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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.

Acetabular shells and femoral stems with porous coatings are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use.

Indications for Biomet G7™ Freedom™ Constrained Liners:

The Biomet G7™ Freedom™ Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

The G7™ Acetabular System is a modular system, designed to provide numerous options for surgeons and patients in one compatible system. The titanium alloy (ASTM F136) shell is available in both a solid shell and limited hole design, with an apical hole and plug. The outer diameter of the shells is coated with Biomet's Porous Plasma Spray (ASTM F1580). The acetabular liners are manufactured from UHMWPE (ASTM F648) as ArComXL® or E1® (UHMWPE infused with vitamin E) and available in a Neutral, High Wall, or Ten Degree Face Changing design. Additionally, the system has provided for a constrained liner and head when such an option is required. The Biomet Freedom" product line has added a 32mm Freedom" head (cobalt chrome, ASTM F1537) to its offerings, as well as a new series of constrained liners (E1®, ASTM F648) designed for compatibility with the G7™ shells. A new line of cobalt chrome (ASTM F1537) femoral heads in varying sizes and neck lengths, with either a Type 1 or 12/14 taper, has been added to the system. The system is compatible with Biomet® ceramic heads and femoral stems.

The provided FDA 510(k) summary for the Biomet G7™ Acetabular System (K121874) describes a medical device, specifically a hip prosthesis system. This document is a premarket notification for a medical device and, as such, focuses on demonstrating "substantial equivalence" to previously cleared devices rather than presenting novel clinical study designs with acceptance criteria and device performance metrics in the way a diagnostic AI/ML device submission would.

Therefore, the information required to populate the requested table (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC, standalone studies, etc.) is not typically included or relevant in a 510(k) submission for a hip prosthesis system.

Here's why and what information is available in the document:

Why the requested information is not present:

• Device Type: The G7™ Acetabular System is a physical orthopedic implant (hip prosthesis), not an AI/ML diagnostic or predictive software device.
• Regulatory Pathway (510(k)): The 510(k) pathway demonstrates substantial equivalence to a legally marketed predicate device. This typically involves non-clinical (bench) testing to show that the new device performs similarly and does not raise new questions of safety or effectiveness compared to the predicate. It does not generally require extensive clinical trials with acceptance criteria, human reader studies, or detailed ground truth studies as would be expected for a diagnostic device.
• Focus of the Document: The document focuses on:
  • Descriptions of the device components and materials.
  • Identification of predicate devices for comparison.
  • Indications for Use.
  • A list of non-clinical (bench) tests performed.
  • A statement regarding the lack of clinical testing.

Information that is available or can be inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided because the testing for an orthopedic implant focuses on mechanical properties, material properties, and compatibility, rather than diagnostic accuracy or sensitivity/specificity metrics. The document states:

   • "Testing demonstrates that the modifications made to the G7™ Acetabular System do not introduce any new risks of safety or efficacy, and that the G7™ Acetabular System is substantially equivalent to the predicates." This is the overarching "acceptance" or conclusion. Specific numerical acceptance criteria for each bench test are not detailed in this summary.

2. Sample Size used for the test set and the data provenance: Not applicable in the context of clinical data for a diagnostic device. The "test set" here refers to the physical components of the implant undergoing bench testing. The sample sizes for these tests (e.g., number of implants tested for fatigue, push-out, etc.) are not specified in this summary. Data provenance would be from laboratory bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI (e.g., expert consensus on medical images) is not relevant for this type of device. Performance is assessed through engineering and material science standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the diagnostic sense. For mechanical testing, the "ground truth" would be established engineering standards, material specifications (e.g., ASTM standards listed for materials), and the performance characteristics of the predicate devices.

8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the AI/ML sense.

9. How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Testing (as listed in the document):

The document lists various non-clinical (bench) tests performed to support substantial equivalence. These tests evaluate mechanical aspects of the device components. While specific acceptance criteria for each of these tests are not provided in this summary, the overall conclusion is that the device passes these tests and is substantially equivalent.

