Search Results

The PROCOTYL® PRIME Acetabular Cup System is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli. and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed.
   Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

The PROCOTYL® PRIME Acetabular Cup System includes acetabular shells, acetabular liners, and optional cancellous bone screws. The design features are summarized below:

• Acetabular Shells
  • Manufactured from titanium alloy
  • BIOFOAM® coated
  • Available in Solid or Quad configurations
  • Outer Diameter sizes 42mm to 68mm in 2mm increments
• Acetabular Liners
  • Manufactured from A-CLASS® highly crosslinked ultra high molecular weight polyethylene)
  • Available in Standard. Lipped Face-changing or Lateralized configurations
  • Inner Diameter sizes 22mm to 44mm
• Bone Screws
  • Manufactured from titanium alloy
  • 6.5mm diameter
  • Available in lengths 15mm to 80mm in 5mm increments

This document is a 510(k) summary for the PROCOTYL® PRIME Acetabular Cup System, a medical device for total hip arthroplasty. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:

Crucially, this document is a 510(k) Pre-Market Notification, which is a regulatory submission to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. It is not a detailed clinical study report or a publication presenting performance metrics against specific acceptance criteria for an AI/ML device.

Therefore, most of the information you are requesting about acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance for an AI/ML device is not present in this document. This document concerns a physical orthopedic implant.

However, I can extract the information that is available and clarify what is missing based on your request.

Summary of Device Acceptance Criteria and Performance (Based on available information):

Missing Information (as per your request, because this is not an AI/ML device nor a typical clinical study report):

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components tested in a lab, not a diagnostic dataset. The document does not specify sample sizes (e.g., number of cups, liners, or screws) for any of the nonclinical tests. Data provenance, in the sense of country of origin or retrospective/prospective for patient data, is also not applicable here.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an orthopedic implant's mechanical properties is typically established through recognized engineering standards (e.g., ASTM) and validated testing methodologies, not expert medical consensus on diagnostic images.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This applies to human review of diagnostic outputs, not mechanical testing.
4. 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 not an AI/ML diagnostic device with human-in-the-loop.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the specifications and performance standards (e.g., ASTM standards) that the device must meet. For biocompatibility, it's defined by the pyrogen limit specification (≤ 20 EU/device). It's not based on expert consensus, pathology, or outcomes data in the conventional sense used for diagnostic devices.
7. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
• 3. correction of functional deformity; and,
• 4. revision procedures where other treatments or devices have failed.

The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are monolithic stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are available in 32 configurations and are coated with titanium plasma spray conforming to ASTM F1580. The 32 configurations consist of standard and reduced flare components (14 sizes reduced and 18 sizes standard). The reduced and standard flares refer to the amount of material in the proximal-medial region. Each flare configuration is available in two neck offset options, Straight (standard) and Varus 8° (extended). The geometry, distal-from-resection, is identical to those available with the predicate device.

The provided document is a 510(k) Premarket Notification for a medical device called "PROFEMUR® Renaissance® Classic Long Neck Hip Stems". This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for establishing novel acceptance criteria or performing extensive studies proving a device meets specific performance criteria in the same way, for example, a new drug might.

Therefore, the information regarding acceptance criteria and studies (especially clinical ones) will be limited to what is relevant for a 510(k) submission, primarily focusing on proving similarity to a predicate device and non-clinical performance.

Here's an analysis based on the provided text, addressing your points:

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

2. Sample sizes used for the test set and the data provenance

The document does not specify the sample sizes (number of devices tested) for the non-clinical tests (fatigue and range of motion). The data provenance is non-clinical/laboratory testing, not human data.

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

This question is not applicable as the "ground truth" for non-clinical engineering tests (fatigue, range of motion) is based on established ISO standards. There are no "experts" establishing unique ground truth in the sense of clinical interpretation.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods are relevant for human-interpreted data, often in clinical studies. Non-clinical tests follow standardized protocols.

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

No MRMC study was done. This is a hip stem (implantable medical device), not an AI diagnostic tool.

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

This question is not applicable as this is not an AI algorithm. The device is a physical hip stem.

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

For the non-clinical tests, the "ground truth" is adherence to the specified ISO standards (ISO 7206-4, ISO 7206-6, and ISO 21535). These standards define the test methods and acceptance limits.

8. The sample size for the training set

This question is not applicable as this is not an AI/machine learning device that requires a training set.

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

This question is not applicable as this is not an AI/machine learning device and therefore has no "training set" or corresponding ground truth.

