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The ETHICON™ 4000 and ETHICON™ 3D Reloads are intended for transection, resection and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.

The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, single-patient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. Together, the ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads deliver 3D staples in the first, second, fifth and sixth rows of staples. The third and fourth rows (nearest the knife) maintain the traditional 2D B-formed staples.

ETHICON™ 4000 60mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The Subject stapler device is available in three different shaft lengths - Compact, Standard and Long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The device is packaged with a primary lithium Battery Pack that must be installed prior to use. There is embedded software to articulate and initiate firing of the device.

The instruments are packaged without a reload and must be loaded prior to use. The instrument may be reloaded for a maximum of 12 firings during a single procedure. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. The instruments' lockout feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.

The staples are permanent implants that provide tissue closure and apposition from the time of implant through the critical phases of healing. The staples remain in place for the patient's lifetime, unless in the opinion of the treating physician, they require removal.

Based on the provided FDA 510(k) clearance letter for the ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads (K250835), here's an analysis of the acceptance criteria and the study proving the device meets them:

Important Note: The provided document is a 510(k) clearance letter, which summarizes the FDA's decision based on the applicant's submission. It does not contain the full details of the studies conducted. Therefore, some information requested (e.g., specific acceptance criteria values, sample sizes for training sets, adjudication methods, details of expert qualifications, and MRMC study effect sizes) is not explicitly stated in this public document. The answers below are derived directly from the content provided and identify where information is not present.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The primary purpose of this 510(k) submission was to expand the indications for use of an already cleared device to include transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen. The acceptance criteria would therefore revolve around demonstrating safe and effective performance of the stapling system in these specific organ tissues.

Based on the document, the general "acceptance criteria" can be inferred from the types of performance tests conducted and the conclusion statement that the "subject devices passed the functional requirements of the device features" and "have been demonstrated to be safe and effective for the expanded indications for use."

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria (e.g., minimum burst pressure, maximum staple height deviation) are not provided in this summary document, we can only infer the categories of performance that were evaluated and determined to be acceptable.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the document. The general descriptions refer to "nonclinical (bench) tests" and "pre-clinical (animal) testing," implying a test set was used, but no specific numbers of samples, instances, or animal subjects are provided.
• Data Provenance:
  • Country of Origin: Not specified. Standard practice for such studies would likely involve labs in the US or collaborating international facilities, but the document does not state this.
  • Retrospective or Prospective: These were prospective studies, as they were conducted specifically to gather data for this 510(k) submission to support the expanded indications for use.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as this submission is for a mechanical surgical stapler and reload system, not an AI or image-based diagnostic device where "ground truth" would be established by human experts in image interpretation. The "truth" in this context is the physical performance and biological outcome (e.g., successful staple formation, hemostasis) confirmed through engineered testing and animal models.

4. Adjudication Method for the Test Set

This information is not applicable as this submission is for a mechanical device. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be inter-reader variability. The "adjudication" in this context would be the rigorous adherence to testing protocols and criteria, verified by engineers and potentially DVMs for animal models.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or CAD (Computer-Aied Detection/Diagnosis) systems where the performance of human readers (e.g., radiologists) is compared with and without AI assistance. This submission is for a mechanical surgical stapler.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as this is not an AI/algorithm-based device. The "standalone performance" of the device is its mechanical function (stapling, cutting) which was assessed through bench and animal testing.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance was established through:

• Bench Test Results: Direct measurement and evaluation of physical characteristics and functional performance (e.g., formed staple height, staple form quality, vessel sealing, staple line integrity) under controlled laboratory conditions. These are objective engineering measurements.
• Animal Model Outcomes: Direct observation and measurement of biological outcomes in live animal tissues (porcine model for liver, spleen, pancreas, isolated vessels, lung, uterine tissues). "Hemostasis performance" implies direct assessment of whether the stapling achieved effective cessation of bleeding. These are physiological and anatomical "truths."

8. The Sample Size for the Training Set

This information is not applicable as this is a mechanical device, not an AI/machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above (not an AI/ML device).

