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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.

Indications for Use

• 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.

Rough grit blast surfaces are intended for uncemented arthroplasty. The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.

Design features of the subject stems are summarized below:

• Cementless modular stems
• Available in 9 sizes
• Manufactured from Titanium alloy with a heavy grit blasted surface.

The subject device is available in 9 sizes (from size 3 to 11). Although the proximal geometries are identical to the predicate from size 3-9, the distal stem length has increased, with two larger sizes (10 and 11) introduced.

This submission (K122778) is for a medical device (PROFEMUR® Z Revision Hip Stem) and as such does not contain information on software acceptance criteria or studies involving AI and human readers. The document details the substantial equivalence of the hip stem to previously cleared predicate devices, primarily through nonclinical (mechanical) testing, rather than clinical studies or algorithm performance evaluations.

Therefore, I cannot provide information on:

• Acceptance criteria and reported device performance related to an algorithm.
• Sample size used for the test set or data provenance for an algorithm.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for an algorithm's test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth for an algorithm.
• Sample size for the training set or how ground truth was established for it.

The document explicitly states: "Clinical data was not provided for the class III hip stem." This further confirms that no clinical studies as you've outlined for AI/software evaluation were performed or submitted.

The "acceptance criteria" in this context are for the mechanical performance of the hip stem and its substantial equivalence to existing devices, evidenced by:

1. Nonclinical Testing: The PROFEMUR® Z Revision Hip Stems were tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8. This demonstrates the device's mechanical integrity under specified stress conditions. The acceptance criteria for such tests would be successful completion of these fatigue evaluations without failure, meeting the standards set by ISO 7206.
2. Substantial Equivalence: The primary "study" is the demonstration of substantial equivalence to predicate devices (K021346, K112080, K121221) based on:
   • Identical Indications for Use: The new device shares the exact same intended uses as the predicate devices.
   • Similar Design Features and Materials: The subject device is a cementless modular stem, available in 9 sizes, manufactured from Titanium alloy with a heavy grit blasted surface, similar to the predicates. While distal stem length increased and new sizes were introduced, the fundamental scientific technology remained unchanged.

The conclusion is that the safety and effectiveness are supported by this substantial equivalence information, materials information, and analysis data, aligning with the FDA's 510(k) pathway for medical devices.

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The DYNASTY® BIOFOAM® Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

• 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 DYNASTY® BIOFOAM® Shell is intended for cementless hip arthroplasty.

Design features of the shells are summarized below:

• Shells manufactured from Titanium alloy substrate, coated with BIOFOAM® coating manufactured from commercially pure (CP) titanium
• Solid shell sizes: 46mm-68mm outer diameter
• Three different hole patterns:
  • 10-hole shell sizes: 46mm-76mm outer diameter
  • 3-hole shell sizes: 46mm-68mm outer diameter
  • 5-hole shell sizes: 46mm-50mm outer diameter

The DYNASTY® BIOFOAM® Shells are identical to previously cleared devices, except that the subject device posses different screw hole patterns. Additionally, the DYNASTY® BIOFOAM® Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results indicates that the DYNASTY® BIOFOAM® Shells are equivalent to predicate devices.

The provided text is related to a 510(k) summary for a medical device called the DYNASTY® BIOFOAM® Shell, an acetabular cup for hip arthroplasty. The document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not describe any clinical study or testing with acceptance criteria and reported device performance in the way a typical AI/ML device submission would.

The core of this submission is based on substantial equivalence to previously cleared devices (DYNASTY® Acetabular System K082924). The key statement that replaces a detailed performance study is:

"The DYNASTY® BIOFOAM® Shells are identical to previously cleared devices, except that the subject device posses different screw hole patterns. Additionally, the DYNASTY® BIOFOAM® Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results indicates that the DYNASTY® BIOFOAM® Shells are equivalent to predicate devices."

And:

"The safety and effectiveness of the DYNASTY® BIOFOAM® Shells are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them because such a study, with the specific details requested, is not present in this 510(k) summary. The submission relies on demonstrating equivalence through design and limited engineering analysis (post-impaction analysis).

