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The VerSys Epoch FullCoat Hip Prosthesis is indicated for:

• Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur.
• Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis.
• Patients suffering from disability due to previous fusion.
• Patients with acute femoral neck fractures.
  This device is intended for cementless use only.

The VerSys Epoch FullCoat Hip stem is an addition to the currently marketed VerSys Epoch FullCoat proximal femoral hip implant family. It is a set of fully porous coated implants that are comprised of Zimaloy™, a cobalt chromium molybdenum (CoCrMo) alloy core surrounded by a layer of injection molded polyetheretherketone (PEEK) encased in a layer of commercially pure titanium fiber metal (FM). The stem is designed to replace the proximal femur in a total hip arthroplasty. It features a 12/14 Morse-type taper to accommodate the attachment of modular femoral heads. The proximal geometry of the device is trapezoidal and comes in two options Reduced Neck Length (RNL) with 125° and 135° angles and Low Head Center (LHC) with a 125° angle.

This document describes the VerSys® Epoch® FullCoat Hip System. The provided text is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study results for novel device categories.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. The submission relies on mechanical testing for substantial equivalence, not a clinical test set from human subjects.
• Data Provenance: Not applicable. The data is non-clinical, related to mechanical testing.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

• Not applicable. Ground truth from human experts is not relevant for this type of mechanical testing submission.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set or human adjudication was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is not relevant for a hip implant submission focused on mechanical substantial equivalence.

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

• Mechanical Performance Data: The ground truth for this submission is based on mechanical testing data comparing the subject device to its predicate. The "ground truth" essentially refers to established engineering and material science principles and the performance of the legally marketed predicate device.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this device and submission type.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. There is no training set for this device.

Summary of the Study Proving Acceptance Criteria:

The Zimmer, Inc. submission for the VerSys® Epoch® FullCoat Hip System (K073499) relies on non-clinical mechanical testing to demonstrate substantial equivalence to its predicate device, the VerSys® Epoch® FullCoat Hip System (K052321).

The study primarily assessed:

• Mechanical Performance: The mechanical testing indicated that the subject device is substantially equivalent to the predicate.
• Intended Use: The device shares the same intended use as the predicate.
• Physical and Performance Characteristics: The device exhibits similar physical and performance characteristics to the predicate.
• Manufacturing Processes: The device is manufactured using similar processes as the predicate.

The report explicitly states: "Clinical data and conclusions were not needed for this device." This indicates that for this specific type of device modification (an "addition to the currently marketed... hip implant family"), the FDA deemed non-clinical mechanical testing sufficient to establish substantial equivalence to a previously cleared device. The acceptance criterion was therefore to demonstrate substantial equivalence in these non-clinical aspects to the predicate.

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The PROFEMUR® RENAISSANCE™ Hip Stem is 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, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity; and,
• revision procedures where other treatments or devices have failed

The design features of the PROFEMUR® RENAISSANCE™ Hip Stem are summarized below:

• Manufactured from titanium alloy (Ti6A14V) .
• Offered in two medial flare options
• 1mm increments from size 10-18
• Tri-planar proximal geometry with plasma sprayed surface or plasma sprayed surface with HA coating
• Cylindrical, splined, and slotted distal stem with glassbead surface
• Threaded hole with slot impaction mechanism .
• Polished distal tip and collar

The provided text is a 510(k) summary for the PROFEMUR® RENAISSANCE™ Hip Stem. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for AI/ML devices.

This document is a regulatory submission for a physical medical device (a hip stem), not a software or AI/ML device. Therefore, the questions related to AI/ML device performance, such as test sets, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable to this document.

The "study" mentioned in this type of 510(k) is usually a demonstration of substantial equivalence, which primarily relies on comparing the new device's design, materials, and intended use to legally marketed predicate devices, along with materials information and analysis data (e.g., mechanical testing, biocompatibility).

Here's what can be extracted from the document in relation to your request, with the understanding that the core elements of your request (AI/ML performance validation) are not present:

Acceptance Criteria and Device Performance (Not Applicable - This is a physical device submission)

• The document describes the device and its intended use, but does not present a table of specific acceptance criteria or quantitative performance metrics for those criteria, as would be expected for an AI/ML device. The "performance" in this context refers to its intended function and safety based on its design and materials.

