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The GI Windows Flexagon Plus OTOLoc System is intended for use in the creation of side-to-side jejunum-jejunum and ileum-ileum anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GI Windows Flexagon SFM Plus OTOLoc is intended for use in adult patients > 21 years.

The Flexagon SFM Plus OTOLoc device is a magnetic compression anastomosis system, which is a surgical device used for the creation of anastomoses in minimally invasive surgery in the gastrointestinal tract. The system is comprised of self-forming magnets and includes the delivery system. The OTOLoc component provides enterotomy preservation for immediate fluidic flow upon implant, while the alternating dipoles of the Flexagon magnet drives magnetic self-alignment to prevent apposition. The anastomosis formation occurs over time once the remodeling of the targeted tissues is complete. The Flexagon magnets compress the opposing tissues which allows the body to dictate the time required for re-epithelialization. Compression and necrosis of tissue is achieved between magnet devices and is created by the polar attraction of the magnet devices with subsequent healing of tissue around the devices. Once the anastomosis is formed, the magnet device is expelled naturally in approximately 3-6 weeks.

The provided text does not contain acceptance criteria or study details for an AI/software device. The document is an FDA 510(k) clearance letter for a physical medical device, the "Flexagon Plus OTOLoc System," which is a magnetic compression anastomosis system.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI device meets them, as the input document is not about an AI device.

The document discusses:

• Acceptance criteria (implicitly met through "Pass" results) for various non-clinical performance tests (biocompatibility, sterilization, packaging, shelf-life, magnetic properties, etc.) and animal studies.
• Clinical performance data for the physical device based on patient outcomes, but not related to an AI's diagnostic or assistive capabilities.

To answer your request, I would need a document detailing the clearance of an AI-powered medical device.

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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 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 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 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 GT Metabolic MagDI System is intended for use in the creation of side duodeno-ileal anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied.

The GT Metabolic MagDI System is intended for use in adult patients > 21years.

The set of two (2) Magnets is a sterile single-use device. The device provides a simple method for the creation of a round (oval/circular) compression anastomosis.

After a period of 7-21 days, a compression-induced necrosis of the tissue between the Magnets occurs and the whole device, together with the necrosed tissue that was compressed by the Magnets, detaches, and is naturally expelled with the stool.

The provided text is a 510(k) Summary for the GT Metabolic MagDI System. It describes the device, its intended use, and summarizes performance testing to support its substantial equivalence to a predicate device. However, this document does not contain explicit acceptance criteria or a detailed study proving the device meets specific acceptance criteria with reported performance metrics in a readily extractable format.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on:

• Same intended use and indications for use.
• Same or similar technological characteristics (with specified changes).
• Performance testing (pre-clinical and clinical summaries).

Here's an attempt to answer your questions based on the available information, noting where information is not present in the document:

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

The document does not explicitly state acceptance criteria in a quantitative table format. It describes the findings of tests performed, which imply successful outcomes but don't define the pre-established thresholds for those successes.

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

• Sample Size: The clinical testing summary states, "The Magnets were successfully placed in all cases... and for all subjects reaching the one-month study visit, the device passed naturally as a set of connected Magnets..." This phrasing implies that "all cases" or "all subjects" were monitored, but the exact number of subjects for the clinical test set is not provided in this document.
• Data Provenance:
  • Country of Origin: Not specified in the given text.
  • Retrospective or Prospective: "Clinical testing was conducted in obese patients with or without type 2 diabetes mellitus using the MagDI System for creation of a side-to-side duodeno-ileal anastomosis." This describes an active study (prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document summarizes clinical outcomes without detailing the mechanism or personnel involved in establishing "ground truth" for those outcomes beyond standard clinical observation and reporting.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, the device is a physical medical device (Magnetic Compression Anastomosis System), not an AI/software device that involves "human readers" interpreting data. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this device's evaluation and was not performed.

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

• No, this is a physical medical device, not a standalone algorithm.

