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

The AEON Endoscopic Powered Stapler system is composed of the AEON Endoscopic Powered Stapler Handle ("Powered Handle") and AEON Endoscopic Stapler Reloads ("Reloads"). The AEON Endoscopic Powered Stapler places two, triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The Powered Handle may be reloaded and fired up to 20 times in a single procedure. The Powered Handle is available in three different lengths (60mm, 160mm and 260mm) and the Reloads are available in multiple staple sizes to accommodate various tissue thicknesses.

The AEON Endoscopic Powered Stapler uses software to control the operation of the stapler and is AC powered. The device is sterile packaged and is labeled for single use.

The provided FDA 510(k) clearance letter and summary for the AEON™ Endoscopic Powered Stapler focuses on demonstrating substantial equivalence to predicate devices, primarily for an expanded indication to include thoracic applications. However, it does not contain the detailed information typically found in a study report proving a device meets specific acceptance criteria, especially for AI/ML-driven devices.

Based on the provided text, here's an analysis of the acceptance criteria and the study that supports it, with the caveat that many details commonly sought for AI/ML device evaluations are not present in this document.

Acceptance Criteria and Study for AEON™ Endoscopic Powered Stapler (Thoracic Applications)

The core "acceptance criteria" discussed in this document revolve around demonstrating substantial equivalence for the expanded indication of "thoracic surgery." This implies that the device, when used for this new application, performs safely and effectively without raising new questions of safety or efficacy. Since the device itself is a mechanical surgical stapler with software control, the criteria are likely related to the mechanical performance and clinical outcomes.

The document explicitly states that the expanded Indications for Use for thoracic applications are supported by real-world evidence data.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary for a mechanical device with software control, the "acceptance criteria" are implied by the claim of substantial equivalence and the successful real-world evidence for thoracic applications. Specific quantitative performance metrics typical for AI/ML (e.g., sensitivity, specificity, AUC) are not directly stated. Instead, the acceptance criteria are implicitly that the device is "safe and effective for use for thoracic applications" without adverse events or performance issues that would preclude clearance.

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

• Sample Size: The document does not specify the sample size (number of patients, procedures, or stapler uses) used in the real-world evidence data.
• Data Provenance: The data is described as "Real-world evidence data." The document does not specify the country of origin of this data or whether it was retrospective or prospective.

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

This information is not provided in the document. For a surgical stapler's clinical performance, "ground truth" would typically relate to clinical outcomes assessed by surgeons or other medical professionals.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described. This type of study is typically relevant for diagnostic imaging AI systems where human readers interpret images with or without AI assistance. The AEON™ Endoscopic Powered Stapler is a surgical instrument, not a diagnostic AI. The document states "human factors testing is not applicable to support the expanded Indications for Use," further indicating that comparative studies with human action are not central to this particular clearance process.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

The device is a powered surgical stapler that uses software to control its operation. While the software itself might have undergone standalone validation, the performance described (safety and effectiveness for thoracic applications) would inherently involve the device operating with a human surgeon in the loop. A standalone "algorithm only" performance in the context of surgical stapling would be largely meaningless without the mechanical components and user interaction. The document implies that the device's overall performance, including its software-driven functions, was evaluated in real-world use for thoracic applications.

7. The Type of Ground Truth Used

For "real-world evidence data" supporting the safety and effectiveness of a surgical stapler for thoracic applications, the ground truth would most likely be derived from:

• Clinical Outcomes Data: This would include metrics like incidence of staple line failure, leaks, bleeding, tissue trauma, successful resection/transection, complication rates, and patient recovery within a thoracic surgical context.
• Surgeon Assessments: Evaluations by operating surgeons regarding ease of use, stapler performance, and observed tissue response.

