(118 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.
Total Hip Arthroplasty (THA) is the replacement of the acetabular and femoral portions of the hip joint. The acetabular aspect of THA includes the replacement of a portion of the pelvis called the acetabulum with a prosthetic cup or an assembly of a modular shell and liner.
The proposed no-hole and cluster hole modular Crown Cups are manufactured from titanium allov (Ti-6A1-4V) and are available with commercially pure (CP) titanium plasma-spray coating or CP titanium plasma-spray with hydroxylapatite coating applied to the exterior. The CP titanium plasma spray provides initial mechanical fixation and bony on growth. The holes allow for the use of 6.5 mm screws that will enhance the primary fixation, if needed.
The proposed Crown Cup liners are available in cross-linked Connection GXL Ultra High Molecular Weight Polyethylene (UHMWPE) (ASTM F648) and come in neutral, lipped, lateralized +5mm, and 10 degrec face-changing lateralized +5mm configurations.
The proposed cups mate with the following devices:
Novation Crown Cup GXL Liners (proposed -subject of this review) .
Novation · Crown Cup GXL and Std, Group 3 Liner (K070479) .
Exactech Bone Screws (K993082) ◆
The proposed liners mate with the following devices:
Novation Crown Cup acetabular shells (proposed -subject of this review) .
Exactech CoCr Femoral Heads (#K041906, #K862334) .
Exactech Zirconia Femoral Heads (#K050398, #K060107) ◆
Exactech BioloxForte Alumina Femoral Heads (#K032964, #K051682)
Here's an analysis of the provided text regarding the Exactech® Novation® Crown Cup® and Liners Special 510(k) submission, structured to answer your questions about acceptance criteria and the supporting study:
Exactech® Novation® Crown Cup® and Liners Special 510(k)
Analysis of Acceptance Criteria and Study
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel performance against specific, pre-defined acceptance criteria for a new device. Therefore, the "acceptance criteria" here are primarily related to showing that the modified device performs comparably to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: Materials conform to recognized industry standards. | The proposed Novation Crown Cups and Liners and predicate devices are composed of equivalent materials conforming to recognized industry standards for permanent implants. The hydroxylapatite coating is the same as described in 510(k) #K070479. |
| Sterilization Process Equivalence: Sterilization processes conform to recognized industry standards. | The proposed Novation Crown Cups and Liners and predicate devices are sterilized using equivalent sterilization processes conforming to recognized industry standards. |
| Design Feature Equivalence: Similar design features, including apical lock mechanism. | The proposed Novation Crown Cups and Liners and predicate devices incorporate similar design features including the apical lock mechanism. (Modifications to cup and liner dimensions and removal of constrained liner feature are noted, requiring further demonstration of equivalence in performance). |
| Performance Specification Equivalence: Conform to recognized performance standards for total hip replacement devices. | Mechanical tests and engineering analyses were conducted to support the claim of substantial equivalence to the predicate Novation Crown Cups and Liners. A design rationale and dimensional analyses compared to the predicate devices demonstrated the substantial equivalence of the proposed design. Testing of lever-out, push-out, and torsional resistance demonstrated that the proposed worst-case scenario met the prescribed acceptance criteria. Additionally, a gap analysis justified the decreased wear rates. Results demonstrate substantial equivalence to cleared predicate devices. |
| Intended Use Equivalence: Identical indications for use statements. | The proposed Novation Crown Cups and Liners and predicate devices are intended for use in total hip joint replacement and have identical indications for use statements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" for a test set in the way one would for a clinical study with human subjects or a large image dataset. The studies described are primarily mechanical tests and engineering analyses.
- Sample Size: Not specified in terms of number of devices tested for each mechanical test (lever-out, push-out, torsional resistance). It mentions "the proposed worst-case scenario," implying a focused testing approach rather than a large statistical sample.
- Data Provenance: The data is technical/engineering in nature, originating from internal product development and testing at Exactech, Inc. The document does not specify a country of origin for the data beyond the company's location in Gainesville, FL, USA. It is prospective in the sense of being performed specifically for this 510(k) submission on the newly modified devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission or the studies described. The "ground truth" for mechanical testing is based on established engineering principles, recognized industry standards (e.g., ASTM F648 for UHMWPE), and performance metrics defined for total hip replacement devices. It does not involve expert consensus in the typical sense of medical image interpretation or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are objective measurements against predefined engineering specifications, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study would involve human readers (e.g., radiologists, clinicians) evaluating cases, often with and without AI assistance, to measure diagnostic/treatment recommendation improvement. The device in question is a physical implant, not a diagnostic or a treatment planning software that would benefit from an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical medical implant, not an algorithm or AI software. The "standalone" performance here refers to the device's inherent mechanical properties, which were tested as described.
7. The Type of Ground Truth Used
The "ground truth" for this submission consists of:
- Predicate Device Performance: The established safety and effectiveness profile of the legally marketed predicate device (K070479).
- Engineering Specifications/Standards: Recognized industry standards and performance specifications for total hip replacement devices (e.g., for lever-out, push-out, torsional resistance).
- Material Specifications: Conformance to recognized material standards (e.g., ASTM F648).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this 510(k) submission, as it does not involve machine learning or AI. The design and manufacturing process for the device would be developed through engineering and design iterations, but these are not referred to as a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned or implied by the nature of the device and submission type, this question is not relevant.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.