(295 days)
The Encompass® 10/12 Hip Stem is intended for use in total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.
The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:
- Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis
- Previously failed surgery
- Proximal femoral neck fractures or dislocation
- Idiopathic avascular necrosis of the femoral head
- Non-union of proximal femoral neck fractures
- Treatment of fractures that are unmanageable using other forms of therapy
- Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis
The Encompass® 10/12 Hip Stem is a one-piece, straight femoral stem, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stem is manufactured from wrought titanium alloy Ti-6Al-4V EU per ASTM F136. The proximal portion of the stem is subsequently plasma-sprayed with Commercially Pure Titanium per ASTM F1580. The stem has a neck with a 10/12 trunnion taper for modular attachment to femoral heads. To accommodate various patient anatomies, the stem is offered with and without collars and in a variety of sizes, including the following ranges: lengths (115-143mm), horizontal offsets (32-46mm), and vertical offsets (29-36mm), with a resection angle of 130°, and neck angle of 132°.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|---|
| Mechanical Performance | Proximal Fatigue (ISO 7206-6:2013) | Implied to meet ISO 7206-6:2013 standards for hip stem fatigue performance. | "Performance testing has been conducted for the subject device Encompass® 10/12 Hip Stem in proximal fatigue in accordance with ISO 7206-6:2013" | The document states testing was conducted in accordance with the standard, implying satisfactory results were achieved to demonstrate substantial equivalence, though specific numerical outcomes are not provided. |
| Mechanical Performance | Distal Fatigue (ISO 7206-4:2010) | Implied to meet ISO 7206-4:2010 standards for hip stem fatigue performance. | "and distal fatigue in accordance with ISO 7206-4:2010." | Similar to proximal fatigue, the device underwent testing according to the standard. |
| Range of Motion | Range of Motion Analysis (ISO 21535:2007(E)) | Implied to meet ISO 21535:2007(E) standards for range of motion analysis in hip implants. | "Range of motion analysis was performed per ISO 21535:2007(E)." | Testing was performed against this standard, suggesting compliance. |
| Material Properties | Plasma Spray Coating (Mechanical Properties & Microstructure) | Implied to demonstrate suitable mechanical properties and microstructure for the plasma spray coating. | "The plasma spray coating underwent testing for mechanical properties and microstructure analysis." | Testing was conducted, implying acceptable results for the coating. |
| Substantial Equivalence | Overall Comparison to Predicates | Similarity in intended use, indications for use, overall design, materials, manufacturing methods, packaging, mechanical performance, and sterilization. | The FDA letter explicitly states the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." | The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to predicate devices, which the FDA affirmed. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The document does not report any clinical studies or human test subjects. The performance testing was non-clinical (mechanical testing of the device itself).
- Data Provenance: Not applicable. All testing mentioned is non-clinical laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. As no clinical studies were performed, there was no human test set requiring expert adjudication for ground truth. The "ground truth" for non-clinical performance testing is based on established engineering standards (ISO).
4. Adjudication Method for the Test Set
- Not applicable. 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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hip stem prosthesis, not an AI or imaging-based diagnostic tool that would typically involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical implant, not an algorithm, so the concept of "standalone performance" in the context of AI does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical performance studies, the "ground truth" is established by adherence to internationally recognized engineering and medical device standards (e.g., ISO 7206-6, ISO 7206-4, ISO 21535). These standards define acceptable performance parameters for hip stem prostheses.
8. The Sample Size for the Training Set
- Not applicable. As no clinical studies or AI/algorithm development are reported, there is no "training set." The device is a physical implant.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no training set.
§ 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.