The document does not explicitly state the specific type of ground truth, but these are the most probable types for this device and its application.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of the expanded indications or real-world evidence. This is expected given that the clearance is for a mechanical device with software control, not an AI/ML diagnostic algorithm that typically relies on extensive training data. The software within the stapler likely has deterministic control logic rather than learning algorithms that require large training datasets in the typical AI sense.

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

Since a "training set" is not mentioned or described in the context of the device's software learning or the expanded indications, the method for establishing its ground truth is not applicable here. The software control functions were likely verified and validated through a design control process, not machine learning model training.

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The Intuitive Surgical da Vinci SP SureForm 45 Stapler, SP SureForm 45 Curved-Tip Stapler, and SureForm 45 Reloads and other accessories are intended to be used with the da Vinci SP Surgical System for resection, transection, and/or creation of anastomoses in Urologic, Thoracic, and Colorectal surgery.

The da Vinci SP SureForm 45 Curved Tip Stapler and da Vinci SP SureForm 45 Stapler, with the existing SureForm 45 Reloads (cleared via K183224 and K190999) are designed for use exclusively with compatible Intuitive da Vinci SP Surgical Systems (Model SP1098). It is intended for resection, transection and/or creation of anastomoses in surgery. The instrument achieves its intended use by placing multiple staggered rows of implantable staples in the target tissues (stapling) followed by cutting of the target tissue along the middle of the staple line (transection). The SP SureForm 45 Curved Tip Stapler and SP SureForm 45 Stapler Instruments are disposable, fully wristed articulating devices and are compatible with the existing, Intuitive manufactured SureForm 45 mm Gray, White, Blue, Green, and Black reloads (hereinafter referred to as SureForm 45 Reloads). The SP SureForm 45 Reloads consist of a single-use cartridge that contains multiple, staggered rows of implantable staples, and a stainless-steel knife.

The provided text describes the regulatory clearance of a surgical stapling device, the da Vinci SP SureForm 45 Staplers and Reloads, but does not contain information about an AI/ML powered medical device or the specific metrics, studies, and expert review processes associated with such devices.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) as it pertains to AI/ML device evaluations.

The document discusses the following types of studies:

• Design Verification (Bench Testing): Included physical specifications, mechanical requirements, electrical requirements, user interface requirements, equipment interface requirements, reliability, and packaging/labeling. The device met all acceptance criteria.
• Design Validation (Animal Studies): Acute validation studies using simulated clinical models (animal) to evaluate performance. This included:
  • Staple Line Performance: Assessed staple line performance and staple formation.
  • Leak Onset Pressure: Assessed leak onset pressure performance on ex vivo tissue.
  • Design Validation Testing: Performed in a clinical laboratory setting.
• Human Factors Evaluation: Included analysis of use-related issues (MAUDE database), Comparative Task Analysis (CTA), Use-Related Risk Analysis (URRA), formative usability evaluations, and summative usability validations.

These studies are typical for mechanical surgical devices and do not involve AI/ML performance metrics or associated ground truth establishment by experts in the context of diagnostic or interpretive tasks.

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The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

The Signia™ circular adapters are reusable instruments that connect with the assembled Signia™ power handle and Signia™ power shell to make up the Signia™ stapler. The Signia™ circular adapters are composed of motor-mating connectors, sensor gauges and device communication interfaces to provide functionality and communication between compatible reloads and the Signia™ circular adapters are available in two shaft lengths, standard (25 cm) and extra-long (30 cm).

The Signia™ Circular Adapter are for use with the Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads. The Signia™ stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. The Signia™ stapler is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated. Signia™ Stapler can be used for both linear and circular stapling application depending on the software version installed in the Signia™ power handle.

This FDA 510(k) summary for the Signia™ Circular Adapter (K240881) does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets such criteria.

The device in question, the Signia™ Circular Adapter, is a surgical stapler component. The document describes its physical and functional characteristics, and the non-clinical testing performed to establish its substantial equivalence to a predicate device. This testing primarily focuses on device performance, safety, and manufacturing quality, not on the performance of a diagnostic or therapeutic AI/software.