Here's a breakdown of why this information is missing based on the document:

• No new clinical study: The document explicitly states the device is "identical to previously cleared devices, except that the subject device posses different screw hole patterns." This indicates that a comprehensive, new clinical performance study, often required for novel devices or significant changes, was not performed or deemed necessary.
• Reliance on Predicate Device Performance: The safety and effectiveness are established by the substantial equivalence to the predicate device (DYNASTY® Acetabular System, K082924). The performance of the predicate device is implicitly accepted.
• Limited "Evaluation" mentioned: The only "evaluation" mentioned is "post-impaction analysis of clearance, form and frictional torque." This is an engineering/benchtop test, not a clinical study involving patients or expert review. The document does not provide specific acceptance criteria or results for this analysis beyond stating it indicates equivalence.

In summary, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving their fulfillment, as it describes a 510(k) submission based on substantial equivalence and engineering analysis rather than a clinical performance study.

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Biomet Metal-On-Metal Total hip replacement components are intended for either cemented or uncemented use to replace the articulating portions of the hip during total hip arthroplasty.

Indications For Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. (a) Revision procedures where other treatment or devices have failed (M2a-Taper™ and M2a-RinglocTM).
   (b) Revision of previously failed total hip arthroplasty (M2a-Magnum™ and M2a-38™).
5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The components of the M2a-Magnum™ system were also cleared for diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, slipped capital epiphysis, subcaptial fractures, and traumatic arthritis indications. The M2a-Taper™ Metal-on-Metal Hip Joint Replacement Prosthesis are intended for use in cemented and non-cemented primary and revision hip joint arthroplastic procedures.

Metal-On-Metal Hip prosthesis components provide for total hip replacement with a direct metal to metal articulation. They consist of a series of metal femoral head prostheses (either monolithic or modular) that articulate with highly congruent mating acetabular components without the need for a ceramic or polyethylene liner.

This submission is intended to notify FDA that Biomet has included additional Contraindications to the labeling for Metal-On-Metal total hip prosthesis components to assure the safe and effective use of Biomet Metal-On-Metal components for the appropriate patient populations. These changes are incorporated into one IFU that will be applicable for all Metal-On-Metal components currently cleared by FDA.

The provided text is a 510(k) summary for a medical device. It explicitly states that no non-clinical or clinical testing was performed or included to support substantial equivalence. The submission is solely for updating the labeling (specifically, adding contraindications) for previously cleared metal-on-metal hip prosthesis components.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement cannot be extracted from this document, as no such studies were conducted for this particular 510(k) submission.

The document indicates:

• "Non-Clinical mechanical testing is not included to support a substantial equivalence determination since this submission is intended only to update labeling for previously cleared medical devices."
• "Clinical testing is not included to support a substantial equivalence determination since this submission is intended only to update labeling for previously cleared medical devices."

As a result, a table of acceptance criteria and reported device performance cannot be generated, nor can any details about studies, sample sizes, experts, or ground truth.

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The CONSERVE® Thin Shells are intended for use in cementless total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

• 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.
• 3. correction of functional deformity; and,
• revision procedures where other treatments or devices have failed 4.

The CONSERVE® Thin Shell is intended for cementless hip arthroplasty.

Design features of the shells are summarized below:

• Monoblock acetabular cup .
• . Available in 12 sizes
• Manufactured from CoCr alloy with a CoCr porous bead coating .

The CONSERVE® Thin Shells are identical to previously cleared devices, except that the subject device does not possess HA coating. Additionally, the CONSERVE® Thin Shells were evaluated via post-impaction analysis of clearance, form and frictional torque. A review of these results indicates that the CONSERVE® Thin Shells are equivalent to predicate devices.

This document describes the CONSERVE® Thin Shell, an acetabular cup intended for use in cementless total hip arthroplasty. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than conducting a new clinical study with specific acceptance criteria and performance metrics for this particular device.

Here's an analysis of the provided information, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain explicit acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical thresholds for novel designs) that the CONSERVE® Thin Shell needed to meet to be cleared. This is typical for a 510(k) submission based on substantial equivalence, especially when the changes are minor.

Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance is assessed by comparing the device's characteristics and functionality to those of already cleared devices.

