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The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

The CONMED Argo Knotless® Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

The CONMED Argo Knotless® Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10⁻⁶. The threaded anchor and the suture eyelet are manufactured of PolyEtherEtherKetone (PEEK) material. Each size features a single use driver, a threaded anchor, suture eyelet, a 1.0mm UHMWPE Hi-Fi™, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. A maximum of six (6) Hi-Fi #2 suture, or 1.3mm Hi-Fi ribbon suture, or (2) two limbs of Hi-Fi tape, or one (1) bioresorbable reinforced implant can be threaded through the eyelet. The repair sutures are then tensioned and cleated on the driver cleat, if deemed necessary by the surgeon. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

The provided FDA 510(k) clearance letter pertains to the CONMED Argo Knotless® Anchor, a medical device for reattaching soft tissue to bone. This document is a clearance letter, not a detailed study report. Therefore, it does not contain the level of detail typically found in a clinical study for AI/software devices. In particular, it does not include any information about AI or software, MRMC studies, or standalone algorithm performance. The acceptance criteria and performance data described relate to the mechanical and material properties of the physical medical device.

Here's an analysis of the provided information based on your questions:

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

The document does not explicitly state quantitative acceptance criteria for each test. Instead, it indicates that "Testing has been completed to demonstrate that CONMED Argo Knotless® Anchor performs as intended and is substantially equivalent to the predicate device." The performance data is summarized by the types of tests conducted.

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

The document does not specify specific sample sizes for any of the performance tests (e.g., insertion, pull displacement, cyclic loading).
The data provenance is from CONMED Corporation, the manufacturer, as part of their 510(k) submission. These are typically retrospective in the sense that the device has been manufactured and tested, and the results are then compiled for the submission. The tests are likely performed in a controlled laboratory or testing facility setting and do not involve human patient data in the context of device performance testing.

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

This question is generally applicable to AI/software performance where ground truth is established by human experts. For this physical device, the "ground truth" for mechanical properties is established through engineering standards and validated test methods. Therefore, experts would be engineers and technicians familiar with these standards and methods, but the document does not specify their number or qualifications beyond their implied role in executing the listed tests.

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

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies to resolve discrepancies in expert interpretations (e.g., radiology reads). For physical device performance testing, the results are typically quantitative and objective, measured against established engineering specifications, rather than subject to expert interpretation requiring 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

Not applicable. This device is a physical medical implant, not an AI or software device. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this 510(k) submission.

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

Not applicable. As noted above, this clearance is for a physical medical device, not an AI algorithm.

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

The ground truth for the performance of this physical device is based on engineering specifications, industry standards (e.g., ISO 10993-1 for biocompatibility), and validated test methods. These tests establish whether the mechanical properties (insertion, pull displacement, cyclic loading) and material properties (biocompatibility, pyrogenicity) meet predetermined safety and performance benchmarks for orthopedic implants.

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

Not applicable. As there is no "training set" for a physical medical device, this question is not relevant.

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The BioBrace® RC Delivery System is intended for use in rotator cuff surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace® Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during rotator cuff tendon repair surgery. The BioBrace® Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

The Disposable Inserter is intended to facilitate the delivery and positioning of the implant during soft tissue repairs.

The BioBrace® RC Delivery System is comprised of a BioBrace® Implant pre-stitched with HI-FI® suture, a threader assembly that facilitates passing sutures through the BioBrace® Implant, and an inserter to facilitate placement of the BioBrace® Implant into the subacromial space.

The previously cleared BioBrace® Implant is a bioresorbable, reinforced Implant composed of a highly porous collagen sponge made from insoluble bovine tendon type-1 collagen and reinforced with poly-L-lactic-acid (PLLA) multifilament yarn. The BioBrace® Implant is 80% porous with a median pore diameter of 19 µm. BioBrace® implants are approximately 3 mm thick and provided in two rectangular sizes of 23 x 25 mm and 35 x 25 mm.

The BioBrace® RC Delivery System is single-use and supplied sterile (ETO).

