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The Y-Knot™ All-Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system 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 Y-Knot™ All-Suture Anchor is a soft-tissue fixation device with an expandable push-in design, provided preloaded on a disposable inserter device. This suture anchor is constructed of a flat suture that is interlaced longitudinally along its central width by one suture strand. The flat suture and the single suture strand are folded back on themselves at the distal end of the disposable inserter. The disposable inserter device has a forked shaped distal end, stainless steel shaft, with an ABS handle, that is provided sterile, for single use and is removed at the end of the repair leaving behind an all suture construct. 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 all-suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The suture anchor configuration is supplied sterile, single use, preloaded onto a disposable driver. The disposable driver is composed of a 300 series surgical grade stainless-steel shaft with an ABS handle. Additional surgical instruments, including a drill bit and drill guides, are Class I, sterile, single-use devices intended for transient use during orthopedic procedures.

The provided text describes a medical device, the Y-Knot™ All-Suture Anchor, and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood in the context of device performance metrics and clinical or analytical evaluations.

Instead, the document focuses on:

• 510(k) Summary: A regulatory submission outlining the device's characteristics and its equivalence to already marketed devices.
• Device Description: What the device is made of and how it works.
• Testing: A general list of testing performed (fixation strength, pull-out, cyclic loading, insertion, biocompatibility, sterilization, shelf-life, packaging/transportation, and side-by-side comparator qualifications), but no specific results or acceptance criteria are reported here.
• Intended Use/Indications: For what medical purpose the device is designed.
• Substantial Equivalence: The FDA's basis for clearing the device, comparing it to existing, legally marketed devices.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria (e.g., minimum pull-out strength, maximum displacement under cyclic loading) are quantified.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as this is related to a cognitive assessment or diagnostic device, not a mechanical fixation device.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of performance metrics for a mechanical device. The ground truth for this device would be its physical behavior under stress, not a diagnostic finding.
8. Sample size for the training set: Not applicable, as this device does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable.

The "Testing" section broadly mentions various tests performed, such as "fixation strength" and "pull-out," which are likely mechanical tests to ensure the device performs as expected. However, the document provided is a summary of the 510(k) submission, and typically does not contain the detailed results, acceptance criteria, and methodologies of these tests. These details would be in the full submission, not in this public summary.

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The Genesys Matryx™ is for attaching soft tissue to bone in orthopedic surgical procedures. Genesys Matryx™ is intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.

The Genesys Matryx is a threaded, cannulated, bioabsorbable interference screw composed of ultra-high strength Self-Reinforced™ (SR) polylactide copolymer and betatricalcium phosphate (ß-TCP). The Genesys Matryx maintains accurate position of a tendon/ligament graft. The manufacturing process preserves the high initial mechanical strength and stiffness, which allows secure fixation, in combination with appropriate immobilization/controlled mobilization until clinical determination of healing. The Genesys Matryx completes resorption within several years. Resorption also depends on patient variables. The Genesys Matryx need not be removed prior to revision surgery, if such is needed. The Genesys Matryx is sterile and non-collagenous.

This document describes a 510(k) premarket notification for the "Genesys Matryx™" bioabsorbable interference screw. This type of submission focuses on demonstrating "substantial equivalence" to legally marketed predicate devices, rather than establishing de novo performance criteria through clinical trials. Therefore, the information requested in your prompt regarding acceptance criteria, specific study design, sample sizes, expert ground truth, MRMC studies, and standalone performance might not be fully available or directly applicable in the context of this 510(k) summary.

However, I can extract the relevant information from the provided text to address your points as much as possible, interpreting "acceptance criteria" as the basis for substantial equivalence for this device.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are typically met by demonstrating that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as legally marketed predicate devices. The "reported device performance" is then characterized through non-clinical testing to support this substantial equivalence.

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

The document explicitly states: "Non-clinical testing was submitted to aid in the characterization of the Genesys Matryx device and to support a determination of substantial equivalence. This testing included in vivo animal testing, in vitro degradation, shelf life, transportation and distribution, verification by analysis, insertion, pullout, cyclic (reliability) and bioburden testing."

