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The OVOMotion Reverse Shoulder Arthroplasty System is intended for primary total shoulder replacement in a reverse shoulder configuration. The device is indicated for a patient with painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis. The humeral head and glenoid vault should be of sufficient bone stock to support loading. The patient's joint must have gross rotator cuff deficiency, a functional deltoid muscle and be anatomically suited to receive the selected implants.

Glenoid Baseplate components are intended for cementless use with the addition of screw fixation. The Humeral Stem components are intended for both cemented and cementless use.

The OVOMotion Reverse Shoulder Arthroplasty System (RSA) is a system of components intended for total shoulder replacement in a reverse shoulder configuration. The humeral side of the system is comprised of a humeral cup and humeral insert which are attached to the Arthrosurface TSA Humeral Stem using an adapter ring. The glenosphere is implanted with the GlenoidBaseplate onto the glenoid side of the joint fixated with locking Center and Peripheral Screws.

This document describes the OVOMotion Reverse Shoulder Arthroplasty System and its equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested. The document primarily focuses on demonstrating substantial equivalence through mechanical and wear testing against established ASTM standards and comparing technological characteristics with a predicate device.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, details of MRMC studies, standalone performance details, type of ground truth used, or training set information.

The document states:

• "No animal or clinical tests were conducted to establish equivalence."
• The performance data provided are primarily mechanical and wear tests against ASTM standards. These tests establish equivalence to a predicate device rather than meeting specific performance acceptance criteria for a novel device.

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The Arthrosurface Total Wrist Arthroplasty System is indicated for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.

The device is a single-use implant intended to be used with bone cement.

The Arthrosurface Total Wrist Arthroplasty (TWA) System is a modular joint restoration system that consists of both a radial implant assembly and carpal implant assembly. The radial implant assembly is comprised of a metallic stemmed tray component and Ultra-High-Molecular-Weight-Polyethylene (UHMWPE) articular component. The carpal implant assembly consists of a taper post component, a carpal plate, an articular component and two auxiliary bone screw components, all of which are metallic. The system is designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint.

The provided text describes a 510(k) premarket notification for the Arthrosurface WristMotion Total Wrist Arthroplasty System. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a study proving the device meets specific performance criteria as would be found for a novel device.

Therefore, many of the requested details, particularly regarding acceptance criteria with reported performance, sample sizes for test and training sets, expert qualifications, and specific AI-related comparative effectiveness or standalone studies, are not applicable or not explicitly provided in this type of regulatory document.

However, based on the information given, here's what can be extracted and inferred:

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

This information is not explicitly provided in a quantified table format in the document. The submission focuses on demonstrating substantial equivalence through non-clinical tests. The "Conclusion" states: "The results have demonstrated the safety and effectiveness of the Arthrosurface Total Wrist Arthroplasty System along with substantial equivalence to the predicate devices." This implies that the device met the performance expectations for these tests, but the specific acceptance criteria (e.g., maximum torque, minimum cycles) and the reported values are not detailed.

Specific Non-Clinical Tests Conducted (without acceptance criteria or reported performance):

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: Not specified. The document mentions "non-clinical tests and/or analysis" but does not detail the number of samples used for each test.
• Data Provenance: The tests are non-clinical, likely performed in a laboratory setting, so country of origin or retrospective/prospective nature of patient data is not applicable.

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 applicable as this submission is for a medical implant (arthroplasty system), not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The "ground truth" for non-clinical device testing refers to engineering standards and physical measurements.

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

Not applicable for this type of non-clinical device testing. Adjudication methods are typically used in clinical studies or for interpreting ambiguous cases in AI/software performance evaluations by humans.

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 submission is for a medical implant, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This submission is for a medical implant.

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

The "ground truth" for the non-clinical tests listed would be based on engineering standards, material properties, and physical measurements performed in a laboratory. For example, for "torsion to failure," the ground truth would be the objectively measured torque at which the screw failed, compared against a pre-defined standard or predicate device performance. For the LAL test, the ground truth is whether the endotoxin level meets the specified USP and AAMI standards.

