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The EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™ transoral circular stapler anvil have 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 and OrVil™ Transoral Circular Stapler Anvil is a manual, single-use device that places a circular, triple staggered row of titanium staples and resects the 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. The subject device is to add new product models with OrVil™ transoral circular stapler anvil to EEA™ circular stapler with Tri-Staple™ technology 21mm or 25mm XL purple or black stapler.

This document describes the premarket notification (510(k)) for the EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil. It is a medical device, specifically a surgical stapler. The provided text, however, does not contain information about software, AI algorithms, or a study involving human readers' improvement with AI assistance.

Therefore, many of the requested points regarding acceptance criteria and study details for an AI-based device, such as sample sizes for test and training sets, expert qualifications, ground truth establishment for AI models, and MRMC studies, cannot be extracted from this document.

The document primarily focuses on demonstrating the substantial equivalence of this new device to previously cleared predicate devices through non-clinical performance data and usability evaluation.

Here's what can be extracted based on the provided text, while acknowledging the limitations for an AI-related request:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

Given that this is a mechanical surgical stapler and not an AI-driven device, the "acceptance criteria" here refer to the successful completion of various performance and safety tests to demonstrate substantial equivalence to predicate devices, rather than AI performance metrics (e.g., sensitivity, specificity).

Study Details (Relevant to this non-AI medical device submission)

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

   • The document mentions "non-clinical performance data" and a series of "Performance Test (In-Vitro)", "Performance Test (Ex-Vivo)", and "Performance Test (In-Vivo)". No specific sample sizes for these tests are provided.
   • Data provenance (e.g., country of origin, retrospective/prospective) is not specified for these non-clinical tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This is not applicable as the submission describes a mechanical device. The "ground truth" for this device would be engineering specifications and functional performance.
   • For the usability study, "intended users (surgeons, nurses)" evaluated the device, but the number and qualifications beyond their professional roles are not specified.

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

   • Not applicable for this type of device testing. Performance is measured against physical specifications.

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. This is not an AI-enabled device.

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

   • No. This is not an AI-enabled device.

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

   • The "ground truth" for this device is based on established engineering specifications, ASTM or ISO standards for medical devices, and successful performance in the described in-vitro, ex-vivo, and in-vivo functional tests. For the usability study, it's based on subjective and objective feedback from intended users against safety and effectiveness criteria.

7. The sample size for the training set:

   • Not applicable. This is not an AI device that undergoes training.

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

   • Not applicable. This is not an AI device that undergoes training.

In summary: The provided document is a 510(k) summary for a traditional mechanical surgical stapler. It does not involve AI or any of the detailed study methodologies typically associated with AI/software medical device submissions. Therefore, most of the questions relating to AI performance, data sets, and expert evaluations cannot be answered from this text.

Ask a specific question about this device

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.

Ask a specific question about this device

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 diameter of the is determined by the selection of the 33 mm, 31 mm, 25 mm stapler. 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 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 (only applicable to 25mm stapler) tipped anvil trocar accessory is provided to assist in introducing the anvil into the surgical field.

The design modification is to add one contraindication per special control 21 CFR 878.4740(b)(2)(ix)(A), and revises IFUs and labels per new regulation requirements.

The provided text is a 510(k) summary for a medical device, the EEA™ Circular Stapler with Tri-Staple™ Technology. It details the regulatory submission and confirms the device's substantial equivalence to a predicate device.

However, the information required to answer your specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria," particularly regarding advanced AI/ML device studies (like those involving multi-reader multi-case studies, ground truth establishment by experts, and sample sizes for training/test sets), is not present in this document. This document describes a traditional medical device submission, not an AI/ML software as a medical device (SaMD) or an AI-enabled device.

The study summarized in this document focuses on non-clinical performance data (specifically, a usability assessment for labeling changes) to demonstrate substantial equivalence, and it explicitly states:

• "Non-clinical performance data - Usability assessment was performed for the proposed labeling changes to demonstrate substantial equivalence to the predicate device."
• "Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies."

Therefore, I cannot provide details on:

• A table of acceptance criteria and reported device performance (in the context of AI/ML metrics).
• Sample sizes for test sets or data provenance for AI/ML validation.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for AI/ML.
• MRMC comparative effectiveness studies or effect sizes for human readers with AI assistance.
• Standalone performance for an algorithm.
• Types of ground truth, training set sample size, or how ground truth was established for a training set (as these are unique to AI/ML development and validation).

This submission is about a physical surgical stapler and a minor change (adding a contraindication) rather than an AI/ML diagnostic or therapeutic device.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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."

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.

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