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Noninflammatory degenerative (oint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory (out disease (IJD), e.g., rheumatoid arthritis.
Failed previous surgery where pain, deformity, or dysfunction persists.
Revision of previously failed hip arthroplasty.

The Subject CoCr Heads are intended to be used as a modular head component for articulation in total hip arthroplasty. A system consisting of a femoral stem, a ball head and a cup or a shell with an insert is used for replacement of the proximal femur in total hip arthroplasty. The articulation is comprised of a modular femoral head and a corresponding cup or acetabular insert. CoCr Heads are to be used in combination with polyethylene cups or inserts. It is also possible to use CoCr Heads in revision cases (unless subsequent to a broken ceramic component) where the stem remains in place.
The Subject CoCr Heads have a head diameter of 38 mm and are provided with 5 different neck lengths (from -8 to +8) to allow an individual adaptation of leg length and offset. A 12/14 taper, incorporated in the design of the head, interlocks with the femoral stem. The CoCr Heads are made from Protasul®-20 (CoCrMo alloy).

This is a good question! However, the provided document is a 510(k) summary for a medical device (CoCr Head) that is a hip prosthesis, not an AI/ML-enabled medical device.

Therefore, the requested information about acceptance criteria and studies demonstrating AI performance (such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Non-Clinical Performance Data: Engineering analyses, wear justification, material equivalence testing (ISO and ASTM standards), and Range of Motion testing (ISO 21535).
• MR Conditional Labeling: Evaluation in accordance with ASTM F2503-13 for RF-induced heating, static magnetic field interactions, and image artifact generation in MRI environments.

It explicitly states: "Clinical data and conclusions were not needed for this device."

In summary, as this document is not for an AI/ML medical device, none of the requested information regarding AI acceptance criteria and performance studies can be extracted.

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1. Joint impairment from arthritis (rheumatoid, osteo and post traumatic).
2. Revision of failed femoral head replacements.
3. When alternative reconstructive techniques are not viable.
4. When arthrodesis is contraindicated.
5. Avascular necrosis or fracture of the femoral head.
6. Congenital defects that will allow adequate function of the system.

The 26 mm CoCr Head and Hooded Liner are manufactured from biocompatible materials: Co-Cr-Mo alloy and ultra-high molecular-weight polyethylene (UHMWPE). These materials are in current use in numerous hip systems and their use has been established through many years of successful clinical application.

This document is a 510(k) summary for a medical device (26 mm Cast CoCr Head and Polyethylene Acetabular Shell Liner) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically seen for a diagnostic or AI-driven medical device.

Instead, the document focuses on demonstrating substantial equivalence to existing devices, which is a different regulatory pathway. The "studies" mentioned are performance tests, but they are not presented as typical clinical trials with acceptance criteria and statistical analyses of performance metrics like sensitivity or specificity.

Here's an analysis based on the provided text, highlighting why the requested information for acceptance criteria and a detailed study is not present:

The 510(k) summary focuses on the materials and size modification of an existing hip replacement component. The primary "proof" of its safety and effectiveness, in this regulatory context, comes from:

• Established Biocompatibility: The materials (Co-Cr-Mo alloy and UHMWPE) are stated to be "biocompatible" and "in current use in numerous hip systems," with "many years of successful clinical application." This is a qualitative reference to past performance rather than a specific study within this submission.
• Prior 510(k) Submissions: "Fatigue testing of the stem and 26 mm head was satisfied under previously released 510(k) submissions." Similarly, "the liner testing was satisfied under previous 510(k) submissions since only the I.D. has been changed." This indicates that the critical performance tests (like fatigue) were conducted and passed for the predicate device, and the current device (with a size change) is considered to meet those same criteria by virtue of its similarity and established performance of the components.

Therefore, the requested information cannot be fully provided from this document. However, I can extract what is implicitly or explicitly stated about the type of assessment conducted:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
This document does not provide specific sample sizes for tests. It refers to tests being "satisfied under previously released 510(k) submissions." The data provenance for any mentioned tests (e.g., fatigue testing) is not specified, but usually, such tests are conducted in a laboratory setting. There is no indication of retrospective or prospective clinical human data for this specific submission; instead, it relies on the clinical history of the materials and predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. For mechanical testing (like fatigue), ground truth is established by test standards and physical measurements, not expert consensus in the diagnostic sense.

