(67 days)
The Apex Interface™ Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for uncemented fixation and single use implantation, and may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur.
The Interface Acetabular System, Acetabular Shell is composed of titanium alloy (ASTM F136), coated with sintered unalloyed titanium beads. The shells are designed for cementless use. The two versions of the shells include a "no hole" and a "3 hole" version (plus an apical hole in both versions). The cup system includes titanium alloy cancellous bone screws (in separate sterile packaging) for optional supplemental fixation of the "3 hole" shell. The Shell uses plastic inserts manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648-00), machined from compression molded sheet, and sterilized using ethylene oxide.
The provided document is a 510(k) premarket notification for a medical device, specifically the Apex Interface Acetabular System, Acetabular Shell. For this type of device, the acceptance criteria are primarily based on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves non-clinical performance testing and a comparison of design features, materials, and intended use. Clinical studies, and thus the specific types of studies and criteria outlined in your request, are generally not performed for 510(k) submissions unless specifically deemed necessary by the FDA.
Based on the provided text, here's a breakdown of the information you requested, highlighting what is implicitly or explicitly stated:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission like this, "acceptance criteria" generally refers to demonstrating that the new device is as safe and effective as the predicate device. This is achieved through a combination of comparing design, materials, and non-clinical testing. The "reported device performance" is essentially the determination of substantial equivalence based on these comparisons.
| Acceptance Criterion (Implied for 510(k)) | Reported Device Performance (from document) |
|---|---|
| Premarket Substantial Equivalence | The Interface Acetabular System, Acetabular Shell, in our opinion, is substantially equivalent to the predicate device. |
The Apex Interface Acetabular System is manufactured, packaged, and sterilized using equivalent materials and processes. The subject device(s) is also substantially equivalent to its predicate(s) based on comparison of design features, intended use, and indications for use. The fundamental scientific technology of the modified device(s) has not changed relative to the predicate device(s). The safety and effectiveness of the devices has not changed relative to the predicate devices. The safety and effectiveness of the Interface Acetabular System is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
(FDA's conclusion: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices...") |
| Material Equivalence | The Interface Acetabular System, Acetabular Shell is composed of titanium alloy (ASTM F136), coated with sintered unalloyed titanium beads. The Shell uses plastic inserts manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648-00), machined from compression molded sheet, and sterilized using ethylene oxide. (Implicitly, these materials are equivalent to or acceptable for the predicate device's function). |
| Design Feature Equivalence | Comparison of design features (e.g., standard sizes 46-76mm and x-sizes 48x-58x mm; "no hole" and "3 hole" versions with apical hole; titanium alloy cancellous bone screws) against the predicate device (K031110 Apex Modular Acetabular Cup), demonstrating substantial similarity. |
| Intended Use and Indications for Use Equivalence | The Apex Interface™ Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures... This prosthesis is intended for uncemented fixation and single use implantation... (These were found to be substantially equivalent to the predicate). |
| Non-Clinical Performance (if applicable) | No additional testing required per dFMEA. (This indicates that based on a design FMEA, existing test data, and comparison to the predicate, no new specific non-clinical tests were deemed necessary to prove substantial equivalence). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document explicitly states: "No clinical studies were performed." Therefore, there is no "test set" in the context of human clinical data. The evaluation was based on non-clinical aspects and comparison to the predicate.
- Data Provenance: Not applicable as no clinical data was used.
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 as no clinical studies were performed and thus no "ground truth" established by experts in a clinical test set. The substantial equivalence determination is made by the regulatory body (FDA) based on the manufacturer's submission and predicate comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical studies were performed.
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 a passive implant (acetabular shell) and does not involve AI or human readers for diagnostic interpretation. 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 a passive implant; there is no algorithm or standalone performance in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable as no clinical studies were performed. The "ground truth" for a 510(k) in this context is implicitly the established safety and effectiveness of the predicate device, against which the new device is compared.
8. The sample size for the training set
- Not applicable as no machine learning/AI training was involved for this passive implant device.
9. How the ground truth for the training set was established
- Not applicable as no machine learning/AI training was involved.
§ 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.