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PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

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
   Hydroxyapatite coatings applied to implant surfaces are intended for uncemented arthroplasty.

The PROFEMUR® GLADIATOR® Thin Hydroxyapatite-coated (HA) Classic Stems with Collar present a monolithic, tapered-wedge design and a reduced distal stem tip. The 'Thin' description is a relative word MicroPort uses as an internal descriptor to clearly identify the difference in product between the currently cleared US-offered HA coating thickness (65um) and the coating thickness offered in outside US (OUS) markets. The subject stems are coated with a 65um HA coating (ASTM 1185), and the uncoated medial collar, proximal shoulder and neck regions of the stem possess a glass-beaded finish (Ra=0.8μm). The subject stems possess a proximal medial collar designed to assist in discouraging subsidence and maximizing rotational stability. The proximal anterior, posterior, and medial surfaces possess grooves perpendicular to the stem's longitudinal axis and parallel with each other. The proximal grooves are designed to provide a maximized bone-stem contact surface for bone apposition and assist in discouraging stem subsidence. The distal anterior and posterior surfaces of the subject stem possess vertical grooves parallel to the stem's longitudinal axis. The distal grooves are designed to assist the stem in resisting against rotational loads. The subject classic stems possess an oval impaction feature on the proximal shoulder for stem insertion into the femoral canal. The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are designed for use in total hip arthroplasty.
The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar are manufactured from forged Ti6Al4V alloy (ASTM F620) and come in 10 sizes, with the stem length ranging from 125mm to 175mm. The subject stems features two different neck options: standard (with a CCD neck angle of 135°) and extended/Varus 8° (with a CCD angle of 127°). The PROFEMUR® GLADIATOR® Thin HA Classic Stems w/ Collar were designed to accommodate a wide range of patient anatomy and to provide an optimized fit to adequately restore the biomechanics of the respective hip (including restoration of the natural leg length and head center offset).

The provided document describes a 510(k) premarket notification for a medical device (PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar) and focuses on demonstrating its substantial equivalence to previously cleared predicate devices. It does not contain information about a study that proves the device meets acceptance criteria in the context of AI/ML device performance (e.g., diagnostic accuracy, sensitivity, specificity, or human-in-the-loop performance).

Instead, the document details nonclinical testing performed on the hip stem to demonstrate its mechanical properties, safety, and equivalence to existing devices. Therefore, I cannot provide all the requested information, particularly those related to AI/ML device performance studies like sample size for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance.

Here's an analysis of the information available in the document regarding "acceptance criteria" and "study" in the context of this orthopedic implant:

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

The document describes various nonclinical tests and their successful completion, implying that passing these tests served as the acceptance criteria for substantial equivalence. However, it does not present a formal table with specific quantitative acceptance criteria alongside exact reported performance values from the tests. Instead, it generally states that the device "met all mechanical testing requirements" and "were successfully performed."

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

• Sample Size: The document does not specify the exact number of hip stems or components used for each nonclinical test (e.g., how many stems were subjected to fatigue testing). It refers to "worst-case construct testing" and "worst case implants" for endotoxin testing, suggesting a representative, but unspecified, sample size.
• Data Provenance: Not applicable in this context. The "tests" are laboratory-based mechanical and biological evaluations, not clinical studies with human patient data.

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 as the evaluation involved nonclinical laboratory testing against pre-defined engineering standards, not expert interpretation of clinical data to establish ground truth.

4. Adjudication method for the test set:

This information is not applicable for nonclinical laboratory testing. The evaluation is based on meeting the quantitative or qualitative criteria of the respective ISO, ASTM, and EN standards.

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. The device is a hip implant, not an AI/ML-based diagnostic or assistive technology for human readers.

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

This information is not applicable. The device is a hip implant, not an AI/ML algorithm.

7. The type of ground truth used:

The "ground truth" in this context refers to the established international and national standards (e.g., ISO 7206 series, EN ISO 21535, ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2503, ANSI/AAMI ST72, USP ) against which the hip stem's mechanical, safety, and material properties were evaluated. Compliance with these standards indicates acceptable performance.

8. The sample size for the training set:

This information is not applicable as the device is a physical hip implant. There is no "training set" in the context of an AI/ML algorithm.

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

This information is not applicable for the same reason as point 8.

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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.

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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.

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Wright Medical 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:

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

The DYNASTY® Acetabular System with Ceramic is manufactured from alumina matrix composite. The components are offered in sizes ranging from 32mm to 40mm.

The provided text describes a 510(k) summary for the DYNASTY® Acetabular System with Ceramic, focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to an AI/ML algorithm.

Therefore, I cannot provide the requested information in the format of a table describing acceptance criteria and device performance for an AI/ML device, nor can I answer questions regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The document states:

• "Clinical data was not provided for the subject devices." This explicitly indicates that no clinical study was performed to assess the device's performance in humans.
• "The subject DYNASTY® Acetabular System with Ceramic was evaluated mechanically, tribologically, and chemically." This suggests non-clinical (laboratory) testing was conducted, but the details of acceptance criteria for these tests and their results are not provided in a summary format. The document mentions that the testing "shows that it can be concluded that the subject ceramic material can be expected to perform well under normal physiological chemical and mechanical conditions," implying the tests were successful in demonstrating performance without specifying the criteria or results.
• The entire submission hinges on "Substantial Equivalence Information" to predicate devices. This means the device is considered safe and effective because it is very similar to devices already cleared by the FDA, rather than proving its effectiveness through new clinical trials against specific performance criteria.

In summary, the provided text does not contain the information needed to answer your questions regarding acceptance criteria and performance studies for an AI/ML device.

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