(160 days)
The OMNI Skirted Heads are intended for use in combination with the NOVAE® Dual Mobility Acetabular Cup and are indicated for total hip replacement, which includes:
• Osteoarthritis
• Femoral neck fracture
• Dislocation risk
• Osteonecrosis of the femoral head
• Revision procedures where other treatments or devices have failed and if bone reconstruction so permits.
SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.
The OMNI Skirted Heads are intended to be used in the primary/revision total hip replacement procedures in combination with the SERF Dual Mobility Acetabular Cup. These femoral heads are manufactured from cobalt chromium (CoCr) and are designed to be used with the SERF Dual Mobility Acetabular cup. These heads offer a skirted feature and when used with the Dual Mobility cups, the skirt extends over the exposed femoral taper and reduces the contact between the SERF polyethylene liner and machined surface of the K1 stem trunnion. SERF obtained clearance to use the OMNI K1 stem with its Dual Mobility NOVAE Acetabular Cup under K111572. In this submission, OMNI proposes two sizes for these skirted heads – 28mm+7 and 22mm+3.5 diameter and neck length respectively.
This is not an AI/ML device and as a result, the acceptance criteria and study information points outlined in the request are not applicable. The device is the OMNI Skirted Heads, which are part of a hip joint prosthesis. The provided document is a 510(k) premarket notification for this medical device, demonstrating its substantial equivalence to previously marketed devices.
However, I can extract information relevant to the device's performance testing and justification for substantial equivalence.
Here's a summary of the available information:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Range of Motion (ROM) per ISO 21535 requirements | Results of testing met the requirements for Range of Motion per ISO 21535. |
| Compatibility with SERF Dual Mobility Acetabular Cups | Demonstrated through Range of Motion testing. |
| Material: Cobalt Chromium (CoCr) | The device is manufactured from Cobalt Chromium (CoCr), which is identical to the skirted heads cleared in the predicate device (K101575). |
| Design Similarity to Predicate Devices (K101575, K000788) | The proposed skirted head is similar in design to skirted heads cleared in the reference predicate K101575 and the same size (22mm and 28mm heads) as those cleared in K000788. |
2. Sample size used for the test set and the data provenance:
- Test Set: The document mentions "Range of Motion testing was conducted." It does not specify the exact sample size for this testing.
- Data Provenance: Not explicitly stated, but it's internal testing conducted by the manufacturer (OMNIlife Science) to support their 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/provided. This device is a mechanical implant, and its performance criteria are based on engineering and material standards (e.g., ISO 21535), not expert interpretation of outputs.
4. Adjudication method for the test set:
- Not applicable. Performance is based on objective measurements against engineering standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, this type of study is not applicable as this is a mechanical medical device, not an AI/ML-driven diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used:
- Engineering Standards and Specifications: The "ground truth" for this device appears to be the requirements of relevant ISO standards (e.g., ISO 21535 for Range of Motion) and the performance characteristics of predicate devices.
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.