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The Proven Gen-Flex™ Total Knee System is intended for:

• Total knee replacement due to osteoarthritis. osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems.
• Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
  The device is intended for cemented use only.

The EXp Tibial Inserts and Patellar Components are made of polyethylene to which Vitamin E has been blended. The tibial inserts are available in "Cruciate Retaining" (CR) and "Posterior Stabilized" (PS) designs. The patellar components are available Single Peg and Three Peg designs. These implants are part of the Proven Gen-Flex™ Total Knee System and will be used in conjunction with a femoral component and tibial baseplate in total knee arthroplasty.

This document describes the 510(k) summary for the EXp Tibial Inserts and Patellar Components for StelKast's Proven Gen-Flex™ Total Knee System, a medical device. This information is not a diagnostic AI device, so the requested information about acceptance criteria, study details, and expert involvement is not applicable.

The document indicates "Preclinical Testing" was performed, which included:

• Non-clinical testing: Assessed the interconnection mechanism between the insert and tibial baseplate, and the integrity of the tibial post on the posterior-stabilized design.
• Knee simulator wear testing: Per ISO 14243-1.
• Oxidative stability testing: Per ASTM F2102, after aging per ASTM F2003, after 10 million cycles of knee simulator wear testing.

The document concludes that "The testing demonstrates that the EXp Tibial Inserts are substantially equivalent to legally marketed predicate devices." This is a regulatory statement of substantial equivalence, not a performance study against specific acceptance criteria for a diagnostic AI device.

Therefore, I cannot provide the requested table and details because they are not present in the provided text, as the device is a knee implant, not a diagnostic AI system.

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The Cross-Over Acetabular Shell and Liner are intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

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 using other techniques.
5. Revision of previously failed total hip Arthroplasty.
   The Cross-Over Acetabular Shell and Liner are used as part of the Provident Hip Systems. The components of this hip system are intended for cementless fixation.

The Cross-Over Acetabular Shell and Liner will be used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty.
The Cross-Over Acetabular Shell is made of titanium alloy with a commercially pure titanium plasma spray coating. The Cross-Over Liner is made of polyethylene blended with Vitamin E. The liner is available in both non-hooded and hooded options.

This K122773 submission for the Cross-Over Acetabular Shell and Liner is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, many of the requested categories in the prompt (e.g., acceptance criteria, reported device performance, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable to this type of submission.

Here's a breakdown of what is available and what is not applicable based on the provided text:

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

• Not Applicable. This submission is for a medical device (hip implant components). The "acceptance criteria" here relate to the mechanical and material properties necessary to demonstrate substantial equivalence to existing devices, not a performance metric like accuracy or sensitivity for a diagnostic algorithm. The document states "Non-clinical testing was performed on the Cross-Over Acetabular Shell and Liner to assess the interconnection mechanism between the shell and liner (i.e., disassembly force, lever-out torque, and rotational failure torque). The results of the performed tests demonstrate that the Cross-Over Acetabular Shell and Liner are substantially equivalent to legally marketed predicate devices." However, specific quantitative acceptance criteria and the numerical results against those criteria are not provided in this summary.

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

• Not Applicable. This is a physical device, and the testing described is non-clinical (mechanical/bench testing), not performance measured on a test dataset of patient data.

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, in the context of expert review, is not relevant for this type of mechanical device testing.

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 a physical hip implant component, not an AI or diagnostic imaging device.

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

• Not Applicable. This is a physical hip implant component.

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

• Not Applicable. For mechanical testing, the "ground truth" would be the measured physical properties according to established engineering standards, rather than expert consensus on medical findings.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable.

Summary of the Study and Substantial Equivalence Claim:

The study described for the Cross-Over Acetabular Shell and Liner is a preclinical (non-clinical) testing program.

• Objective: To assess the interconnection mechanism between the shell and liner.
• Specific Tests Conducted: Disassembly force, lever-out torque, and rotational failure torque.
• Purpose: To demonstrate substantial equivalence to legally marketed predicate devices. This means the device met the expected performance characteristics in these non-clinical tests, and these results were deemed comparable to those of the predicate devices.
• Predicate Devices:
  • Acetabular Shells in the Stelkast Provident Hip System (K001745)
  • EXp Acetabular Liner (K094035)
• Basis for Substantial Equivalence: The predicate devices have the same intended use, general design, similar size range, and are made of the same materials. The non-clinical testing confirmed similar performance characteristics for the interconnection mechanism.

In essence, this submission focuses on demonstrating that the new device is as safe and effective as already legally marketed devices, based on comparative design, materials, indications for use, and a limited set of non-clinical mechanical tests, rather than establishing performance against de novo acceptance criteria through clinical or algorithmic studies.