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

The document does not describe a specific "test set" or a clinical study with human subjects for the CONSERVE® Thin Shell itself. The evaluation relied on bench testing and comparison to predicate devices.

• Sample Size: Not applicable in the context of a human clinical test set. The "samples" would relate to the number of CONSERVE® Thin Shell units used for the post-impaction analysis. This specific number is not provided.
• Data Provenance: Not applicable for human data. The "data" comes from engineering analysis and comparisons to existing device specifications.

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

This information is not applicable as there was no test set involving human subjects where expert ground truth was established by human readers/assessors. The "ground truth" here is derived from engineering standards, material science, and the established performance and safety profiles of the predicate devices as understood by the FDA and the manufacturer.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring multi-expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The submission establishes equivalence through design, materials, and bench testing, not through human reader performance studies.

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

Not applicable. This device is a physical medical implant, not an algorithm or software requiring performance evaluation in a standalone or human-in-the-loop context.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

• Predicate device safety and effectiveness: The established performance and safety of the CONSERVE® HA Shells and CONSERVE® Acetabular Shell (TRANSCEND® Articulation System) serve as the benchmark.
• Engineering specifications and material science: Compliance with recognized standards for materials (CoCr alloy) and design features is the basis for evaluation.
• Bench testing data: Specifically, the post-impaction analysis of clearance, form, and frictional torque provided objective data to support the claims of equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm device that requires a training set.

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

Not applicable. As there is no training set for this physical device.

In summary: The K113322 submission for the CONSERVE® Thin Shell relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This type of submission typically uses bench testing, material characterization, and comparison of design features and intended use to establish safety and effectiveness, rather than new clinical trials with acceptance criteria based on patient outcomes or expert reads. The key "study" mentioned is the "post-impaction analysis of clearance, form and frictional torque," which supported the claim that the device is equivalent to its predicates despite the absence of an HA coating.

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The Preserve Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use:

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 Preserve hip stem is intended for cementless hip arthroplasty.

The Preserve stems are short modular hip stems that couple with modular necks. Design features of the stems are summarized below:

• . Cementless stem with proximal cpTi plasma spray coating
• Available in 9 sizes (4-12)
• Manufactured from Ti alloy

The Preserve Hip Stems were evaluated via mechanical testing; including fatigue, fretting; and distraction evaluation. A review of these results indicates that the Preserve Hip Stems are equivalent to predicate devices and are capable of withstanding expected in vivo loading without failure.

Based on the provided text, the document is a 510(k) Summary of Safety and Effectiveness for the PROFEMUR® Preserve Hip Stems, a medical device used in hip replacement surgery. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/algorithm-based medical device.

The document focuses on demonstrating substantial equivalence to predicate devices through:

• Device Description: Material, size, and design features.
• Intended Use and Indications for Use: Identical to previously cleared predicate devices.
• Technological Characteristics: Similar to predicate devices.
• Nonclinical Testing: Mechanical testing (fatigue, fretting, distraction evaluation) per ISO standards.
• Clinical Testing: Explicitly states, "Clinical data was not provided for the class III hip stem."

Therefore, I cannot extract the requested information to fill in the acceptance criteria table or describe a study proving the device meets acceptance criteria as an AI/algorithm.

If this were a submission for an AI-based device, the missing information would be crucial for FDA review. The current document describes a traditional orthopedic implant, where "acceptance criteria" are typically met through engineering testing (like fatigue strength), material compatibility, and demonstrated substantial equivalence to predicate devices, rather than statistical performance metrics of an algorithm.

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The PROFEMUR® GLADIATOR® HA Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use:

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 PROFEMUR® Gladiator HA Hip Stem is intended for cementless hip arthroplasty.

The PROFEMUR® GLADIATOR® HA stems are hydroxyapatite coated hip stems that couple with modular necks. Design features of the stems are summarized below:

• Cementless stem with hydroxyapatite plasma spray coating
• Available in 10 sizes
• Manufactured from Ti alloy (Ti-6Al-4V) conforming to ASTM F620
• Hydroxyapatite coating conforming to ASTM F1185
• Available with and without collar

I am sorry, but based on the provided text, there is no information about an AI/ML device, its acceptance criteria, or a study proving that it meets those criteria. The document describes the PROFEMUR® GLADIATOR® HA Hip Stems, which are a mechanical medical device (a hip implant). The evaluation for this device was based on mechanical testing (fatigue, fretting, and distraction evaluation) and a comparison to predicate devices, not on AI/ML performance metrics.