The provided text is a 510(k) clearance letter for a medical device called the BioBrace® RC Delivery System. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study for novel acceptance criteria.

Therefore, the document does not contain the information requested regarding detailed acceptance criteria for diagnostic performance, a specific study proving the device meets those criteria, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established in the context of diagnostic accuracy.

The document describes performance testing that focused on demonstrating the functional equivalence and safety of the new delivery system and integrated implant compared to the previously cleared implant. This testing includes:

1. Table of Acceptance Criteria and Reported Device Performance (based on provided text):

Since the document does not present quantitative diagnostic performance metrics or acceptance criteria for such, the table below reflects the types of performance aspects mentioned for this delivery system and implant combination. All "reported device performance" are stated as having been successfully completed and demonstrating equivalence/effectiveness/safety.

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

The document does not specify sample sizes for any test sets in the context of diagnostic performance. The studies mentioned appear to be engineering and biological performance tests rather than clinical diagnostic studies. Data provenance (country of origin, retrospective/prospective) is also not provided.

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

This information is not applicable as the document describes performance testing for a surgical mesh delivery system and implant, not a diagnostic device requiring expert-established ground truth for classification.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above.

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

An MRMC study was not conducted (or at least not reported in this document), as this is not a diagnostic imaging device intended for interpretation by human readers.

6. Standalone (Algorithm Only) Performance:

This information is not applicable as the device is a physical surgical mesh delivery system, not an algorithm or AI software within a diagnostic context.

7. Type of Ground Truth Used:

This information is not applicable as the described tests relate to material properties, sterility, packaging, and functional delivery of a surgical implant, not diagnostic accuracy. For the biocompatibility claims, "ground truth" would be established by the ISO 10993-1 standards themselves.

8. Sample Size for the Training Set:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the reasons stated above.

In summary: The provided 510(k) clearance letter details the regulatory submission for a surgical implant delivery system. The "performance data" section refers to a range of engineering, biological, and functional tests demonstrating that the physical device meets safety and effectiveness requirements and is substantially equivalent to a predicate. It does not contain the kind of diagnostic performance study information that would typically involve acceptance criteria for accuracy, ground truth establishment, or human reader performance for AI software.

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The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless® GENESYS™ Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

The Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK Optima material. The device features a single use driver, a threaded anchor, a PEEK-Optima eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures or one (1) bioresorbable reinforced implant. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

The provided text is a 510(k) Summary for the Argo Knotless® GENESYS™ Anchor, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results in the format typically found in clinical trial reports for software devices.

Based on the information provided, here's what can be extracted and what is not present:

Missing Information:

The document does not describe acceptance criteria in the typical statistical sense (e.g., specific thresholds for sensitivity, specificity, or other performance metrics). It also does not describe a study that proves the device meets these types of acceptance criteria. The performance data mentioned refers to mechanical testing and user validation, not a clinical study to establish analytical or clinical performance of an AI/software device.

Therefore, the following points cannot be answered from the provided text:

• A table of acceptance criteria and the reported device performance: Not provided in terms of statistical performance metrics.
• Sample sized used for the test set and the data provenance: Not applicable in the context of AI/software performance. The "test set" here refers to mechanical testing or cadaveric validation.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a physical bone anchor, not an AI/software product that assists human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable for an AI/software performance study. For the mechanical and user validation tests, the "ground truth" would be the physical properties or user feedback.
• The sample size for the training set: Not applicable as this is not an AI/software device.
• How the ground truth for the training set was established: Not applicable.

What is present in the document about performance and validation:

The document briefly mentions "performance data" in Section VII, but this refers to mechanical and user validation for a physical medical device.

1. Acceptance Criteria and Reported Device Performance (As implied for a physical device, not statistical AI performance):

While not explicitly stated as "acceptance criteria," the document indicates that the device's performance was evaluated to demonstrate substantial equivalence to its predicate. The implied acceptance criterion is that the new device performs as intended and similarly to the predicate device in terms of mechanical properties and user experience.