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding AI/ML-specific questions:

• 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable.
• 4. Adjudication method: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done... effect size: 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: For a physical device, "ground truth" would relate to engineering specifications, material properties, and clinical outcomes data from studies of similar devices or the device itself (if clinical trials were performed, though not detailed here for 510k). The 510(k) primarily relies on substantial equivalence to predicate devices.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as interpreted for a 510(k) submission):

The "study" or justification for the PROFEMUR® RENAISSANCE™ Hip Stem meeting regulatory requirements is primarily the demonstration of substantial equivalence to legally marketed predicate devices, as detailed in section C, "SUBSTANTIAL EQUIVALENCE INFORMATION" on page 1.

The document states:
"The indications for use and materials of the PROFEMUR® RENAISSANCE™ Hip Stem are identical to the predicate devices. The design features of the PROFEMUR® RENAISSANCE™ Hip Stem are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the PROFEMUR® RENAISSANCE™ Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."

This means that instead of conducting a new, elaborate clinical trial (which PMA devices often require), the manufacturer asserts that their device is sufficiently similar to devices already approved and on the market to be considered safe and effective for its stated indications. The supporting data would include:

• Comparison tables: Detailing specifications of the new device against predicate devices (not provided in this summary, but would be in the full submission).
• Material information: Documentation of the titanium alloy (Ti6A14V) and other coatings used, along with biocompatibility data.
• Analysis data: This would typically refer to non-clinical testing, such as mechanical testing (e.g., fatigue, static strength) to ensure the device meets engineering specifications and performs comparably to predicate devices under stress.

The FDA's letter (pages 2-3) confirms that based on the provided information, they found the device substantially equivalent, allowing it to proceed to market.

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The CONSERVE® Total Femoral Head is 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 CONSERVE® Total Femoral Head is intended for single patient use only.

Manufactured from wrought cobalt-chromium-molybdenum .
The articulating surface of the implants will be superfinished .
Available sizes: 36mm, 38mm, 42mm, 42mm, 46mm, 48mm, 50mm, 52mm, 52mm, . 54mm, 56mm
The taper connection is identical to previously cleared taper connections and is . intended to be used with our existing femoral stems manufactured with WMT12/14 taper.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance for CONSERVE® Total Femoral Head

The acceptance criteria for the CONSERVE® Total Femoral Head are primarily focused on its wear performance compared to a predicate device, the Metal TRANSCEND® Femoral Head.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The marketing claims present a ratio of improvement, while the reported performance provides a difference in absolute volumetric wear. The document implies that the 1.02 mm³ difference at 5 million cycles in favor of the CONSERVE® head is sufficient to meet the spirit of the acceptance criteria, particularly the cumulative volumetric wear claim. However, a precise calculation to verify the "3.2 times lower" claim based only on the 1.02mm³ difference and without knowing the absolute wear of the control device is not possible with the given information.

2. Sample Size and Data Provenance for the Test Set

• Sample Size:
  • The document states, "Both the test and control devices were 54mm diameter femoral heads." It also notes, "The hip simulators used were orbital bearing hip wear test machines manufactured by Shore Western Manufacturing, Inc." This phrasing suggests a limited number of devices were tested on these machines. While not explicitly stated, it's common for such in vitro wear tests to use a small number of samples (e.g., n=3 or n=6 for test and control groups) run in parallel on a simulator. The exact number of samples is not provided.
• Data Provenance: The data is from in vitro hip wear simulator tests. The country of origin for the data is not specified, but the applicant (Wright Medical Technology, Inc.) is based in Arlington, Tennessee, USA, suggesting the testing was likely conducted in the USA. The study is retrospective in the sense that the testing was completed prior to the 510(k) submission.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This is an in vitro mechanical wear test, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the objectively measured volumetric wear using established laboratory methods.

4. Adjudication Method for the Test Set

Not applicable. As this is an in vitro mechanical test with objective measurements, there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an imaging or diagnostic device. The study described is an in vitro mechanical wear test, not a clinical study involving human readers.

6. Standalone Performance Study

Yes, in a sense. The wear test described is a standalone in vitro performance study of the device itself (algorithm only, if one were to stretch the analogy, as it's purely mechanical performance). It measures the wear of the CONSERVE® Total Femoral Head and compares it directly to the Metal TRANSCEND® Femoral Head without human intervention in the measurement process.

7. Type of Ground Truth Used

The ground truth used is objective quantitative measurement of volumetric wear obtained through controlled in vitro hip wear simulator tests. This is a form of engineering or laboratory "ground truth."

