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The ACTERA™ hip system may be designed from a patient's preoperative CT scan which must include certain necessary anatomic landmarks that are clearly identifiable. 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 osteoarthrits, 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 posterior surgical technique.

The ACTERA™ hip system is an uncemented, primary total hip replacement system comprised of femoral and acetabular components. All implanted components are provided sterile. Optional Surgical plans (iViews) and iJgs/ancillary instruments are also available. Non-sterile reusable instruments are provided.
The subject ACTERA™ is comprised of the subject Actera™ femoral stem (cleared in K221104) with additional sizes (0, 1 and 10, 11, 12) added to the size portfolio. Additionally, the subject ACTERA™ will offer a patient specific neck option. This option has the same stem body (K221104) with a patient specific neck (K192198). The patient specific neck has the same neck version angle, and similar neck length as that cleared in the secondary predicate Conformis Hip System (K192198). The subject hip stems with patient specific necks are compatible with the same femoral heads and acetabular components as the patient specific necks cleared in the Conformis Hip System (K192198). The ACTERA™ with the patient-specific neck option will be ordered as 'ACTERA™ HipRx'.
This submission also seeks clearance of iJigs®/Ancillary Instruments to assist in the positioning of the ACTERA™ implants. The iligs® are sterile, single-use disposable instruments of nylon material. These instruments may be standardized or patient specific. These instruments are the iJig instrumentation described in the secondary predicate K192198 (and K202484). These instruments were not offered with the initial release of the ACTERA™ device, primary predicate Actera™ K221104. Additionally, Surgical Plans, called iViews, are also part of this submission. The iligs and iViews are provided based on ordered options.
The stem taper is identical to the predicates. The subject device, ACTERA™ is compatible with the previously cleared femoral heads (Ceramic or CoCrMo) and acetabular components. The femoral head is unchanged from the previously cleared predicate Conformis Cordera Hip system (K202484). The Cordera acetabular cup, Cordera cup liner and Cordera screws are unchanged from the previously cleared predicate Conformis Cordera Hip system (K202484). There are no changes with this these components and are not the subject of this submission.

The provided text is a summary for a 510(k) premarket notification of the ACTERA™ hip system. It does not describe a study involving an AI medical device or digital health software, nor does it present specific acceptance criteria with quantifiable performance metrics.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document focuses on the substantial equivalence of new components (extended sizes for the femoral stem, patient-specific neck option, iJigs, and surgical plans) to previously cleared predicate devices, supported by non-clinical performance evaluations like fatigue testing of the physical implants.

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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:

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.

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