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The SBI Ulnar Head Implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection.

The uHead™ Ulnar Head Replacement prosthesis is currently approved under 510(k) K010786 and marketed by Small Bone Innovations. This device is used to treat patients with rheumatoid, degenerative, or post-traumatic disabilities presenting the following; pain and weakness of the wrist joint not improved by conservative treatment, instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes, and failed ulnar head resection. The sigmoid notch component is used in conjunction with the uHead™ device. Dependent upon the severity of degenerative joint disease and forearm stability, the sigmoid notch component can be used to restore stabile wrist function and improve forearm kinematics that is not always obtainable with the uHead™ prosthesis alone.

This 510(k) summary for the SBI Ulnar Head Implant primarily focuses on establishing substantial equivalence to previously marketed devices. It does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Information on a specific study conducted for this 510(k) submission to demonstrate performance against acceptance criteria. Instead, it refers to documentation showing substantial equivalence.
• Details about sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The provided text is a regulatory submission for premarket notification (510(k)) for a medical device. A 510(k) typically demonstrates substantial equivalence to existing devices rather than requiring an extensive de novo clinical trial with defined acceptance criteria for performance in the same way a PMA submission might.

Therefore, many of your requested points cannot be answered from the provided text.

Here's what can be extracted from the document:

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

• Not Available. The document does not provide specific performance acceptance criteria or a "reported device performance" table as if from a study designed to meet specific metrics. It states, "Documentation is provided which demonstrated the SBI Ulnar Head Implant to be substantially equivalent to other legally marketed devices."

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

• Not Available. There is no mention of a "test set" or a study in this context that would involve a sample size for performance evaluation. The substantial equivalence argument likely relies on design, material, and intended use comparison to predicate devices, rather than a new performance study.

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)

• Not Applicable / Not Available. This information is not relevant to a 510(k) substantial equivalence submission for this type of device. There is no mention of a "ground truth" establishment process within this document.

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

• Not Applicable / Not Available. No test set or adjudication method is described.

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

• No. This is a physical implant device, not an AI diagnostic tool. Therefore, an MRMC study and AI assistance are not applicable.

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

• No. This is a physical implant device.

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

• Not Applicable / Not Available. The concept of "ground truth" as typically applied to diagnostic algorithms or imaging interpretation is not relevant for this device's 510(k) submission.

8. The sample size for the training set

• Not Applicable / Not Available. This is a physical implant device, not an AI algorithm. Therefore, there is no "training set."

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

• Not Applicable / Not Available. As above, no training set exists for this device.

Study/Evidence that Proves the Device Meets Acceptance Criteria:

The document states: "Documentation is provided which demonstrated the SBI Ulnar Head Implant to be substantially equivalent to other legally marketed devices."

This indicates that the "study" proving the device meets acceptance criteria (which, in a 510(k), are generally met by demonstrating equivalence to a predicate device) is a comparison against legally marketed predicate devices. The specific details of that "documentation" are not elaborated on in this summary but would typically include:

• Comparison of Intended Use: Showing the new device has the same intended use as predicate devices. (The document explicitly lists the intended use).
• Comparison of Technological Characteristics: Demonstrating that the new device has substantially similar technological characteristics (e.g., materials, design principles, operating principles) to predicate devices. (The document mentions material: "implantable grades of cobalt chrome (ASTM 1537-94), with CpTi coating.").
• Performance Data (if necessary): For an implant, this would primarily involve non-clinical testing (e.g., mechanical testing, biocompatibility testing) to ensure it performs safely and effectively in a similar manner to the predicate, or that any differences do not raise new questions of safety and effectiveness. This summary does not detail these non-clinical tests, but they would be part of the "documentation."

In summary, the provided text is a high-level summary for a 510(k) premarket notification. It asserts substantial equivalence to predicate devices as the basis for marketing clearance, rather than detailing a specific clinical performance study against pre-defined acceptance criteria.

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The WMT Modular Ulnar Head Implant is indicated for the following indications:

• Replacement of the distal ulnar head for disorders of the distal radioulnar joint in rheumatoid, degenerative and post-traumatic arthritis presenting with the following findings:
  • -pain and weakness of the wrist joint not improved by nonoperative treatment;
  • -instability of the ulnar head with radiographic evidence of dislocation or erosive changes of the distal radioulnar joint;
  • -failed ulnar head resection; e.g. Darrach resection
• Primary replacement after fracture of the ulnar head or neck.
• Revision following failed ulnar head arthroplasty.

The design features of the WMT Modular Ulnar Head Implant (Figure 1) is substantially equivalent to the Avanta uHead™ modular ulnar head implant (previously submitted and cleared under AVANTA ULNAR HEAD IMPLANT -- 510(k): K010786).

The WMT Modular Ulnar Head Implant was designed as a more anatomic alternative to the previously submitted and cleared Avanta uHead™ modular ulnar head implant (previously submitted and cleared under AVANTA ULNAR HEAD IMPLANT – 510(k): K010786) that utilizes axisymmetric head and stem components. The anatomy of the distal ulna is not axisymmetric, but rather consists of a head that is offset medial-lateral and dorsal-volar from the ulnar canal. Cadaveric analysis has shown that there is no correlation between head and stem location, thus a system where the head is offset relative to the stem is required to replicate normal anatomy and thus, joint kinematics.