8. The sample size for the training set:

Not applicable. This submission is for a physical medical implant, not a machine learning model that requires a training set.

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

Not applicable. As above, this is for a physical implant, not an AI/ML device.

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Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement or without bone cement.

The Arthrosurface MTP implant incorporates an articular resurfacing component and a taper post component that mate together via a morse taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

Per K132496, the MTP can be used in conjunction with the Arthrosurface Proximal Phalanx Implant as a Total Toe option. K132496 also cleared the most recent version of the mating articular component.

Fixation components are being included in the system that contain an additional ring of material intended to improve stabilization in a first metatarsal that presents with a distal bone void. The articulating component and taper configuration are unchanged. The phalangeal implant is unchanged.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for an AI/algorithm-based medical device.

The document is a 510(k) premarket notification for the BOSS Toe Fixation System, which is a physical implant (a hemi-arthroplasty implant for the metatarsophalangeal joint).

Therefore, I cannot extract the following information from the provided text:

• A table of acceptance criteria and the reported device performance (for an algorithm)
• Sample size used for the test set and the data provenance (for an algorithm)
• Number of experts used to establish the ground truth for the test set and their qualifications (for an algorithm)
• Adjudication method (for an algorithm's ground truth)
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone performance study was done (for an algorithm)
• The type of ground truth used (for an algorithm)
• The sample size for the training set (for an algorithm)
• How the ground truth for the training set was established (for an algorithm)

The document focuses on demonstrating substantial equivalence to an existing predicate device based on its indications for use, operating principle, materials, instrumentation, packaging, sterilization, and non-clinical tests (mechanical strength, cadaveric evaluation, bacterial endotoxins test). These tests are standard for a physical implant, not for an AI/algorithm.

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Intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar dislocation or patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.

The Patello-Femoral Wave《hung Arthroplasty System is a line extension to the Sponsor's previously cleared and commercially marketed HemiCAP™ Patello-Femoral Resurfacing System.

The line extension consists of a larger femoral component for increased coverage of the trochlear groove. The additional sizes will address larger defects of the superior aspect of the trochlea and provide greater coverage superiorly. The system also includes larger mating UHMWPE patella components as described within.

The larger PF Kahuna trochlear Patello-Femoral Wave"«ከ«ባ articular component is designed to mate with the currently marketed Arthrosurface Patello-Femoral fixation component.

The majority of the implantation technique steps are the same. The PF Kahuna trochlear component is implanted using the same Instrumentation Set as with the HemiCAP™ Patello-Femoral Resurfacing System, with the addition of a reaming operation to create the superior ream. The reamers, associated implant trials etc. are contained within an adjunct Patello-Femoral WaveKahuna Instrumentation Kit.

The provided text is a 510(k) premarket notification letter and summary for a medical device, the "Patello-Femoral Wave (Kahuna) Arthroplasty System." This document primarily focuses on demonstrating the device's substantial equivalence to a legally marketed predicate device (HemiCAP Patello-Femoral Resurfacing Prosthesis K071413) based on its design, materials, indications for use, and testing.

It is important to note that this document does NOT describe the acceptance criteria or a study that proves the device meets specific performance metrics in the way that an AI/ML medical device submission would. This is a traditional medical device (implant) 510(k) submission, and the "tests" mentioned are primarily about material compatibility, mechanical performance (e.g., contact area, subluxation testing), and sterility rather than a performance study involving diagnostic accuracy or clinical outcomes in the sense of an AI/ML device.

Therefore, most of the requested information regarding acceptance criteria, study sample sizes, expert involvement, ground truth, and AI/ML specific studies (MRMC, standalone performance) for an AI/ML device is not applicable or present in this document.

