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The Biocore9 Femoral Resurfacing Head Component, is indicated for the treatment of painful hip arthritis due to post-traumatic arthritis, or rheumatoid arthritis, as well as painful hip arthroplasty when sufficient femoral head and neck stock exist to stabilize a resurfacing femoral head. The Biocore9 Femoral Resurfacing Head Component is intended for cemented use only. This device is intended for hemi-arthroplasty only.

The Biocore9 Femoral Resurfacing Head component is a non-constrained orthopedic implant intended to replace the articular surface of the existing femoral head in the patient's hip joint. The Biocore9 Femoral Resurfacing Head Component is intended for in the reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis. Sufficient bone stock on the femoral head and neck is necessary to stabilize a resurfacing femoral component. This device is intended for cemented use only. Components are available in thirteen sizes with available outside diameters 39.5, 41, 42.5, 47, 49, 51, and 52.5 mm.

The Biocore9 Femoral Resurfacing Head Component is manufactured from Ti-6Al-4V alloy (ASTM F136-13) with a Titanium Nitride (TiN) thin film ceramic coating. The titanium nitride coating is an inert, highly adherent, near diamond-hard surface coating.

The Femoral Resurfacing component is axisymmetric with a truncated spherical shell and a tapered central alignment stem. The component consists of a thin-walled spherical shell. The internal surface of the spherical shell is covered with a porous coating consisting of titanium beads. The stem is not porous coated.

This document describes a medical device, the Biocore9 Femoral Resurfacing Head Component, and its substantial equivalence to a predicate device. However, the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The information provided pertains to the regulatory clearance of a physical medical implant, specifically a hip joint femoral resurfacing prosthesis. The performance testing mentioned (TiN coating characterization, porous coating characterization, wear testing, abrasion resistance, and fatigue testing) are typical for mechanical implants to demonstrate material properties and durability, not for evaluating the performance of an AI/ML algorithm.

Therefore, I cannot answer your request regarding:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device).
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is about a Class II medical device (orthopedic implant) that is cleared based on demonstrating substantial equivalence to a predicate device through material and mechanical testing, not through clinical or AI/ML performance evaluation.

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The Cormet Cementless Resurfacing Femoral Head is indicated for hemi hip resurfacing arthroplasty in patients with non-inflammatory degenerative joint disease, including osteo and rheumatoid arthritis, post traumatic disease and avascular necrosis.

It is indicated for relief of pain and disability, and to restore hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, the bearing surface and supportive bone structure of the acetabulum being normal.

It is intended for patients having deformities of the hip that do not lend themselves to conventional total hip replacement such as:

• previously failed femoral osteotomy, .
• early deformities of the proximal end of the femur. .

The Cormet Cementless Resurfacing Femoral Head is indicated for cementless use only.

The Cormet Cementless Resurfacing Femoral Head is a femoral component manufactured from cast cobalt-chromium-molybdenum (Co-Cr-Mo) alloy complying with the requirements of ASTM F75 and ISO 5832-4. It is designed to replace the outer surface of the natural femoral head for hemi hip arthroplasty and articulates against the natural acetabulum. The component has a central stem and three internal splines to provide anti-rotational stability. The inner, bone contacting surfaces of the component have coatings of plasma sprayed titanium and hydroxyapatite for cementless fixation. The Cormet Cementless Resurfacing Femoral Head is not approved for use with an acetabular component in the US.

The provided text is a 510(k) summary for a medical device called the "Cormet Cementless Resurfacing Femoral Head." It outlines the device description, intended use, and claims of substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets such criteria.

Specifically, the document states:

• "Non-clinical testing submitted to support a determination of substantial equivalence was based on coating characterization. The coating applied to the Cormet Cementless Resurfacing Femoral Head consisting of plasma sprayed titanium and hydroxyapatite was characterized and cleared under K083312 (Corin MiniHip Stem)." (Section 11)
• "No additional bench testing was required since the cemented version of the device is a legally marketed predicate device." (Section 11)
• "Clinical testing was not necessary to determine substantial equivalence between the Cormet Cementless Resurfacing Femoral Head and the predicate devices." (Section 12)

Therefore, based on the provided text, I cannot complete the requested information, as the device's approval was based on substantial equivalence to existing devices and coating characterization, not on a study demonstrating its performance against specific acceptance criteria.