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

For the clinical testing, the "ground truth" seems to be based on:

• Clinical observation/outcomes data: Successful placement, alignment, natural passage of the device, incidence of adverse events (SAEs, internal hernia, bowel obstruction, anastomotic bleeding, leakage, infection, obstruction, deaths), and assessment of patent anastomoses.
• Imaging/surgical observation (implied): To confirm placement and alignment.

8. The sample size for the training set

This information is not provided in the document. The document details a clinical test (performance evaluation) but does not mention a "training set" in the context of device development, which is typically relevant for machine learning algorithms.

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

Not applicable, as no training set (for an algorithm) is mentioned in the document.

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The Intuitive Surgical 8mm SureForm 30 staplers and reloads and accessories are intended to be used with a compatible da Vinci Surgical system for resection of vasculature and tissue and/or creation of anastomoses in General, Thoracic, Gynecologic, Urologic, and Pediatric surgery.

The 8mm SureForm 30 Staplers are fully wristed, articulating, surgical staplers which are designed for use exclusively with a compatible da Vinci Surgical System (herein referred to as "system"). The staplers are controlled by the surgeon using the Surgeon Console of the system. They are intended for resection, transection and/or creation of anastomoses in surgery and achieves its intended use by placing multiple staggered rows of implantable staples in the target tissue (stapling) followed by cutting of the target tissue along the middle of the staple line (transection).

The 8mm SureForm 30 Reloads consist of a single-use cartridge that contains four staggered rows of implantable titanium alloy (Ti3Al2.5V) staples. The implantable staples are provided in various staple leg lengths (Gray, White, Blue) to accommodate various tissue types.

The provided document is a 510(k) summary for the Intuitive Surgical 8mm SureForm 30 Stapler and Reloads. It outlines the device description, indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, it does not contain detailed acceptance criteria, specific reported device performance values, sample sizes for test sets, data provenance, expert details for ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, ground truth types, training set sizes, or how training set ground truth was established for the device.

The document indicates that design verification, compatibility verification, transit verification, biocompatibility, design validation (simulated clinical use), and human factors testing were performed. It states, "The successful completion of testing demonstrated that the subject 8mm SureForm 30 Staplers and 8mm SureForm 30 Reloads design outputs continue to meet design inputs."

Since the detailed information you requested is not present in the provided text, I cannot complete the table or answer points 2-9. The document focuses on demonstrating substantial equivalence rather than providing a detailed technical report of specific performance metrics against acceptance criteria for a new AI/software device.

Here's a breakdown of what can be inferred or directly stated from the document, and where information is missing:

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

Missing Information for Table: The document doesn't provide specific numerical acceptance criteria (e.g., "staple height +/- 0.1mm") or quantitative performance results (e.g., "average staple height was X mm with a standard deviation of Y mm"). It only states that testing was "successful" and criteria were "met."

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

• Sample Size: Not specified for any of the tests (design verification, transit, biocompatibility, design validation, human factors).
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This is not applicable as the document describes a surgical stapling device, not an AI/software device that requires expert-established ground truth on medical images or data. The "ground truth" for this type of device would be physical measurements and performance against engineering specifications. No experts are mentioned in this context.

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

• Not applicable for this type of device submission. Adjudication methods are typically associated with expert review of medical data for AI/software evaluations.

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. This is a surgical stapling device, not an AI-assisted diagnostic or therapeutic device for human readers.

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

• Not applicable. This is a physical medical device.

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

• For a surgical stapler, the "ground truth" would be established by engineering specifications, physical measurements (e.g., staple formation, cutting efficiency), and functional performance in simulated tissue models. The document refers to "functional design inputs" and "product specifications" rather than medical ground truth sources like pathology.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model.

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

• Not applicable. This is a physical medical device, not a machine learning model.

In summary, the provided document is a 510(k) submission for a surgical stapler, which is a physical medical device. The detailed information requested in points 2-9 typically applies to AI/software as a medical device (SaMD) clearances or approvals, which involve data sets, ground truth establishment by experts, and performance evaluation of algorithms. The submission confirms that the device underwent standard physical device testing (mechanical, biocompatibility, usability) and met its design inputs, demonstrating substantial equivalence to its predicate.

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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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