However, I can extract the information that is present:

Summary of Device Performance and Equivalence (based on the provided text):

The "Patello-Femoral Wave (Kahuna) Arthroplasty System" is a line extension of a previously cleared device. Its approval is based on demonstrating substantial equivalence to the predicate device by showing:

• Same Indications for Use
• Same operating principle
• Manufactured using the same implant grade orthopedic materials
• Utilizes similar instrumentation for proper placement
• Packaged and sterilized using the same materials and processes

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

(Not directly applicable in the AI/ML context, but here's what's presented for this traditional medical device):

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: Not specified in terms of patient or case numbers for clinical tests. The "tests" listed are bench-top mechanical and material characterization tests.
• Data Provenance: Not applicable in the context of clinical data for this type of submission. The tests are laboratory-based.

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 document does not describe a study involving expert readers or ground truth establishment for a diagnostic or AI/ML performance evaluation. The "experts" would be the engineers and scientists conducting the described non-clinical tests.

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

• Not applicable. This is not a study assessing diagnostic accuracy or clinical outcomes via human interpretation.

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

• No. This document does not mention or present any MRMC study, nor is it an AI/ML device.

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

• No. This document describes a physical implant, not an algorithm.

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

• Not applicable in the AI/ML sense. The "ground truth" for this device's approval relates to established engineering and material science standards (e.g., USP chapters, AAMI standards for endotoxins, mechanical test methodologies) and comparison to the predicate device's known characteristics.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" or corresponding ground truth establishment for this traditional medical device.

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For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck and glenoid be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable.

The device is a single use implant intended to be used for hemiarthroplasty or in conjunction with the Arthrosurface glenoid component for total shoulder arthroplasty.

Both humeral and glenoid components of the OVOMotion™ Shoulder Arthroplasty System are intended for cemented use only.

The OVOMotion™ Humeral prosthesis incorporates an articular resurfacing component and a taper post fixation component that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface.

The Arthrosurface OVOMotion™ Shoulder Arthroplasty System is intended as hemiarthroplasty or in conjunction with Sponsor's previously cleared and commercially marketed glenoid prosthesis (K091196) to repair and replace a shoulder joint when both articular surfaces of the joint are affected.

Humeral articular components are manufactured from CoCrMo and mate with corresponding Ti fixation component. Glenoid components are made from Ultra High Molecular Weight Polyethylene (UHMWPE). Both humeral and glenoid components are available in multiple sizes and curvatures and are intended to be implanted using bone cement.

This document is a 510(k) premarket notification for a medical device called the OVOMotion™ Shoulder Arthroplasty System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study to prove acceptance criteria for a new AI/software device.

Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly for an AI/software-based medical device.

The information provided describes:

• The device: OVOMotion™ Shoulder Arthroplasty System, a shoulder arthroplasty (joint replacement) system.
• Its purpose: Reconstruction of painful and/or severely disabled shoulder joints due to post-traumatic degenerative disease or avascular necrosis.
• Materials: Humeral articular components from CoCrMo, Ti fixation components, and glenoid components from UHMWPE.
• Intended use: Hemiarthroplasty or total shoulder arthroplasty, intended for cemented use only.
• Regulatory classification: Class II medical device.
• Basis for clearance: Substantial equivalence to predicate devices (previously cleared shoulder arthroplasty systems).
• Non-clinical tests performed: Device comparative analysis, humeral head mechanical testing (Assembly & Disassembly, Resistance to Torque, Cyclic Fatigue, Fretting Corrosion, Static Compression to Failure, Shear Testing, Lever Out), and a Kinetic Chromogenic LAL Test for Bacterial Endotoxins.

None of these elements pertain to acceptance criteria for an AI/software device, clinical study data, ground truth establishment, or multi-reader, multi-case studies.

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The Arthrosurface Bone Screws (2.0-3.0 mm solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist.

The Arthrosurface Bone Screws (3.5 mm and larger, solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, shoulder, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula.

The Arthrosurface Bone Screws have diameters ranging from 2.0 mm to 4.0 mm and lengths ranging from 8 mm to 50 mm. The screws are either partially or fully threaded, solid or cannulated, self-tapping or self-drilling and are manufactured from implant grade stainless steel or titanium alloy. Depending on their size, these bone screws are intended to be used for different indications for use.

