(112 days)
Total hip replacement using the Actera™ hip system is indicated for use in skeletally mature individuals undergoing total hip replacement due to:
· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
· Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
· Revision procedures for failed previous hip surgery (excluding situations where hardware is present).
The Actera™ hip system implants are intended for cementless fixation using an anterior, lateral or surgical technique.
The Actera™ hip system is an uncemented, total hip replacement system comprised of femoral and acetabular components. All implanted components are provided sterile. X-ray templates, acetate or digital, are provided for determining implant sizes and component placement. Non-sterile reusable instruments are provided. The subject Actera™ hip system is comprised of the subject Actera™ femoral stem and the previously cleared compatible femoral head, Cordera acetabular cup, Cordera cup liner and Cordera screws (predicate K202484).
The subject, Actera™ femoral stem, is a re-designed stem. The stem is a proximally filling, triple-tapered design that is substantially equivalent to the cleared predicate device DEPUY ACTIS® Hip Stem (K210581).
The femoral stem has an integrated neck with neck angle of 132° and neck length that progressively increases with stem size. Each size has two neck options: a standard neck, and a high offset neck that is shifted medially to provide additional femoral offset with the same leg length. The trunnion is a Conformis standard 12/14 taper, possessing a 12.7 mm diameter along with 5° 42′ 30″ angle with an asmachined geometry to form a taper lock with a mating femoral head implant. The trunnion is identical to that of the predicate Conformis Cordera femoral stem. The trunnion is designed to mate with existing standard 12/14 femoral heads. The stem body has a smooth tapered geometry in three planes. The proximal neck surface of the stem is highly polished; its geometry is intended to maximize range of motion. The femoral stems are designed to maximize contact between the stem and cancellous bone of the intramedullary canal and utilize press-fit fixation. The stem body is fully coated with hydroxyatite (HA) coating in conformance to ASTM F1185 on top of a proximal coating of commercially pure titanium (CPTi) conforming to ASTM F1580.
The femoral heads are unchanged from the previously cleared reference device Conformis Cordera Hip system (K202484). The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (BIOLOX® delta). The femoral heads are designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem.
The acetabular component is unchanged from the previously cleared reference device Conformis Cordera Hip system (K202484). It consists of a standard size shell in 1mm increments with standard screw hole placement, a mating vitamin E polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fit through the acetabular shell screw holes and are driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation.
The purpose of this submission is to seek clearance of the subject Actera™ femoral stem which is substantially equivalent to the cleared predicate device DEPUY ACTIS® Hip Stem (K210581). The subject Actera femoral stem is compatible with the previously cleared femoral head, Cordera acetabular cup and liner, Cordera screws and reusable instruments (class I) as described in the predicate K210581. . This submission also seeks clearance for new class II reusable instruments. New class I 510Kexempt reusable instruments and x-ray templates are also described.
The provided text describes a 510(k) premarket notification for a hip replacement system (Actera™ hip system). This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials as seen with PMAs or de novo devices.
Therefore, the information you're asking for, such as acceptance criteria based on metrics like sensitivity, specificity, or ROC AUC, sample sizes for test/training sets for AI, expert numbers for ground truth, MRMC studies, or standalone algorithm performance, is not applicable to this type of device submission and its accompanying documentation.
The document primarily focuses on:
- Device Description: What the device is and its components.
- Indications for Use: What conditions the device is intended to treat.
- Technological Characteristics Comparison: How the new device (specifically the Actera™ femoral stem) is similar to a predicate device in terms of materials, design principles, manufacturing, etc.
- Non-Clinical Performance Evaluation: This section details bench testing (in vitro/mechanical testing) performed on the device to ensure it meets established standards and performs comparably to the predicate. This is crucial for demonstrating substantial equivalence for orthopedic implants.
Here's a breakdown of the provided information in relation to your request, highlighting what's present and what's absent (due to the nature of a 510(k) for an orthopedic implant):
1. A table of acceptance criteria and the reported device performance
For this type of orthopedic implant, acceptance criteria are typically defined by engineering and mechanical performance standards, not statistical metrics for AI performance. The document lists the types of tests performed:
| Test Type | Standard/Method | Reported Performance/Conclusion |
|---|---|---|
| Proximal Stem Fatigue Testing | ISO 7206-6 | Results support device is safe, effective, and performs as well as predicate |
| Distal Stem Fatigue Testing | ISO 7206-4 | Results support device is safe, effective, and performs as well as predicate |
| Range of Motion Analysis | ISO 21535 | Results support device is safe, effective, and performs as well as predicate |
| Impingement Analysis | Not specified (implied by ISO 21535) | Results support device is safe, effective, and performs as well as predicate |
| Coating Characterization Testing | ASTM F1854 | Results support device is safe, effective, and performs as well as predicate |
| (Stereological Porous Coating Evaluation) | ASTM F1147 | |
| (Static Tensile Testing) | ASTM F1044 | |
| (Static Shear Testing) | ASTM F1160 | |
| (Shear and Bending Fatigue Testing) | ASTM F1978 | |
| (Taber Abrasion Testing) | ASTM F1926 | |
| (Dissolution Rate Testing) | ASTM F2024 | |
| (Phase Composition Testing - X-ray | Not specified (XRD, wet chemistry) | |
| Diffraction) | ||
| Ca/P Ratio Characterization Testing | ||
| Endotoxin Levels (Biocompatibility/Sterility) | Limulus Amebocyte Lysate (LAL) using gel-clot method | Within recommended levels of 0.5 EU/mL or 20 EU/device |
Note: The document states, "The results of the testing support that the subject device is safe, effective and performs as well as or better than the predicate device. No new issues of safety or efficacy were raised." Specific numerical performance data (e.g., fatigue strength in MPa) are typically found in the full 510(k) submission, but usually not summarized in the publicly available summary letter.
2. Sample sizes used for the test set and the data provenance
- Sample Size: Not applicable. For mechanical testing, "samples" refer to physical test specimens (e.g., a certain number of stems subjected to fatigue testing), not patient data for an AI algorithm. The document does not specify the number of physical specimens tested for each type of bench test.
- Data Provenance: Not applicable. This is not a study involving patient data (retrospective or prospective) from specific countries, but rather laboratory bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable: This device does not involve AI or image analysis where human expert ground truth is established. The "ground truth" for mechanical testing is adherence to international standards (ISO, ASTM) and predefined engineering specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable: No human adjudication is involved for bench testing of an orthopedic implant.
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 is an orthopedic implant, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable: This is an orthopedic implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable: The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards (e.g., ISO, ASTM).
8. The sample size for the training set
- Not applicable: This is an orthopedic implant, not an AI device that requires training data.
9. How the ground truth for the training set was established
- Not applicable: This is an orthopedic implant, not an AI device.
In summary, the provided document aligns with the typical process for 510(k) clearance of a Class II orthopedic implant. The "study" that proves the device meets acceptance criteria is a series of non-clinical (bench) tests designed to demonstrate that the device performs equivalently to the predicate and meets relevant industry standards for mechanical properties and biocompatibility.
§ 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.