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The CONSERVE® Pressfit Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.

CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use

The design features of the CONSERVE® Femoral Resurfacing Component are summarized below:

• Manufactured from Cobalt Chrome Alloy
• 12 Sizes in 2mm increments
• Plasma Spray undersurface

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it describes a substantial equivalence determination for a medical device.

Therefore, I cannot fulfill your request as the required information is not present in the provided text.

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Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis.

The device is a single use implant intended for press-fit application.

The ReCap® HA Press-Fit Femoral Resurfacing Head is a singleuse, hemi-hip femoral resurfacing head, designed to replace the outer surface of a natural femoral head, while preserving as much natural bone as possible.

The provided document is a 510(k) summary for the ReCap® HA Press-Fit Femoral Resurfacing Head, a hemi-hip femoral prosthesis. It explicitly states that no clinical testing was required for this device as it was found substantially equivalent to a predicate device based on non-clinical testing (mechanical testing, engineering analysis, and cadaver studies) and minor modifications.

Therefore, the study design elements requested in the prompt, such as acceptance criteria, reported device performance from clinical studies, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable to this submission. The device's acceptance criteria were met through non-clinical methods demonstrating substantial equivalence to a legally marketed predicate device.

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FOR HEMI-HIP RESURFACING ARTHROPLASTY:

The Durom Hip Resurfacing system femoral component, when used for hemi-hip arthroplasty, has been designed for cemented use in patients who are likely to outlive a conventional hip prosthesis. Femoral hip resurfacing hemi arthroplasty is most appropriate for patients with good bone quality in the femoral head and acetabulum, where the bearing surface and supportive bone structure of the acetabulum is normal, and where acetabular replacement is neither required nor desirable. Such patients will generally be under the age of 65.

• Non inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis if remaining bone stock is adequate, and osteoarthritis
• Inflammatory joint disease (IJD), e.g. rheumatoid arthritis
• Joint replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives

Additional indications include other abnormalities where major pathology affects the femoral head; where the bearing surface and supportive bone structure of the acetabulum is normal; and where acetabular replacement is neither required nor desirable

• WARNING: The Durom Femoral component is not approved for use with the Durom Acetabular cup for total hip surface replacement arthroplasty in the USA.

The Durom® Hip Resurfacing System femoral component consists of a monoblock head and slim-line femoral guide pin. The head is an extended hemisphere (greater than 180°). It is available in 12 sizes with Outside Diameters (ODs) ranging from 38mm to 60mm. The spherecity of the head is tightly controlled to less than 10 microns. The underside of the head has recesses for controlled pressurization of cement into the cancellous bone, and for rotational stability after implantation.

The provided text describes the Zimmer Durom® Hip Resurfacing System's femoral components and its FDA 510(k) clearance. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as typically found in studies for AI/software devices.

This document is a traditional 510(k) premarket notification for a physical medical device (a hip resurfacing system), not a software or AI device. Therefore, the types of performance data and study methodologies you're asking about (e.g., test sets, ground truth by experts, MRMC studies, standalone algorithm performance) are not applicable or present in this filing.

Instead, the "Performance Data (Non-clinical)" section briefly mentions:
"The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective."

This statement implies that the device underwent engineering and biomechanical testing typical for orthopedic implants, such as fatigue testing, wear testing, material characterization, and possibly cadaveric studies or computational modeling, to ensure its structural integrity, biocompatibility, and mechanical performance under simulated physiological conditions. However, the specific details, results, and acceptance criteria for these tests are not included in this summary.

In summary, based only on the provided text, I cannot answer the questions as they pertain to a software or AI device's performance study. The document outlines the device's description, intended use, and substantial equivalence to predicate devices based on material, design, and similar performance characteristics evident from non-clinical laboratory testing.

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The CONSERVE® Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.

The CONSERVE® Femoral Resurfacing Component is indicated for cemented use only.

The design features of the CONSERVE® Femoral Resurfacing Component are summarized below:

• Manufactured from Cobalt Chrome Alloy .
• 11 Sizes in 2mm increments .

The provided text describes a 510(k) summary for the CONSERVE® Femoral Resurfacing Component but does not contain information related to acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The document is for a medical device (a prosthetic hip component) and uses "substantial equivalence" to a predicate device as its basis for clearance, not performance metrics from a study against predefined acceptance criteria for an AI/ML algorithm.