Here's a breakdown of the acceptance criteria and the study information based on the provided FDA 510(k) summary for the Arthrosurface Bone Screws:

It's important to note that this document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to existing devices, rather than proving a new device meets specific, novel acceptance criteria through a clinical trial. Therefore, the "study" described is primarily non-clinical testing to show equivalence in performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for bone screws, the "acceptance criteria" are generally derived from recognized industry standards for mechanical performance and safety, and the "reported device performance" are the results demonstrating compliance with these standards.

Note: The document states "demonstrated that the Arthrosurface Bone Screws are substantially equivalent to the predicate devices" and "The safety and effectiveness... is adequately supported by the substantial equivalence and performance testing information," implying that the device met the established criteria within these standards.

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

• Test Set Sample Size: The document does not specify the exact number of screws or tests performed for each non-clinical test (torque, pullout, LAL). It typically refers to "the Arthrosurface Bone Screws" as a general product line being tested.
• Data Provenance: The data is generated from non-clinical laboratory testing conducted by the manufacturer, Arthrosurface, Inc. The location of the testing is not specified beyond the company's address in Franklin, Massachusetts. This is prospective testing conducted specifically for the 510(k) submission.

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

This section is not applicable in the context of this 510(k) submission for bone screws.

• Ground truth is typically established through expert consensus or clinical outcomes for diagnostic or AI-driven devices. For implantable mechanical devices like bone screws, "ground truth" is determined by objective physical and chemical testing against established engineering and biocompatibility standards (e.g., ASTM, USP). There are no human experts "establishing ground truth" in the way one would for image interpretation.

4. Adjudication Method for the Test Set

This section is not applicable. As described above, the "test set" involves physical and chemical property measurements against predefined international standards, not subjective assessments requiring adjudication among human experts.

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

No, an MRMC comparative effectiveness study was not done.

• MRMC studies are typically used for diagnostic devices (e.g., imaging AI) to compare the performance of human readers with and without AI assistance. This device is a mechanical bone fixation fastener, not a diagnostic tool.

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

No, this concept is not applicable.

• This question pertains to AI/software as a medical device (SaMD). The Arthrosurface Bone Screw is a physical implantable device. There is no "algorithm" or standalone software performance to evaluate in this context.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance testing is based on:

• Established engineering standards: Specifically, ASTM F543 for mechanical properties (torque to failure, insertion/removal torque, axial pullout force).
• Biocompatibility and sterility standards: United States Pharmacopeia (USP) Chapter Bacterial Endotoxins Test, USP Chapter Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies.

8. The Sample Size for the Training Set

This section is not applicable.

• There is no "training set" in the context of a 510(k) submission for a mechanical bone screw. Training sets are used for machine learning algorithms.

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

This section is not applicable for the same reason as point 8.

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Intended for fixation during the healing process for:

• . Syndesmotic trauma, such as syndesmosis disruptions in connection with Weber B and C ankle fractures.
• . Reconstruction (correction) of a hallux valgus deformity by providing for the reduction of 1st metatarsal-201 metatarsal (IM) angle.

The KISSloc™ Suture System is a non-resorbable system consisting of a small Suture Plate, UHMWPE Suture Assembly and Arrow Plate for security. The suture is hooked around the Arrow Plate and passes through the two holes in the plate to form the entire assembly. This implant construct is intended to be used for fracture fixation between two bone segments and/or realignment and stabilization of an underlying skeletal (bony or soft tissue) deformity. Ancillary instruments required to aid in insertion of the KISSloc™ Suture System will be provided separately in a sterile disposable package. All implant components will also be provided in a sterile package.

The provided document is a 510(k) premarket notification decision letter from the FDA regarding the KISSloc™ Suture System. This document does not contain information related to an AI/ML medical device submission. It pertains to a mechanical fixation device (suture system) and its substantial equivalence to previously marketed predicate devices based on non-clinical mechanical testing.

Therefore, I cannot provide the requested information about acceptance criteria, study details for an AI/ML device, sample sizes, expert qualifications, ground truth establishment, or human-in-the-loop studies. These concepts are relevant to the evaluation of AI/ML software as a medical device (SaMD), but not to the traditional mechanical device described in this 510(k).

