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The SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for tibiotalocalcaneal arthrodesis of the ankle following:

• Post traumatic and degenerative arthritis involving both ankle and subtalar joints,
• Rheumatoid arthritis,
• Osteoarthritis,
• Pseudoarthrosis,
• Severe foot/ankle deformity, or
• Instability and skeletal defects after tumor resection.
  These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.

The SBi Anatomic Ankle Arthrodesis Interlocking Nail System consists of implants, associated instruments, and trays. The implants are made of implantable grade titanium while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials.
This Premarket Notification is to add 5.0mm Tibial Locking Screws in 20 to 24mm lengths, 5.0 mm Talar Screws with Threaded Head in 40 to 44mm lengths, and 6.0mm Calcaneal Locking Screws with Threaded Head in 50 to 68mm lengths to the system.

This 510(k) premarket notification is for a modification to an existing device, the SBi Anatomic Ankle Arthrodesis Interlocking Nail System. The submission is to add shorter lengths of existing screw types (5.0mm Tibial Locking Screws, 5.0 mm Talar Screws with Threaded Head, and 6.0mm Calcaneal Locking Screws with Threaded Head) to the system.

Given that this is a "Special 510(k)" submission for a modification to existing, substantially equivalent devices, the nature of the "acceptance criteria" and "study" described in the provided text focuses on demonstrating that the modified devices maintain substantial equivalence to the predicate devices. It's not a performance study of a novel AI device with specific accuracy or sensitivity metrics.

Here's an analysis based on the provided text, addressing your questions where applicable:

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

For a Special 510(k) seeking to modify an existing device, the "acceptance criteria" revolve around demonstrating that the modification does not negatively impact the safety and effectiveness of the device compared to its predicate. The "reported device performance" reflects that these criteria were met.

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

This submission does not involve clinical studies with human test sets or data provenance in the way an AI diagnostic device would. The "study" here is a bench testing and engineering rationale.

• Test Set Sample Size: Not applicable in the traditional sense. The "test set" would be the modified screw components themselves, which are physically tested or analyzed through engineering principles. The document doesn't specify a number of screws fabricated and tested, but rather refers to an "Engineering Rationale" which implies calculations and potentially physical testing of representative samples.
• Data Provenance: Not applicable. The "data" comes from engineering analysis, material properties, and potentially physical bench testing conducted by the manufacturer.

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. "Ground truth" for this type of modification is established by engineering principles, accepted material standards (ASTM F136), and regulatory requirements for medical devices. There are no radiologists or clinical experts involved in establishing "ground truth" for the mechanical properties or sterilization validity of the screws.

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

Not applicable. This is not a clinical study involving human interpretation or consensus. The "adjudication" is implicitly the regulatory review process by the FDA, where their experts evaluate the provided engineering rationale and bench test results against established standards to determine substantial equivalence.

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 applicable. This is not an AI device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this modification is based on:

• Engineering mechanics (e.g., bending load calculations)
• Materials science (e.g., ASTM F136 standard for TiAl6V4 titanium)
• Sterilization validation principles (e.g., impact of mass on sterilization parameters)
• Regulatory requirements for demonstrating substantial equivalence to a predicate device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. There is no training set for this device.

Summary of the Study:

The "study" in this context is an Engineering Rationale and Bench Testing (or analysis), rather than a clinical trial. The manufacturer submitted documentation demonstrating that the modified screws (shorter versions of existing screws) maintain or improve upon the safety and effectiveness of the predicate screws. This was achieved by providing:

• Material equivalence: Showing the new screws use the identical, implantable grade titanium as the predicate.
• Design equivalence: Confirming that the critical design features (head, diameters, thread) are identical, with only length being varied.
• Mechanical assessment: An engineering rationale that concluded shorter screws would experience lower bending loads (an improvement) compared to longer ones of the same minor diameter.
• Sterilization assessment: An engineering rationale that concluded the reduced total mass of the modified configuration ensured existing sterilization parameters remained valid.

Based on this engineering rationale and bench testing, the FDA determined the modified device (SBi Anatomic Ankle Arthrodesis Interlocking Nail System with the added shorter screws) was substantially equivalent to the predicate device (K112982).

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The SBi Anatomic Ankle Athrodesis Interlocking Nail System is indicated for tibiotalocalcaneal arthrodesis of the ankle following:

• Post traumatic and degenerative arthritis involving both ankle and subtalar joints,
• Rheumatoid arthritis,
• Osteoarthritis,
• Pseudoarthrosis,
• Severe foot/ankle deformity, or
• Instability and skeletal defects after tumor resection.
  These include neuro-osteoarthroplasty (Charcot's foot), avascular necrosis of the talus, failed joint replacement, failed ankle fusion, and for distal tibia fracture non-unions when used concomitantly with tibiotalocalcaneal pathology.

The SBi Anatomic Ankle Arthrodesis Interlocking Nail System consists of implants, associated instruments, and trays. The implants are made of implantable grade titanium while the instrument components and trays are made of several materials: Aluminum, stainless steel, PEEK, POM, and composite materials. The implants are intended for single use only and will be offered sterile and non-sterile.

The provided text is a 510(k) Premarket Notification Summary for a medical device called the "SBi Anatomic Ankle Arthrodesis Interlocking Nail System." This documentation describes a surgical implant, not an AI/ML-based device or a diagnostic tool that would typically have acceptance criteria and a study proving its performance in the way your request outlines (e.g., accuracy, sensitivity, specificity, human reader improvement, standalone performance).

Therefore, I cannot extract the information you requested about acceptance criteria and studies demonstrating device performance related to AI or diagnostic metrics because this document does not contain such information.

Specifically, the document focuses on:

• Device Description: What the device is made of and how it functions.
• Intended Use: The medical conditions it is designed to treat (tibiotalocalcaneal arthrodesis of the ankle for various forms of arthritis, deformity, etc.).
• Substantial Equivalence: Comparing the device to already legally marketed predicate devices (Stryker T2 Ankle Arthrodesis Nail and Synthes Titanium Cannulated Hindfoot Arthrodesis Nail Expert System). This is the primary method of approval for 510(k) devices.
• Non-clinical data: Fatigue testing, cadaver implantation evaluations, literature search and evaluation, finite element analysis, and engineering/dimensional analysis. These are engineering and mechanical performance tests, not clinical studies in the diagnostic/AI sense.

There is no mention of:

• Acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
• A "study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy.
• Sample sizes for test sets or training sets for an algorithm.
• Data provenance, experts establishing ground truth, adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Any AI/ML components.

In summary, the request is not applicable to the provided document.

Ask a specific question about this device