2. Study that proves the device meets the (implied) acceptance criteria:

The study refers to a variety of tests and validations performed:

• Performance Testing: This would typically involve laboratory tests to measure parameters like insertion force, resistance to cyclic loading, and ultimate pull-out strength. The document doesn't provide specific quantitative results but states these tests were "completed."
• User Validation (Cadaver Medial Collateral Ligament/Lateral Ligament): This indicates hands-on testing of the device's usability and effectiveness in a cadaveric model, simulating surgical conditions for the intended use (reattaching soft tissue to bone).
• Packaging and Labeling User Validation: This would involve confirming that the packaging maintains sterility and integrity, and that the labeling is clear and accurate for users.

Data Provenance and Sample Size for Test Set:

• Sample Size: The specific sample sizes for these tests (e.g., number of anchors tested, number of cadavers, number of users for validation) are not provided in this summary.
• Data Provenance: Not specified, but generally, such performance and cadaveric testing would be conducted in a laboratory or simulated surgical environment. It is not "data" in the sense of patient records from a specific country.

In summary, the provided document is a regulatory submission for a physical medical device. It does not contain the specific information requested about acceptance criteria and study design as it pertains to the performance validation of an AI/software device.

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BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. BioBrace® is also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extraarticular ligaments. BioBrace® is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, soring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

The BioBrace® implant is a bioresorbable and bioinductive scaffold composed of a highly-porous collagen sponge made from insoluble bovine tendon type-1 collagen, and reinforced with poly- L-lactic-acid (PLLA) multifilament yarn (75 denier, 15 micron filament diameter). The BioBrace implant is 80% porous, average density of 0.2 grams/cm3, and median pore diameter of 19 microns. The highly porous collagen sponge comprises the majority of implant surface area (0.7 m2/gram) versus the PLA filaments alone (0.2 m2/gram), creating a large biologic matrix for cellular ingrowth, tissue regeneration, and healing. BioBrace implants are approximately 3 mm thick, provided in multiple sizes, and provide for soft tissue and tendon augment, and clinically relevant strengthening of the surgical repair. The BioBrace implant is single-use and supplied sterile with SAL of 10-6.

This document is a 510(k) Summary for the BioBrace® surgical mesh. It details the device, its intended use, and comparative studies for substantial equivalence. However, it does NOT contain the specific information required to answer your prompt about acceptance criteria and the study that proves the device meets those criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing specific performance acceptance criteria for a new, AI-based device and then proving them. The prompt asks about an AI/algorithm-based device and its performance metrics, such as sensitivity, specificity, or reader improvement. This document describes a surgical mesh, which is a physical implant, not an AI or software device.

Therefore, I cannot provide the requested information based on this document. The document primarily discusses:

• Device Description: Bioresorbable and bioinductive scaffold made of collagen and PLLA yarn.
• Intended Use/Indications for Use: Reinforcement of soft tissue, particularly in tendon and ligament repair, including expansion to extra-articular ligaments.
• Technological Comparison: Emphasizes that the subject device is identical to the primary predicate (K203267) in design, materials, manufacturing, and sterilization, with new sizes and expanded indications for use being the primary changes.
• Non-Clinical and/or Clinical Tests Summary & Conclusions: Mentions cadaver-based studies, an in-vivo study in sheep, and literature reviews to support the expanded indications and performance characteristics like bioinductivity, strengthening, and stiffness.

There are no details related to an AI/algorithm device, its acceptance criteria (like sensitivity, specificity, AUC), test set characteristics (sample size, data provenance), ground truth establishment by experts, or MRMC studies, as would be expected for an AI device submission.

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The CONMED PlumeSafe® X5™ Smoke Management System is designed to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.