In summary, the 510(k) clearance for the ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads for expanded indications was based on a combination of rigorous nonclinical (bench) testing to verify mechanical performance and engineering specifications, and pre-clinical (animal) testing to demonstrate in vivo safety and effectiveness, particularly hemostasis performance in the newly indicated solid organs (liver, pancreas, kidney, spleen) and associated vasculature. The acceptance criteria were implicitly met by the successful completion and positive outcomes of these tests, demonstrating substantial equivalence to predicates and no new questions of safety and effectiveness for the expanded uses.

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The ETHICON ™ Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues.

The ETHICON™ Linear Stapler delivers two staggered rows of titanium staples in order to approximate internal tissues. The Subject device is sterile, single patient, disposable device used in conjunction with reloadable ETHICON™ Linear Stapler 3D Reloads to staple tissue in one firing stroke. The Subject device is a next generation Linear Stapler to be used in open procedures requiring a surgical stapler. The Subject device incorporates proven Gripping Surface Technology (GST) Reload Technology, leveraged from Ethicon Endocutters, along with a 3-D staples developed for other Ethicon Endocutters and open mechanical devices.

The ETHICON™ Linear Stapler 30 mm, 60 mm and 90 mm Staplers are sterile, single- patient-use instruments that staple tissue. There are two staggered rows of staples, on either side of the staple line. This device may be used on the general population for routine wound closure via stapling. The 30 mm reload creates a 30 mm staple line. The 60 mm reload creates a 60 mm staple line. The 90 mm reload creates a 90 mm staple line.

The 90mm device and compatible reloads have also been developed. The 90mm device can be used by surgeons who prefer to use a 90mm device when transecting wider tissue such as completing the closure of a side-to-side anastomosis or when performing a sleeve gastrectomy. The Predicate device does not currently offer a 90mm size but the principles of operation are the 30mm and 60mm devices. Design verification testing demonstrates that the 90mm device and compatible reloads do not raise new types of safety or effectiveness questions.

The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instrument may be loaded eight times for a maximum of eight firings per instrument during a single procedure. There are blue and green reload options for each device size.

The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.

The provided text does not contain information about acceptance criteria or a study proving a device meets them in the context of an AI/ML powered medical device. Instead, the document is an FDA 510(k) clearance letter and summary for a surgical stapler and its reloads.

The information in the document details the substantial equivalence of the ETHICON™ Linear Stapler to a predicate device, focusing on bench performance testing and animal testing for mechanical, functional, and biological properties of the stapler itself, NOT an AI/ML algorithm.

Therefore, I cannot provide the requested information, such as:

• Acceptance criteria and reported device performance for an AI/ML product: The document outlines engineering specifications and performance evaluations for a mechanical device.
• Sample size for the test set and data provenance: No test set for an AI/ML algorithm is mentioned.
• Number of experts used to establish ground truth and their qualifications: Ground truth for AI/ML is not relevant here.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted as it's not an AI-assisted device.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable for an AI/ML algorithms ground truth, but for the mechanical stapler, the "ground truth" would be successful stapling outcomes and tissue integrity observed in bench and animal tests.
• Sample size for the training set: No training set for an AI/ML algorithm is mentioned.
• How the ground truth for the training set was established: Not applicable.

The document focuses on:

• Bench Performance Testing:
  • Formed Staple Height (FSH)
  • Staple Form Quality (SFQ)
  • Staple Line Integrity (SLI)
  • Force to Close
  • Force to Fire
  • Jaw Aperture
  • No Spent Reload/Lockout
  • Human Factor Report/Usability Testing
  • Staple line Strength Test
• Animal Testing (In-vivo):
  • Acute Hemostasis evaluation study
  • Tissue Healing response, Survival Study
• Biocompatibility: Based on ISO 10993-1.

All of these tests "passed the criteria for success," indicating the device met the pre-defined performance requirements for a mechanical surgical stapler.

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The ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials.

The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, singlepatient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. Together, the ETHICON™ 4000 60 mm Staplers and ETHICONTM 3D Reloads deliver 3D staples in the first, second, fifth and sixth rows of staples. The third and fourth rows (nearest the knife) maintain the traditional 2D B-formed staples.

ETHICON™ 4000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The Subject stapler device is available in three different shaft lengths - Compact, Standard and Long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The device is packaged with a primary lithium Battery Pack that must be installed prior to use. There is embedded software to articulate and initiate firing of the device.

