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

Alloclassic® Zweymüller® SL/ SL Offset Femoral Stems:

• Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.

· Failed previous surgery where pain, deformity, or dysfunction persists.

• Revision of previously failed hip arthroplasty

The Alloclassic® Zweymüller® SL Femoral Stem is designed as a conical straight stem with a rectangular cross section to ensure rotational stability. The general design of the Alloclassic Zweymüller SL Femoral Stem comprises a slim neck and a short taper. Alloclassic Zweymüller SL Femoral Stems are available in 14 sizes and can be implanted to achieve primary stability in cases of unexpected poor bone quality. Distally the stem is anchored primarily by its edges; proximally the surfaces anchor against the bone cortex. The Alloclassic Zweymüller SL Femoral Stem is manufactured from wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM 1295-16). The entire stem below the neck of the hip stem is grit basted to provide enhanced bone/prosthesis interface.

The design of Alloclassic® Zweymüller® SL Offset Femoral Stem is very similar to the previously cleared Alloclassic Zweymüller SL Femoral Stems (K962101, K030373), and identical to the previously cleared Alloclassic Zweymüller SL Offset Femoral Stem (K033664). Similar to the Alloclassic Zweymüller SL Femoral Stem, the Alloclassic Zweymüller SL Offset Femoral Stem is a conically shaped straight stem with a rectangular cross section for rotational stability. The entire stem below the neck of the hip stem is grit blasted to provide enhanced bone/prosthesis interface. The stem is available in 14 sizes and is manufactured from the wrought Ti-Al-Nb titanium alloy (Protasul-100™, ISO 5832-11 / ASTM 1295-16). In contrast to the Alloclassic Zweymüller SL Femoral Stem, the Alloclassic Zweymüller SL Offset Femoral Stem provides an additional 6.25 mm of offset (per size) and has a CCD/neck angle of 121° (vs 131° for SL stem). Overall the Alloclassic Zweymüller SL Offset Femoral Stem design provides a higher offset sometimes needed for correcting insufficient soft tissue balancing, restoration of leg length, and sufficient joint stability following total hip arthroplasty.

The provided text is a 510(k) summary for the Alloclassic® Zweymüller® SL Femoral Stem and Alloclassic® Zweymüller® SL Offset Femoral Stem. It does not describe an acceptance criteria table or a study proving the device meets an established acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and modifications to packaging and instrument classification.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to performance studies with specific metrics, sample sizes, ground truth establishment, and expert involvement, which are not detailed here.

However, I can extract the following relevant information:

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

This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than reporting against specific acceptance criteria for performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No specific test set or data provenance for performance evaluation is mentioned. The document states that "Packaging Configuration testing was conducted by representative worst-case products," but it does not specify the sample size or provenance for this testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document, as it does not detail a study involving expert-established ground truth.

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

This information is not provided in the document, as it does not detail a study involving adjudication.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a hip implant, not an AI-assisted diagnostic tool.

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

This information is not applicable, as the device is a hip implant, not an algorithm.

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

This information is not applicable as there is no mention of ground truth establishment for performance evaluation. The document focuses on demonstrating equivalence through design, materials, and mechanical integrity rather than clinical outcomes data for the modified components.

8. The sample size for the training set:

This information is not applicable as there is no mention of a training set for an algorithm.

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

This information is not applicable as there is no mention of a training set for an algorithm.

Summary of available information regarding compliance/testing:

The document mentions two types of non-clinical performance activities:

• Packaging configuration change: Testing was performed to verify package integrity (sterile barrier, protection during sterilization, handling, distribution, and storage) according to ISO 11607-1:2006 and ISO 11607-2:2006. This testing was conducted on "representative worst-case products."
• Correction of instrument classification from Class I to Class II: This involved an "Amendment of Design Controls with verification of mechanical integrity and resistance."

The document explicitly states: "Clinical data and conclusions were not needed for this device." This indicates that no clinical studies were performed to demonstrate performance or meet specific acceptance criteria in a clinical setting. The justification for clearance is based on substantial equivalence to predicate devices and non-clinical testing for specific modifications.

Ask a specific question about this device

Wagner Cone Prosthesis:
• Noninflammatory degenerative joint disease (NID), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis.
· Failed previous surgery where pain, deformity, or dysfunction persists.
· Optional use in revision: in some medical conditions (e.g., early revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

Wagner SL Revision Stem Lateral:
· Revision of previously failed hip arthroplasty

The Wagner SL Revision Stem Lateral is a straight stem manufactured from forged titanium alloy and is available in four lengths. The neck design of the stem is provided with the standard 12/14 taper for connection with any Zimmer modular femoral head utilizing a 12/14 taper. The Wagner SL Revision Stem Lateral incorporates a circular stem cross-section and equally spaced conical anchorage ribs, which run nearly the full length of the stem.

The Wagner Cone Prosthesis stem is a straight, collarless stem system designed for uncemented fixation. The surface of the prosthesis is rough blasted, and it has a tapered shape with an angle of five degrees. The stem has eight longitudinal ribs, and it is available in two different CCD angles, 125° and 135°. The stems are available in twelve diameters, ranging from 13 to 24 mm.

This document is a 510(k) summary for the Wagner Cone Prosthesis System and Wagner SL Revision Stem Lateral hip prostheses. It details the substantial equivalence determination made by the FDA. It does not contain information about an AI/ML-based device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, or standalone performance of an AI/ML device, as this document is not related to such a device.

The document primarily focuses on:

• Device Description: Provides details about the design and materials of the Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis.
• Indications for Use: Lists the medical conditions for which these devices are intended, such as noninflammatory degenerative joint disease, inflammatory joint disease, failed previous surgery, and revision hip arthroplasty.
• Comparison to Predicate Device: States that the intended use has not changed despite proposed modifications to indications for use (limiting them) and packaging configuration. It also mentions a reclassification of some instruments from Class I to Class II.
• Performance Data (Nonclinical and/or Clinical):
  • Non-Clinical: Mentions packaging performance testing according to ISO standards to verify sterile barrier integrity and product protection during sterilization, handling, distribution, and storage. It also notes an amendment of design controls for mechanical integrity and resistance due to the instrument reclassification.
  • Clinical: Explicitly states that "Clinical data and conclusions were not needed for this device." This signifies that a clinical trial or study in humans was not required for this 510(k) submission, likely because equivalence was established through non-clinical testing and comparison to predicate devices.
• Conclusion: Reiterates that the subject devices have the same intended use and similar indications for use, and a similar operating principle, design, labeling, manufacturing, and sterilization processes as the predicate devices. It concludes that observed differences do not raise new questions of safety and effectiveness, and the devices are at least as safe and effective as the legally marketed predicate devices.

Ask a specific question about this device