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The SBi AutoFIX Twin Pitch Cannulated Compression Screw System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small bones.

The SBI AutoFix™ System consists of a series of Cannulated and Non-Cannulated bone screws varying in length and diameter. The SBI AutoFix™ System is intended for use on selected fractures in the body as medically indicated and bone mass compatible.

The provided text is related to a 510(k) premarket notification for a medical device called the "SBI AutoFix™ System" and primarily discusses its regulatory clearance based on substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, a study proving the device meets acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot provide the requested table and information based on the given input. The document is a regulatory approval letter, not a technical performance study report.

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SBI WristFIT™ (Fracture In Tension) Distal Radius System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small and long bones. This includes:

• . distal radius fractures
• t distal ulna fractures
• . radial osteotomies
• . radial fusions
• . tarsal fractures

The system features non-sterile stainless steel plates with cortical locking, non-locking, and Cannulated screws in two diameters (2.4mm and 2.7mm), high angle screws with low profile heads when inserted into specially designed screw holes at angles as high as 60° to 70° off perpendicular, or 30° to 70° from the plate or bone axis, and the instruments with which to implant them.

This K051747 510(k) summary describes a medical device (SBI WristFIT™ Internal Fixation System), not an AI/ML powered device. As such, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of AI/ML performance metrics are not applicable here.

The 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is a regulatory pathway for non-AI medical devices. This typically involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device. The information provided in the document confirms this:

• Substantial Equivalence: The document explicitly states: "Documentation is provided which demonstrated the SBI WristFIT™ to be substantially equivalent to other legally marketed devices."
• Predicate Devices: The FDA letter confirms the substantial equivalence determination.

Therefore, the requested AI/ML specific information (acceptance criteria table, sample sizes, ground truth, MRMC studies, etc.) cannot be extracted from this document, as it pertains to a different type of device and regulatory assessment.

In summary, none of the requested information regarding acceptance criteria or studies proving device performance, in the context of AI/ML, can be provided as this document describes a traditional medical device (internal fixation system) undergoing a 510(k) substantial equivalence review.

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The SBI K-Wires are indicated for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.

SBI K-Wires are provided non-sterile. They range in diameter from 0.9mm - 2.0mm and are 150mm long. They are available in single point, double point, and threaded single point.

The provided text is a 510(k) summary for the SBI K-Wires, indicating clearance by the FDA based on substantial equivalence to predicate devices. It describes the device, its intended use, and materials.

However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria. The 510(k) process for devices like K-wires typically focuses on demonstrating substantial equivalence to existing, legally marketed devices, rather than requiring the submission of a diagnostic performance study with specific acceptance criteria as would be expected for an AI/ML-based diagnostic device.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method: Not provided.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable to this type of device and not provided.
6. Standalone performance: Not applicable to this type of device and not provided.
7. Type of ground truth used: Not applicable and not provided.
8. Sample size for the training set: Not applicable (no AI/ML algorithm involved) and not provided.
9. How the ground truth for the training set was established: Not applicable and not provided.

The 510(k) summary primarily states that "Documentation is provided which demonstrated the SBI K -Wires to be substantially equivalent to other legally marketed devices." This implies that the device's characteristics and performance are comparable to devices already on the market, which is how its "acceptance" by the FDA is established for market clearance.

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The SBI Hand Fixation System™ is a system of plates and screws that is intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.

The SBI Hand Fixation System™ consists of a series of stainless steel plates and screws of varying lengths and thicknesses and is provided in various configurations, including straight, T-, Y-, Z-, compression L-, compression T-, and compression Y-plates. These plates are attached to bone via 1.5, 1.7, 2.0, 2.2, 2.4, and 2.6mm self tapping cortex screws.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, or any study details that would allow me to populate the requested table and answer your questions. The document is a 510(k) summary and the FDA's response letter for the SBI Hand Fixation System, which focuses on device description, intended use, and substantial equivalence to predicate devices, rather than detailed performance data or study methodology.

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