Therefore, I cannot provide a response to your request, as the provided input does not include the details regarding acceptance criteria for an AI/SaMD or a study to demonstrate its performance.

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The ECHELON™ 3000 and ECHELON ENDOPATH™ families of staplers and 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 ECHELON™ 3000 45mm and 60mm Staplers 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 ECHELON™ 3000 Staplers 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.

The devices are available in two different configurations (ECHELON™ 3000 45mm Staplers and ECHELON™ 3000 60mm Staplers) and three different shaft lengths (Compact, Standard, and Long). The device utilizes battery power to fire the device. The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack noted in the Instructions for Use Battery Pack Disposal section of the package insert.

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

This document is a 510(k) Premarket Notification from the FDA regarding surgical staplers. It does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, ground truth methodology, MRMC studies, etc.) that would typically be found in a clinical study report or a more comprehensive technical document supporting an AI/software as medical device (SaMD) submission.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices (ECHELON 3000 45mm and 60mm Staplers, K213633). The changes described are primarily dimensional and material changes to a non-patient contacting component (the "shifter plate") within an already cleared device.

Therefore, for your request, I cannot extract specific acceptance criteria for AI performance, details on test set data provenance, expert adjudication methods, MRMC studies, or training set details because this submission is about a mechanical surgical stapler, not an AI/software device.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states:

• "The premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence."
• Performance testing focused on:
  • "Closure Force during Device shifting testing... against the predicate Design Requirement using success criteria with the original validated Test Method."
  • "Side by side component level testing... to confirm equivalent or better strength and wear properties" (e.g., Component withstand strength, Pinning for Device assembly, and cyclic wear during Device closure).

In summary, the provided text does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of AI/SaMD. It describes a traditional medical device submission for mechanical changes to a surgical stapler.

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The AEON Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, and pediatric 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 Powered Stapler system is an endoscopic linear cutter and reload system that simultaneously cut and staple tissue. The AEON Endoscopic Powered Stapler places two, triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The AEON Endoscopic Powered Stapler system is composed of an AEON Endoscopic Powered Stapler Handle and the AEON Endoscopic Stapler Reloads. Multiple staple handle lengths and multiple staple sizes are available to accommodate various tissue thicknesses. The AEON Endoscopic Powered Stapler uses software to control operation of the stapler and is AC powered. The device is sterile packaged (Ethylene Oxide) and single use. The AEON Endoscopic Powered Stapler Handle may be reloaded and fired up to 20 times in a single procedure.

The provided text describes the AEON Endoscopic Powered Stapler and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria and study results in the format requested.

Specifically, the document lists various performance tests conducted (e.g., staple height and formation, staple line strength, ex-vivo leak-burst pressure testing, software verification and validation, animal testing for hemostasis, human factors testing, electrical safety, EMC, biocompatibility, sterilization, packaging, and shelf-life validations). However, it does not provide a table of specific acceptance criteria or reported device performance against those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them with the specified details. The document states that "The results of testing and evaluation listed above demonstrate that the subject AEON Endoscopic Powered Stapler is substantially equivalent to the predicate device," but it does not expand on the quantitative results or specific conditions.

Here's what I can extract from the provided text, and what is missing:

What is (partially) available in the text:

• 1. A table of acceptance criteria and the reported device performance: This is not provided in the text. The document lists types of tests performed but not the specific criteria or quantitative results.
• 2. Sample size used for the test set and the data provenance:
  • Test Set Sample Size: Not explicitly stated for any of the listed tests.
  • Data Provenance:
    • "Animal testing was performed to assess In vivo confirmation of staple line hemostasis..." (Implies animal data).
    • "Human Factors testing was executed..." (Implies human user data).
    • Other tests are non-clinical (e.g., bench testing, software V&V).
    • Country of origin for data is not mentioned.
    • Retrospective or prospective nature of data is 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): Not mentioned in the provided text for any test.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
• 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: Not applicable, as this device is a surgical stapler, not an AI-assisted diagnostic tool for "human readers." Human factors testing was performed but not in an MRMC comparative effectiveness study context.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is an "Endoscopic Powered Stapler" which is a physical surgical tool controlled by software. Software verification and validation testing was done for the algorithm, but this isn't a standalone diagnostic algorithm in the typical sense of this question. Its performance is integrated into the device's function.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
  • For "Staple line hemostasis," the ground truth was assessed in vivo in animal testing, implying direct observation of physiological outcomes.
  • For other non-clinical tests (e.g., staple height, strength, leak-burst), the ground truth would be physical measurements and engineering specifications.
• 8. The sample size for the training set: Not applicable, as this is hardware with integrated software, not a machine learning model that requires a "training set" in the common understanding. Software verification and validation primarily involve testing against requirements rather than training on data.
• 9. How the ground truth for the training set was established: Not applicable for the same reason as point 8.

In summary, the provided FDA 510(k) clearance letter and summary discuss the device and the types of non-clinical, software, animal, and human factors testing performed to demonstrate substantial equivalence, but it does not elaborate on the specific acceptance criteria, quantitative performance results, or detailed methodologies of these studies as requested. These details would typically be found in the manufacturer's full 510(k) submission, which is more comprehensive than the publicly available summary.

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The GIATM stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.

The GIA™ stapler with Tri-Staple™ technology places two triple staggered rows of titanium staples and simultaneously cuts and divides tissue between these two triple rows. The GIA™ staplers and cartridges with Tri-Staple™ technology are currently available in 60mm and 80 mm length. The subject device provides the thin/medium staple size. Staplers for thin/medium tissue (tan) deploy three height-progressive rows of 2.4 mm, 2.7 mm and 3.0 mm titanium staples. Each GIA™ stapler with Tri-Staple™ technology may be reloaded with a GIAT™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument. The GIA™ Stapler with Tri-Staple™ Technology is a single-use device. It is packaged and sterilized via ETO (ethylene oxide) with a 5-year shelf life, and intended for multiple use during a single procedure.

This document is a 510(k) summary for a medical device called the "GIA™ Stapler with Tri-Staple™ Technology". It describes the device, its intended use, and the tests performed to demonstrate its substantial equivalence to a legally marketed predicate device.

Based on the provided text, there is no information about acceptance criteria or a study proving that an AI/Software device meets acceptance criteria. The document is for a surgical stapler, which is a physical medical device, not a software or AI product.

Therefore, I cannot provide the requested information, as the input document does not contain details about an AI medical device or its validation studies.

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The TA™ Stapler with DST Series™ technology is indicated for use in abdominal and thoracic surgical procedures for transection or resection of tissue.

The intended purpose of the device is the application of staples for the purpose of tissue approximation and is limited to the aspect of stapling the tissue to prepare for the transection and resection of tissue.

The TA™ Stapler with DST Series™ Technology with a TA™ Loading Unit with DST Series™ Technology is a modular stapling system indicated for use during transection of tissue during surgical procedures.

The TA™ Stapler is a handheld mechanical stapler handle used to position and deploy TA™ Loading Units, which are staple cartridges containing titanium staples. The TA™ staplers and TA™ Loading Units are supplied sterile. To perform its intended use, the distal shaft of a TA™ Stapler is assembled with a TA™ loading unit. The TA™ Stapler acts as a stapler handle used by the surgeon to insert and position the TA™ Loading Units inside the body via an incision. The TA™ Loading Unit is then mechanically activated by the surgeon by squeezing the handle of the TA™ stapler, thereby deploying staggered rows of titanium staples to close incisions in abdominal and thoracic tissue. The TA™ Stapler is reloadable meaning the surgeon can manually remove a fired TA™ Loading Unit and replace it with a new TA™ Loading Unit for subsequent firing in a single patient surgical procedure. The TA™ Stapler can be reloaded up to 7 times for a total of 8 firings per instrument.

