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The Renewal™ Acetabular Cup System is intended for primary or revision reconstruction, with or without bone cement, of the acetabular portion of severely disabled and/or very painful hip joints, where radiographic evidence of sufficient sound bone is present. Clinical Indications for Use are:

1. Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory joint disease (IJD), e.g., rheumatoid arthritis;
3. patients with failed previous surgery where pain, deformity, or dysfunction persists;
4. revision of previously failed hip arthroplasty; and
5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Renewal™ Acetabular Cup System consists of metal acetabular shells and UHMWPE acetabular liners.
The Renewal™ Acetabular Shell will be available in a hemispherical titanium alloy shell with and without a 2 mm peripheral rim flare. The shells will be coated with commercially pure titanium porous beads.
Design features of the Renewal™ Acetabular shell are summarized below:

• Total hemispherical design .
• Hemispherical design with a 2 mm peripheral flare .
• Coated with CPTi porous beads ●
• . No-Hole, 3-hole, 5-Hole, and 9-Hole options
• Threaded apical hole plug
  The Renewal™ Acetabular Liners will be available with 0°, 10°, 15°, 20° overhangs with/without a 6+mm lateralized shift. The liner's internal geometry will be intended to be used with existing femoral heads manufactured from cobalt chrome or ceramic. The Renewal™ liner's external geometry will be designed to accept the Renewal™ Acetabular Shells.
  Design features of the Renewal™ Acetabular Liner are summarized below:
• 360° liner overhang positioning options .
• Features an easy-to-assemble snap lock system to lock the liner into the shell .
• . The lip of the 10° and 20° liners will be full hemispheres
• The lip of the 15° liner will be machined to 180° .
• The liners will be offered with 0°, 10°, 15°, and 20° overhangs .
• The 0° and 10° liners will also be offered with a 6+mm lateralized shift ●
• Internal diameter will have a 2mm chamfer to minimize impingement. .
  The thinnest part of any UHMWPE articulating insert will be greater than 4mm if attached to a metal backing.

This document is a 510(k) summary for the Orthopaedic Innovations Renewal™ Acetabular Cup System. It is an FDA submission seeking clearance to market a medical device, and as such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results as one might find for a novel device or a clinical trial.

Therefore, the provided text does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Instead, the document asserts that the device is "substantially equivalent" to previously cleared competitive devices based on its intended use, material, type of interface, and design features. It also mentions "testing results provided within the Premarket Notification" but does not detail what those results were, what the acceptance criteria for those tests were, or how they were quantified in terms of device performance.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• Acceptance Criteria and Reported Device Performance: Not provided. The document states "The safety and effectiveness of the Renewal™ Acetabular Cup System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." However, it does not enumerate specific acceptance criteria or report performance against them.
• Sample Size for Test Set and Data Provenance: Not provided.
• Number of Experts and Qualifications: Not applicable as no expert-adjudicated test set is described.
• Adjudication Method: Not applicable as no expert-adjudicated test set is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. This type of study is typically used for diagnostic devices involving human interpretation, which is not directly applicable to an acetabular cup system.
• Standalone (Algorithm Only) Performance: Not applicable. This is a medical device (implant), not an algorithm.
• Type of Ground Truth Used: Not applicable in the context of an "AI" or diagnostic device study. The "ground truth" for an implant's safety and effectiveness relies on material testing, design validation, and clinical outcomes (which are not presented here, but are typically part of post-market surveillance or larger clinical trials).
• Sample Size for Training Set: Not applicable. This is not an AI/ML device.
• How Ground Truth for Training Set was Established: Not applicable. This is not an AI/ML device.

In summary, the provided text is a regulatory submission focused on "substantial equivalence" for a physical medical implant (acetabular cup system), not a study report detailing performance metrics against specific acceptance criteria for an AI or diagnostic device.

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The Cobra device is designed to externally connect and stabilize pins and/or k-wires inserted into bone fragments allowing the fragments to heal in the proper orientation. The device is intended for fractures near the wrist joint, specifically fractures of the distal extremity of the radius, to include; extra-articular fractures, intra-articular fractures and impacted or die-punch fractures.

The device a two-piece hinged external fixator. Set-screws are used to secure orthopedic pins or K-wires to the fixator and establish the fixation angle.

This document describes a 510(k) premarket notification for the "Cobra External Fixator", a medical device. 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device.

Therefore, the typical concepts of "acceptance criteria," "reported device performance," and "study that proves the device meets the acceptance criteria" in the sense of a rigorous clinical or performance study with defined endpoints are not directly applicable in the same way they would be for a new drug or a more complex, novel medical device.

