(90 days)
The Empire Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
The Empire Acetabular Augment is affixed to the mating acetabular shell using PMMA bone cement. Therefore, acetabular shells with HA coating must not be used with Empire Acetabular Augments. The assembled construct is intended for press-fit fixation. The construct may also be used with bone cement at the discretion of the surgeon.
The proposed acetabular augments are manufactured by an additive manufacturing process from titanium alloy to create a porous structure designed to provide initial mechanical fixation in addition to the potential for long-term biological fixation. The augments feature holes that allow for the use of 4.5mm bone screws for adjunct fixation of the acetabular augment and the surrounding bone. The acetabular augments are available in 3 heights (8mm, 11mm, and 13mm) and cover acetabular shell outer diameter sizes 48-58mm.
The proposed augments mate with the following devices:
The provided text describes a medical device, the Exactech® Novation® Empire™ Acetabular Augments, and its 510(k) submission for substantial equivalence to a predicate device. This document is a regulatory submission, not a study report, and therefore does not contain the detailed information typically found in a study focused on establishing acceptance criteria and proving performance through rigorous testing and analysis as requested by the prompt.
Specifically, the document does not describe an AI/ML-based device, nor does it detail a study with acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating substantial equivalence of a physical medical implant to a legally marketed predicate device through engineering analyses and mechanical/animal studies.
Therefore, many of the requested fields cannot be directly extracted or are not applicable to the provided text. I will fill in what can be inferred and explicitly state when information is not available or not applicable.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of numerical thresholds for performance metrics for a diagnostic or AI device. Instead, it relies on demonstrating substantial equivalence to a predicate device (Zimmer Hedrocel Acetabular Augment) through material, design, sterilization, and, critically, performance specifications and mechanical tests, animal studies, simulated-use tests, and engineering analyses. The "reported device performance" is essentially that it conforms to recognized performance standards for total hip replacement devices and is substantially equivalent to the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Similar to predicate. | The Empire Acetabular Augments and predicate Zimmer Hedrocel Acetabular Augments have similar indications for use statements, intended for use as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies. |
| Materials: Composed of materials conforming to recognized industry standards for permanent implants. | Composed of titanium alloy, conforming to recognized industry standards. Demonstrated through a test summary and reports of the material based on FDA Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement. |
| Sterilization Processes: Provided sterile, conform to recognized industry standards. | Provided sterile for single use and conform to recognized industry standards. |
| Design Features: Similar to predicate. | Incorporate similar design features to the predicate. Demonstrated through cadaver lab validation (outside geometry and overall scope). |
| Performance Specifications: Conform to recognized performance standards for total hip replacement devices. | Conforms to recognized performance standards. Demonstrated through mechanical tests, animal studies (comparing biological fixation characteristics of porous Ti-6Al-4V to historical data), simulated-use tests, and engineering analyses. The studies "demonstrate the proposed Empire Acetabular Augments are substantially equivalent." A clinical literature review of predicate acetabular augment devices was also performed to support this. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated with a specific numerical value. The "test set" in this context refers to the samples used in mechanical tests, simulated-use tests, and animal studies. These types of studies often use a limited number of physical samples (e.g., a few augments for mechanical testing, a cohort of animals for an animal study), but the exact numbers are not provided.
- Data Provenance: Not specified. The document is a 510(k) summary from Exactech®, Inc., located in Gainesville, FL, USA. The studies would likely have been conducted in a similar regulated environment, but specific countries of origin for the data are not mentioned. The studies can be considered prospective in the sense that they were conducted for the purpose of this submission (e.g., the animal study comparing biological fixation characteristics).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. This device is a physical implant, not an AI/ML diagnostic tool requiring expert ground truth for interpretation of images or patient data. The "ground truth" here is based on objective measurements from mechanical tests, biological responses in animal models, and engineering analyses, rather than expert interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is not a diagnostic study requiring inter-reader agreement or adjudication for ground truth establishment.
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. This is not an AI/ML device, and no MRMC comparative effectiveness study was conducted or is applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is established through scientific and engineering methods:
- Mechanical Test Data: Objective measurements of mechanical properties (e.g., strength, durability, fixation).
- Animal Study Data: Biological responses (e.g., bone ingrowth, inflammation) in animal models, compared against historical data.
- Engineering Analyses: Calculations and simulations based on design specifications and material properties.
- Cadaver Lab Validation: Demonstrating design features and fit.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device requiring a training set.
§ 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.