The instruments are packaged without a reload and must be loaded prior to use. The instrument may be reloaded for a maximum of 12 firings during a single procedure. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. The instruments' lockout feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.

The staples are permanent implants that provide tissue closure and apposition from the time of implant through the critical phases of healing. The staples remain in place for the patient's lifetime, unless in the opinion of the treating physician, they require removal.

The Subject stapler and reloads will not be compatible with previous ECHELON™ staplers and reloads. This is a new platform that will work with 3D reloads only.

This 510(k) summary is for the ETHICON™ 4000 60mm Staplers and ETHICON™ 3D 60mm Reloads. It focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list a table of acceptance criteria with corresponding performance metrics for the reasons stated below. Instead, it indicates that the devices either met or improved upon the predicate devices' performance, or passed functional requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for the test sets used in the non-clinical studies (e.g., staple performance, functional performance, staple line strength, hemostasis, tissue healing).

The data provenance is from non-clinical studies, which implies laboratory or animal testing rather than human subject data. Pre-clinical data for hemostasis and tissue healing response were conducted in "Abdominal and Thoracic procedures," indicating animal models.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the evaluation relies on non-clinical (bench and pre-clinical animal) testing and not on expert interpretation of human clinical data or images. Ground truth, in this context, would be established by objective measurements and scientific protocols.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on non-clinical testing, not subjective assessments that would require 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

An MRMC study was not done. This device is a surgical stapler and reload system, not an AI-assisted diagnostic or interpretive device that would involve human readers.

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

This information is not applicable. The device is a surgical stapler, which is a physical medical instrument, not an algorithm or software-only device.

7. The type of ground truth used

The ground truth for the non-clinical tests would be established through:

• Objective Measurements: For staple performance, functional performance, and staple line strength, measurements of physical properties (e.g., staple formation, closure force, staple line integrity, burst pressure) would serve as ground truth, compared against pre-defined engineering specifications or predicate performance.
• Histopathology/Pathology and Physiological Measurements: For hemostasis and tissue healing response in pre-clinical animal studies, ground truth would be established through direct observation, macroscopic assessment, histological examination (pathology), and physiological measurements relevant to bleeding control and tissue repair.
• Compliance with Standards: For biocompatibility, ground truth is compliance with the requirements of ISO 10993-1.

8. The sample size for the training set

This information is not applicable. The device is a physical surgical instrument, not an AI/ML algorithm that requires a "training set." The development process would involve extensive engineering design, prototyping, and iterative testing, but not a "training set" in the context of machine learning.

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

This information is not applicable for the reasons stated in point 8.

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The Anika Tissue Tack is indicated for the fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures, such as rotator cuff repair.

The Anika Tissue Tack Fixation System consists of dart shaped tacks and a delivery instrument. The tissue tacks are comprised of bioabsorbable 82/18 poly(lactic-co-glycolic acid) [PLGA] and dyed with D&C Violet #2. The tissue tacks are designed to provide stable fixation of a prosthetic material or biologics to soft tissues during the healing process and are used in conjunction with a delivery instrument from Anika. The delivery instruments are comprised of surgical grade stainless steels and high temperature plastics and are designed to deliver the tissue tacks. The tissue tacks and delivery instruments are provided sterile for single use only. The tacks are packaged in a caddy within a dual sterile seal configuration.

I am sorry but this document does not contain the information requested. This document is a 510(k) summary for a medical device which describes the device, its indications for use, and its substantial equivalence to predicate devices based on non-clinical testing. It does not include information about acceptance criteria or specific studies that demonstrate the device meets those criteria in the way you have asked for (e.g., with detailed statistics on performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance).

Specifically, the document states:

• "No clinical testing was submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence for the Anika Tissue Tack Fixation System."
• The performance testing summarized includes "Mechanical retention strength, tensile & shear", "Degradation testing", "Insertion and removal evaluation", "Biocompatibility Testing", and "Bacterial endotoxin limit test". However, no specific acceptance criteria or detailed results are provided.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies for this device.

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The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, thoracic and urologic surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.

