(115 days)
The Reliance Long Stem Femoral components are intended to be used in primary or revision surgery for patients diagnosed with rheumatoid arthritis, osteoarthritis, avascular necrosis, metastatic lesions, or traumatic femoral fractures. These femoral components are intended to be used with Howmedica's V40™ femoral heads. Unipolar or Bipolar components, and acetabular components.
The Reliance® Long Stem Femoral Components consist of a family of Cobalt-Chromium-Molybdenum (Vitallium) femoral stems. These femoral components are manufactured from Cobalt-Chromium-Molybdenum (Vitallium) alloy, which meets the requirements of ASTM specification F 799.
The provided text describes a 510(k) summary for a medical device, the Reliance® Long Stem Femoral Components. It focuses on establishing substantial equivalence to previously marketed devices rather than detailing a specific study to prove the device meets acceptance criteria through performance metrics as might be found in clinical trials or software validation studies.
Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission. This document highlights engineering testing (fatigue load capacity) rather than detailed clinical performance studies in the way modern AI/software device submissions would.
Here's what can be extracted based on the provided text, and where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Notes |
|---|---|---|
| Fatigue Load Carrying Capacity: Exceeds minimum ISO load requirements. | The fatigue load carrying capacity of the Reliance® Long Stem Femoral Components exceeds the minimum ISO load requirements. | This is the primary performance metric explicitly stated. The specific ISO standard and quantitative "minimum load requirements" are not provided, nor is the exact quantitative value by which the device exceeds these requirements. The phrase "exceeds" indicates compliance. |
| Material Equivalence: Meets ASTM specification F 799. | Manufactured from Cobalt-Chromium-Molybdenum (Vitallium) alloy, which meets the requirements of ASTM specification F 799. | This is a material specification compliance, not an operational performance metric. |
| Substantial Equivalence (General): Equivalent in intended use, materials, design, and relative indications and contraindications to predicate devices. | Stated as substantially equivalent to Howmedica's Reliance® Total Hip system (K936126), Partnership Revision Femoral Components (K972893), and Modular Replacement System (K952970). | This is the overarching goal of a 510(k) submission, demonstrating similarity to legally marketed devices. It's an acceptance criterion for market clearance, not a performance metric from a "study." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "testing" for fatigue load, but does not provide details on the number of units tested, the statistical methods, or the sample size used.
- Data Provenance: Not applicable in the context of this engineering test. This refers to material and mechanical testing, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable. Material and mechanical testing (like fatigue) typically relies on standardized test methods and machine measurements rather than expert consensus on a "ground truth" derived from clinical assessment.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This type of study assesses human reader performance (often with and without AI assistance) across multiple cases, which is not relevant for the mechanical testing of a hip prosthesis.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a physical implant, not a software algorithm. The "standalone" performance here refers to the device's mechanical integrity, which was assessed, but not in the context of an algorithm or AI.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the fatigue testing, the "ground truth" would be defined by the ISO standard's minimum load requirements and the physical measurements obtained from the mechanical testing equipment. For the material, it's compliance with ASTM F 799. This is objective, measurement-based truth, not expert consensus, pathology, or outcomes data in a direct clinical sense for performance evaluation.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable.
Summary of Study that Proves the Device Meets Acceptance Criteria:
The key study mentioned is mechanical fatigue testing. The document states:
- "Testing has demonstrated that the fatigue load carrying capacity of the Reliance® Long Stem Femoral Components exceeds the minimum ISO load requirements."
This inference of meeting an acceptance criterion (exceeding ISO standards) is based on this engineering study. The 510(k) submission relies on this and the direct material compliance (ASTM F 799) to establish substantial equivalence to predicate devices, rather than a prospective clinical trial proving superior patient outcomes for a novel technology.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.