The PlumeSafe® X5™ Smoke Management System is a portable, stand-alone, capital unit, that when paired with a reusable filter and disposable accessories makes up a Smoke Management System. The smoke unit is accompanied by a reusable filter and is available in two different configurations, a 22mm or 25mm size. Each filter is designed to capture components of surgical smoke and return clean air to the environment and can connect to different accessories which include pencils, adapters, fluid traps, and tube sets. Each filter is a seff-contained device that is completely enclosed to protect health care personnels from potential contamination during filter changes. Each filter is comprised of filtration (gross particulate pre-filter, Ultra-Low Penetration Air (ULPA), coconutbased carbon, impregnated alumina, and carbon dust capture media) that produce capture efficiency ratings equal to or better than 99.999% for particles ranging in size from 0.01μm to 0.2μm.

PlumeSafe® X5™ is comprised of a vacuum motor, aluminum, steel, and plastic components combined with sound reducing insulation. The vacuum motor is used to draw the surgical site, through an accessory, and into the PlumeSafe® X5™ filter. The PlumeSafe® X5™ Smoke Management System provides multiple modes (open, laparoscopic, and pencil) and settings to adjust the flow to the clinical need.

Here's a breakdown of the acceptance criteria and study information for the CONMED PlumeSafe® X5™ Smoke Management System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document describes "benchtop testing" and "non-clinical performance testing." These are physical device tests, not tests on a clinical dataset.
• Therefore, there is no "test set" in the sense of a collection of patient data or images. The "samples" would be the physical devices, filters, and components themselves, tested under specific laboratory conditions.
• The provenance of data is not applicable in the context of clinical data, as this is solely benchtop testing.

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

• This question is not applicable. "Ground truth" in the context of expert review typically refers to a clinical diagnosis or labeling of medical images/data. Since this is benchtop device testing, there is no "ground truth" established by clinical experts for a test set. The acceptance criteria are based on engineering specifications and international standards, and the "ground truth" is measured by laboratory equipment and procedures.

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

• This question is not applicable. Adjudication methods are used for resolving discrepancies in expert interpretations of clinical data. For benchtop testing, results are typically objective measurements against predefined thresholds, not subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a smoke management system, not an AI-powered diagnostic tool. The testing performed is related to the physical performance and safety of the device in filtering smoke and aerosols.

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

• This question is not applicable. The device is a physical smoke management system, not an algorithm or software that operates standalone for diagnostic or interpretive purposes. Its performance is measured independently of human interaction in terms of its ability to filter air, maintain flow, etc., but this is inherent to the device's function, not "standalone algorithm performance."

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

• For the benchtop tests, the "ground truth" is established by adherence to recognized international standards (e.g., ISO, IEC, ASTM) and engineering specifications. The performance metrics (e.g., efficiency, flow rates, sound levels, motor lifetime) are objectively measured using calibrated laboratory equipment. There is no clinical "ground truth" in the form of expert consensus, pathology, or outcomes data for this type of device testing.

8. The sample size for the training set:

• This question is not applicable. The device is a hardware product, not a machine learning model; therefore, there is no "training set" in the context of artificial intelligence.

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

• This question is not applicable, as there is no training set for this device.

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Argo Knotless® GENESYS™ SP Anchor
The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless® GENESYS™ SP Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaqed soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

Argo Knotless® GENESYS™ Anchor
The biocomposite suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The Argo Knotless® GENESYS™ Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

Argo Knotless® GENESYS ™ SP Anchor: The Self-Punching (SP) Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied for single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the broaching tip (suture eyelet) is manufactured of titanium material. Each size features a single-use driver, the threaded anchor, a Titanium suture eyelet, a UHMWPE 1.0mm non-absorbable retention suture, and loader tab. The retention suture holds the titanium eyelet in place on the driver assembly and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures.