• Test Set Sample Size: The document does not specify exact sample sizes for each of these non-clinical tests. For non-clinical tests, sample sizes are typically determined based on statistical justification for demonstrating material properties and mechanical performance, rather than patient cohorts.
• Data Provenance: The testing is described as "non-clinical," which implies it was conducted under controlled laboratory conditions or using animal models for in vivo studies. There is no mention of human clinical data or patient-derived data in this 510(k) summary. Given the non-clinical nature, country of origin specifics are not provided, but these tests would typically be performed in a controlled research facility. The data is entirely retrospective in the sense that it's generated for submission, not from ongoing patient care.

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

Since this is a non-clinical 510(k) submission, there is no mention of "experts used to establish ground truth" in the context of clinical interpretation, especially not like radiologists for image analysis. The "ground truth" for the non-clinical tests (e.g., pullout strength, degradation rate) would be the objective measurements and analysis performed by engineers, material scientists, and laboratory personnel following established protocols and standards. Their qualifications are not specified in this summary.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies with human readers/assessors. As this is a non-clinical testing summary for a 510(k) submission, such methods are not relevant.

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

No. An MRMC comparative effectiveness study is a type of clinical study involving human readers interpreting cases, often in the context of diagnostic imaging. This 510(k) summary only mentions non-clinical testing.

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

Yes, in essence. The "Genesys Matryx™" is a physical medical device (an interference screw), not a software algorithm. Therefore, its performance is inherently "standalone" in function, meaning it acts independently once implanted according to its mechanical and absorbable properties. The non-clinical tests assess the device's inherent performance characteristics without human interpretation as part of its function.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on objective, quantifiable measurements from the specified non-clinical tests:

• In vivo animal testing: Physiological responses, integration, or degradation in a living system. Ground truth would be derived from histological analysis, imaging, and necropsy findings.
• In vitro degradation: Chemical and physical analysis (e.g., mass loss, mechanical property changes) over time in a simulated environment.
• Shelf life, transportation and distribution: Stability and integrity of the device under stress conditions, assessed against pre-defined specifications.
• Verification by analysis: Engineering calculations and simulations.
• Insertion, pullout, cyclic (reliability) testing: Direct mechanical measurements (e.g., force, displacement, cycles to failure) using standardized test methods.
• Bioburden testing: Microbiological analysis to quantify microbial contamination levels.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable, as there is no training set for this type of device.

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The ConMed Linvatec Sequent™ Meniscal Repair Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including the repair of meniscal tears.

The ConMed Linvatec Sequent™ Meniscal Repair Device is an all-inside meniscal repair device that sequentially deploys implants and suture. This device allows the surgeon to generate multiple stitches in order to create fixation points along a soft tissue tear. The hand held, disposable device, provided sterile for single use, is removed at the end of the repair leaving behind a suture/implant construct. The implant encompasses a cleat which retains the suture and allows the knotless feature.

This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a detailed study proving the device meets those criteria. The provided text is a summary of safety and effectiveness for a medical device submitted to the FDA, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive study report with specific acceptance criteria and performance data.

Below is an attempt to extract and infer information based on the provided text, while also explicitly stating where information is not available in the document.

Acceptance Criteria and Device Performance

Detailed Study Information:

The provided document describes the general types of testing conducted but does not provide details about a specific study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement as you've requested for a device performance study. The core of a 510(k) submission for substantial equivalence is often bench testing and comparison to predicates, as opposed to a full clinical trial with "ground truth" as typically defined for diagnostic or AI-driven devices.

Here's a breakdown of the specific points you requested, with clarification on what is and isn't available:

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

   • As seen in the table above, explicit numerical acceptance criteria, specific thresholds, or detailed performance metrics from the testing (e.g., "cyclic loading withstood X cycles with Y force") are not provided in this 510(k) summary. The summary broadly states that testing showed the device "performs as well as or better than" predicates and is "safe and effective."

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

   • Not specified. The document mentions "verification and validation testing including cyclic loading characteristics, ultimate fixation strength," etc., but does not provide details on the number of samples tested for each type of bench testing, nor does it refer to clinical data or its provenance. This is typical for a device like a surgical instrument/implant in a 510(k) where substantial equivalence is often shown through engineering validation and comparison to existing devices.

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 applicable/Not specified. The "ground truth" concept, especially in the context of expert consensus, is more relevant for diagnostic devices or AI algorithms that interpret medical data. For a mechanical surgical device like the Sequent™ Meniscal Repair Device, "ground truth" would be established through objective physical measurements (e.g., force, displacement, cycles) in benchtop testing, or potentially by surgical outcomes if clinical trials were cited (which they are not in this summary). There's no mention of expert readers or consensus to establish ground truth for this type of device.