• Poly Push Out
• Poly Lever Out
• Poly Torque Out
• Poly Rim Impingement
• Poly Deformed Cup Push Out
• Poly Deformed Cup Lever Out
• Poly Fatigue, Lever Out
• Poly Constrained Liner Rim Impingement and Lever Out Testing
• Range-of-Motion Study (Poly)
• Poly Deformed Cup Push In
• Freedom Head Pull Out of Constrained Liner
• Screw Pull Through
• Screw Torsional Properties
• Torque Curve for MIM Screw Hole Plugs
• Verification of Insertion Torque and Measurement of Torque Out
• Poly Wear Simulator
• Metal Head Justification
• MRI Justification
• Metal Head Axial Head Pull Off
• Metal Head Fretting/Corrosion

Conclusion:

The K121874 submission is for a traditional medical device (hip prosthesis) seeking 510(k) clearance by demonstrating substantial equivalence through non-clinical bench testing. It does not involve AI/ML components or clinical studies with the type of acceptance criteria, reader studies, and ground truth establishment typically requested for diagnostic software devices. Therefore, most of the specific categories in your request are not applicable to this document.

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The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The system is intended for use either with or without bone cement in total hip arthroplasty.

The proposed Continuum and Trilogy IT Acetabular System Shells are a line extension to the predicate modular acetabular shells, with a smaller 40 mm outer diameter. The Longevity IT Elevated Liner in this submission is offered in a size to be used with the 40 mm Continuum and Trilogy IT Shells above and has a 22 mm articulation diameter. The Longevity IT Offset and Oblique Liners are modular acetabular cup liners intended to be used with the Continuum and Trilogy IT Acetabular Systems. Offset Liners have a head center that is offset 7 mm beyond the acetabular shell center of rotation and the Oblique Liners have a liner face and head center tilted by 10° relative to the acetabular shell rim.

The provided document describes the Zimmer Continuum® and Trilogy® IT Acetabular Systems & Longevity® IT Highly Crosslinked Polyethylene Elevated, Offset, and Oblique Liners. This is a medical device for total hip arthroplasty. The document details the non-clinical performance and conclusions, but explicitly states that clinical data and conclusions were not needed for this device. This means there was no study involving human subjects or expert readers to evaluate its performance against specific acceptance criteria in a clinical setting as would typically be done for AI/diagnostic devices.

Therefore, many of the requested elements for an AI/diagnostic device's acceptance criteria and study design are not applicable to this submission.

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

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

Since this is a non-clinical evaluation of a hip prosthesis, the "acceptance criteria" are related to mechanical and physical performance rather than diagnostic accuracy. The document lists the specific non-clinical tests conducted, implying that the device "met performance requirements." However, the specific quantitative acceptance criteria for each test (e.g., "liner push-out force must exceed X Newtons") and the actual numerical results are not explicitly detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided because the study was non-clinical (mechanical testing of physical devices), not a clinical study involving patients or data. The "test set" would refer to the number of physical liners and shells subjected to each mechanical test. This specific quantity is not disclosed in the summary document.

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. Ground truth for mechanical testing is established by engineering specifications and measurements, not expert human interpretation.

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

Not applicable. Adjudication methods are relevant for subjective human assessments, not objective mechanical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical hip prosthesis, not an AI diagnostic tool that assists human readers.

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

Not applicable. This is not an algorithm.

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

For non-clinical performance, the "ground truth" implicitly refers to engineering specifications, material science standards, and biomechanical requirements for an implantable device to function safely and effectively within the human body. For example, a "liner push-out" test would have an engineering specification for the minimum force required to dislodge the liner, and the measured force would be compared against that.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. This is a physical device, not an AI model.

In summary: The provided document is a 510(k) premarket notification for a medical device (hip prosthesis) based entirely on non-clinical performance testing. It states that "Clinical data and conclusions were not needed for this device" because it is a line extension of previously cleared predicate devices and it met performance requirements through various mechanical and material tests. Therefore, questions related to clinical studies, expert readers, AI performance, and AI training/ground truth are not relevant to this specific submission.

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