(132 days)
The indications for the Corin Icona Hip Stem as a total hip arthroplasty, and when used in combination with a Corin hemiarthroplasty head, as a hip hemiarthroplasty, include:
- · Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- · Correction of functional deformity
- · Treatment of non-union and femoral neck fractures
- Developmental dysplasia of the hip (DDH) / congenital dysplasia of the hip (CDH)
The Corin Icona Hip Stem is indicated for cementless use only.
The Corin Icona Hip Stem is a tapered stem design manufactured from Titanium alloy (Ti6Al4V) (ASTM F136) with a layer of commercially pure titanium (ISO 5832-2, ASTM F1580) and an additional layer of electrochemically deposited calcium phosphate (ASTM F1609) applied.
The Icona Hip Stem is intended for use in hemiarthroplasty and total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.
The design is a fully-coated titanium femoral hip stem featuring a polished neck with 12/14 tapered male trunnion for assembly with Corin modular femoral head components. Additionally, the Icona stem features a trapezoidal, tripled tapered body, providing for rotational and axial stability.
The Icona Hip Stem is a collared stem available in two different offsets (Standard and Lateralised) and twelve (12) different sizes, totaling 24 options.
The Icona Hip Stem is compatible with the following acetabular systems:
· Traditional – Trinity (K093472, K110087, K111481, K122305, K130128, K130343, K131647) and Trinity PLUS (K17255) · Dual mobility - Trinity Dual Mobility (K170359) and MobiliT (K191831)
· Bipolar - Bipolar-i (K183114)
This document is a 510(k) Premarket Notification from the FDA for a hip stem device (Icona Hip Stem). It does not describe an AI/ML medical device, but rather a traditional medical device (hip implant). Therefore, much of the requested information regarding acceptance criteria and studies for AI/ML performance metrics (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document.
However, I can extract the relevant information regarding the traditional device's performance criteria and supporting studies as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance / Compliance |
|---|---|---|
| Mechanical Performance | Distal stem fatigue (ISO 7206-4) | Results show the device is substantially equivalent to predicate devices. |
| Neck fatigue (ISO 7206-6) | Results show the device is substantially equivalent to predicate devices. | |
| Range of motion (ROM) (ISO 21535) | Cadaveric evaluation demonstrated performance. | |
| Impingement performance | Engineering rationale provided. | |
| Femoral head disassembly and corrosion performance | Engineering rationale provided. | |
| Biocompatibility | Material: Titanium alloy (Ti6Al4V) (ASTM F136), commercially pure titanium (ISO 5832-2, ASTM F1580), electrochemically deposited calcium phosphate (ASTM F1609) | Materials are industry standards and consistent with predicate devices, supporting biocompatibility by equivalence. |
| Indications for Use | Functional equivalence for: Non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union and femoral neck fractures, Developmental dysplasia of the hip (DDH) / congenital dysplasia of the hip (CDH). Indicated for cementless use only. | The Icona Hip Stem is "substantially equivalent" to predicate devices (Actis DuoFix, TriFit CF, Metafix, OMNI MOD Hip System) in terms of intended use and indications, with the exception of OMNI MOD Hip Stem which is also indicated for revision. |
| Design Equivalency | Tapered stem design, fully-coated titanium femoral hip stem, polished neck, 12/14 tapered male trunnion, trapezoidal triple tapered body, two offsets (Standard and Lateralised), twelve sizes (24 options). | Substantially equivalent to predicate devices Actis DuoFix Hip Prosthesis (K150862) (material, triple-taper geometry, collar design, stem sizes), TriFit CF (K173880) (material, coating, taper design, neck geometry), OMNI MOD Hip System (K000788, K201657) (material, neck geometry, finish), and MetaFix Hip Stem (K082525, K121439, K153381, K212069) (intended use, indications, material, neck geometry, taper design, packaging). |
2. Sample Size Used for the Test Set and the Data Provenance
This information is typically not provided in detail within a 510(k) summary for mechanical testing of traditional orthopedic implants. The document states "Non-clinical testing and rationales provided to support substantial equivalence," but does not specify sample sizes for these mechanical tests (e.g., number of stems tested for fatigue).
- Provenance: The tests are non-clinical (laboratory/mechanical testing), not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for a traditional orthopedic implant's mechanical testing or equivalence comparison to predicate devices. "Ground truth" in this context would refer to established engineering standards (ISO, ASTM) and the performance of predicate devices.
4. Adjudication Method
Not applicable for this type of device submission. Adjudication is relevant for expert review of data, often in clinical studies or for AI ground truth establishment.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, this is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, this is not an AI/ML device.
7. The Type of Ground Truth Used
For this traditional device, the "ground truth" used to establish substantial equivalence is primarily:
- Established engineering standards: ISO 7206-4, ISO 7206-6, ISO 21535, ASTM F136, ASTM F1580, ASTM F1609. The device's performance in these tests is compared against the performance of the predicate devices or the requirements of these standards.
- Performance of legally marketed predicate devices: The Icona Hip Stem's design, materials, and mechanical performance are compared to those of already cleared predicate devices. Substantial equivalence implies that the new device performs as safely and effectively as the predicate.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/ML device; there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set."
§ 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.