Based on the provided document, here's a breakdown of the requested information, focusing on what is available and an explanation of why certain information is absent in a 510(k) submission:

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

• Acceptance Criteria: For a 510(k) submission like this, the primary "acceptance criteria" is demonstrating substantial equivalence to a previously legally marketed device (the predicate). This is achieved by showing that the new device has the same intended use, principle of operation, and material requirements, and that any differences do not affect safety and effectiveness. The document states: "All devices have the same intended use, principle or operation and material requirements. Differences between the new and other predicate devices do not affect safety and effectiveness."
• Reported Device Performance: The document does not provide specific quantitative performance metrics (e.g., strength, durability, biocompatibility test results) in a results table format. It relies on the equivalence to the predicate device to infer performance. The summary mentions that the device is a "two-piece hinged external fixator" that uses "set-screws to secure orthopedic pins or K-wires to the fixator and establish the fixation angle." This describes its functional mechanism, implying it performs the same function as predicate devices.

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

• Not applicable for this 510(k) document. This submission primarily relies on demonstrating equivalence through comparison of design, materials, and intended use, rather than presenting a performance study with a test set of data. If any bench testing (e.g., mechanical strength) was performed, the details would typically be in a separate, more extensive submission document, not summarized in this brief safety and effectiveness statement. Such testing is usually conducted in a lab and wouldn't have "data provenance" in the clinical sense.

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. As no clinical "test set" with "ground truth" established by experts is described in this 510(k) summary, this information is not provided. The review process involves regulatory experts at the FDA assessing the submission against existing regulations and predicate devices.

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

• Not applicable. No test set requiring expert adjudication is described in the provided summary.

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 mechanical external fixator, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating diagnostic image interpretation.

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

• Not applicable. This device does not involve an algorithm.

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

• Not applicable. As there is no described performance study requiring "ground truth" to evaluate the device, this is not present. The "ground truth" in a 510(k) is effectively the established safety and effectiveness of the predicate device(s).

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not an AI or machine learning algorithm requiring a "training set."

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

• Not applicable. As there is no training set, there is no ground truth to establish for it.

In summary:

This 510(k) submission for the Cobra External Fixator demonstrates substantial equivalence to existing predicate devices. The "acceptance criteria" revolve around matching the predicate's intended use, principle of operation, and materials, and ensuring any differences do not impact safety or effectiveness. The document itself is a summary provided to the FDA to support the claim of substantial equivalence, and therefore, it does not contain the detailed performance study data, expert reviews, or AI-related metrics that would be expected for a novel, more complex device or an AI/ML product.

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The Prime Modular Endo Heads, with the Prime Cemented Femoral Stems, are intended to replace the femoral head in cases of femoral head and neck fracture, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed hip fracture treatment.

The Prime Modular Endo Heads feature a one piece spherical endo head and a Morse-type taper. This Morse-type taper provides for modular component selection, allowing the head to attach to the Prime Cemented Calcar Femoral Stems. The Prime Modular Endo Heads are provided in diameters from 36mm to 70mm in 1 mm (one millimeter) increments. It is constructed from Cobalt-Chrome Alloy, per ASTM F-1537. Sold Presterile.

This document is a 510(k) summary for a medical device (hip joint femoral prosthesis). It describes the device, its intended use, and compares it to substantially equivalent products. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical or performance validation study report for an AI/algorithm-based device.

The provided text is from a regulatory submission (510(k)) for a physical medical device (orthopaedic implant). The questions in your prompt are geared towards the validation of a software or AI-based medical device, which is a different type of submission and validation process.

Therefore, I cannot extract the requested information from the provided text because it does not exist within this document.

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This product is intended for use as a clamping mechanism between a group of percutaneous Schanz type pins and connecting rods. A minimum of four of these clamps combined with percutaneous pins and connecting rods would be used to externally bridge a fracture or non-union of a long-bone to provide a more stable environment for soft tissue and/or bone healing to occur. Indications for use include: fracture fixation(open and closed); pseudarthrosis or long bones (both congenital and acquired); limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of osteotomies; and correction of bony or soft tissue defects.

The product consists of AISI 316L stainless steel pins inserted above and below the fracture site. The carbon-fiber tubes in combination with pin clamps act to hold the transfixation pins at the desires angle and position. Bar-bar clamps are used to combine additional carbon fiber tubes in the desired configuration

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for an external fixation system, which describes the product, its intended use, and compares it to substantially equivalent products. It does not include details about device performance metrics, studies, or clinical trial data as requested in your prompt.

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Ask a specific question about this device

Ask a specific question about this device