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The EXp Acetabular Shell Liner is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

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 using other techniques.
5. Revision of previously failed total hip Arthroplasty.
   Cemented and Uncemented Applications

The EXp Acetabular Shell Liner is made of polyethylene to which Vitamin E has been added. It is available in both hooded and non-hooded options. The liner is part of a complete total hip system and will be used in conjunction with an acetabular shell, femoral head and femoral stem in total hip arthroplasty. The femoral heads which are to be mated with the EXp Liner are made of Biolox forte, Biolox Delta, or CoCr alloy.

The provided text describes a 510(k) summary for the EXp Acetabular Shell Liner. This documentation focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than conducting a controlled clinical study with acceptance criteria often seen in AI/ML device submissions. Therefore, many of the requested elements for AI/ML device evaluation (like sample sizes for test sets, expert ground truth, MRMC studies, training set details) are not applicable or present in this specific type of submission.

However, I can extract and structure the information related to the performance claims and the studies that support them.

Acceptance Criteria and Study for EXp Acetabular Shell Liner

The submission details several claims regarding the oxidative stability and mechanical performance of the EXp material and the EXp liners, which can be interpreted as the performance goals or "acceptance criteria" for the device to be deemed substantially equivalent. The "reported device performance" are the results of the non-clinical tests conducted to support these claims.

1. Table of Acceptance Criteria and Reported Device Performance

• Maximum ASTM F2102 oxidation index for EXp: increased from 0.1 ± 0.02 to 0.2.
• Maximum ASTM F2102 oxidation index for conventional GUR1050: increased from 0.1 ± 0.04 to 3.8 ± 0.2.
• Ultimate load for EXp (ASTM F2183): remained constant (63.3 ± 8.9 N non-aged, 73.1 ± 5.2 N 4-week-aged).
• Ultimate load for conventional GUR1050: decreased from 71.5 ± 3.0 N (non-aged) to an embrittled condition (no sample could be machined after 4 weeks; 45.7 ± 5.9 N after 2 weeks). |
  | Morphology of EXp UHMWPE is consistent with conventional UHMWPE.
  Criteria: No consolidation defects or voids when imaged at high magnification under scanning electron microscopy. | Freeze fracture analysis and scanning electron microscopy showed both EXp UHMWPE and 25kGy GUR 1050 material demonstrated no consolidation defects or voids at high magnification. |
  | Vitamin E blended into EXp UHMWPE does not elute from the material.
  Criteria: No Vitamin E detected in hexane or isopropanol (IPA) extracts using GC-MS and LC-MS. | GC-MS and LC-MS analysis confirmed no Vitamin E was extracted from EXp material when refluxed in hexane at 74°C for 24 hours (detection limits: 50-250 ppb) or soaked in IPA at room temperature for 18 hours (detection limits: 1000 ppm). |
  | EXp liners remain resistant to oxidation after 5 million cycles of wear testing and artificial aging.
  Criteria: Resistance to oxidation (per ASTM F2102) after wear testing (ISO 14242-1) followed by accelerated aging (ASTM F2003). | After 5 million cycles of wear testing (ISO 14242-1) and subsequent 4 weeks of oxidative aging (ASTM F2003):
• Maximum oxidation index (ASTM F2102) for EXp liners: increased from 0.1 ± 0.02 (non-aged EXp material) to 0.2 ± 0.02 (4-week-aged EXp material). |
  | EXp liners experience no failures from dynamic impingement testing.
  Criteria: Resistance to rim fracture under fatigue loading conditions to 1.0 MC (million cycles) per ASTM F2582, with no failure of the locking mechanism. | Dynamic impingement testing per ASTM F2582:
• Three (3) artificially aged EXp liners were loaded to engage the rim with the femoral neck at 4.6 Nm (70% of static peak dislocation moments).
• All three samples reached run-out (1.0 MC) with no fractures observed and no failure of the locking mechanism. |

Regarding the other requested information, which is more relevant to AI/ML device studies:

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

• Not applicable. This submission is for a physical medical device (acetabular liner) and relies on non-clinical, in vitro, and mechanical bench testing, not data analysis from patient studies. The "samples" refer to physical specimens of the material or device.

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 in this context is established by standardized physical, chemical, and mechanical testing protocols (e.g., ASTM, ISO standards), not human expert consensus on images or clinical data.

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

• Not applicable. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical or image-based studies. This submission relies on objective physical measurements.

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 device, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This is a physical device, not an algorithm.