4. Adjudication method for the test set
This information is not applicable and not provided. Mechanical tests do not typically involve adjudication.

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 information is not applicable and not provided. This is a medical implant, not an AI-driven diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This is a medical implant, not an algorithm.

7. The type of ground truth used
For the mechanical performance (e.g., fatigue testing), the "ground truth" would be established by physical measurements against ISO or ASTM standards for orthopedic implants. For the material biocompatibility, the "ground truth" relies on historical clinical evidence and generally accepted scientific principles for the specified materials. There is no pathology or outcomes data specifically generated for this submission detailed here.

8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device.

9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/ML device.

In summary: The provided text is a regulatory submission demonstrating substantial equivalence for a medical implant, rather than a clinical study report for a diagnostic device (especially an AI-driven one). The "proof" of performance relies on established materials, prior testing of predicate devices, and meeting design objectives.

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Not Found

The 22 mm CoCr Head and Hooded Liner are manufactured from biocompatible materials: Co-Cr-Mo alloy and ultra-high molecular-weight polyethylene (UHMWPE). These materials are in current use in numerous hip systems and their use has been established through many years of successful clinical application.

This document is a 510(k) summary for a medical device: a 22 mm CoCr Head and Polyethylene Acetabular Shell Liner. It is from 1996. The information provided is insufficient to answer your detailed questions about acceptance criteria and a study proving device meets those criteria in the context of modern AI/machine learning device evaluation.

Here's why and what information is available:

This document describes a traditional orthopedic implant, not an AI or machine learning-driven device. Therefore, many of your questions, such as those regarding ground truth, sample sizes for training/test sets, expert consensus, MRMC studies, or standalone algorithm performance, are not applicable.

Here's a breakdown of what can be gleaned from the provided text according to your request, with an explanation of why other points are not applicable:

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

   • Acceptance Criteria (Implicit from the text):
     • Manufactured from biocompatible materials (Co-Cr-Mo alloy and UHMWPE).
     • Fatigue testing of stem and 22 mm head satisfied under previously released 510(k)s.
     • Liner testing satisfied under previous 510(k)s (since only I.D. changed).
     • Increase polyethylene minimal thickness in smaller diameter acetabular cups (this is a design goal, not a direct performance metric here).
     • Be considered "substantially equivalent" to predicate devices.
   • Reported Device Performance: The document states that these materials are "in current use in numerous hip systems and their use has been established through many years of successful clinical application." It also mentions "Fatigue testing...was satisfied" and "liner testing was satisfied." There are no numerical performance metrics detailed in this summary.

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 type of device. Testing for orthopedic implants typically involves bench (mechanical) testing, not "test sets" in the AI sense. The document refers to "fatigue testing" and "liner testing" which are standard biomechanical tests. No human patient data is mentioned for performance evaluation in this summary.

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

   • Not applicable. There is no "ground truth" establishment in the AI/radiology sense for this device. Ground truth for an implant involves material properties, mechanical strength, and clinical outcomes over time, evaluated by engineers and orthopedic surgeons.

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

   • Not applicable. This applies to expert review of medical images/diagnoses, not mechanical implant testing.

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 is for AI-assisted diagnostic tools.

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

   • Not applicable. This is for algorithmic performance.

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

   • Implicitly: For mechanical properties, the "ground truth" would be established by validated engineering standards and testing protocols. For biocompatibility and clinical success, it's based on long-term clinical use and literature for the materials. No "expert consensus" on imaging or pathology is relevant here.

8. The sample size for the training set

   • Not applicable. No training set for an algorithm is involved.

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

   • Not applicable. No training set is involved.

In summary: This document is a regulatory submission for a physical medical implant from 1996, focusing on material biocompatibility and mechanical testing in comparison to previously approved devices. It pre-dates and does not involve AI or machine learning, rendering most of your detailed questions about AI device evaluation inapplicable.

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