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The Lateralized Taperloo® Microplasty™ Femoral Components are indicated for use in patients requiring hip replacement due to the following:

• Non-inflammatory degenerative ioint 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 of previously failed femoral head resurfacing component

The Lateralized Taperioc® Microplasty™ Femoral Components are intended for uncemented use only.

Specific indications for compatible components that can be used with the Lateralized Taperloc® Microplasty™ femoral Components include:

Constrained Liners (K030047)

Constrained liners are intended for general use in skeletally mature individuals undergoing primary and/or revision surgery at high risk of hip dislocation due to history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

The Lateralized Taperloc® Microplasty™ Femoral Components are straight, collarless, flat, tapered stems designed to match the geometry of the femur. The stems are proportionally sized and shaped in sizes 5.0mm to 25.0mm diameters. The stems are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or F-1472 and a proximal portion of each femoral stem is covered with Biomet's full plasma spray porous coating.

The provided text is a 510(k) summary for the Biomet Lateralized Taperloc® Microplasty™ Femoral Components. This document discusses the device's description, intended use, and substantial equivalence to a predicate device, primarily based on non-clinical testing. The document explicitly states that no clinical testing was performed or provided.

Therefore, it is not possible to complete the requested table and detailed study information as there is no clinical study described in the provided text that proves the device meets acceptance criteria. The device's clearance was based on demonstrating substantial equivalence through non-clinical mechanical testing to a legally marketed predicate device.

Here's a breakdown of why the requested information cannot be provided based on the input:

1. Acceptance Criteria and Reported Device Performance: This would typically involve clinical endpoints (e.g., success rates, complication rates) and their corresponding performance metrics from a clinical study. Since no clinical study was performed, there are no reported device performance figures of this nature. The "acceptance criteria" for a 510(k) without clinical data primarily relate to demonstrating substantial equivalence in design, materials, manufacturing, and non-clinical performance (e.g., mechanical strength, wear resistance) compared to a predicate device.

2. Sample Size, Data Provenance: No clinical study, therefore no sample size, test set, or data provenance.

3. Number of Experts, Qualifications, Adjudication Method: These points are relevant to establishing ground truth in clinical studies, particularly for imaging or diagnostic devices. Not applicable here.

4. MRMC Comparative Effectiveness Study: No clinical study, so no MRMC study.

5. Standalone Performance: This refers to the algorithm's performance in AI/diagnostic devices. Not applicable to a hip implant.

6. Type of Ground Truth: In clinical studies, this refers to the definitive diagnostic label (e.g., pathology, clinical outcome). Not applicable here as there is no clinical study data.

7. Sample Size for Training Set, Ground Truth for Training Set: These are relevant for AI/machine learning models. Not applicable to a physical hip implant device.

Conclusion based on the provided document:

• Acceptance Criteria: Not explicitly detailed in terms of clinical performance metrics because no clinical testing was performed. The implicit acceptance criteria were demonstrating substantial equivalence through non-clinical mechanical testing, materials, and design similarity to the predicate device (Taper 2 TM Porous femoral Stem - K050441).
• Study Proving Acceptance Criteria: A "Non-Clinical Testing" study was performed.
  • Description: "Mechanical testing has demonstrated equivalence between the Lateralized Taperloo® Microplasty™ Femoral Components and the predicates."
  • Details regarding study: The document does not provide details about the specific mechanical tests, their protocols, acceptance thresholds, or results beyond the general statement of equivalence.
  • Clinical Testing: "None provided."

The 510(k) clearance was based on the FDA's determination of substantial equivalence to a predicate device, supported by non-clinical (mechanical) testing, rather than a clinical study proving specific performance acceptance criteria for the new device.

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