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The study focuses on direct mechanical performance testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device and study.

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The M²a™/C²a™ Acetabular System is intended for cemented or non-cemented use in cases of:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Revision procedures where other treatment or devices have been unsuccessful
5. Treatment of non-union, femoral neck fracture, trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

The M²a™/C²a™ Acetabular System consists of a titanium outer acetabular shell with a cobalt alloy metallic liner for metal articulation.

The acetabular shells are hemispherical in shape to closely match the natural acetabulum. Two screw holes in the dome allow for additional fixation by the use of screws. The outer surface of the shells are covered with Biomet's plasma sprayed coating.

The metallic cobalt alloy bearing liner fits into the outer shell by means of a taper similar to the taper used for the attachment of a modular head to a femoral stem. The metallic liners articulate with cobalt alloy modular heads.

The provided text describes a 510(k) submission for the M²a™/C²a™ Acetabular System, a metallic hip implant. This document is a premarket notification to the FDA for a medical device and therefore does not contain acceptance criteria or a study demonstrating device performance in the context of AI/ML or diagnostic accuracy studies.

The key information from the document related to testing is:

• Non-Clinical Testing: None provided
• Clinical Testing: None provided.

This indicates that the device's substantial equivalence was claimed based on its technological characteristics being similar or identical to legally marketed predicate devices, rather than through new non-clinical or clinical studies. This is a common pathway for 510(k) clearances, especially for devices where the fundamental technology is well-established.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving device performance because this type of information is not present in the provided 510(k) summary. These types of details are more common in PMAs (Premarket Approval applications) or specific studies related to a device's diagnostic accuracy or clinical outcomes, which is not the nature of this document.

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The PROFEMUR® S Hip Stem is 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, ankylosis, protrusio acetabuli, and painful hip dysplasia;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• correction of functional deformity; and,
• revision procedures where other treatments or devices have failed

The design features of the PROFEMUR® S Hip Stem are summarized below:

• Offered in two medial flare options .
• Modular neck taper .
• Triplanar proximal geometry w/ plasma spray .
• Splined, slotted, and cylindrical distal stem w/ grit blast .
• Dimple with cross slot on lateral shoulder ●
• Polished distal tip and collar .

The provided text does not contain any information regarding specific acceptance criteria or a study that evaluates the performance of the PROFEMUR® S Hip Stem against such criteria.

The document is a 510(k) Summary of Safety and Effectiveness for the PROFEMUR® S Hip Stem, which is focused on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device, rather than providing a performance study with specific acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on:

• Intended Use: What the device is designed for.
• Device Description: Its features.
• Substantial Equivalence Information: Comparing it to existing devices to show it's fundamentally similar in design, materials, and technology.

There is no mention of a performance study, acceptance criteria, sample sizes, expert review, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for any test or training sets.

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The PROFEMUR® Tapered Hip Stem is 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 design features of the PROFEMUR® Tapered Hip Stem are summarized below:

• Modular neck taper
• Tapered cylindrical distal stem
• Plasma Sprayed proximal body
• Grit blasted distal stem
• Polished bullet tip
• Spines

This document is a 510(k) summary for the PROFEMUR® Tapered Hip Stem. It asserts substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in this type of document.

Here's an analysis based on the provided text, highlighting what is and isn't present:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. This 510(k) summary does not present specific quantitative acceptance criteria or a study demonstrating direct device performance against those criteria. Instead, it argues for substantial equivalence to existing predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No new study involving a test set is described. The submission relies on "substantial equivalence information, materials information, and analysis data" (page 1) in comparison to predicate devices. The data provenance and sample sizes for this "analysis data" are not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. There is no described test set requiring ground truth establishment by experts.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This device is a hip stem (a medical implant), not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers or AI assistance are irrelevant to this submission.

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 new ground truth for performance evaluation is established or described explicitly. The basis for safety and effectiveness is "substantial equivalence" to predicate devices, implying that the established safety and effectiveness of the predicates serve as the basis for comparison.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/algorithm-based device requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. This is not an AI/algorithm-based device.

Summary of what is available from the document:

The document, a 510(k) Summary of Safety and Effectiveness, focuses on establishing substantial equivalence of the PROFEMUR® Tapered Hip Stem to legally marketed predicate devices.

