(466 days)
The MSB Sacroiliac Joint Fusion Device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
The MSB Sacroiliac Joint Fusion Device is designed to provide stabilization of the sacroiliac joint until fusion occurs. This product is manufactured from medical grade titanium alloy (Ti-6AL-4V) conforming to ASTM F136. The device is offered in a variety of sizes ranging from 5mm to 12mm in diameter and from 20mm to 60mm in length. One design option consists of a solid outer form. The alternative design contains holes along the sides of the implants which can be used to pack graft material. Both versions are cannulated and may be implanted via a minimally invasive approach.
The provided text describes the Medtronic Sofamor Danek MSB Sacroiliac Joint Fusion Device and its 510(k) summary (K110472). However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.
Instead, the document focuses on:
- Product Description: Materials, sizes, design options (solid vs. holes for graft material), and cannulation.
- Indications for Use: Sacroiliac joint fusion for disruptions and degenerative sacroiliitis.
- Non-Clinical Performance Data: Engineering calculations, push-out, torque-to-fail, and four-point bending testing performed according to ASTM standards (F543-07 and F2193-02). These tests are about structural integrity and mechanical properties, not clinical performance or diagnostic accuracy.
- Technological Comparison: Statement that characteristics "do not raise any new questions of safety or effectiveness."
- Substantial Equivalence: A list of predicate devices to which the MSB device is compared, based on technological characteristics and safety/effectiveness. This is the primary "proof" for 510(k) clearance – demonstrating equivalence to an already legally marketed device.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text. The document describes a traditional medical device (implant) and its path to FDA clearance via substantial equivalence to predicate devices, rather than a device requiring a clinical performance study with defined acceptance criteria for metrics like accuracy, sensitivity, or specificity.
Here's a breakdown of what can be inferred or stated based on the given text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| ASTM F543-07: | Testing performed according to ASTM F543-07 (Standard Specification and Test Methods for Metallic Medical Bone Screws). |
| ASTM F2193-02: | Testing performed according to ASTM F2193-02 (Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System). |
| Engineering Calculations: | Demonstrated that under worst-case conditions, the device would not raise new safety/effectiveness issues. |
| Push-out, Torque-to-fail, Four-point bending: | Testing performed and found substantially equivalent to the SI-Bone device and Pioneer Cannulated Screw test items. |
| Substantial Equivalence to Predicate Devices: | Demonstrated substantial equivalence to multiple predicate devices (e.g., iFuse Implant System, Pioneer Cannulated Screw System, Globus Medical SI-LOK Sacroiliac Joint Fixation System, Zyga's Simmetry, DePuy SIJF Cannulated Screw System, Synthes 6.5 Cannulated Screw, Alphatec Cannulated Bone Screws). This implies the device's overall safety and effectiveness are comparable to these established devices. |
Missing from the text: Specific numerical acceptance thresholds (e.g., "minimum push-out force of X Newtons") and the exact numerical results for the reported device performance. The text only states that testing was performed and found to be substantially equivalent.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided. The document describes non-clinical, engineering, and mechanical testing, not a clinical "test set" with patient data.
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 Provided. Ground truth (in the context of clinical or diagnostic studies) is not mentioned as this is not a diagnostic device or a study involving human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided.
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 a static implant device, not an AI-assisted diagnostic or interpretive system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For non-clinical testing, the "ground truth" or reference standards are defined by the ASTM specifications for mechanical properties (e.g., bone screw strength, bending characteristics).
8. The sample size for the training set
- Not Applicable. This device did not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not Applicable.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.