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The ONVOY Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.

The ONVOY Acetabular System is used in conjunction with Globus/StelKast Hip Systems. The acetabular components of this hip system are intended for cementless fixation.

The ONVOY™ additional implants consist of acetabular shells, liners, and dual mobility liners and bearings that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. New femoral head sizes are also being introduced. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Shells are available in a cluster-hole design, liners are available in hooded, non-hooded, and lateralized designs used in conjunction with ONVOY shells. Dual mobility polyethylene bearings are used with dual mobility liners.

ONVOY™ acetabular shells are additively manufactured from titanium alloy powder per ASTM F3001. Acetabular liners and dual mobility bearings are manufactured from highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Dual mobility liners are manufactured from Cobalt Chrome (CoCr) alloy and femoral heads are manufactured from alumina matrix composite ceramic.

This document is an FDA 510(k) clearance letter for a medical device called the "ONVOY™ Acetabular System." It details the device's purpose, indications for use, and the basis for its substantial equivalence to other legally marketed devices.

However, it does not contain information about acceptance criteria and a study proving a device meets those criteria for an AI/Software as a Medical Device (SaMD).

This clearance is for an orthopedic implant (hip prosthesis components: acetabular shells, liners, dual mobility implants, and femoral heads), not a software device or an AI application. Therefore, the questions related to MRMC studies, ground truth establishment, training sets, and expert adjudication are not applicable to the content provided in this FDA 510(k) letter.

The "Performance Data" section solely refers to mechanical and material testing standards relevant to orthopedic implants (fatigue, wear, range of motion, material composition, etc.) and states that "Performance data demonstrate substantial equivalence to the predicate devices." It does not describe any clinical study involving human readers or AI performance metrics.

In summary, based on the provided text, I cannot describe acceptance criteria and a study that proves a device meets those criteria, as the document pertains to an orthopedic implant and not an AI/SaMD.

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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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