The AEON™ Endoscopic Stapler places two triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The size of the staples and staple line length are based on the selection of the Stapler Reload.

This 510(k) revises the labeling, including indications, contraindications, and warnings, for the AEON Endoscopic Stapler.

The provided text describes a 510(k) premarket notification for the AEON™ Endoscopic Stapler. The submission aims to revise the labeling of the existing device, specifically expanding its indications for use.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria for the AEON™ Endoscopic Stapler in the context of expanding its indications. Instead, the performance data section focuses on "safety and effectiveness" as the overarching goal for the revised labeling.

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

• Sample Size: The document does not specify an exact numerical sample size for the retrospective clinical studies. It vaguely refers to "the results of the retrospective clinical studies."
• Data Provenance: The studies are described as "retrospective clinical studies." There is no mention of the country of origin.

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

The document does not provide information about the number or qualifications of experts used to establish ground truth for the retrospective clinical studies.

4. Adjudication method for the test set:

The document does not mention any adjudication method for the retrospective clinical studies.

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 is not applicable as the device is a mechanical stapler, not an AI-assisted diagnostic tool or an imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is mentioned or relevant.

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

This is not applicable as the device is a mechanical stapler.

7. The type of ground truth used:

For the retrospective clinical studies, the ground truth appears to be outcomes data in terms of observed complications or lack thereof during real-world surgical use. The statement "no complications associated with the AEON™ Endoscopic Stapler" suggests that the absence of adverse events served as the evidence for safety and effectiveness in the expanded indications.

8. The sample size for the training set:

This is not applicable as a training set is typically associated with machine learning or AI models. The studies described are retrospective clinical studies of a mechanical device.

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

This is not applicable for the reasons mentioned in point 8.

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The ECHELON LINEAR™ Cutters have application in gastrointestinal, thoracic, and pediatric surgery for transection, resection, and the creation of anastomoses.

The ECHELON LINEAR™ Cutter delivers two, double-staggered rows of staples while simultaneously dividing the tissue between rows. The instrument has a safety lockout feature that is designed to prevent firing if either no reload or a used reload is installed. An unclamp lockout feature prevents knife exposure by allowing the instrument to open only when the Firing Knob is in the home position. A clamp lockout feature prevents closure of the jaws when the knife is not in the home position. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation.

This device may be used on the general population for routine wound closure via stapling.

The 60 mm reload creates a 61 mm staple line and cuts tissue approximately 52 mm beyond the tissue stop.

The 80 mm reload creates an 81 mm staple line and cuts tissue approximately 72 mm beyond the tissue stop.

The 100 mm reload creates a 101 mm staple line and cuts tissue approximately 92 mm beyond the tissue stop.

The instruments are shipped without a reload and must be loaded prior to use. The instrument may be loaded eight times for a maximum of eight firings per instrument during a single procedure.

This document describes the premarket notification (510(k)) for the ECHELON LINEAR™ Cutters, demonstrating its substantial equivalence to a predicate device. As such, the "acceptance criteria" and "device performance" in this context refer to the results of bench and animal testing that demonstrate the new device functions as intended and is safe and effective when compared to existing, legally marketed devices.

It's important to note that this is a 510(k) summary, not a detailed study report. Therefore, some granular details like exact sample sizes for each specific test might not be explicitly stated, but the types of tests and the overall conclusion are provided. The document specifically states that no clinical studies were performed.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" for performance data typically refers to demonstrating that the new device performs comparably to the predicate device and meets functional requirements (e.g., staple formation, strength, operational forces). The document states that the testing demonstrated substantial equivalence, implying the "acceptance criteria" were met by the "reported device performance."