Therefore, I cannot provide a response to the requested subsections as they pertain to AI/ML device evaluation, which is not present in the given text.

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The PMMA Distal Centralizers are 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
   The PMMA Distal Centralizers are single use components, intended for use as part of a cemented total hip arthroplasty.

The PROFEMUR® X" Wingless Distal Centralizer and PERFECTA® Distal Centralizer are molded PMMA centralizers placed within the femoral canal before the hip stem implant, providing a guide for the implant and allowing the surgeon to easily center the hip stem implant within a uniformly thick cement mantle. The centralizer bears no body weight, since the cured bone cement transfers all loading forces from the stem to the bone. The materials used for the Distal Centralizers are identical to the materials used for the predicate devices (molded PMMA), but unlike the predicate the replacement will not contain any additives.

The provided 510(k) summary does not describe an AI medical device. It pertains to PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer, which are physical medical devices (molded PMMA centralizers for hip stem implants).

Therefore, the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies, which are typically associated with AI/ML device evaluations, is not applicable to this document.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

• Intended Use and Indications for Use
• Technological Characteristics (materials, function)
• Nonclinical Testing (mechanical testing, material analysis, cytotoxicity)

Key points from the document regarding the device's assessment:

• Acceptance Criteria/Performance: The device is considered to have met acceptance criteria if it is "substantially equivalent" to predicate devices. The document concludes that the PROFEMUR® X™ Wingless Distal Centralizer and PERFECTA® Distal Centralizer are equivalent to predicate devices and are capable of withstanding expected in vivo conditions without failure based on nonclinical testing.
• No Clinical Testing: The document explicitly states, "Clinical data was not provided for the centralizers." This means no human subject studies were conducted to assess the device's performance in a clinical setting.
• Ground Truth: For a physical device like this, "ground truth" isn't established in the same way as for AI. Instead, it relies on established material science standards and mechanical testing to demonstrate that the device performs as intended and is safe.
• Study Type: This is a nonclinical study focused on material characterization and mechanical performance to demonstrate substantial equivalence to legally marketed predicate devices.

Summary of what can be extracted from the document in relation to the prompt's categories (with N/A where not applicable):

Acceptance Criteria and Device Performance (Non-AI Device)

Study Information (as requested by prompt, but adapted for this non-AI device context)

1. Sample size used for the test set and the data provenance: Not applicable in the context of an AI device. For this physical device, specific N values for experimental samples in mechanical and material tests are not provided in the summary. The tests are nonclinical, performed in a lab setting.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material and mechanical properties are evaluated against established ASTM standards and comparable predicate device data, not expert consensus on interpretations.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a nonclinical device assessment.
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 device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, "ground truth" relates to adherence to material specifications (e.g., ASTM F451), measured mechanical properties (compressive strength), and biochemical analyses (e.g., residual monomer, cytotoxicity) which are compared to predicate devices and recognized safety thresholds.
7. The sample size for the training set: Not applicable. This is not an AI device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI device.

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The Gladiator Hip Stems are intended for use in uncemented total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
Indications for Use:

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 Gladiator cpTi Plasma Sprayed hip stem is intended for cementless hip arthroplasty. The Cemented hip stem is intended for cemented hip arthroplasty.

The Gladiator stems are modular hip stems that couple with modular necks. Design features of the stems are summarized below:

• Cementless stem with proximal cpTi plasma spray coating.
• Available in 10 sizes
• Manufactured from Ti alloy
• Cemented
• Available in 5 sizes
• Manufactured from CoCr alloy
• Distal centralizers available

Acceptance Criteria and Study for PROFEMUR® Gladiator Hip Stems

This section details the acceptance criteria and the study conducted to demonstrate the safety and effectiveness of the PROFEMUR® Gladiator Hip Stems.

