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The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Zimmer G7 Acetabular System / Taperloc Complete Hip System devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.

Cycle: Dynamic Air Removal
Temperature: 270 F/132 C
Exposure Time: 4 minutes
Drying Time: 10 minutes

Validations included the worst case load configurations of the EZ- TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Devices.

• . Contents in the validated configuration include reusable surgical instruments (impactors, trials, acetabular reamers, broaches, etc)
• No lumened devices were validated within the tray system as part of the product load. The EZ-. TRAX ™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device does not have any lumen claims.
• Healthcare facilities should not exceed 25 pounds (EZ-TRAX™ Containment Device + Sterile Barrier . System + Zimmer G7 Acetabular System / Taperloc Complete Hip System Devices).

The EZ-TRAX™Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport and store G7 Acetabular System / Taperloc Complete Hip System Devices between surgical uses. The EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA cleared sterile barrier system.

The subject device protects the inteterior components during transportation, sterilization, and storage.

The EZ-TRAX™Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device is composed of intrinsically stable metals and thermoplastic polymers. The trays and lids are composed of anodized aluminum with stainless steel handles. The dividers are composed of Aluminum and the posts are composed of medical grade thermoplastic polymers.

The lids and bottom of travs are fully perforated with an evenly distributed hole pattern. The sides of the travs are partially perforated. The travs are used with locking lids,

The trays were designed to be used for sterilization via steam sterilization and used in standard autoclaves found in hospitals and healthcare facilities. The trays were designed in such a way to withstand repeated steam sterilization cycles.

This document describes the safety and performance of the EZ-TRAX™ Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device, a sterilization cassette. The information provided relates to non-clinical testing for mechanical, thermal, and biological compatibility, not a study involving human subjects or AI-assisted diagnosis.

Therefore, many of the requested categories, such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and effect size of human reader improvement with AI assistance, are not applicable to this type of device and study.

Here's the information that can be extracted and a clear indication of why other information is not present:

Acceptance Criteria and Reported Device Performance

The device passed all non-clinical performance tests.

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

This document describes non-clinical laboratory testing of a medical device (sterilization cassette), not a study involving patient data. Therefore, concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as they relate to clinical or AI diagnostic studies are not applicable. The sample size for each specific test (e.g., number of units tested for mechanical cleaning, number of cycles for material compatibility) is not explicitly detailed in this summary document beyond "repetitive cleaning and sterilization processing cycles" or testing a specific number of cycles (e.g., 25 cycles for material compatibility). The data provenance is from laboratory testing performed according to recognized standards (e.g., AAMI, ISO, ASTM).

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

This is not applicable. Ground truth, in this context, refers to scientific and engineering standards for evaluating physical and biological performance (e.g., sterility, cleanliness levels, material degradation). These are established through validated test methods and instrumentation, not through expert human interpretation of medical images or diagnoses.

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

This is not applicable, as it pertains to human interpretation/diagnosis, not physical device performance 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

This is not applicable. This device is a sterilization cassette, not an AI-powered diagnostic tool.

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

This is not applicable. This device does not involve an algorithm.

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

The "ground truth" for this device's performance is based on established engineering and microbiological standards and measurable parameters (e.g., sterility assurance level (SAL) of 10-6, specific levels of residual hemoglobin and protein, material integrity after defined cycles, maintenance of temperature profiles). This is determined by validated laboratory test methods, not clinical expert consensus, pathology, or outcomes data from patients.

8. The sample size for the training set

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

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

This is not applicable.

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· Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
· Rheumatoid arthritis.
· Correction of functional deformity.
· Treatment of non-union. femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement. unmanageable by other techniques.
· Revision procedures where other treatment or devices have failed.
Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented use.

The G7 Acetabular System is a modular system, designed to provide numerous options for surgeons and patients in one compatible system. It is modular in design including multiple variants of acetabular shells: a titanium alloy (ASTM F136) shell with an apical hole and plug, the outer surface of the shell is coated with Biomet's Porous Plasma Spray (PPS®) (ASTM F1580) or produced by additive manufacturing using titanium alloy powder as OsseoTi® (ASTM F2924), available in solid shell, limited hole, and multi-hole designs as well as PPS Finned limited hole shells. The other main component is an acetabular liner manufactured from UHMWPE polyethylene, offered in both highly crosslinked polyethylene (HXPE) and Vitamin-E Highly Crosslinked polyethylene (VEHXPE), available in Neutral, High Wall, Neutral +5mm, or 10 Degree Face Changing designs.

The provided text describes a 510(k) premarket notification for the Zimmer, Inc. G7 Acetabular System, specifically focusing on the introduction of new acetabular liners.

Based on the document, there is no acceptance criteria or study that proves a device (in the context of an AI/ML medical device) meets acceptance criteria, an MRMC comparative effectiveness study, or standalone algorithm performance data.

The document pertains to a hip prosthesis which is a physical implant, not an AI/ML medical device. The "performance data" mentioned refers to non-clinical mechanical testing and engineering analysis for the physical implant, demonstrating that modifications to the physical device do not adversely affect its safety and efficacy.

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and performance from this document. The questions posed are relevant to AI/ML or diagnostic devices, but this document describes a physical orthopedic implant.

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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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