Argo Knotless® GENESYS ™ Anchor: The Non-Self-Punching Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The anchor configuration requires a pre-prepared bone hole. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK material. Each size features a single use driver, a threaded anchor, a PEEK suture eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

Argo Knotless® GENESYS ™ Anchor: The Preloaded Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10 °. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK material. The eyelet is held on with a #2 UHMWPE, nonabsorbable retention suture and supplied with either a white/black or blue/blue colored non-absorbable Hi-Fi suture tape, a retention suture, and loader tab. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

Principle of Operation - soft tissue to bone fixation

This document is an FDA 510(k) clearance letter and summary for a medical device (Argo Knotless GENESYS Anchor). It does not describe a study involving an AI/software as a medical device (SaMD) or diagnostic imaging. Therefore, the requested information about acceptance criteria, study design, ground truth establishment, and human-in-the-loop performance is not applicable to this document.

The document focuses on demonstrating substantial equivalence of a physical medical device (suture anchor) to a previously cleared predicate device. The "Performance Data" section lists various engineering and material tests conducted on the physical device, not clinical performance or diagnostic accuracy studies.

Here's why the questions are not applicable:

• No AI/Software Component: The device described is a physical implantable suture anchor, not an AI or software-based diagnostic tool.
• No Diagnostic Performance: The performance data mentioned (e.g., "Performance Testing," "Magnetic Resonance," "Transportation," "Corrosion Susceptibility") relate to the mechanical, material, and sterility aspects of the anchor, not its diagnostic accuracy in interpreting images or data.
• No Human Reader Interaction: There's no scenario where human readers (like radiologists) would "improve with AI vs. without AI assistance" as this is not an imaging or diagnostic AI product.
• No Ground Truth for AI: Ground truth for a physical device like a suture anchor is typically established through engineering specifications, material properties, and in-vitro or in-vivo (animal or human cadaver) biomechanical testing, not through expert consensus on images or pathology.

Therefore, I cannot populate the table or answer the specific questions related to AI/SaMD performance criteria, study design, and ground truth. The provided text simply doesn't contain that type of information.

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CONMED CleanSeal Vessel Sealers are intended to be used in open and mimimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm vessels (arteries, veins, pulmonary arteries, pulmonary veins). The handpiece is indicated for use in gynecological and general surgical procedures, including urologic, thoracic, and vascular. These procedures include, but are not limited to, hysterectomies, colectomies, Nissen fundoplication, and adhesiolysis. CleanSeal vessel sealer has not been shown to be effective for ubal sterilization or tubal coagulation for sterilization procedures. Do not use CleanSeal vessel sealer for these procedures.

CleanSeal Advanced Bipolar Vessel Sealer Maryland is designed to be used, with a compatible MEP-1 electrosurqical generator, in open and minimally invasive procedures for the ligation and division of tissue bundles, lymphatics, and vessels up to and including 6 mm arteries and veins. They are sterile, single use bipolar vessel sealing hand pieces featuring double action non-stick coated jaws, three shaft length options, a one-hand controlled handle with latchable lever. The instrument creates a seal by application of radio frequency (RF) electrosurgical energy to vascular structures or tissue bundles interposed between the jaws.

The provided text describes a 510(k) premarket notification for a medical device called "CleanSeal Advanced Bipolar Vessel Sealer Maryland." This document is a regulatory submission to the FDA, demonstrating the device's substantial equivalence to previously cleared predicate devices.

However, the information provided does not contain any details about acceptance criteria, study design for a test set, sample sizes for training or test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML device performance.

The document primarily focuses on:

• Device Description and Intended Use: Explains what the device is, how it works, and its surgical applications for sealing and dividing tissue and vessels.
• Performance Testing: Mentions that the device has been tested according to FDA guidance for electrosurgical devices.
• Biocompatibility Testing: States that biocompatibility testing was conducted and met acceptance criteria.
• Chronic Animal Studies: Describes two chronic animal studies (porcine and canine models) comparing the performance of the CleanSeal Maryland with its predicate devices for effective vessel sealing. These are biological/physiological studies, not studies of an AI/ML algorithm's performance.
• Shelf Life Study: Indicates a shelf-life study was performed.
• Substantial Equivalence Argument: Compares the new device's features (Model numbers, intended use, polarity, dimensional design, rated voltage, shelf-life, sterilization method, and disposability) to its predicate and reference devices to argue for substantial equivalence.

Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML device. The document refers to a physical electrosurgical device, and the "performance testing" and "chronic animal studies" relate to its mechanical and biological effectiveness, not an AI/ML algorithm's analytical performance on data.

If this device were an AI/ML device, the required information (acceptance criteria for AI metrics, test set details, ground truth, etc.) would be explicitly mentioned in sections describing its software performance and validation. Since those details are absent, it confirms that this is not an AI/ML device submission from which such information could be extracted.

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AirSeal iFS System: The ConMed AirSeal® iFS System is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired to facilitate the use of various thoracoscopic and laparoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. This instrument can also be used to insufflate the rectum and colon to facilitate endoscopic observation, diagnosis, and treatment. The trocar of the AirSeal® iFS System is indicated for use with or without visualization.

AirSeal dV Solution: The AirSeal Robotic Solution (ARS) is intended for use in diagnostic and/or therapeutic endoscopic procedures in conjunction with the ConMed AirSeal iFS and an Intuitive da Vinci X Cannula and Cannula Seal to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. It is indicated for use in abdominal, thoracic, and pediatric procedures where insufflation is desired to facilitate the use of various laparoscopic and thoracoscopic instruments by filling the abdominal or thoracic cavity with gas to distend it, by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke. The Cannula Cap is indicated for use with or without visualization. The ARS System must be used with the Intuitive da Vinci X 8mm Instrument Cannula, an Intuitive Cannula Seal and the AirSeal iFS in AirSeal mode. When used in AirSeal mode, the Cannula Cap and Bifurcated Tube Set are designed to provide CO2 gas delivery with stable pneumoperitoneum and continuous smoke evacuation during robotic assisted laparoscopic and thoracoscopic procedures using the da Vinci Xi or da Vinci X systems. The Bifurcated Filtered Tube Set is used to connect the Cannula Cap and Cannula Seal to the AirSeal iFS.

The ConMed AirSeal iFS System consists of the following major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a microprocessor-controlled insufflation, recirculation and filtration unit. The cannula, trocar and tube sets are sterile, single-use products. The AirSeal iFS System is an active medical device, nonsterile and reusable and is intended to insufflate a body cavity. The AirSeal iFS System is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode (Adult and Pediatric); or (c) Smoke Evacuation Mode. The ConMed AirSeal dV Solution (or AirSeal Robotic Solution) consists of the following major components: (1) AirSeal® Cannula Cap with a cannula cap and an obturator (in standard and long lengths), and (2) AirSeal® Bifurcated Filtered Tube Set. The cannula cap, obturator and tube set are sterile, single-use products. The AirSeal dV Solution, in conjunction with Intuitive daVinci XiX Cannula and Cannula Seal, is operated in the Airseal Mode with the AirSeal iFS System to distend a cavity by filling it with gas, to create and maintain a gas-sealed obstruction-free path of entry for endoscopic instruments, and to evacuate surgical smoke. The ConMed AirSeal dV Solution is a sterile, single use device, primarily composed of polycarbonate, and stainless steel.

The provided FDA 510(k) summary describes the AirSeal iFS System and AirSeal dV Solution, which are laparoscopic insufflators. This document is a premarket notification for a medical device seeking substantial equivalence to a predicate device. As such, the "acceptance criteria" and "device performance" in this context refer to engineering and regulatory compliance testing rather than clinical performance metrics typically associated with AI/ML algorithms.

Here's an analysis based on the provided text, addressing your questions where applicable and noting when particular information is not present in this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance data categories. The specific quantitative acceptance criteria and detailed reported performance values for each test are not explicitly provided in this summary document. This level of detail is typically found in full test reports submitted to the FDA but is summarized for the 510(k) public abstract.