The TA™ Staplers with DST Series™ Technology are available with staple line anvil lengths that accommodate 30, 45, 60 and 90 mm length TA™ Loading Units. The TA™ Loading Unit with DST Series™ Technology are available with staple heights of 2.5 mm (white vascular cartridge, 3 rows of staples, 30 mm length only); 3.5 mm (blue cartridge, 2 rows of staples, 30, 45, 60 and 90 mm lengths); 4.8 mm (green cartridge, 2 rows of staples, 30, 45, 60 and 90 mm lengths).

The TA™ Loading Unit with DST Series™ Technology and TA™ Staplers with DST Series™ Technology are intended to be used by medical professionals qualified in the transportation, preparation, and use of surgical devices. The TA™ Loading Unit with DST Series™ Technology and TA™ Staplers with DST Series™ Technology are intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.

I am sorry, but there is no information about acceptance criteria or specific studies to prove device performance in the provided text. The document is an FDA 510(k) clearance letter and a 510(k) summary for a surgical stapler. It describes the device, its indications for use, its substantial equivalence to a predicate device, and the types of non-clinical performance data that were submitted (bench top, ex-vivo, in-vivo pre-clinical testing, biocompatibility, shelf life, usability, and MR safety). However, it does not provide quantitative acceptance criteria or detailed results of these studies. Therefore, I cannot generate the table or answer the specific questions you've asked.

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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.

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The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

The Tri-Staple™ 2.0 black circular reloads place a circular triple staggered row of titanium staples. After staple formation, the knife blade resects the excess tissue, creating a circular anastomosis such as endto-end, end-to-side, or side-to-side anastomosis as the user sees fit. The new circular reloads will be offered for an extra thick tissue thick is identified by the black staple quide. The circular reloads deploy three height-progressive rows of 4.0 mm. 4.5 mm staples. The Tri-Staple™ technology incorporated in the black reload is essentially the same as the legally-marketed K192330 in terms of reload design. The Tri-Staple™ 2.0 black circular reloads are provided sterile for single use, and available in three lumen sizes: 28, 31, and 33 mm. The Tilt-Top™ anvil is available with all circular reloads.

The Tri-Staple™ 2.0 black reloads are for use with the previously-marketed Signia™ Circular Adapter. as part of the Signia™ stapler. The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads.

The provided text discusses the Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters). Based on the information present, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document doesn't explicitly state "acceptance criteria" in a tabulated format with specific functional thresholds directly next to "reported device performance." Instead, it highlights various performance tests and evaluations conducted to demonstrate substantial equivalence to predicate devices, inferring that meeting these study outcomes signifies acceptable performance.

However, based on the "Summary of Studies" and the "Substantial Equivalence" table, we can infer some key performance aspects and their assessment:

• Bench top testing
• Ex-vivo testing
• In-vivo pre-clinical testing
• Chronic GLP study (healing metrics, anastomotic index) |
  | Shelf-Life/Stability | Device maintains intended performance over its specified shelf-life. | Stability/Shelf-Life study for single-use devices. |
  | Biocompatibility | Meets ISO 10993 series and FDA 2016/2020 guidance. | Biocompatibility evaluation conducted in accordance with FDA 2020 guidance and ISO 10993-1. |
  | Usability | Meets usability requirements as per FDA guidance and IEC 62366-1. | Usability study performed following FDA's 2016 guidance as well as IEC 62366-1. |
  | Software Functionality | Software performs as intended, verified and validated. | Software verification & validation activities completed following FDA's guidance documents and IEC 62304. |
  | Sterilization | Achieves minimum Sterility Assurance Level (SAL) of 10-6. | Ethylene oxide (EO) sterilization validation for single-use devices with a minimum SAL of 10-6. Previously demonstrated compliance remains unimpacted. |
  | Disinfection | Device can be effectively disinfected. | Disinfection validation performed per FDA 2015 reprocessing guidance. |
  | Reliability | Reusable components maintain performance over their extended life. | Reliability data supporting the extended end of life of the reusable devices. |
  | Electrical Safety & EMC | Meets relevant ANSI/AAMI ES 60601-1, IEC 60601-1, and IEC 60601-1-2 standards. | Electrical safety testing repeated per ANSI/AAMI ES 60601-1 & IEC 60601-1 and electromagnetic compatibility (EMC) testing per IEC 60601-1-2. |
  | MR Safety | MR characteristics are maintained. | Testing repeated per the latest applicable standards, previously cleared via K182475. |

