(68 days)
The ESOP® Co-Cr Femoral Heads are intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there is sufficient sound bone to seat the prosthesis. This device is intended for cementless application.
The Metallic Femoral Heads are intended to be adapted to special cones machined for this purpose. Femoral head are available in several diameter for use in full hip or intermediary replacement. The length of the neck on the femoral stem can be adjusted by using the heads available in different insertion depths (short, medium, long and extra-long collars), and of different diameter.
This document is a 510(k) premarket notification for a medical device called "Metallic Femoral Head" (later referred to as ESOP® Co-Cr Femoral Heads). This type of submission is for substantiating that a new device is "substantially equivalent" to an already legally marketed predicate device, rather than proving its effectiveness through clinical studies with acceptance criteria in the way a diagnostic AI device would.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as typically applied to performance claims of AI/diagnostic devices, is not applicable to this 510(k) submission for a metallic femoral head.
Instead, the submission focuses on demonstrating substantial equivalence by comparing material, design, and intended use with existing predicate devices, and supported by non-clinical (laboratory) performance data.
Here's a breakdown of why each point is not applicable in this context:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This submission is for a mechanical orthopedic implant, not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy. The "performance data" mentioned refers to "Testings conducted to characterize the materials under defined laboratory conditions," which are typically mechanical and material property tests (e.g., fatigue, wear, strength). No specific acceptance criteria or reported performance values are detailed in the provided text.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There is no "test set" in the context of clinical images or patient data for this device. The testing would involve mechanical samples of the device, not a set of clinical cases.
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. There is no "ground truth" to establish for a mechanical implant in the way there is for an AI diagnostic algorithm. The material and mechanical properties are assessed through standardized laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used in clinical trials or diagnostic studies to resolve discrepancies in expert interpretation of cases. This is not relevant to the mechanical testing of an orthopedic implant.
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 metallic femoral head, not an AI-powered diagnostic tool. MRMC studies are completely irrelevant to this type of medical device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. Again, this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For mechanical implants, "ground truth" typically refers to established standards for material properties (e.g., tensile strength, fatigue limits) and biomechanical performance in a laboratory setting, rather than clinical outcomes or diagnostic interpretations.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning model.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" or corresponding ground truth.
Summary of the K021109 Submission:
The K021109 submission for the "Metallic Femoral Head" is a 510(k) premarket notification. Its purpose is to demonstrate "substantial equivalence" to predicate devices already on the market, meaning it is as safe and effective as those devices.
- Device: Metallic Femoral Head (later ESOP® Co-Cr Femoral Heads)
- Intended Use: Prosthetic replacement of the femoral head associated with hip prosthesis.
- Predicate Devices: Headloc™ Femoral Head, Primaloc® Cementless Hip System (K953977), Intrinsic® Cementless Total Hip System (K923911), Exactech AcuMatch Hip System (K010081).
- Comparison Basis: Same intended use, made of the same material (chrome cobalt), similar size, and collar + cone dimensions as the predicate devices.
- Performance Data: "Testings conducted to characterize the materials under defined laboratory conditions are provided to support a finding of substantial equivalence." (These are generally mechanical and material characterization tests, not clinical performance studies comparing diagnostic accuracy).
- Conclusion: The device is substantially equivalent to predicate devices in terms of intended use, safety, and effectiveness.
§ 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.