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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

• · Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
• · Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
• · Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

The Exactech Alteon Short Tapered Wedge is a collarless, press-fit femoral stem component to be used in total or hemi hip arthroplasty, and is designed to emphasize medial/lateral fixation of the device and axial/rotational stability when implanted in the femoral/medullary canal.

The Alteon Short Tapered Wedge has seventeen size offerings and two lateral offsets per size. It is made from titanium alloy and includes a 12/14 trunnion, a polished neck region, a commercially pure titanium plasma spray coated press-fit region, and a bead-blasted (satin) distal surface finish. The 12/14 trumion allows for compatible connection with Exactech femoral heads. As a line extension to the predicate, the proposed Alteon Short Tapered Wedge differs from the predicate in that it features a shortened distal stem length.

This document is a 510(k) premarket notification for a medical device called the Exactech® Alteon® Short Tapered Wedge femoral stem. It focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving the device meets specific acceptance criteria through a study involving human or AI performance.

Therefore, the requested information about acceptance criteria, study design for device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment is not available in this document.

This notice details:

• Device Name: Exactech® Alteon® Short Tapered Wedge
• Purpose: Femoral Stem Hip Prosthesis, used in total or hemi hip arthroplasty.
• Indicated Use: For skeletally mature individuals undergoing primary surgery for hip replacement due to various conditions (osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems, proximal femoral fractures) and potentially for ankylosing spondylitis, congenital hip dysplasia, revision of failed reconstructions, and to restore mobility from previous fusion.
• Substantial Equivalence Claim: The device claims substantial equivalence to the Exactech Alteon Tapered Wedge Femoral Stem (K140674) based on similar indications for use, materials, performance requirements (conforming to recognized standards), manufacturing, sterilization, and design features.
• Non-Clinical Testing: The document lists various non-clinical engineering and mechanical tests performed to demonstrate performance (e.g., Distally Fixed Fatigue testing, Femoral Neck Proximal Fatigue testing, Femoral Head Modular junction burst testing, Coating characterization, Range of Motion analysis, Template Studies, Cadaveric Evaluation), but these are not "studies" in the context of clinical performance or AI/human reader performance as implied by the user's request.

In summary, this document is a regulatory submission for a physical medical device (femoral stem), not a software or AI-driven diagnostic device that would typically involve the requested performance study elements.

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ONE Planner™ Hip is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

ONE Planner™ Hip (OPH) is an interactive software application intended to be used as a preoperative tool for Total Hip Arthroplasty. It enables 2D sizing and positioning of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on the patient's pelvic kinematics. The biomechanical measurements include measurements related to leg length and femoral offset. The functional analysis includes determination of pelvic parameters (e.g. pelvic tilt), and cup orientation calculations.

The software application consists of an automated templating system and a web-based templating user interface.

The provided document is an FDA 510(k) clearance letter for the ONE Planner™ Hip, a software device for preoperative surgical planning in total hip arthroplasty. It details the device's intended use, technological characteristics, and the non-clinical testing performed to establish substantial equivalence to a predicate device.

However, the document does not provide information on:

• Specific acceptance criteria and reported device performance in a table format.
• Details of the test set: sample size, data provenance, number/qualifications of experts, or adjudication methods.
• MRMC comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used for performance evaluation.
• Details about the training set: sample size, or how its ground truth was established.

The document explicitly states:

• "Software verification and validation testing was conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process)."
• "The software is considered a 'moderate' level of concern, a malfunction in the device could lead to a minor injury."
• "Non-clinical testing was performed to assess the usability and performance of the ONE Planner™ Hip to demonstrate that the device functions as intended."
• "Clinical testing was not necessary for the determination of substantial equivalence."

This indicates that the clearance was based on non-clinical software verification and validation, and usability/performance testing, demonstrating that the device functions as intended and does not introduce new questions of safety and effectiveness compared to the predicate device. It does not describe a study involving an AI component with specific performance metrics against a ground truth, expert readers, or a test/training set in the context of an AI-driven medical device. The "Acceptance Criteria" and "Study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, or reader improvement) are not present in this document.

Therefore, many of the requested details cannot be extracted from the provided text.

Based on the available information, here's what can be addressed:

1. A table of acceptance criteria and the reported device performance

• Not provided in the document. The document mentions "Software verification and validation testing" and "Non-clinical testing to assess the usability and performance...to demonstrate that the device functions as intended." It does not specify quantitative performance metrics or acceptance criteria for those metrics.

2. Sample sized used for the test set and the data provenance

• Not provided in the document. The document refers to "non-clinical testing" but does not detail the size or provenance of any "test set" in the context of evaluating an AI model's performance; instead, it refers to software V&V and usability.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not provided in the document. Since "clinical testing was not necessary" and no AI performance study with a test set evaluated by experts is described, this information is absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not provided in the document.

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 provided in the document. The document does not describe any MRMC study or AI assistance to human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not provided in the document. The device is described as "interact[ing]" with the user, suggesting a human-in-the-loop, but no standalone performance data is presented.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not provided in the document.

8. The sample size for the training set

• Not provided in the document. There is no mention of a training set as would be relevant for an AI model.

9. How the ground truth for the training set was established

• Not provided in the document.

Summary of what's described in the document regarding testing:

• Type of Testing: Software Verification & Validation Testing and Non-Clinical Testing (Usability and Performance).
• Purpose of Testing: To satisfy FDA guidance (IEC 62304) and demonstrate that the device functions as intended and does not introduce new safety and effectiveness questions compared to the predicate device.
• Level of Concern: Moderate (malfunction could lead to minor injury).
• Clinical Testing: Not deemed necessary for substantial equivalence determination.

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The ICONACY I-Hip system is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthrius, theumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ICONACY I-Hip system consists of femoral stem and acetabular cup (i.e., shell) porous coated components intended for cementless, press-fit fixation

The ICONACY I-Hip consists of a collarless, tapered, forged titanium alloy femoral stem, mated to a cobalt chrome modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispheric titanium alloy cup (i.e., shell) coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion and two screw holes to permit the use of screws for adjunct fixation. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press fit fixation. A titanium locking ring is fixed into a groove on the cup to engage the groove in the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.

The provided text describes a 510(k) submission for the ICONACY I-Hip System, a total hip replacement device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information about device performance, study details, and ground truth establishment is not available in the provided text.

Here's an breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical test set or human subject data was used. The evaluation was based on nonclinical (bench) testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. No expert-established ground truth for a test set was used, as no clinical testing was performed.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication process was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A multi-reader multi-case comparative effectiveness study was not performed. The submission explicitly states "Clinical Testing: Clinical testing was not required for determining substantial equivalency with the predicate devices."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical orthopedic implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence was derived from nonclinical (bench) testing results (e.g., measurements of material properties, mechanical performance under various loads, wear rates) compared against established performance characteristics of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an AI/ML algorithm. The device's design and manufacturing processes are informed by engineering principles and existing knowledge of predicate devices.

9. How the Ground Truth for the Training Set was Established

Not applicable. As noted above, there was no "training set" for an algorithm. The design and manufacturing relied on established engineering standards and performance data from predicate devices.

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