Therefore, most of the requested information cannot be extracted from this document, as it outlines a different type of regulatory submission.

Here's what can be stated based on the provided text:

Acceptance Criteria and Device Performance for the CONSERVE® Femoral Resurfacing Component:

This document is a 510(k) summary for a physical medical device (CONSERVE® Femoral Resurfacing Component), not an AI/ML-driven device. As such, it does not detail specific quantitative acceptance criteria or a study proving the device meets these criteria in the manner typically described for AI/ML performance. Instead, its acceptance is based on substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the specific points for an AI/ML study, the information is not present in the provided text:

• 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device, not an AI/ML algorithm evaluated on data sets.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical hip implant is not established in this manner.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML ground truth. The "truth" for this device relates to its material properties, design specifications, and clinical performance (which is inferred from historical data of the predicate device).
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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Indications for use include a severe disabling and/or painful hip associated with the following indications: 1) Osteoarthritis, 2) Traumatic arthritis, 3) Rheumatoid arthritis, 4) Advanced avascular necrosis, 5) Congentital hip dysplasia, and 6) Slipped captial femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

The all-metal cobalt chrome TARA Resurfacing device is a single unit component and is porous coated on the inner cylindrical wall and ceiling only. The cobalt chrome porous coating is a -45 +60 Mesh x .030" thick surface coating. The all-metal TARA is only avaiable in the short stem version, again with nine head sizes from 38mm to 55mm in 2 mm increments. The all-metal TARA is fixed to the bone with cement.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The provided text is a 510(k) summary and an FDA clearance letter for the BIOPRO TARA Femoral Resurfacing Component. These documents outline the device's substantial equivalence to predicate devices, its intended use, and its classification. They do not detail specific performance acceptance criteria or report on studies designed to demonstrate the device meets such criteria. Typically, performance data and acceptance criteria are found in a separate section of the 510(k) submission, not summarized in these publicly available portions.

Therefore, I cannot provide the requested information based on the given text.

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The DePuy ASR™ Resurfacing Femoral Heads are intended for cemented use in hemiarthroplasty (partial hip replacement procedure). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acctabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

The DePuy ASR™ Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a onepiece cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm to suit varying patient anatomy.

The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the ninimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum.

This submission (K032659) does not contain information about studies with acceptance criteria or device performance data. It is a 510(k) summary for the DePuy ASR™ Resurfacing Femoral Heads, focusing on substantial equivalence to predicate devices.

The document states that DePuy considers the ASR™ Resurfacing Femoral Heads to be substantially equivalent to previously marketed devices (DePuy T.A.R.A. Total Hip, Biomet Cemented Femoral Resurfacing Head device) based on "mechanical properties, material composition, and intended use."

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This 510(k) submission primarily establishes substantial equivalence based on prior device characteristics and does not present new performance study data against defined acceptance criteria.

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Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis. The device is a single use implant intended for press-fit application.

The Press-Fit Head Resurfacing device is designed to replace the outer surface of the femoral head while preserving as much natural bone as possible. The device retains the diameter of the natural femoral head and articulates aqainst the natural acetabulum (hemi-hip). The device is manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75. It has a highly polished outer surface and a titanium plasma spray coated inner surface. A central post is provided for stabilization. The device is available in diameters of 38mm to 60mm, in one-millimeter increments.

The provided document is a 510(k) premarket notification for a medical device, the "Press-Fit Head Resurfacing Device." It does not present any clinical study data or acceptance criteria related to device performance.

Based on the content of the document, the following observations can be made relevant to your request:

1. Table of acceptance criteria and reported device performance:

   • Not Applicable: The document explicitly states "Non-Clinical and Clinical Testing: None provided." This indicates that no performance data from such studies, nor specific acceptance criteria, are included or were required for this 510(k) submission.

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

   • Not Applicable: As no clinical or non-clinical testing data is provided, there is no test set or associated sample size discussed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable: No clinical or non-clinical testing was provided, so no ground truth establishment by experts is mentioned.

4. Adjudication method for the test set:

   • Not Applicable: No clinical or non-clinical testing was provided, so no adjudication method 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:

   • Not Applicable: This device is a physical implant (a hemi-hip prosthesis), not an AI-powered diagnostic or imaging device. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

   • Not Applicable: This device is a physical implant, not an algorithm.