• Basis for Equivalence: The submission states, "The safety and effectiveness of the PROFEMUR® Tapered Hip Stem are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification" (page 1).
• Predicate Devices: The device is deemed substantially equivalent to the PROFEMUR® Z Hip Stem, the PERFECTA® RS Hip Stem, and the PERFECTA® Plasma Sprayed Hip Stem. The indications for use and materials are stated to be identical to the PROFEMUR® Z Hip Stem.
• Device Information: The document provides a description of the device's design features (e.g., modular neck taper, tapered cylindrical distal stem, plasma sprayed proximal body).
• Intended Use/Indications for Use: These are clearly defined for total hip arthroplasty in skeletally mature patients with conditions such as non-inflammatory degenerative joint disease, inflammatory degenerative joint disease, correction of functional deformity, and revision procedures.

In essence, a 510(k) submission like this does not typically include a direct study proving device performance against acceptance criteria in the way an AI/software device would. Instead, it's a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device.

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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 Metal TRANSCEND® Articulation System components are for single use only.

The Metal TRANSCEND® Articulation System consists of components that are identical to the previously submitted components under the Metal TRANSCEND® Articulation System IDE: metal acetabular shells, metal acetabular liners, and metal femoral heads.

Design features of the Metal TRANSCEND® Acetabular Shell are summarized below:

• Manufactured from Ti6Al4V conforming to ASTM F-136 or ASTM F620 .
• Porous coated with commercially pure titanium (ASTM F67 or F 1580) sintered . beads
• Features three screw holes and an apical hole ●
• Designed for use with Apical Hole Plug and bone screws .
• Internal geometry of the shell features an 18.8750° (included) taper to accept . acetabular liners
• Available in 12 sizes ranging from 46mm to 68mm in 2mm increments .

Design features of the Metal TRANSCEND® Acetabular Liner are summarized below:

• Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . E75
• Designed for use with metal acetabular shell .
• Available in three inside diameters: 28mm, 32mm, and 36mm ●

Design features of the Metal TRANSCEND® Femoral Head are summarized below:

• Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM . E75
• Available in three sizes: 28mm, 32mm, and 36mm .
• Available in four neck lengths: short, medium, long, and extra-long ●

Here's an analysis of the provided text regarding the Metal TRANSCEND® Articulation System.

Please note that the document describes a medical device for total hip arthroplasty, and therefore the "acceptance criteria" and "device performance" are related to clinical outcomes and material properties, not typical AI/software performance metrics like accuracy, sensitivity, or specificity. The study described is a clinical trial, not an AI model validation study.

Acceptance Criteria and Device Performance for Metal TRANSCEND® Articulation System

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Clinical Data, which serves as the "test set" for performance evaluation): Not explicitly stated. The document mentions "multi-sites" for data collection but does not give the exact number of patients or procedures. It refers to "a single site with significantly poorer survival" being excluded, implying multiple sites contributed.
• Data Provenance: Prospectively collected from multi-sites. The country of origin is not specified, but the submission is to the US FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This is not applicable in the context of this device study. "Ground truth" for a total hip arthroplasty device would be derived from structured clinical outcome measures (like Harris Hip Score, SF-12), radiographic assessments, and direct observation of complications. These are typically assessed by orthopedic surgeons, clinical research coordinators, and radiologists involved in the study, but not in the sense of "experts establishing ground truth" for an AI model.

4. Adjudication Method for the Test Set

• Adjudication methods for clinical endpoints are not explicitly detailed. However, the outcomes such as Harris Hip Score, SF-12, radiolucencies, subsidence, and migration are typically based on standardized clinical assessments and radiographic measurements, often reviewed by the study investigators. The document states that a single site was identified as having problems with surgical technique and was excluded, suggesting some level of data quality monitoring or review was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study with AI assistance was not done. This document describes the clinical validation of a physical medical device (hip implant), not an AI diagnostic or assistive tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This pertains to a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Clinical Outcomes Data and Radiographic Assessments: The "ground truth" for the device's safety and effectiveness was established through:
  • Patient-Reported Outcomes: Harris Hip Score, SF-12 physical function component score.
  • Observed Clinical Events: Complications and adverse events.
  • Radiographic Evidence: Presence of radiolucencies (>2mm), subsidence of stem (>2mm), and migration of cup (>2mm).

8. The Sample Size for the Training Set

• Not applicable. This is a clinical trial for a physical medical device, not an AI model. Therefore, there is no "training set" in the machine learning sense. The clinical data collected serves as the evidence for the device's performance.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

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