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

   • Not applicable/Not specified. Adjudication methods are typically used in clinical studies involving human interpretation or clinical endpoints. This summary describes engineering and performance testing.

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 surgical repair device, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

   • Not applicable. This device is a physical surgical tool and implant, not an algorithm.

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

   • As inferred from the "Testing" section, the "ground truth" for this device would be based on objective engineering and biomechanical measurements relevant to its function, such as:
     • Measurements of cyclic loading endurance.
     • Measurements of ultimate fixation strength.
     • Measurements of material degradation (e.g., tensile strength loss over time).
     • Functional assessments of the device's deployment mechanism.
   • The document implies that these measurements were compared against either internal specifications or the performance of predicate devices.

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" as this device is not an AI or machine learning model.

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

   • Not applicable. As above, no training set is relevant for this type of device.

In summary, the 510(k) summary for the ConMed Linvatec Sequent™ Meniscal Repair Device demonstrates substantial equivalence primarily through bench testing comparing its performance (cyclic loading, fixation strength, etc.) to legally marketed predicate devices. It does not provide the granular data or study design details for "acceptance criteria" and "ground truth" in the way one would expect for a diagnostic or AI-powered medical device. The "acceptance criteria" appear to be broadly defined by the performance of the predicate devices and general safety and effectiveness standards for such implants.

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The ConMed Linvatec CrossFT™ BC Suture Anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures. The system 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 ConMed Linvatec CrossFT™ BC Suture Anchor is a device that is used to assist the surgeon in reattaching soft tissue to bone. The device includes anchors, manufactured of 96L/4D PLA co-polymer + β-TCP and two (2), or three (3) Hi-Fi® sutures manufactured of polyethylene and polypropylene. The device is bioabsorbable and is available in sizes between 4.5mm to 6.5mm diameter and 17mm lengths. A disposable driver is included to implant the suture anchor.

I am sorry, but the provided text does not contain the detailed information necessary to complete all sections of your request. The document is a 510(k) summary and FDA clearance letter for a medical device (suture anchor), which primarily focuses on substantial equivalence to predicate devices rather than a detailed study proving performance against specific acceptance criteria.

Here's what I can extract and what is missing based on the provided text:

Acceptance Criteria and Study Information for ConMed Linvatec CrossFT™ BC Suture Anchor

1. Table of Acceptance Criteria and Reported Device Performance

The document states "The verification and validation testing of the ConMed Linvatec CrossFT™ BC Suture Anchor includes fixation strength, cyclic loading, insertion torque, material degradation and packaging/transportation qualification." However, it does not provide the specific quantitative acceptance criteria (e.g., minimum pull-out strength in Newtons, maximum displacement under cyclic loading) nor the numerical results obtained by the device for these tests.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (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

This information is typically relevant for studies involving human interpretation (e.g., image analysis, clinical assessments). For a mechanical device like a suture anchor undergoing physical and material testing, the "ground truth" is established through standardized engineering and material science testing methods and reference standards. The document does not mention the use of human experts in this context.

4. Adjudication method for the test set

Not applicable in the context of purely physical/mechanical device testing as described.

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 medical device for surgical implantation, not an AI or diagnostic imaging device that involves 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, not an algorithm.

7. The type of ground truth used

For the mentioned tests (fixation strength, cyclic loading, insertion torque, material degradation, packaging/transportation qualification), the ground truth would be established by:

• Standardized Test Methods: Adherence to recognized ASTM, ISO, or other industry standards for mechanical testing of orthopedic implants and materials.
• Material Specifications: Compliance with established specifications for the raw materials (PLA co-polymer + β-TCP) and components (sutures).
• Predicate Device Performance: Comparison to the established performance characteristics of the predicate devices, as the basis for substantial equivalence.

8. The sample size for the training set

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

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

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

Summary of Missing Information & Why:

The provided document is a 510(k) summary, which is a premarket notification to the FDA. Its primary purpose is to demonstrate "substantial equivalence" to legally marketed predicate devices, not to provide a detailed technical report of the device's performance against specific, quantitative acceptance criteria. While it states that "verification and validation testing" was performed, it does not disclose the specific numerical results of these tests or the exact acceptance criteria used. These details would typically be found in the full design history file or specific test reports, which are not part of the publicly available 510(k) summary. For mechanical devices, the "ground truth" is typically derived from engineering standards and material properties, rather than expert consensus or pathology in the clinical sense.