The document explicitly states: "No clinical data was provided in support of this substantial equivalency." and the evaluation was based on "non-clinical testing" like "Static tensile load to failure".

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Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.

The ToeMATE® Hammertoe Correction System consists of two intramedullary bone screws, a taper lock pin and a set of instruments used for implant site preparation and delivery. The implants are offered in three size options, x-small, small and large. The taper lock pin provides a press fit connection between the two screws with light contact pressure and is available in straight and angled configurations. The implant components are manufactured using implant grade titanium alloy and cobalt-chrome alloy.

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding the "ToeMATE® Hammertoe Correction System". This document focuses on the regulatory clearance process and establishing substantial equivalence to previously cleared predicate devices.

It does not contain information about acceptance criteria, device performance, or any specific study details such as sample sizes, data provenance, expert qualifications, ground truth establishment, or specific study types like MRMC or standalone performance. The document primarily discusses:

• Device Name and Regulation Information: ToeMATE® Hammertoe Correction System.
• Indications for Use: Small bone fusion, fractures, and inter-digital fusion of the fingers, toes, and small bones.
• Device Description: Two intramedullary bone screws, a taper lock pin, and instruments, made from implant grade titanium alloy and cobalt-chrome alloy.
• Substantial Equivalence: Claiming substantial equivalence to predicate devices (K130859, K101165, K120645) based on similar indications for use, operating principles, materials, instrumentation, packaging, and sterilization.
• Non-Clinical Tests: Lists "Device Comparative Analysis," "Mechanical Testing" (static and dynamic cantilever bending, torque to failure, insertion/removal torque, axial pullout, and disassembly), and a "Kinetic Chromogenic LAL Test" for bacterial endotoxins.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided document. The document states that the results demonstrated substantial equivalence but does not provide those results or the detailed methodology of how performance was assessed against any specified acceptance criteria.

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Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

The AlignMATE™ Lapidus Arthrodesis System consists of bone plates and bone screws (locking, non-locking and interfragmentary), which are intended to be used for surgical fusion or arthrodesis between two bone segments (ex. 1st metatarsalcuneiform fusion as in a Lapidus procedure). All implant components are manufactured from implant grade titanium alloy.

This document is a 510(k) premarket notification for a medical device (AlignMATE™ Lapidus Arthrodesis System), not an AI/ML medical device. Therefore, the information requested in your prompt regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment, is not applicable to this document.

This document describes a traditional medical device (bone plates and screws) and proves its substantial equivalence to previously cleared predicate devices based on:

1. Indications for Use: The new device has the same intended uses as the predicate devices.
2. Operating Principle: It functions in the same way.
3. Materials: It is made from the same implant-grade titanium alloy.
4. Instrumentation: It uses similar tools for placement.
5. Packaging and Sterilization: These processes are consistent with the predicate devices.
6. Non-clinical Testing: Mechanical testing (bending, torsional, insertion/removal, pullout) per ASTM standards and a bacterial endotoxins test were performed to demonstrate performance comparable to predicate devices.

There is no mention of any AI/ML component in the AlignMATE™ Lapidus Arthrodesis System, nor any AI/ML performance study conducted or referenced in this FDA submission.

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Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

The Arthrosurface Bone Screws have a diameter of 2.0/2.7 mm and are made available in lengths varying from 8 mm to 24 mm with 2 mm increments. The bone screws have a snap-off feature and are designed to work with a powered wire driver, and are manufactured from implant grade stainless steel or titanium allov.

The provided text describes a 510(k) premarket notification for Arthrosurface Bone Screws and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The document is a traditional 510(k) submission for a physical medical device (bone screws), where substantial equivalence to a predicate device is demonstrated through comparisons of indications, materials, and non-clinical tests like a pyrogenicity test. It does not mention any AI/ML components, comparative effectiveness studies (MRMC), standalone algorithm performance, or the involvement of experts for establishing ground truth as would be relevant for AI/ML devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance as it pertains to AI/ML devices from this text.

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