1. Table of Acceptance Criteria and Reported Device Performance

"The GLADIATOR® Hip Stems have been tested in distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8." (Implies meeting the standards set by these ISO specifications, which are designed to ensure mechanical integrity for hip implants.) |
| Material Compatibility | Use of materials identical to those used in predicate devices with established safety and performance records. | "The materials used for the GLADIATOR® Hip Stems are identical to the materials used for the predicate devices." |
| Technological Equivalence| The fundamental scientific technology and design features (e.g., modular design, cross-section, tapered profile) are substantially equivalent to predicate devices. | "The GLADIATOR® Hip Stems have the same technological characteristics as the predicate device. GLADIATOR® Hip Stems are straight cemented and uncemented hip stems with a modular design. They feature a proximal trapezoidal cross-section and a distal rectangular cross-section. For fixation stability in three planes, the stem has a vertically tapered profile in the frontal and lateral planes." "The fundamental scientific technology of the modified devices has not changed relative to the predicate devices." |
| Intended Use & Indications| The intended use and indications for use are identical to previously cleared predicate devices. | "The indications for use of the Gladiator Hip Stems are identical to the previously cleared predicate devices." |

2. Sample Size and Data Provenance for the Test Set

• Sample Size: Not applicable. This submission relies on non-clinical (mechanical) testing and comparison to predicate devices, not a clinical test set with human subjects.
• Data Provenance: The mechanical testing data would be generated from laboratory experiments. The country of origin for this testing is not specified, but it would presumably be conducted by or for Wright Medical Technology, Inc., located in Arlington, TN, USA. The data is prospective in the sense that the tests were conducted specifically for this device submission.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: Not applicable. The ground truth for mechanical testing is established by adherence to international standards (e.g., ISO 7206 series) and engineering principles, not expert consensus on clinical cases.
• Qualifications of Experts: Not applicable in the context of clinical ground truth. However, the testing would be overseen by qualified engineers and scientists specialized in biomechanical testing of orthopedic implants.

4. Adjudication Method (Test Set)

• Adjudication Method: Not applicable. No clinical test set requiring adjudication of findings was used.

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

• Was an MRMC study done? No.
• Effect size of human reader improvement: Not applicable, as no MRMC study was conducted. This device is an implantable orthopedic device, and its approval relies on mechanical performance and substantial equivalence to predicate devices, not on the interpretation of medical images or data by human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Was a standalone study done? Yes, in the context of mechanical testing. The device's performance was evaluated in isolation through fatigue, fretting, and distraction tests as per ISO standards. This is a "standalone" evaluation of the physical device's mechanical integrity.
• Details of the study: The GLADIATOR® Hip Stems underwent "distal and proximal fatigue evaluation per the loading regimen prescribed by ISO 7206-4, -6 and -8," in addition to fretting and distraction evaluation. The results demonstrated equivalence to predicate devices and the capability to withstand in vivo loading.

7. Type of Ground Truth Used (Test Set)

• Type of Ground Truth: The ground truth for this submission is based on adherence to international mechanical testing standards (ISO 7206-4, -6, and -8) and the established safety and effectiveness profile of predicate devices through direct comparison of design features, materials, and mechanical performance. There is no clinical or pathology-based ground truth from a test set of human cases.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device approval is based on a 510(k) submission demonstrating substantial equivalence, primarily through mechanical testing and comparison to existing predicate devices. It does not involve machine learning algorithms or a "training set" in the computational sense.

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

• How Ground Truth Was Established: Not applicable. As there is no training set for a computational model, there is no ground truth to establish for it. The "ground truth" in the broader sense for this submission is derived from the established performance and safety of the predicate devices and the robust mechanical testing standards it adheres to.

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Total hip replacement for patients with:

• Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, . osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
• . Femoral neck fractures.
• . Failed previous surgery where pain, deformity, or dysfunction persists.
• Revision of previously failed hip arthroplasty. .

Hemi-hip replacement for patients with:

• Femoral neck fractures. .
  This femoral stem is for cementless use only.