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The anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The device 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 proposed device is a bioabsorbable push-in (press fit) suture anchor that is preloaded on a disposable inserter device with one or two non-absorbable. braided, polyethylene sutures. The proposed device is manufactured from 100% Poly L-lactic Acid with colorant D&C violet #2. The polymer is inert and noncollagenous through the absorption process. The device dimensions are 2.9mm diameter and 10.75mm in length.

The provided text is a 510(k) summary for a medical device (ConMed Linvatec Presto™ Suture Anchor) and an FDA clearance letter. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot provide the requested information as it is not present in the given text.

The document primarily focuses on:

• Device Identification: Trade name, common name, classification, product code, and regulation.
• Predicate Devices: Listing previously cleared devices for substantial equivalence comparison.
• Device Description: Material, dimensions, and general mechanism.
• Intended Use/Indications: Explaining what the device is for.
• Substantial Equivalence Claim: Stating that the new device is substantially equivalent to predicate devices.
• FDA Clearance Letter: Confirming the FDA's acceptance of the 510(k) submission.

In summary, none of the requested information regarding acceptance criteria or the specific studies to prove device performance are available in the provided text.

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ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of containment devices for medical device sterilization.

The Hip Arthroscopy Master Tray is intended for use only with the following instruments and/or other instruments of similar type and size: (list of instruments provided)

Sterilize the Hip Arthroscopy Master Tray using the following parameters: (steam sterilization parameters provided)

The PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) are designed to hold a variety of powered ConMed Linvatec handpieces as well as attachments and/or accessories that may be used with the powered handpieces.

Cannulated handpieces or attachments with an internal diameter not less than 0.031 inches (0.079cm) and a cannulated length no greater than 5.75 inches (14.61cm) and/or handpiece accessories such as pneumatic air supply hoses with a lumen not less than 0.187 inches (0.475 cm) in diameter and a cannulated length no greater than 15 feet (4.6 m) may be sterilized in this tray along with other non-cannulated, non-porous instruments.

Sterilize the PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) using the following parameters. (steam sterilization parameters provided)

ConMed Linvatec Anodized Aluminum Sterilization Trays are constructed of metal with perforations to facilitate sterilant penetration, evacuation and drying, These trays are designed to fit any standard autoclave and are manufactured from durable, biocompatible materials that are corrosion resistant and compatible with the environment of repeated steam sterilization. Since the trays are perforated, an FDA cleared sterilization wrap must be used to maintain sterility of the contents. Although these trays are reusable they will not be serviced or repaired.

ConMed Linvatec Anodized Aluminum Sterilization Trays are available under various trade names and in various sizes and tray configurations. Interior structures of the trays have the ability to separately hold each individual instrument during the entire duration they are in contact with the trav.

This document is a 510(k) Summary for ConMed Linvatec Anodized Aluminum Sterilization Trays. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Based on the provided text, a "study" in the traditional sense (e.g., a clinical trial with acceptance criteria and reported performance metrics like accuracy, sensitivity, specificity, etc.) was not conducted or reported. This document is a premarket notification for a medical device (sterilization trays), and the "acceptance criteria" and "device performance" described are related to the sterilization parameters and physical characteristics of the trays, rather than a diagnostic or AI-driven system.

Therefore, many of the questions regarding sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the content provided.

However, I can extract information related to the performance parameters defined for the sterilization process.

1. Table of Acceptance Criteria and Reported Device Performance

For the ConMed Linvatec Anodized Aluminum Sterilization Trays, the key acceptance criteria and performance are related to the sterilization cycles they can withstand. The "device performance" here refers to the validated sterilization parameters for using the trays.

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

This document does not describe a test set or data provenance in the context of an AI/algorithmic study. The "testing" mentioned refers to the validation of the sterilization parameters for the physical device. The exact sample size for this physical testing (e.g., number of sterilization cycles, number of trays tested) is not specified. The origin of the testing data would likely be from ConMed Linvatec's internal testing labs, based in Largo, Florida, USA.

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 applicable. This is a submission for a physical medical device (sterilization trays), not an AI/diagnostic system requiring expert readers for ground truth establishment.

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

Not applicable. There is no adjudication method described as there's no diagnostic or interpretative output from the device.

