(561 days)
The Osteonics® HA-AD Coated Devices are single-use, acetabular of femoral hip implant devices intended for cementless applications. The following indications for use are consistent with previous submissions for these acetabular and femoral components intended for cementless application.
Indications for Osteonics® HA-AD Acetabular Components
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous failed femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.
Indications for Osteonics® HA-AD Femoral Components
For use as a Bipolar Hip Replacement :
- Femoral head/neck fractures or non-unions.
- Aseptic necrosis of the femoral head.
- Osteo-, rheumatoid, and post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- Pathological conditions or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
- Salvage of failed total hip arthroplasty.
For use as a Total Hip Replacement:
- Painful, disabling joint disease of the hip resulting from: degenerative arthritis. rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
The devices which are the subject of this 510(k) are commercially-available Osteonics hip acetabular and hip femoral components featuring Osteonics' HA-AD coating.
The provided text describes a 510(k) submission for Osteonics HA-Coated Devices, focusing on claims related to the performance of their HA-AD coating. It is noteworthy that this submission is from 1999, and the type of detailed performance criteria, ground truth establishment, and multi-reader studies applied to modern AI/ML devices were not standard practice for medical device submissions at that time.
Therefore, many of the requested categories for AI/ML device studies will not be present in this document.
Here's an analysis based on the provided text, highlighting what is (and isn't) present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the way a modern AI/ML device submission would, with quantifiable thresholds for performance metrics. Instead, it refers to "additional performance claims" demonstrated by referenced literature.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Increase in bone apposition compared to AD coated samples | Performance: HA/AD coating increases bone apposition (Ref. 1). |
| Study: "Cortical Remodeling and Bone Apposition to a Textured Canine Hip Implant with and without Hydroxylapatite." Agins HJ, BauerTW, Kudrna JC, Cannestra V, Ming J. Trans, AAOS, February 1997. | |
| Increase in linear bone contact compared to AD coated samples | Performance: HA/AD coating increases linear bone contact (Ref. 3). |
| Study: "Biomechanical and Histological Analysis of an HA-Coated, Arc Deposited CPTi Canine Hip Prosthesis." Walenciak MT, Zimmerman MC, Harten RD, Ricci JL, Stamer DT. J. Biomed. Mater. Res. 31 (4):465-474, 1996. | |
| Increase in degree of bone penetration into implantable chambers | Performance: HA/AD coating increases the degree of bone penetration into implantable chambers (Ref. 2). |
| Study: "Arc Deposited CP Titanium with and without Hydroxyapatite Coating. Preclinical Evaluation Using the Canine Implantable Chamber Model." Hawkins M, Ricci JL. (Book chapter) | |
| Early evidence of increased bony response | Performance: Increased bony response may be evidenced as early as 6 weeks after implantation. |
| Study: Implied from the referenced animal studies, likely Ref. 1 and 2. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text for the individual studies. The studies are described as using "animal models" (canine hip implant, canine implantable chamber model, canine hip prosthesis).
- Data Provenance: Animal models (canine). All studies appear to be prospective experimental studies. The original location/country of the animal studies is not stated within this 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Given the nature of these animal studies (histological and biomechanical analyses), the "ground truth" would likely be established by trained researchers and pathologists examining tissue samples and conducting measurements, but explicit details on the number or qualifications of experts are absent.
4. Adjudication Method for the Test Set
This information is not provided.
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 MRMC study was done, as this submission pre-dates the common use of AI in medical devices and the associated study designs.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable, as the device is a physical implant, not an algorithm. Therefore, "standalone" performance testing in the AI/ML sense was not conducted. The "performance data" refers to the biological response to the coating.
7. The Type of Ground Truth Used
The ground truth used was histological analysis (e.g., bone apposition, linear bone contact, bone penetration) and biomechanical analysis performed on animal tissue samples. This is analogous to pathology or biological outcomes data in a clinical context.
8. The Sample Size for the Training Set
No "training set" in the context of AI/ML algorithms is mentioned or relevant here, as this device is a physical implant, not a software algorithm. The studies referenced are experimental studies on the biological performance of the coating.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI/ML algorithm. The ground truth for the performance studies themselves (as described in point 7) was established through scientific experimental methods, including histological and biomechanical assessments, as detailed in the referenced research papers.
§ 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.