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

   • Not Applicable: No clinical or non-clinical testing was provided, so no ground truth is discussed.

8. The sample size for the training set:

   • Not Applicable: There is no mention of a training set as no machine learning or AI component is involved.

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

   • Not Applicable: No training set or associated ground truth establishment is mentioned.

Summary of Safety and Effectiveness from the Document:

The document states one "Summary of Safety and Effectiveness." The basis for substantial equivalence is primarily on material and design similarities, not on performance data from primary studies.

"The materials, surface finishes and processing of the Press-Fit Head Resurfacing Device are similar to the predicate device."

This 510(k) submission relies on demonstrating substantial equivalence to already legally marketed devices based on technological characteristics and intended use, rather than presenting novel clinical performance data. The FDA's decision to clear the device (K023188) was based on this substantial equivalence to predicate devices (K021799, K811008, K962514, K811718), and not on a new study demonstrating its performance against specific acceptance criteria.

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Relief of pain and disability, and restoration of hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, with the bearing surface and supportive bone structure of the acetabulum being normal. The device is a single use implant intended to be used for cemented, hemi-hip, resurfacing applications only.

The Contoured Articular Prosthetic (CAP) system is intended for resurfacing of the femoral head in patients with post-traumatic degenerative disease or avascular necrosis. The natural acetabulum bearing surface and supportive bone structure should be essentially normal. The device is a single use implant intended to be used with bone cement.

The CAP implant consists of two components, a fixation component and an articular 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 fixation component is a modified cancellous screw manufactured of a Ti-6Al-4V ELI alloy per ASTM F136. The screw has a tapering distal tip, a full-length cannulation, and a proximal female taper bore.

The articular component is a dome shaped component manufactured of a Cobalt-Chromium-Molvbdenum alloy per ASTM F799 and ASTM F1537. The articular component has a bone contact surface that is coated with a CP Titanium coating and a polished articular bearing surface.

Utilizing the drill quide provided within the CAP instrumentation set, a surgeon is able to define a working axis that is normal to the articular cartilage surface at the site of the defect. After drilling a pilot hole, the fixation component is screwed into place using the trial cap to ensure that the surface of the articular component will be tangent and congruent to the existing cartilage surface when seated. Using the contact probe instrument corresponding to the implant diameter, offset measurements are taken to define the topography of the patients surrounding articular surface by revolving the probe around a centering shaft coaxial to the working axis of the screw. With these offset measurements, the surgeon is able to select the articular component (sized to match femoral head sizes from 40mm to 58mm) that will allow it to seat flush to the surrounding articular surface. Offset increments in .5mm sizes will allow for an optimal fit to the existing articular cartilage.

A reamer, which matches the articular component internal geometry is used to prepare the site for the prosthetic to be implanted. This allows for a precise fit of the implant to the prepared site and minimizes bone resection, so as to provide minimal impact to any future arthroplasty procedure. The articular component is then impacted to seat the taper interlock between the two components.

The prosthetic is intended to provide an effective means for managing pain and disability in the younger patient until a total or joint arthroplasty treatment option becomes more necessary and less likely to create an early-age-revision scenario. The prosthetic may also provide a treatment option for the older patient who may not tolerate the morbidity of a total joint arthroplasty procedure.

This 510(k) summary (K021549) describes the Contoured Articular Prosthetic (CAP) Femoral Head Resurfacing System but does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The document focuses on:

• Device Description: What the CAP system is, its components, materials, and how it is implanted.
• Substantial Equivalence: Comparing the CAP system to legally marketed predicate devices (Cormet 2000 Hemi Hip Metallic Resurfacing Prosthesis and Nelson Resurfacing Head) based on intended use, indications for use, materials, design, and other features. This is the primary method of evaluation for 510(k) clearances, relying on the safety and effectiveness of previously cleared devices.
• Regulatory Information: Classification, product code, and the FDA's decision letter of substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria from this document.

The specific details requested, such as sample sizes, ground truth establishment methods, expert qualifications, adjudication methods, MRMC studies, and standalone performance data, are typically found in more comprehensive clinical validation or performance studies, which are not included in a 510(k) summary. For medical devices cleared via 510(k), regulatory clearance is often based on demonstrating substantial equivalence to a predicate device, rather than requiring new, extensive clinical trials proving specific performance metrics against pre-defined acceptance criteria in the same way a PMA device might.

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