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 physical medical device, not an AI system.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device is the

• Physical and chemical properties of the materials used in the trays (biocompatibility, corrosion resistance).
• Effectiveness of sterilization cycles as demonstrated through standardized microbiological indicator tests (e.g., biological indicators, chemical indicators) and physical monitoring. These tests would confirm that the parameters listed achieve sterility and that "wet packs" are avoided. This is an engineering/biology-based ground truth, not an expert consensus or pathology on a patient case.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI system that undergoes training.

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

Not applicable. This is a physical medical device, not an AI system.

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The ConMed Linvatec Zen™ Wireless Footswitch and Adapter is an accessory that is intended to interface with compatible ConMed Linvatec power drive consoles to selectively control ConMed Linvatec surgical instruments.

The ConMed Linvatec Zen™ Wireless Footswitch and Adapter consists of a Wireless Footswitch (W1000) and a Wireless Footswitch Adapter (W1100) used for control of handpieces connected to a compatible ConMed Linvatec drive console. The Wireless Footswitch is designed to receive a communication signal from the Wireless Footswitch Adapter and, when a footswitch pedal is depressed, activate the drive console accordingly to power a ConMed Linvatec handpiece.

The provided text is a 510(k) summary for the ConMed Linvatec Zen™ Wireless Footswitch and Adapter. This document focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria or a study proving device performance against such criteria.

The 510(k) document is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically includes comparisons to predicate devices in terms of intended use, technological characteristics, and performance data (which often includes design verification and validation testing, but not necessarily a clinical study with detailed acceptance criteria as you've described).

Therefore, I cannot extract the requested information as it is not present in the provided text.

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The ConMed Linvatec Microfracture Instrument Sterilization Tray (MFX-TRAY) is a containment device for medical device sterilization. The tray is constructed of metal and plastic with perforations to facilitate steam penetration.

The ConMed Linvatec Microfracture Instrument Sterilization Tray (MFX-TRAY) is a containment device for medical device sterilization. The tray is constructed of metal and plastic with perforations to facilitate steam penetration.

The provided text is a 510(k) summary for a medical device (sterilization tray) and does not contain information about the acceptance criteria or a study proving the device meets certain performance criteria in the context of AI/ML or diagnostic performance. Instead, it details regulatory information, device classification, and indications for use, primarily focusing on sterilization methods and the instruments the tray is designed to hold.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, ground truth, MRMC study, standalone performance, training set details) from the provided text as it is not relevant to the type of device or performance evaluation typically associated with those terms.

The document discusses "sterilization validation has been conducted in accordance with the requirements of AAMI TIR 12" and "Validation was conducted using an FDA cleared sterilization wrap with a maximum load of 8.1 lbs. (3.67 kg)", which are related to performance, but not in the context of an AI/ML clinical study.

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The Bio Mini-Revo Suture Anchor is intended to reattach soft tissue to bone in arthroscopic or open hip procedures; such as acetabular labral repair.

The Linvatec Bio Mini-Revo® suture anchor is a bioabsorbable screw-in suture anchor that is preloaded on a disposable inserter device with one nonabsorbable, braided, polyethylone suture. The Bio Mini-Revo® suture anchor is manufactured from Self-Reinforced (96L/4D) PLA Copolymer. The Copolymer is inert and non-collagenous through the absorption process. The device will be available in two versions; with or without colorant D&C violet #2.

ConMed Linvatec Bio Mini-Revo Suture Anchor A Acceptance Criteria and Study Details

The provided document is a 510(k) summary for the ConMed Linvatec Bio Mini-Revo Suture Anchor, which aims to demonstrate substantial equivalence to legally marketed predicate devices, not clinical performance against specific acceptance criteria. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets them, nor does it include details about AI device performance.

The 510(k) process focuses on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (predicate device) in terms of intended use, design, materials, and technological characteristics. This typically involves comparative testing against the predicate device or established standards, rather than defining novel acceptance criteria for clinical performance and conducting a dedicated study to prove it.