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Sizes for Test Set (Bench and Animal Testing): The specific sample sizes for each bench test (e.g., number of staples tested for FSH, SFQ, SLI; number of devices for force measurements) and for the animal studies are not explicitly stated in this 510(k) summary. These details would be contained in the full submission, but not in this public summary.
• Data Provenance: Not explicitly stated. For bench and animal testing typically conducted internally or by contract research organizations, the country of origin is usually the manufacturer's location or the location of the testing facility. The data would be considered prospective as it's generated for the purpose of the submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/not provided in this context. For a device like a surgical stapler, "ground truth" is established through engineering specifications, scientific principles, and established methods for evaluating device performance (e.g., measuring staple dimensions, tensile strength, in-vivo tissue response). There isn't a subjective "expert read" or "adjudication" in the same way there would be for an AI diagnostic algorithm.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As explained above, for a mechanical device, performance is evaluated against objective, measurable criteria, not subjective expert opinion requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence." This device is not an AI diagnostic tool and does not involve human readers for interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm study was not done. This device is a mechanical surgical stapler, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device is based on:

• Engineering specifications and design parameters: For bench testing (e.g., desired staple height, cutting length, force requirements).
• Biomechanical principles: For staple line strength and integrity.
• Physiological outcomes: For animal testing (e.g., hemostasis, tissue healing).
• Comparison to predicate device performance: The core of a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, implying that the predicate's established safe and effective performance serves as a benchmark for the new device.

8. Sample Size for the Training Set

This information is not applicable/not provided. This is a mechanical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided. As above, there is no "training set" for a mechanical device.

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The Disposable Endoscopic Cutter Stapler and Cartridge has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. The Disposable Endoscopic Cutter Stapler and Cartridge is not to be used in the transection and resection of solid organs.

Disposable Endoscopic Cutter Stapler and Cartridge place two, triple-staggered rows of progressive titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths with cartridge in 2.0/2.5/3.0, 3.0/3.5/4.0, 4.0/4.5/5.0 three progressive staple sizes to accommodate carious tissue thickness. The device may be reloaded and fired up to 12 times in a single procedure.

The provided document is a 510(k) summary for a medical device (Disposable Endoscopic Cutter Stapler and Cartridge), not a report for an AI/ML-based medical device. Therefore, the information required to answer your specific questions about acceptance criteria, study details, expert involvement, and ground truth for an AI device is NOT present in this document.

The document demonstrates the substantial equivalence of the new stapler to a predicate device through:

• Non-clinical tests: These include biocompatibility testing (ISO 10993 series, USP standards), sterilization validation (ISO 11135), and bench tests on porcine tissue (Pressure Resistance, Closed Staple Height, Staple Formation, Force Required to Fire Stapler).
• Comparison table (Table 1): This table directly compares various characteristics of the proposed device and the predicate device, often stating "SE" (Substantially Equivalent) if they are sufficiently similar or providing a qualitative "SE Analysis" if there are differences.

There is no mention of:

• AI/ML algorithms.
• Data sets for training or testing AI models.
• Human readers, expert consensus, or specific ground truth methodologies for evaluating an AI system.
• MRMC studies or effect sizes for human improvement with AI assistance.

Therefore, I cannot populate the requested table and answer the specific questions related to AI/ML device validation based on this document.

The document specifically states under "7. Clinical Test Conclusion": "No clinical study is included in this submission." This further confirms the absence of the type of information you are seeking regarding device performance in a clinical or reader study context for an AI device.

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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 Signia™ small diameter curved tip gray and white reloads have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of vasulature using gray reloads and thin tissue and vasculature using white reloads.

The Signia™ small diameter regular (round) tip white reload has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of thin tissue and the creation of anastomosis.

Signia™ Small Diameter Reloads are 8 mm diameter reloads that shall be utilized for open and minimally invasive surgical procedures for the transection of tissue, specifically vascular and thin tissue structures. They shall be offered with both a curved tip (cleared in predicate submission K191070) and a new reqular (round) tip model. The Signia™ small diameter regular (round) tip white reloads shall be indicated for use in the creation of anastomosis.

The reload is the distal shaft and jaws of the stapler system comprised of a single-use knife. fixed anvil, and the fixed stapler cartridge with two (2) rows of titanium staples on either side of the cut line. The reload is single use only and the cartridges cannot be replaced.