The WMT Modular Ulnar Head is manufactured from cobalt chrome (ASTM F799 or F1537). The triangulated head will have a highly polished exterior surface across the articulating arc and distal surface, and will have a plasma sprayed textured surface laterally for tissue adhesion. The heads will be available in sizes ranging from 16mm to 22mm in diameter, 8mm to 11mm in height, and 1.5mm to 3mm in offset. The WMT Modular Ulnar Head Implant will contain suture holes for attaching soft tissues and a locking taper mechanism for engaging the modular head onto the stem.

The WMT Modular Ulnar Stem is manufactured from titanium (ASTM F136). The stems will be available in a standard and revision option: the standard stem will be tapered 4.5° to match the anatomical canal geometry while the revision stem will have a 1º taper to match proximal canal geometry. Each stem option will be available in distal diameters ranging from 5.5mm to 8mm and in two lengths: a standard length will have a 1mm platform and 25mm stem, and the extended length will have a 20mm platform and a 50mm stem. The stems will be fluted and will have a heavy grit blast finish over entire part except for the taper.

The provided text is a 510(k) summary for the WMT MODULAR ULNAR HEAD. It describes the device and its intended use, and claims substantial equivalence to a previously cleared device (Avanta uHead™ modular ulnar head implant). However, it does not contain any information about acceptance criteria, specific performance study results (statistical metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods), or MRMC studies.

The core of this submission is a claim of "substantial equivalence" based on design features, materials, and intended use, rather than a detailed performance study against explicit acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated. The document asserts "substantial equivalence" to a predicate device (Avanta uHead™ modular ulnar head implant) based on shared intended use, materials, and design features. It does not provide quantitative acceptance criteria or specific performance metrics obtained from a study comparing the WMT Modular Ulnar Head implant to these criteria.

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

Not applicable. The document does not describe a clinical or performance study with a test set of data. The "testing results" mentioned generally refer to materials data and mechanical testing to support the safety, but not a study to evaluate performance against specific criteria.

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

Not applicable. Ground truth establishment is irrelevant as no test set requiring such expert assessment is described.

4. Adjudication Method for the Test Set

Not applicable. No test set or expert adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a physical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related metrics are irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. As above, no test set with ground truth is discussed.

8. The Sample Size for the Training Set

Not applicable. No training set is mentioned as this is not a machine learning or AI-based device.

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

Not applicable. No training set with ground truth is discussed.

Summary of what is present in the document:

The 510(k) submission for the WMT Modular Ulnar Head states its safety and effectiveness are supported by:

• Substantial equivalence information
• Materials data
• Testing results (implied mechanical/biocompatibility testing, not clinical performance against specific metrics)

The main argument for clearance is based on the device being "substantially equivalent" to the Avanta uHead™ modular ulnar head implant (K010786) in terms of intended use, materials, type of interface, and design features. The design differences (e.g., more anatomic shape, different sizing options) are presented as improvements, but without a comparative clinical performance study.

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Avanta Orthopaedics Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:

• Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic disabilities presenting the following:
  • Pain and weakness of the wrist joint not improved by conservative treatment
  • Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes
  • Failed ulnar head resection

The ulnar head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the distal ulnar head.

The provided text is a 510(k) Summary for the Avanta Orthopaedics Ulnar Head implant. This document is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device for marketing purposes. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical trial reports or performance studies for AI/medical device software.

The document focuses on comparing the Avanta Ulnar Head implant to a predicate device (Silastic Swanson Ulnar Head Implant) in terms of design, materials, indications for use, and other characteristics to establish substantial equivalence for regulatory approval.

Therefore, I cannot provide the requested information from the given text.

To address your request fully, a document detailing performance testing, clinical studies, or verification and validation activities specific to the Avanta Ulnar Head Implant would be required. Such a document would typically include:

1. Acceptance Criteria and Reported Device Performance: Usually presented for mechanical properties (e.g., tensile strength, fatigue life), biocompatibility, or sterility, and compared against predefined thresholds.
2. Sample Size and Data Provenance: For material testing, it would be the number of test articles. For any human-related data (e.g., historical clinical outcomes for a previous version or similar device if used as supportive data), it would specify the source.
3. Number of Experts/Qualifications: Not applicable for a purely mechanical or material device performance study. This is relevant for diagnostic devices where ground truth is established by clinical experts.
4. Adjudication Method: Not applicable for the type of device described here.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: Not applicable as this is a physical medical implant, not an AI or diagnostic imaging device.
6. Standalone Performance: For an implant, this would refer to its inherent material and mechanical properties, not an "algorithm."
7. Type of Ground Truth: For an implant, "ground truth" relates to material specifications, engineering standards, biocompatibility testing results (e.g., ISO standards), and clinical outcomes from long-term use of similar devices.
8. Sample Size for Training Set: Not applicable as this is not an AI/ML device.
9. How Ground Truth for Training Set was Established: Not applicable as this is not an AI/ML device.

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