Here's a breakdown of why the requested information is absent and what is available in the document:

Missing Information (and why it's not present in a 510(k) summary of this type):

• A table of acceptance criteria and the reported device performance: This document does not establish new acceptance criteria for the device beyond demonstrating substantial equivalence. Performance is typically compared to the predicate, not against pre-defined, novel clinical metrics with acceptance thresholds.
• Sample size used for the test set and the data provenance: Clinical studies with specific test sets and data provenance (country, retrospective/prospective) are generally associated with PMA (Premarket Approval) applications or de novo classifications for novel devices, or for specific clinical claims, not a 510(k) for substantial equivalence of this type of device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no clinical "test set" in the context of an AI device or a novel clinical study for this 510(k), this information is not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the same reasons as above.
• 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 document concerns a physical medical device (suture anchor), not an AI diagnostic or assistive tool. Therefore, MRMC studies and AI performance metrics are not relevant.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm or AI device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no clinical "ground truth" establishment in this context. Substantial equivalence is demonstrated by comparing device characteristics, not clinical outcomes in a broad sense.
• The sample size for the training set: Not applicable, as this is not an AI device or a device involving machine learning.
• How the ground truth for the training set was established: Not applicable, as this is not an AI device or a device involving machine learning.

What the document does describe in terms of "proving" the device:

The document aims to prove substantial equivalence to predicate devices. This is achieved by comparing the new device (ConMed Linvatec Bio Mini-Revo Suture Anchor) to existing, legally marketed devices (ConMed Linvatec Bio Mini-Revo Suture Anchor K053561 and Arthrex Bio-FASTak Suture Anchor K061863) based on:

• Design: Bioabsorbable screw-in suture anchor, preloaded on a disposable inserter, with one nonabsorbable braided polyethylene suture.
• Manufacturing Materials: Self-Reinforced (96L/4D) PLA Copolymer.
• Intended Use: Reattach soft tissue to bone in arthroscopic or open hip procedures, such as acetabular labral repair.
• Principles of Operation: Similar mechanism of action for tissue reattachment.
• Technical Characteristics: Comparison of properties relevant to a suture anchor, such as material composition, dimensions (implied by "mini-revo" and comparison to similarly purposed predicates), and mechanical performance (though specific data is not provided in this summary, it would have been part of the full 510(k) submission).

The FDA's letter (Page 2-3) confirms their review of the 510(k) premarket notification and their determination that the device is substantially equivalent to legally marketed predicate devices. This determination allows the device to be marketed.

In summary, the provided text describes a regulatory pathway (510(k)) that demonstrates substantial equivalence, not a clinical study proving performance against defined acceptance criteria by an AI or new medical device claiming novel functions.

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The ConMed Linvatec Osprey™ Drill System is intended for cutting, drilling, and manipulation of soft tissue and bone in the following applications: orthopedic, neurosurgical, spinal, cranial, otolaryngological, oral/maxillofacial, reconstructive, and plastic.

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The provided text describes a 510(k) summary for the ConMed Linvatec Osprey™ Drill System. A 510(k) submission is a premarket notification demonstrating that a medical device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include detailed information about acceptance criteria and specific studies proving those criteria, especially in the context of AI/ML performance metrics as requested in the prompt.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert qualifications, and ground truth are not present in this document. The document focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against specific quantitative acceptance criteria through detailed studies.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not list specific quantitative acceptance criteria or detailed performance metrics in the way that would be found in a study proving algorithm performance (e.g., sensitivity, specificity, AUC thresholds). The "performance" described implicitly is the substantial equivalence to predicate devices, meaning it performs as intended and is as safe and effective.

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

• Cannot be provided. The document describes a medical device, not an AI/ML algorithm that would use test sets of data. Therefore, there's no mention of sample sizes or data provenance for a test set.

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)

• Cannot be provided. As above, there's no mention of a "test set" or involvement of experts to establish ground truth in the context of an algorithm's performance.

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

• Cannot be provided. Not applicable to this type of device submission.

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

• Cannot be provided. This is not an AI-assisted device. The document pertains to an electric surgical drill system.

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

• Cannot be provided. This is not an AI algorithm.

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

• Cannot be provided. Not applicable. The "ground truth" for a surgical drill system would be its mechanical and functional performance, safety, and effectiveness in surgical procedures, as demonstrated through engineering tests and comparison to predicate devices, not through expert consensus on data interpretation.

8. The sample size for the training set

• Cannot be provided. There is no "training set" as this is not an AI/ML device.

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

• Cannot be provided. Not applicable.

Summary based on the provided document:

The ConMed Linvatec Osprey™ Drill System is an electric surgical system, not an AI/ML powered device. The 510(k) submission process focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against specific quantitative acceptance criteria through studies with data sets, ground truth, and expert adjudication, which are typically associated with AI/ML device evaluations. Therefore, the requested information regarding acceptance criteria and study details (sample size, experts, ground truth, MRMC studies) is not found in this 510(k) summary.

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