Summary based on the document:

The PROFEMUR® Renaissance® Classic Long Neck Hip Stems are a line extension of an existing predicate device (PROFEMUR® Renaissance® Classic Hip Stem, K130984). The substantial equivalence claim is primarily based on:

• Identical Indications for Use to the predicate device.
• Identical Material (forged titanium alloy, ASTM F620, with titanium plasma spray coating, ASTM F1580) to the predicate device.
• Identical Geometry (distal-from-resection) to the predicate, with the exception of neck length, which is the defining characteristic of the "long neck" extension.
• Non-clinical testing to demonstrate performance in fatigue and range of motion, adhering to ISO standards.

The document explicitly states: "Clinical data was not provided for the subject devices." This is typical for a 510(k) submission for a device modification or line extension where substantial equivalence can be demonstrated through non-clinical data and comparison to a predicate.

Ask a specific question about this device

MicroPort total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis; 2.
• correction of functional deformity; and, 3.
• revision procedures where other treatments or devices have failed 4.

Modular shells with porous metal bead coating may be used in either cemented or uncemented arthroplasty. Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

The DYNASTY® Acetabular System with Ceramic contains femoral heads in size 28mm manufactured from alumina matrix composite, mating acetabular liners manufactured from crosslinked polyethylene, and beaded acetabular shells manufactured from titanium alloy.

The provided 510(k) summary for the DYNASTY® Acetabular System with Ceramic does not contain information related to acceptance criteria for a device, nor does it describe a study that proves the device meets specific acceptance criteria in the manner typically associated with AI/software devices.

Instead, this document describes a traditional medical device (an orthopedic implant) and focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "study" mentioned is purely for mechanical and tribological (wear) evaluation, not clinical or performance criteria as would be relevant for software or AI.

Therefore, I cannot extract the requested information in the format provided because it's not present in the document.

Here's why and what the document does provide:

• Type of Device: The DYNASTY® Acetabular System with Ceramic is a physical orthopedic implant (acetabular shell, liner, and femoral head for total hip replacement). It is not a software device or an AI algorithm.
• Regulatory Pathway: This is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as for a PMA.
• "Acceptance Criteria" in this context: For a physical implant like this, "acceptance criteria" relate to engineering specifications, material properties, biocompatibility, mechanical strength, wear resistance, and manufacturing quality. These are typically assessed through bench testing and adherence to recognized standards.
• "Study" in this context: The "study" mentioned is non-clinical mechanical and tribological testing.

Specific answers based on the provided text, explaining why other points are not applicable:

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

   • Not Applicable. The document does not provide a table of acceptance criteria or performance metrics in the way one would for a software or AI device (e.g., sensitivity, specificity, AUC). It discusses mechanical and tribological evaluations and comparisons to predicate devices rather than specific performance targets against clinical gold standards.

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. This refers to mechanical testing, not a clinical study involving a test set of data. The "subject size 28mm ceramic head was used as a worst case" for burst, post-fatigue burst, rotational stability, and pull-off force testing, implying a limited number of physical samples (likely one or a few) were subjected to these mechanical tests. No patient data or clinical retrospective/prospective studies were conducted.

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. This device is not a diagnostic or AI tool requiring expert ground truth for a test set.

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

   • Not Applicable. This is not a clinical study requiring adjudication of expert opinions.

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 a physical medical device, not an AI system.

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

   • Not Applicable. This is a physical medical device, not an AI algorithm.

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

   • Not Applicable. For mechanical testing, the "ground truth" would be the physical properties derived from standardized test methods (e.g., force measured at failure, wear volume). The document states:
     • "The subject DYNASTY® Acetabular System with Ceramic was evaluated mechanically and tribologically."
     • "The mechanical testing on the subject and predicate devices was performed on wrought Cobalt Chrome modular neck spigots cleared under K091423 and K100866."
     • "The subject size 28mm ceramic head was used as a worst case in burst, post-fatigue burst, rotational stability, and pull off force testing."
     • "Wear testing compared the subject size 28mm femoral heads to the K130376 DYNASTY® Acetabular System."
     • "Range of motion evaluation compared the subject system to the predicate K052026 in three planes."
     • This implies physical engineering measurements as the "ground truth" for evaluating the device's mechanical characteristics.

8. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device requiring a training set.

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

   • Not Applicable. This is not an AI/ML device requiring a training set.

In summary, the provided document describes a "Traditional 510(k)" pathway for a physical orthopedic implant. The demonstration of safety and effectiveness relies on substantial equivalence to predicate devices and non-clinical bench testing, not clinical studies or performance criteria typically associated with software/AI medical devices.

Ask a specific question about this device