's technical and performance characteristics compared to its predicates rather than proving clinical effectiveness through a multi-reader multi-case (MRMC) study or a standalone algorithm performance study.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of quantitative acceptance criteria with corresponding reported device performance metrics in the way one might expect for a diagnostic AI device. Instead, it describes various performance tests conducted. The "acceptance criteria" are implied to be that the subject device performs comparably to the predicate devices and existing reference devices, and that it meets established engineering and functional benchmarks for surgical staplers.

   However, the document lists several performance tests that were conducted. For each of these, the implicit acceptance criterion is successful completion and/or performance comparable to the predicate/reference device.

   Acceptance Criterion (Implied)	Reported Device Performance
   Performance Test (In-Vitro):
   Visual/Packaging Inspection: Device meets visual and packaging specifications.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   IFU Walkthrough: Device functions as described in Instructions for Use.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Safety Lock Release Force Test: Safety lock releases within specified force range.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Staple Formation on Test Medium: Staples form correctly and consistently on a test medium.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence; this is a fundamental functional test.
   Anvil Retention Force Test: Anvil is retained with adequate force.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Anvil Attach Force Test: Anvil attaches correctly with specified force.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Anvil Detach Force Test: Anvil detaches correctly with specified force.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Clamping Force Test: Device applies specified clamping force.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Unclamping Force Test: Device unclamping functions as specified.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Firing Force Test: Device fires within specified force range.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Performance Test (Ex-Vivo):
   Ex-Vivo Firings: Device fires successfully on ex-vivo tissue.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Knife Cut Evaluation: Knife provides a clean and complete cut.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Leak / Burst Test: Anastomosis created by stapler meets specified leak/burst pressure integrity.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Performance Test (In-Vivo):
   Atraumatic Tissue Test: Stapler application is atraumatic to tissue.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Hemostasis Test: Stapler application achieves hemostasis.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Staple Formation on Tissues: Staples form correctly on in-vivo tissues.	Not explicitly stated quantitatively, but implied to be acceptable as part of demonstrating substantial equivalence.
   Chronic animal study: No differences in healing metrics or anastomotic index compared to reference.	"The chronic animal study submitted in K172361 to evaluate the performance of the subject device and reference device shows no differences in healing metrics or anastomotic index." (This refers to a study for a predicate device, and the current device is deemed to perform similarly.)

2. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify the exact sample sizes for each of the non-clinical (in-vitro, ex-vivo, in-vivo) tests. It merely lists the types of tests performed. For the "chronic animal study," it refers to a study submitted in K172361, but doesn't detail the sample size for that study in this document.
   • Data Provenance:
     • Country of Origin: Not explicitly stated for each test beyond the submitter being in "Min Hang District, Shanghai, China."
     • Retrospective or Prospective: These are primarily prospective engineering and performance tests conducted specifically for this submission, simulating device use. The animal study from K172361 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 in the document. The tests described are primarily objective engineering and biological performance tests, not typically subjected to "expert ground truth" in the same way an AI diagnostic model would be. For the animal study, veterinarians or pathologists would assess outcomes, but their number and specific qualifications are not detailed here.

4. Adjudication method for the test set:

   This information is not provided. Adjudication methods (e.g., 2+1, 3+1) are typically relevant for subjective evaluations or labeling in AI or clinical trial contexts. For engineering performance tests, results are usually based on objective measurements against pre-defined specifications.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic accuracy or physician performance with AI assistance, which is not applicable to a surgical stapler device. The device is a manual surgical instrument, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   No, a standalone algorithm performance study was not done. This device is a manual surgical stapler, not an algorithm or an AI-powered system. Therefore, standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   The "ground truth" for the performance tests would be defined by engineering specifications, physical measurements, and biological outcomes. For example:

   • In-vitro tests: Measured forces, dimensions, visual inspection against specification.
   • Ex-vivo tests: Measured burst pressure, visual inspection for knife cut completeness, visual assessment of staple formation.
   • In-vivo/Animal study: Histopathological analysis (pathology), gross observation of healing, assessment of anastomotic integrity, and physiological outcomes (referred to as "healing metrics or anastomotic index").

8. The sample size for the training set:

   Not applicable. This device is a mechanical surgical instrument, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established:

   Not applicable. As above, there is no training set for a mechanical surgical stapler.

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