(85 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
- Cemented femoral stems and cemented acetabular cups are intended for . cemented fixation only.
- Press-fit femoral stems and acetabular cups are intended for press-fit . fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
- Femoral heads and endoprostheses are intended for use in cemented and . press-fit applications.
Not Found
This device is a modified version of previously cleared devices (AcuMatch 12/14 C-Series Cemented Femoral Stems, AcuMatch 12/14 L-Series Cemented Femoral Stems, and Novation Cemented Femoral Stems). The nature of the modifications are changes to geometry, dimensions, and material specifications for some components.
Therefore, the study performed to demonstrate that the device meets acceptance criteria is based on engineering evaluations and empirical testing to verify performance, rather than clinical trials with human readers or standalone algorithm performance.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | The modified device must perform adequately for anticipated in vivo use and maintain substantial equivalence to the predicate devices. | "Testing and engineering evaluations were conducted to verify that the performance of the new Exactech AcuMatch 12/14 Cemented Femoral Stems and Novation Cemented Stems would be adequate for anticipated in vivo use. This includes empirical testing and engineering analyses. Based on successful results we conclude that the proposed devices are substantially equivalent to Exactech's predicate femoral stems." |
| Biocompatibility | (Not explicitly stated, but implied for medical devices with material changes) The materials must be biocompatible for human implantation. | The L-Series cemented stem material was changed from cast Co-28Cr-6Mo (ASTM F75) to forged Co-28Cr-6Mo (ASTM F799). Both ASTM F75 and ASTM F799 are widely accepted biocompatible materials for orthopaedic implants. The submission likely included documentation demonstrating the new material's compliance with ISO/ASTM standards for medical implant materials, which would inherently include biocompatibility testing (although not detailed in this summary). |
| Mechanical Integrity | Devices must withstand anticipated in vivo mechanical stresses and maintain structural integrity. | "Testing and engineering evaluations were conducted to verify that the performance... would be adequate for anticipated in vivo use. This includes empirical testing and engineering analyses." While specific tests (e.g., fatigue, static strength, push-out tests for cemented stems) are not detailed, these are standard tests for orthopaedic implants undergoing geometric or material changes. The "successful results" indicate these tests confirmed the device's mechanical integrity. |
| Fit and Taper Compatibility | The new 12/14 Euro-Style taper must be compatible with existing femoral heads. | "The femoral head/neck taper geometry was modified from Exactech's proprietary taper design to the '12/14 Euro-Style' threadform taper design." This modification would have required testing to ensure proper mating with standard 12/14 Euro-Style femoral heads, including tests for seating, rocking, and potential fretting-corrosion. The "successful results" imply these aspects were verified and met predefined specifications ensuring proper articulation with compatible components. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The study involved "empirical testing and engineering analyses" which typically refers to samples of the device itself (e.g., a certain number of each stem configuration to undergo mechanical testing) rather than a human patient test set.
- Data Provenance: Not explicitly stated, but the nature of the study (engineering evaluations) implies it was internal laboratory testing, likely conducted at Exactech facilities or by contract testing labs. There is no indication of human patient data or country of origin for such data. This is a retrospective analysis in the sense that no new clinical data from patients was gathered; it relied on existing engineering principles and physical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This type of study does not involve "experts" in the context of establishing ground truth for diagnostic accuracy (e.g., radiologists interpreting images). The "ground truth" for engineering evaluations is established by engineering specifications, industry standards (e.g., ASTM, ISO), and regulatory requirements. The "experts" involved would be design engineers, material scientists, and quality engineers who define these specifications and interpret test results against them. Their qualifications would be in their respective engineering fields.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data. For engineering tests, results are judged against predetermined pass/fail criteria derived from standards or validated computational models.
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 device is an orthopedic implant, not a diagnostic AI tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an orthopedic implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this 510(k) submission, the "ground truth" relies on:
- Engineering Specifications and Standards: Adherence to established ASTM/ISO standards for material properties and mechanical performance.
- Predicate Device Performance: The primary ground truth is the established safe and effective performance of the predicate devices. The modifications must not adversely affect this equivalence.
- Regulatory Requirements: Compliance with FDA regulations for medical devices.
8. The Sample Size for the Training Set
- Not applicable in the context of an engineering evaluation for an orthopedic implant. There is no concept of a "training set" as there would be for an AI algorithm. The device design and manufacturing processes are developed based on extensive engineering knowledge and prior product experience, but not a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons stated in point 8.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.