Search Results

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.

Ask a specific question about this device

The b-ONE™ Total Hip System is intended for primary or revision total hip replacement in skeletally mature patients with a severely disabled hip joint and/or hip damage due to the following conditions:

Osteoarthritis, traumatic arthritis, avascular necrosis of the femoral head, noninflammatory degenerative joint disease (NIDJD), slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis and congenital dysplasia; treatments of nonunion, acute traumatic fracture of the femoral head or neck; failed endoprosthesis, femoral osteotomy, or Girdlestone resection; and fracture-dislocation of the hip.

The b-ONE™ Total Hip System KOSMO™ HA coated stems are intended for cementless use only. The b-ONETM Total Hip System KOSMOTM stainless steel stems are intended for cemented use only.

b-ONETM Total Hip System components are not intended for use with other total hip systems.

The b-ONE Total Hip System is an artificial hip replacement system comprised of femoral stems and mating femoral heads; acetabular shells and mating acetabular liners; optional acetabular bone screws. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. Compatibility of the femoral head to the stem is only claimed for the b-ONE Total Hip System. There is no allowed interchangeability with systems manufactured by other companies.

This 510(k) premarket notification is being submitted as a line extension to the current b-ONE Total Hip System by adding a bone compacting Femoral Stem component. The KOSMO™ Femoral Stem is compatible with the b-ONE™ Primary Acetabular components. The KOSMO™ Cementless Femoral Stem components are compatible with the b-ONE™ 12/14 Taper CoCr or Ceramic Femoral Heads. The KOSMO™ Cemented Femoral Stem components are compatible with the b-ONE™ 12/14 Taper Ceramic Femoral Heads only.

b-ONE Total Hip System KOSMO Femoral Stem consists of cementless and cemented bone compacting stem options. The KOSMO Femoral Stem is composed of HA coated titanium alloy Ti-6Al-4V-ELI (ASTM F136) for cementless stems and Stainless Steel (ASTM F1586) for cemented stem. All system components are supplied sterile and are single use devices.

This is a 510(k) premarket notification for a medical device (KOSMO Femoral Stem, a hip joint prosthesis), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study data, expert involvement, and ground truth for an AI/ML model is not applicable.

The provided text describes a submission for a traditional medical device and focuses on establishing substantial equivalence to legally marketed predicate devices through material properties, design features, manufacturing processes, sterilization methods, and bench performance testing.

However, to directly answer your request based only on the provided text, and assuming the question is about the acceptance criteria and supporting studies for the medical device itself (not an AI/ML component lacking in this document), here is what can be inferred:

Acceptance Criteria and Study Information for the KOSMO Femoral Stem (Medical Device)

The document does not explicitly state quantitative "acceptance criteria" in the format one might expect for an AI/ML performance study (e.g., minimum sensitivity, specificity, or AUC). Instead, for this traditional medical device, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices through various non-clinical studies. The "performance" being assessed is the physical and mechanical integrity and biological compatibility of the implant.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in this 510(k) summary. For bench testing of medical devices, sample sizes are typically determined by relevant ISO standards (e.g., ISO 7206 for hip implants) but are not detailed in this high-level summary.
• Data Provenance: The studies are "Non-Clinical Studies," meaning they are bench tests (mechanical, chemical, biological) performed in a lab setting, not on human patients. Therefore, country of origin of data or retrospective/prospective clinical data are not applicable here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable as this is not an AI/ML application or a clinical study requiring expert ground truth for interpretation of complex clinical data. The "ground truth" for a mechanical device is based on engineering specifications, material science, and established test methods.

4. Adjudication Method for the Test Set

• Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for bench testing of a traditional medical device.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• Not applicable. MRMC studies are used to assess the impact of an AI algorithm on human reader performance, which is not relevant for this traditional medical device.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This is for an AI/ML algorithm. This device is a physical implant. The "standalone performance" refers to its mechanical and material properties as assessed by bench tests. The summary indicates that "Performance Testing - Bench" was done.

7. Type of Ground Truth Used

• For the non-clinical studies mentioned (Endurance, Impingement, Biocompatibility, etc.), the "ground truth" is derived from:
  • Engineering Specifications: Design tolerances, material properties, and mechanical performance requirements derived from national and international standards (e.g., ISO, ASTM) for hip implants.
  • Pre-defined Pass/Fail Criteria: Established by industry standards and regulatory expectations for the safety and effectiveness of such devices.

8. Sample Size for the Training Set

• Not applicable. This refers to AI/ML model training data. For a traditional medical device, there is no "training set" in this context. Device design and manufacturing processes are refined through engineering, prototyping, and testing, but not in the sense of training an algorithm.

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

• Not applicable, as there is no "training set" in the AI/ML sense. The "ground truth" for the device's development and validation relies on established biomechanical principles, material science, regulatory standards for medical device safety and effectiveness, and comparisons to legally marketed predicate devices.

Ask a specific question about this device