2. 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 the sample sizes used for the various tests (bench top, ex-vivo, in-vivo, usability, etc.). It also does not explicitly state the country of origin or whether the data was retrospective or prospective for these non-clinical studies. Given it's a 510(k) submission, the studies are typically conducted by the manufacturer (Covidien/Medtronic) and are usually prospective engineering, preclinical, or human factors studies designed for regulatory submission.

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 on the number of experts or their qualifications for establishing ground truth for any of the studies mentioned. For pre-clinical animal studies (GLP), typically veterinarians and pathologists would be involved, and for usability, medical professionals, but specifics are not given.

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

The document does not describe any adjudication method for establishing ground truth in its studies. This type of detail is more common for clinical trials involving human interpretation of medical images or outcomes, which is not the primary focus of these non-clinical performance studies for a 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:

The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is relevant for AI-powered diagnostic or interpretive devices involving human readers (e.g., radiologists interpreting images), which is not the nature of this surgical stapler reload. The device is a mechanical stapling device with a "powered stapling technology" and "software-controlled tissue compression," not an AI diagnostic assistant for human interpretation.

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

While the device has "software-controlled tissue compression," it is a surgical instrument used by a human surgeon. Therefore, a "standalone algorithm only" performance, in the sense of a diagnostic AI device, is not applicable or discussed. However, the software verification and validation activities essentially represent the "standalone" performance assessment of the integrated software components within the device's operational context.

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

The ground truth for the various non-clinical studies would likely be established as follows:

• Bench top/Ex-vivo: Engineering specifications, physical measurements (e.g., staple height, tissue gap, burst pressure, leak tests), and defined experimental outcomes.
• In-vivo/Chronic GLP study: Histopathological analysis (pathology records), clinical observation of healing progress, measurements of anastomotic integrity, and gross examination performed by trained veterinary professionals and pathologists.
• Usability: Observation of user interaction, task completion rates, error rates, and user feedback against predefined usability goals and safety criteria.
• Biocompatibility: Laboratory testing against ISO standards for material toxicity, sensitization, etc.

8. The sample size for the training set:

The document does not mention a "training set" in the context of machine learning, as this is a mechanical surgical device with integrated software for control, not an AI model that requires a training dataset for learning. The software is developed and validated through traditional software engineering V&V processes.

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

As no "training set" in the AI/ML sense is indicated, the concept of establishing ground truth for it is not applicable to this device. The software's correct functioning is established through design specifications, verification, and validation against intended logic and operational parameters.

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The ECHELON FLEX™, ECHELON™ 3000, and ECHELON ENDOPATH™ families of staplers and reloads are intended for transection, and/or creation of anastomoses. The instruments have application 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 of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

The ECHELONTM 3000 45 mm and 60 mm Staplers 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.

The ECHELON™ 3000 45 mm Staplers have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long.

The ECHELON™ 3000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm 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 instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack. Refer to the Battery Pack Disposal section.

The instruments are packaged 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 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 is a 510(k) summary for the ECHELON™ 3000 Surgical Stapler. It outlines the device description, indications for use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence. However, it does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria and the specifics of a study proving the device meets those criteria for an AI/algorithm-based medical device.

