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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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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 vault should 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 with bone cement.

The Arthrosurface® glenoid components are intended to interface and articulate with the Sponsor's previously cleared and commercially marketed humeral head resurfacing prosthesis (K023096) to repair and replace a shoulder joint when both articular surfaces of the joint are affected. They are comprised of Ultra High Molecular Weight Polyethylene (UHMWPE) and are offered in both a peg and keel design. These components will be available in several sizes and are intended to be implanted using bone cement.

The provided text is a 510(k) premarket notification for a medical device, the GRS™ Glenoid Resurfacing System. It's a regulatory document demonstrating substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot fulfill your request for the table of acceptance criteria and device performance, nor can I provide information on sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document focuses on:

• Device Description: The GRS™ Glenoid Resurfacing System is an UHMWPE glenoid component, available in peg and keel designs, intended to articulate with Arthrosurface's previously cleared humeral head resurfacing prosthesis.
• Indications for Use: Reconstruction of painful/disabled shoulder joints due to post-traumatic degenerative disease or avascular necrosis, with sufficient bone stock and an intact/reconstructable rotator cuff. It's a single-use implant intended for use with bone cement.
• Substantial Equivalence: The key argument for market clearance is that the device is substantially equivalent in intended use, materials, and application to the DePuy Global™ Shoulder Glenoid Component K981487, Biomet Modular Hybrid Glenoid Synthes Epoca Shoulder Prosthesis System K060694, and K072578.

To gather the information you requested, an engineering validation report or a clinical study report (if one were required and performed for this type of device) would be necessary. These documents are generally not part of the initial 510(k) summary provided to the public unless specifically requested or if clinical data was a critical component of the substantial equivalence determination for complex devices. For a Class II orthopedic implant like this, substantial equivalence is often primarily based on material properties, design similarities, and mechanical testing against established standards, rather than extensive clinical efficacy studies in the same way a new drug or an AI diagnostic would be evaluated.

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The HemiCAP™ Patello-femoral Resurfacing Prosthesis is 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 HemiCAP™ Patello-Femoral Resurfacing Prosthesis incorporates a distal femoral trochlear surface articular component that mates to a fixation stud via a taper interlock, and an allpolyethylene patella component. The prosthesis is intended to be used in cemented arthroplasty.

The femoral articular component is manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The component has a bone contact surface that is coated with a spray-applied CP Titanium coating and a polished articular bearing surface. The fixation stud component is a short tapered cylinder, 13mm in length, manufactured of a Ti-6Al-4V ELI alloy per ASTM F136. The stud has a tapering helix, a full-length cannulation, and a proximal female taper bore. The patella prosthesis component is comprised of ultra-high-molecular weight polyethylene (UHMWPE) manufactured and tested to meet standards specified in ASTM F 648-04, Type I. The materials, manufacturing methods, and surface finish requirements for these components are identical to those used for the Sponsor's previously cleared devices (K021549, K023096, K031859, K050373).

The provided document is a 510(k) summary for the HemiCAP™ Patello-Femoral Resurfacing Prosthesis. It discusses the device's description, indications for use, and a statement regarding performance testing. However, it explicitly states that clinical data was not needed for this device as part of its substantial equivalence determination.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets those criteria.

Specifically, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria or report on device performance against them.
2. Sample size used for the test set and the data provenance: No clinical test set data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is discussed.
4. Adjudication method for the test set: No test set adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a medical prosthesis, not an AI diagnostic tool, so an MRMC study with human readers and AI is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a prosthesis.
7. The type of ground truth used: No clinical ground truth is discussed.
8. The sample size for the training set: No training set (clinical or otherwise for an AI/diagnostic algorithm) is mentioned.
9. How the ground truth for the training set was established: Not applicable.

The document highlights Non-Clinical Performance Testing was completed as part of the Arthrosurface Design Control Procedure to demonstrate safety and substantial equivalence to predicate devices. However, details of these non-clinical tests (e.g., specific acceptance criteria, test results) are not provided in this summary. The materials and manufacturing methods are stated to be identical to those used for the Sponsor's previously cleared devices, implying reliance on the established safety and effectiveness of those predicates.

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