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1. Osteoarthritis
2. Rheumatoid arthritis with severe hip pain and limited joint motion.
3. Avascular necrosis
4. Traumatic arthritis
5. Acetabular cavity deformities caused by congenital problems.
6. Revisional surgery after one or more total hip operations.
7. Fixation with bone cement and/or cancellous bone screws.

The rimmed acetabular component is manufactured of Titanium 6 A1-4V Bli (ASTM F136). It is available in five sizes: 54mm, 58mm, 64mm, 70mm, and 76mm. The BioPro rimmed acetabular component accommodates BioPro's 28nun and 32mm Cox Comb inserts: 28x55 (10068), 28x58 (10069), 28x65 (10071), 28x69 (10074), 28x75 (11227), 32x55 (10077), 32x58 (10078), 32x65 (10081), 32x69 (10083), and 32x75 (10084).

This document is a 510(k) summary for the BioPro Rimmed Acetabular Component, detailing its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document focuses on regulatory approval based on equivalence rather than performance testing against specific criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. This type of information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) summary.

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The BIOPRO Cobalt Trapeziometacarpal Replacement is intended to resurface the joint in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present themselves as either a painful, instable thumb with limited range of motion.

The BIOPRO Cobalt Trapeziometacarpal Replacement is a one-piece resurfacing component for the basal thumb joint. It has an anatomically configured tri-flanged stem that fits into the medullary canal at the proximal end of the first metacarpal. This tri-flanged configuration allows for compaction of bone around the implant to provide stable fixation and to prevent rotation of the device. The head is spherical and extends just beyond a hemisphere, slightly medialized on the stem and is at a 20° varus angle to the stem to properly space the joint and allow for sufficient range of motion. The trapezium is resurfaced to contain the head of the implant and this resurfacing is continued into the second metacarpal. Resurfacing the second metacarpal prevents impingement of the implant against that bone and decreases the possibility of dislocation of the joint.

This document is a 510(k) premarket notification for a medical device, specifically a joint replacement implant. It does not describe a study that uses AI or machine learning, nor does it present acceptance criteria or detailed performance data in the way you've outlined for AI/ML device evaluations.

Therefore, I cannot populate the table and answer the questions based on the provided text, as this document pertains to a traditional medical device submission and not an AI/ML device.

Here's why and what information could be derived if this were an AI/ML context:

• Acceptance Criteria & Reported Performance: Not provided for an AI system. The text describes the device's design and intended function, not a data-driven performance metric.
• Sample size (test set) & Data Provenance: Not applicable. The document describes the device itself, not a dataset used to evaluate an algorithm.
• Number of experts & Qualifications: Not applicable. There's no mention of expert review for establishing ground truth of an AI model's output.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

What the document does describe (and why it doesn't fit your AI/ML questions):

• Device Name: BIOPRO Cobalt Trapeziometacarpal Replacement
• Intended Use: Resurface the basal thumb joint for conditions like rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture deformation/bone loss.
• Predicate Device: Swanson Titanium Condylar Implant (K864488) This is crucial for 510(k) submissions, as the new device's safety and effectiveness are established by demonstrating substantial equivalence to a legally marketed predicate device.
• Device Description: Detailed physical characteristics, material (Cobalt Chrome), design features (tri-flanged stem, spherical head, varus angle), and how it addresses biological mechanics (stable fixation, range of motion, impingement prevention).
• Similarities and Differences to Predicate: This is the core of a 510(k) submission, comparing function, materials, and shapes to argue for substantial equivalence.

In summary, the provided text is a traditional medical device 510(k) summary, not an AI/ML device performance study.

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Both systems are indicated for treatment of osteoarthritis, rheumatoid arthritis, avascular necrosis, and traumatic arthritis. Contraindications include: excessive bone loss, septic arthritis, periarticular osteomyelitis, and local or systemic infection.

proprietary name: Horizon Hip System common name: prosthetic. Total Hip System classification name: prosthetic, Total Hip System

Femoral component: The Horizon Femoral Stem is manufactured from cobalt chrome and features a collar to distribute stress in a physiological manner. It is available with or without porous coating. The femoral component is available in five sizes: 12mm, 15mm, 16,5mm, and 18mm.

Acetabular Insert: The Horizon Acetabular Insert is manufactured of UHMWPE. It is designed to snap fit into the acetabular shell. The insert will accept 28mm heads. It is offered in sizes ranging from 46mm to 60mm.

Acetabular Shell (cup): The Horizon Acetabular Shell is manufactured of cobalt chrome. It features three spikes to prevent rotation. It also features a groove on its I.D. to accept the mating acetabular insert. The acetabular shell is porous coated to promote long term fixation. The acetabular shell is available in eight sizes: 46mm, 48mm, 52mm, 52mm, 56mm, 56mm, and 60mm.

This document is a 510(k) summary for a medical device (Horizon Hip System) and does not describe a study involving an algorithm or AI. Therefore, it does not contain the information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or comparative effectiveness studies for an AI-powered device.

The provided text focuses on demonstrating substantial equivalence between the Horizon Hip System and predicate devices (Depuy AML femoral stems and AML Plus Depuy cup) based on material, design, and intended use for regulatory clearance, not on reporting performance metrics from a technical study.

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The Townley Elbow System contains three components which are intended for single use. Cement fixation of the components is required.

Indications: Osteoarthritis, Rheumatoid arthritis with severe elbow pain and limited joint motion.

Humeral Component: The humeral component of the Townley Total Elbow is manufactured of Cobalt Chrome (ASTM F-799). It is offered in both right and left designs and features a stabilizing intramedullary stem that is angled in five degrees of valgus to accommodate the normal carrying angle of the elbow. The proximal, bone-interfacing, non-articulating side of the body is designed with a squared receptical to accept the similarly remodeled humeral condyles. The articulating surface of the humeral component is contoured to allow a snap-fit with the ulnar component and is extended laterally to articulate with the radial head. It is offered in three sizes: 35mm, 40mm, and 45mm.

Ulnar Insert: The ulnar insert is manufactured of UHMWPE. The insert is designed to snap onto the humeral component and provide a stable joint while retaining multiplanar flexibility. It is offered in two sizes: small and large.

Ulnar Tray: The ulnar tray is manufactured of Cobalt Chrome (ASTM F-799). It features a L-shaped body which provides support for the polyethylene insert as well as a stem that aids in fixation. It is offered in two sizes: small and large.

This document is a 510(k) Summary for the Townley Total Elbow System, submitted by Biopro. It describes a medical device, specifically a prosthetic total elbow, and compares it to a predicate device, the Capitello-Condylar Total Elbow.

Analysis of the Provided Text for Acceptance Criteria and Study Details:

The provided text does not contain any information regarding clinical studies, acceptance criteria, or performance metrics in the way one would typically describe a study proving a device meets acceptance criteria.

Instead, the document is a 510(k) Summary which 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.

The entire "study" in this context is a comparison to a predicate device based on design features, materials, and general function, rather than an independent clinical trial with defined acceptance criteria and performance outcomes.

Therefore, I cannot extract the requested information in the format you provided because the document describes a device comparison for substantial equivalence, not a clinical performance study with acceptance criteria.

Here's how the information would look if the document did contain the requested details, along with an explanation of why it's absent:

Acceptance Criteria and Study for Townley Total Elbow System (Information Not Present in Document)

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

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