The document discusses performance data for a surgical stapler, which is a mechanical device, not an AI/algorithm-based diagnostic or therapeutic tool. Therefore, the types of "acceptance criteria" and "studies" will differ significantly from those for an AI system.

Here's how the information provided relates to your request, and where there are gaps due to the nature of the device:

Regarding the Surgical Stapler (as described in the document):

• Acceptance Criteria and Reported Performance: The document lists various bench testing criteria (Formed Staple Height (FSH), Staple Line Integrity (SLI), Force to Close, Staple Line Visual Analysis, Staple Line Strength) and animal testing (Acute Hemostasis evaluation, Tissue Healing response, Survival Study). For a 510(k), the "acceptance criteria" are generally that the device performs comparably to a predicate device and does not raise new questions of safety or effectiveness. The reported performance is that these tests "demonstrate that the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness." However, specific numerical acceptance criteria (e.g., FSH must be within X range) and the exact numerical performance results are not provided in this summary. This level of detail is typically found in the full 510(k) submission, not the public summary.

  Given that this is a mechanical device, not an AI, a table like you requested would list mechanical properties and their measured values against predefined acceptable ranges derived from the predicate device or engineering specifications.

• Sample Size: The document mentions "bench testing" and "animal testing" but does not specify the sample sizes used for these tests.

• Data Provenance: Not specified for the bench or animal testing.

• Number of Experts/Qualifications/Adjudication Method for Test Set: Not applicable in the context of this device's testing. These are relevant for AI systems relying on expert ground truth.

• MRMC Comparative Effectiveness Study: Not applicable. This is a study design for evaluating the impact of AI on human reader performance. This device is a mechanical stapler.

• Standalone Performance: The "bench testing" and "animal testing" can be considered "standalone" performance testing for a mechanical device, as it evaluates the device's physical properties and function without human intervention beyond operation.

• Type of Ground Truth: For a mechanical device like a stapler, "ground truth" equates to established engineering specifications, mechanical properties (e.g., staple height, tensile strength), and biological outcomes (e.g., hemostasis, healing) validated through standard scientific and engineering practices. It's not "expert consensus" on an image, but rather measurable physical and biological parameters.

• Sample Size for Training Set: Not applicable. This device is not an AI/machine learning model that undergoes a "training set" process.

• How Ground Truth for Training Set was Established: Not applicable for the same reason.

If the request was hypothetically for an AI-based medical device, and we were to invent the details based on common FDA expectations for AI/ML:

Let's imagine this document was for an AI-powered diagnostic tool. Here's what such a response would include, creating hypothetical details where the provided document has gaps:

Hypothetical Acceptance Criteria and Study for an AI-Powered Diagnostic Device (e.g., for detecting a specific condition in medical images):

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 500 cases (e.g., 250 positive, 250 negative for the condition).
• Data Provenance:
  • Country of Origin: Multi-site, primarily from hospitals in the United States and Europe.
  • Retrospective/Prospective: Primarily retrospective data collected from institutional archives. A small subset (50 cases) was prospectively collected to ensure generalizability.

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

• Number of Experts: 3 independent expert readers.
• Qualifications: All were board-certified radiologists with at least 10 years of experience in diagnosing the target condition. Two had fellowship training in the relevant sub-specialty.

4. Adjudication Method for the Test Set

• Method: 2+1 adjudication. Initial reads by two independent expert radiologists. In cases of disagreement, a third, senior-level radiologist (the "tie-breaker") reviewed the case and the initial reads to make a final ground truth determination.

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

• Yes, an MRMC study was performed.
• Effect Size: The study demonstrated a statistically significant improvement in human reader performance when assisted by the AI.
  • Sensitivity: Human readers' sensitivity improved by an average of 6.1 percentage points (e.g., from 82% unaided to 88.1% AI-assisted, p

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