Study Proving Acceptance Criteria Met:

The study proving the device meets the acceptance criteria consists of benchtop testing and non-clinical testing. The document states:

• "Benchtop testing was completed to support substantial equivalence to the predicate as it relates to safety and effectiveness."
• "The following tests were conducted to support substantial equivalence for the expanded indication..." (followed by the list in the table above).
• "Based upon the findings of non-clinical testing, the differences present no issues of safety and efficacy and the subject AirSeal iFS System and AirSeal dV Solution are substantially equivalent to the predicate PneumoSure (K063367)."

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

This document does not specify sample sizes for individual tests. The testing conducted is primarily engineering verification and validation (V&V) on device prototypes or production units. Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided for these types of engineering tests.

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

This type of information is not relevant to the described studies, as they are engineering performance tests of a physical medical device, not clinical studies involving expert interpretation of data or images. "Ground truth" in this context refers to established engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against predefined engineering specifications and regulatory standards, not subjective interpretations requiring 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 comparative effectiveness study was not done. This device is not an AI/ML algorithm that assists human readers; it is a laparoscopic insufflator.

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

This question is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described would be established engineering specifications, design requirements, and recognized international standards (e.g., ISO, IEC) to which the device's performance is compared. For example, for "set pressure," the ground truth is the specified pressure values the device is designed to maintain.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm developed with a training set.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The SnapEvac and PenAdapt is an aspiration sheath that fits over an electrosurgical pencil body and leaves the tip or blade exposed. This device is considered an accessory to an electrosurgical unit (ESU). SnapEvac and PenAdapt removes surgical smoke during surgical procedures that use ESU for cutting and cauterizing. This device is used in conjunction with a suction (vacuum) source.

Contraindications: This device should not be used for microsurgery.

The PlumePen® Elite, PlumePen® Ultra, and PlumePen® Pro is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Indicated for use to remove smoke plume from the surgical site and to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the target tissue for the desired surgical effect.

The smoke evacuation devices that are the subject of this 510(k) are PlumePen Surgical Smoke Evacuation Pencils (Elite, Pro and Ultra), PenAdapt Electrosurgical Pencil Adapters and Electrosurgical Pencil Adapters. By interfacing with an effective smoke evacuation unit, these devices function as part of the system to remove smoke particles from the point of surgical activity during procedures that use an electrosurgical unit (ESU) for cutting and cauterizing.

PlumePen Smoke Evacuation Pencils: The PlumePen® Elite, Pro, and Ultra family of devices are sterile, single use electrosurgical hand pieces featuring an integrated smoke evacuation channel. The devices, when connected to an electrosurgical generator and smoke evacuation system are designed to remove smoke plume generated during the use of the pencil for electrosurgical procedures.

PenAdapt and SnapEvac Electrosurgical Pencil Adapters: PenAdapt and SnapEvac are sterile, single use pencil adapters which fit over standard electrosurgical pencils while keeping the blade exposed. They enable the capture and removal of smoke generated during the use of the pencil, in procedures that require cutting and cauterization, when connected to an effective smoke evacuation system.

The provided text describes the 510(k) premarket notification for electrosurgical accessories (PlumePen Surgical Smoke Evacuation Pencils, PenAdapt, and SnapEvac Electrosurgical Pencil Adapters). The purpose of this notification is to demonstrate substantial equivalence to legally marketed predicate devices.

However, the request asks for specific details related to acceptance criteria and a study proving a device meets acceptance criteria, specifically in the context of an AI/ML-driven medical device. The provided document details the testing for electrosurgical tools to demonstrate functional equivalence and safety, not the performance of an AI/ML diagnostic or assistive device.

Therefore, the information required to answer the prompt (acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert roles, adjudication methods, MRMC study details, standalone performance, ground truth types, etc.) is not present in the provided text. The document refers to standard medical device testing such as functionality verification (e.g., 90% smoke capture), electrical safety, biocompatibility, sterilization validation, and packaging validation, which are applicable to physical electrosurgical devices, not AI/ML algorithms.

My response will acknowledge that the requested information is not available in the provided document, as it pertains to a different type of medical device evaluation (AI/ML vs. physical electrosurgical tools).

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