Signia™ Small Diameter Reloads feature a narrow shaft, narrow end-effector, narrow anvil with either a curved tip or regular (round) tip, and multiple articulation angles up to 45 degrees. These features facilitate device access to smaller or tighter surgical spaces (e.g. intercostal) as well as difficult-to-reach vasculature. Signia™ Small Diameter Reloads shall be available in multiple configurations with the following features:

• Open Staple Height: 2.0 mm (grav cartridge) and 2.5 mm (white cartridge) ●
• Cartridge Length: 30 mm and 45 mm .
• Anvil Tip: Curved tip (gray and white) and Regular (Round) tip (white) ●
• Reload Shaft Length: Short (15 cm) and Long (24 cm) ●
• Reload Diameter (upper-shaft to distal end): 8 mm ●

The curved tip on the distal-end of the reload can be used to aid in positioning the reload around target tissue / vessels for subsequent firing. The working length of the Signia™ small diameter reload will fit down an 8mm trocar sleeve or larger, and is compatible with existing Covidien manual and powered stapling handles (see Section 11.10: Compatible Stapling Handles). The short shaft length (15 cm) is recommended for use in open, thoracoscopic or laparoscopic procedures and are compatible with appropriately-sized trocar sleeves, 8 mm or larger. The long shaft length (24 cm) is recommended for use in laparoscopic procedures with appropriately-sized trocar sleeves, 8 mm or larger. The Signia™ Small Diameter Reloads are recommended for use with Covidien compatible short stapler adapters and handles. The reloads contain an intelligence chip, which has the ability to communicate with the Covidien powered Signia™ Stapler handle that has a compatible communications interface.

Through this submission, a new reload model SIGSDL45VT with a regular (round) tip anyil shall be added to the stapling family of Signia™ Small Diameter Reloads as a line extension. Additionally, the indications of Signia™ Small Diameter regular (round) tip white reloads shall be expanded to include creation of anastomosis based on the supporting data provided in this submission.

This document describes the Signia™ Small Diameter Reloads for surgical staplers. The existing curved tip reloads were previously cleared, and this submission (K222641) adds a new regular (round) tip model and expands the indications for the regular (round) tip white reloads to include the creation of anastomosis.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with pass/fail thresholds. Instead, it details a comprehensive suite of performance tests performed to demonstrate substantial equivalence to a predicate device (K191070) and a reference device (K111825) for anastomosis. The fundamental acceptance criterion seems to be that the subject device performs comparably to or better than the predicate/reference devices in relevant performance tests.

Here's a summary of the performance tests conducted, implying "acceptance" if the subject device performs equivalently or acceptably:

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

The document provides the following details:

• Bench Tests: The specific sample sizes for each bench test are not provided.
• Animal Acute Tests: The specific sample sizes for these tests are not provided.
• Chronic Survival Testing in Animal:
  • Lobectomy (Thorax of Canine): Sample size not specified.
  • Nephrectomy, Splenectomy, Ovariohysterectomy (Abdomen of Porcine): Sample size not specified.
  • Jeju-Jejunostomy (Small Bowel of Canine): Sample size not specified.
• Provenance: All animal studies (acute and chronic) were conducted as pre-clinical studies by the manufacturer (Covidien). The country of origin for the animal studies is not explicitly stated but is typically conducted at contract research organizations. These are prospective studies given they are conducted to support a new device feature/indication.

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

This section is not applicable as the evaluation of the device performance is based on physical and biological measurements in bench and animal studies, not on interpretations by human experts establishing a "ground truth" for a test set in the context of diagnostic AI/imaging.

4. Adjudication method for the test set

This section is not applicable as the evaluation of the device performance is based on physical and biological measurements in bench and animal studies, not on adjudicating expert opinions.

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, an MRMC comparative effectiveness study was not done. This device is a surgical stapler, which is a physical medical device, not an AI-assisted diagnostic tool.

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

This section is not applicable. The device is a surgical stapler, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context is established through:

• Physical measurements: For bench tests (e.g., staple formation, burst pressure, forces, dimensions).
• In-vivo observations and histological/pathological evaluation: For animal acute and chronic studies (e.g., tissue trauma, hemostasis, staple formation in tissue, long-term healing and integrity of staple lines, anastomosis success). This would involve veterinary pathologists and surgeons assessing outcomes.
• Usability testing: Direct observation and feedback from users (e.g., surgeons).

8. The sample size for the training set

This section is not applicable as this is a physical medical device, not a machine learning model that requires a training set.

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

This section is not applicable.

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