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

• The "ground truth" for the performance claims is derived from standardized physical and chemical measurements according to established industry standards (e.g., ASTM F2183, ASTM F2003, ASTM F2102, ISO 14242-1, ASTM F2582).

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling. The material properties are inherent to its manufacturing process and composition.

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

• Not applicable. As above, no training set is described for this physical device.

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The StelKast Proven Stem Extenders are intended for use with compatible components of the Proven Knee System for the following indications:

1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems;
2. Revision of failed previous reconstructions where sufficient bone stock and soft integrity are present; and
3. Cemented use only.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the StelKast Proven Stem Extender, a knee joint prosthesis component. This document grants market clearance based on substantial equivalence to a predicate device.

It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device, clinical trial, or performance study with metrics like sensitivity, specificity, or AUC.

The document primarily focuses on:

• Confirming 510(k) clearance for the device.
• Indications for Use (for total knee replacement due to various conditions, revision of failed reconstructions, and cemented use only).
• Regulatory classification and associated general controls.
• Points of contact for regulatory guidance.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these details are not present in the provided text.

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• 1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems.
• 2. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
• 3. For cemented use only.

Not Found

This FDA 510(k) clearance letter for the "Proven Knee System High Flexion Tibial Insert" does not contain information about acceptance criteria and a study proving a device meets those criteria, as typically seen for AI/ML-driven diagnostics or imaging devices.

This document pertains to a traditional medical device (a knee implant) and focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving performance against specific quantitative metrics that an AI algorithm would require.

Therefore, I cannot extract the requested information (points 1-9) from the provided text. The document is a regulatory clearance for a physical medical implant, not a study report for an AI-powered device.

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The StelKast Proven Revision Modular Tibial Tray is intended for cemented use only in total knee replacement with the following indications:

1. osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems;
2. revision of failed previous reconstructions where sufficient bone stock and soft integrity are present.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the "StelKast Proven Revision Modular Tibial Tray." This document concerns the regulatory approval of a medical device and does not contain any information about acceptance criteria, device performance studies, or AI/software analysis.

Therefore, I cannot fulfill your request for information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, ground truth establishment for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How training set ground truth was established.

This document is solely about the FDA's determination of substantial equivalence for a physical medical implant (a knee joint component) to a legally marketed predicate device, allowing it to be marketed. It does not involve any AI or software-based diagnostic or prognostic device, or performance studies that would typically include the details you are asking for.

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The 32mm Modular Ceramic Femoral Head is a single use device used for reconstruction of the articulating surface of the femoral head portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head.

StelKast 32mm Modular Ceramic Femoral Head

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA letter granting 510(k) clearance for the "StelKast 32mm Modular Ceramic Femoral Head" and its Indications For Use. It confirms the device's substantial equivalence to a legally marketed predicate device but does not detail any specific performance acceptance criteria or the results of a study to demonstrate compliance with such criteria.

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• 1. Moderate joint impairment from painful arthritis (rheumatoid, osteo and/or posttraumatic).
• 2. Revision of a failed unicompartmental knee implant or other procedure.
• 3. Alternative to tibial osteotomy in patients with unicompartmental arthritis.

StelKast Unicondylar Knee System

I'm sorry, but this document does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a medical device (StelKast Unicondylar Knee System), which indicates that the device is substantially equivalent to a legally marketed predicate device.

The clearance letter does not include:

• Acceptance criteria for device performance.
• Any study details for evaluating the device's performance against acceptance criteria (e.g., sample size, data provenance, expert involvement, ground truth methods, MRMC studies, or standalone algorithm performance).

The information provided pertains to regulatory clearance, not performance study outcomes.

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1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
2. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
3. For cemented use only.

Stelkast Proven Cemented, Semi-Constrained Total Knee System

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, specifically a total knee system. It states that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it is a regulatory approval notice based on substantial equivalence, which is a different regulatory pathway than requiring clinical studies to prove specific performance metrics.

Therefore, I cannot provide the requested information from this document.

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1. The ProClass Press Fit Hip Stem is a single use, cementless device used for reconstruction of the articulating surface of the femur portion of the hip that is severely disabled and/or very painful resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or fracture of the femoral head provided there is sufficient sound bone to seat the prosthesis.
2. The stem can be used for primary hip implant or for hip revision of a failed implant.
3. The stem can be used for congenital defects that will allow adequate function of the system.

ProClass Press Fit Hip Stem is a single use, cementless device.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, study designs, sample sizes (for test or training sets), data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

The document is an FDA 510(k) clearance letter for the "ProClass Press Fit Hip Stem." It primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended "Indications For Use." It does not include data from a study that would demonstrate the device meets specific acceptance criteria.

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