(373 days)
The Novae® Dual Mobility and Hype® Hip Systems 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 acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use.
Hype® SCS, SCC, SCV, SCC mini, and SCLA mini hip stems are intended for press-fit use.
The Novae® Dual Mobility System consists of cemented acetabular shells and a polyethylene liner. Novae® XPEO-E liners are made from highly crosslinked vitamin E stabilized polyethylene and are spherical in geometry for dual mobility articulation. The inner articular surface mates and retains a Biolox® delta ceramic or CoCrMo metal femoral head. The outer articular surface articulates within the highly polished inner diameter of Novae® cementless or cemented cups. Novae® cups are manufactured from stainless steel, with pressfit options coated with titanium and hydroxyapatite (HA). Pegs and cortical bone screws for optional ancillary fixation are made from stainless steel.
Hype® press-fit hip stems are compatible with the Novae® Dual Mobility System and Serf CoCrMo and Biolox® delta femoral heads. Hype® press-fit hip stems are made from titanium alloy coated with titanium and HA.
The primary purpose of this 510(k) notification is a line extensions to the 510(k) cleared Novae® acetabular cups (K111572) that are compatible with: (1) liner option made from highly crosslinked and vitamin E stabilized polyethylene (XPEO-E), (2) femoral heads made from CoCrMo alloy and Biolox® delta ceramic, and (3) Hype® press-fit hip stems.
The Novae® Dual Mobility System and Hype® Hip System did not conduct a clinical study to prove the device meets acceptance criteria. Instead, the device's substantial equivalence was established through laboratory testing and engineering analyses, comparing its performance to predicate devices. Therefore, several of the requested information points (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable in this context.
Here's the available information:
1. A table of acceptance criteria and the reported device performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Range of motion analysis for Hype hip stems and Novae acetabular cups (ISO 21535) | Predetermined acceptance criteria (not specified in the document) | Met predetermined acceptance criteria. |
| Head-liner assembly / disassembly tests | Predetermined acceptance criteria (not specified in the document) | Met predetermined acceptance criteria. |
| Lever-out testing for Novae® acetabular cups and liners (ASTM F1820-13) | Predetermined acceptance criteria (not specified in the document) | Met predetermined acceptance criteria. |
| Impingement analyses and testing for Hype® hip stems and Novae® acetabular cups (ASTM F2582) | Predetermined acceptance criteria (not specified in the document) | Met predetermined acceptance criteria. |
| Articular surface wear for pristine, outer bearing only, and abrasive conditions (ISO 14242-1) | Predetermined acceptance criteria (not specified in the document) | Met predetermined acceptance criteria. |
| Fatigue strength testing of Hype hip stems (ISO 7206-4, -6) | Predetermined acceptance criteria (not specified in the document) | Met predetermined acceptance criteria. |
| Fretting corrosion of Hype hip stem tapers and CoCrMo femoral heads (ASTM F1875) | Predetermined acceptance criteria (not specified in the document) | Met predetermined acceptance criteria. |
| Torque-off and pull-off testing of femoral heads and Hype® hip tapers (ISO 7206-10, -13) | Predetermined acceptance criteria (not specified in the document) | Met predetermined acceptance criteria. |
| Fatigue, post-fatigue burst strength of femoral head from stem (ISO 7206-10 and ASTM F2345-21) | Predetermined acceptance criteria (not specified in the document) | Met predetermined acceptance criteria. |
| Physical, chemical, and mechanical tests and analyses of titanium and HA coatings for cementless Hype Hip Stems (ASTM F1854-15, F1160-14, F1044-05, F1147-05, F1978-18, F1185-03, F1926-14, F2024-10, F1609, ISO 13779-3, -6) | Predetermined acceptance criteria (not specified in the document) | Met predetermined acceptance criteria. |
| Assessment of MRI compatibility and determination of conditional labeling requirements per ASTM F2503 and performance testing per ASTM F2052, F2213, F2182A, and F2119 | Predetermined acceptance criteria based on standard guidelines for MRI compatibility (not specified in the document). | Met predetermined acceptance criteria, allowing for conditional labeling. |
| Assessment of biocompatibility of Novae® Dual Mobility and Hype® devices per ISO 10993-1 | Acceptable biocompatibility as per ISO 10993-1 guidelines. | Demonstrated acceptable biocompatibility. |
| Bacterial Endotoxin Testing (BET) / LAL chromogenic method | Acceptable levels of endotoxins. | Demonstrated acceptable levels of endotoxins. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The study involved laboratory bench testing and engineering analyses, not a clinical test set with patient data.
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. Ground truth was established through adherence to industry standards and objective measurements in laboratory settings, not by expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.
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 mechanical implant, not an AI-assisted diagnostic or treatment system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a mechanical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance testing was established by internationally recognized and industry-accepted standards (e.g., ISO, ASTM) and engineering principles for mechanical and material properties, wear, and biocompatibility of orthopedic implants.
8. The sample size for the training set
Not applicable. This device is a mechanical implant; there was no training set in the context of machine learning. The "training" in this context refers to standard design, manufacturing, and quality control processes to meet the specified performance criteria.
9. How the ground truth for the training set was established
Not applicable. Refer to point 8.
§ 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.