The CLS Brevius Stem with Kinectiv Technology is a modular, titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design with a proximal-to-distal taper and a trapezoidal cross-section. The proximal portion of the stem contains a tapered female junction to allow for attachment to Kinectiv Technology modular necks and features for attachment of insertion/extraction instrumentation.

The provided text is a 510(k) Summary for a medical device (CLS® Brevius™ Stem with Kinectiv® Technology) seeking clearance from the FDA. This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove a device meets specific acceptance criteria through a study as would be described for a diagnostic AI/ML device.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. The document focuses on non-clinical (lab) performance testing and does not describe a clinical study of the type that would involve a test set, ground truth experts, or AI/ML performance metrics.

Here's a breakdown based on the information provided in the document and why certain sections are not applicable:

1. Table of acceptance criteria and the reported device performance

The document does not present acceptance criteria in a quantitative table format that measures diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it lists performance tests and concludes that the device is "safe and effective and substantially equivalent to the predicate devices."

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

• Not Applicable. This document describes non-clinical (lab) performance testing of a physical medical device (femoral stem prosthesis), not a diagnostic AI/ML system. There is no "test set" of patient data in the context of diagnostic performance. The tests performed are engineering/mechanical tests on the device itself.

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

• Not Applicable. See point 2. Ground truth in the context of diagnostic AI/ML is not relevant here. The "ground truth" for non-clinical testing refers to established engineering standards and validated testing methodologies.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 implant device, not an AI/ML diagnostic algorithm. Therefore, no MRMC study or AI assistance comparison was conducted.

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

• Not Applicable. See point 5.

7. The type of ground truth used

• For the non-clinical performance testing, the "ground truth" implicitly refers to the established engineering and biomechanical standards and validated test methods against which the device's performance (e.g., fatigue strength, stability) is evaluated. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the AI/ML sense in this document.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device. There is no "training set" of data.

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

• Not Applicable. See point 8.

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision procedures where other treatment or devices have failed.
   Porous coated components are intended for uncemented biological fixation.

The TaperIoc® Complete Microplasty Stems are an update to the existing TaperIoc® Microplasty Stems and are designed to replace the patient's natural hip, femoral neck, and head, due to disease or accident. The Taperloc® Complete Microplasty Stems will combine the design features of the Taperioc® Complete full-length stems to the shortened design of the existing Taperloc® Microplasty Stems. These design features include: a reduced neck angle, shorter/longer neck lengths, reduced Type 1 taper geometry with neck flats, polished neck, standard and high offset versions, two distal profiles, and an updated insertion hole. Stem sizes ranges are within the ranges of legally marketed predicates. The substrate material is Ti-6AI-AV, ASTM F-136. The proximal intramedullary region is sprayed with porous plasma spray.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Mechanical Testing: 6 worst-case stems were used for both distal and proximal stem fatigue testing. The sample size for the Range of Motion analysis is not explicitly stated but implies at least one simulation.
• Data Provenance: The data is from non-clinical testing performed by Biomet Manufacturing Corp. The country of origin is not explicitly stated, but the company is based in Warsaw, IN, USA. The data is prospective in the sense that it was generated for the purpose of this 510(k) submission, not gathered retrospectively from existing patient data.

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

This section is not applicable as the studies described are non-clinical mechanical engineering tests, not studies requiring human expert assessment of medical images or patient outcomes. The "ground truth" for these tests is defined by the international standards (e.g., ISO, ASTM) and the specified load/cycle requirements.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as above. There were no human expert assessments requiring adjudication. The tests were objective mechanical measurements against predefined pass/fail criteria.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This device is a hip implant, and the testing described is mechanical, not related to AI-assisted human reading.

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

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests was based on internationally recognized engineering standards and specifications. Specifically:

• Distal Stem Fatigue: ISO 7206-4:2002, ASTM F2068-03
• Proximal Stem Fatigue: ISO 7206-6:1992
• Range of Motion Analysis: ISO 21535:2009
• PPS Plasma Sprayed Coating: "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" and 21 CFR 888.3358.

The "ground truth" is therefore adherence to these established mechanical performance and material characterization standards.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The number of samples for mechanical testing (6 worst-case stems) served as the test set.

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

This section is not applicable for the same reason as above. There is no training set mentioned or implied.

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