Search Results

Indications For Use:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Rheumatoid arthritis.
• Correction of functional deformity. 3.
• 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.

Taperloc® Complete Size 4mm Stems
The Taperloc® Complete Size 4mm stems will combine the design features of the Taperloc® Complete fulllength stems (K101086 and K103755) and the shortened design of the new Taperloc® Complete Microplasty, K110400. This submission is extending the implant size range to 4mm for the Full Profile (full-length and Microplasty), the Reduced Distal Profile (full-length and Microplasty), and the Traditional Reduced Distal Profile (full-length only). The design characteristics of the size 4mm full-length stems and Microplasty stems are identical to the Taperloc® Complete implants (K101086, K103755 and K110400); this is simply a line extension of our current offerings. These characteristics include: trapezoidal neck design, short taper, 133° neck angle, same material properties of the stem and plasma spray, a reduced profile distal stem, and an updated insertion/extraction hole.

Taperloc® Complete XR 123° Stems
The Taperloc® Complete XR 123° implants incorporate all the benefits of the Taperloc® Complete system, both full-length and Microplasty, as mentioned above, with a single offset neck option for the Full Profile and the Reduced Distal Profile. The only change is the 123° offset option, which was developed to reduce vertical offset (leg length), while maximizing horizontal offset. This option is supported through additional mechanical testing.

The provided text describes mechanical testing conducted on the Taperloc® Complete Size 4mm and XR 123° hip stems to demonstrate their substantial equivalence to predicate devices. This is a submission for a medical device (hip prosthesis), and the "acceptance criteria" and "study" refer to mechanical fatigue testing rather than a clinical study evaluating AI performance.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 6 stems were used for each individual test (Proximal Pot Fatigue and Distal Pot Fatigue) for both the 4mm 133° and XR 123° models.
• Data Provenance: The tests are explicitly referred to as "Non-Clinical Testing." They are laboratory-based mechanical fatigue tests, not human subject studies. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the same way it would be for clinical data.

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

Not applicable. This is a mechanical engineering study, not one using expert human interpretation for "ground truth." The "ground truth" here is the physical performance of the device under simulated physiological conditions.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical testing, not a study requiring adjudication of expert opinions.

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 document is for a medical device (hip prosthesis) and its mechanical performance, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This document is for a medical device (hip prosthesis) and its mechanical performance, not an AI-powered algorithm.

7. The type of ground truth used

The "ground truth" for these mechanical tests is the physical failure or survival of the device when subjected to specified loads for a defined number of cycles, as per established ASTM standards and FDA guidance. This is an objective, measurable outcome from engineered testing.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" in this non-clinical mechanical testing context. The tests are designed to validate the mechanical properties of the final device, not to train an algorithm.

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

Not applicable. See point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

The Taperloc Complete hip stems are intended for uncemented biological fixation. This is the same intended use as the predicate Taperloc® stems cleared in K101086.

Indications For Use:

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 Taperloc® Complete hip stems are a line extension of the legally marketed Taperloc® Complete stems cleared in K101086.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Taperloc® Complete, Sizes 5mm and 6mm:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size (i.e., number of stems) used for the non-clinical fatigue tests. It only mentions "All components passed."

The data provenance is from non-clinical testing conducted in accordance with ASTM standards. This implies laboratory testing rather than human subject data. Therefore, questions of country of origin and retrospective/prospective do not apply in the typical sense for clinical studies.

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

This information is not applicable as the studies were non-clinical fatigue tests based on established ASTM standards, not clinical studies requiring expert interpretation or ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

This information is not applicable as the studies were non-clinical fatigue tests. Adjudication methods are typically relevant for clinical trials where multiple evaluators assess outcomes and discrepancies need to be resolved.

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

This information is not applicable. The submission describes a medical device (hip stems) and its non-clinical performance, not an AI-assisted diagnostic or interpretative tool.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was adherence to the performance requirements specified in the respective ASTM standards:

• ASTM F-1612-95, Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components with Torsion: The standard itself defines the pass/fail criteria for the fatigue test.
• ASTM F-2068-03 Standard Specification for Femoral Prostheses - Metallic Implants: This standard specifies the requirements for femoral prostheses, including fatigue testing, and defines what constitutes a "pass."

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical implant, and the testing described is non-clinical performance evaluation, not machine learning model training.

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

This information is not applicable for the same reasons as above.

Ask a specific question about this device

Ask a specific question about this device