(518 days)
The NADIA SI Fusion System is intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The NADIA SI Fusion System is intended to provide support and structural stability during sacroiliac fusion surgery. The NADIA sacroiliac (SI) fusion system consist of different sizes of lattice fenestrated screws that accept cannulated instruments. NADIA screws are manufactured from titanium alloy per ASTM F136 and will be provided gamma sterilized. The screws are available in multiple lengths and diameters and are provided either uncoated or coated with hydroxyapatite. Instrumentation necessary for proper implantation is also included.
This document is a 510(k) Summary for a medical device called the "NADIA SI Fusion System". It's a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical trial results with specific acceptance criteria and detailed study designs typically found in clinical publications.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics against those criteria, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone AI performance is not present or not applicable in this type of regulatory document.
Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations of this document type:
1. A table of acceptance criteria and the reported device performance
This document describes non-clinical (mechanical) testing and states that clinical data was also provided to support a substantially equivalent safety and effectiveness profile compared to the predicate. However, it does not present specific acceptance criteria or quantitative performance results for either the mechanical tests or the clinical data. The mechanical tests performed are listed as:
- ASTM F543-13, Annex 2: Driving Torque
- ASTM F543-13, Annex 1: Torsional Failure
- ASTM F543-13, Annex 3: Pushout Strength
- ASTM F2077-14: Compression Shear Fatigue Test
- ASTM F1264-16: Bending Fatigue Test
The "reported device performance" is a general statement that "The subject device was shown to be substantially equivalent to its legally marketed predicates in terms of design, intended use, material composition, function, and range of sizes." and that "Clinical data was also provided to support a substantially equivalent safety and effectiveness profile compared to the predicate." No specific metrics or thresholds are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "Clinical data was also provided to support a substantially equivalent safety and effectiveness profile," but provides no details on the study design, sample size, or data provenance.
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 as this summary does not detail the methodology for ground truth establishment for any clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is 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
An MRMC study is not mentioned in this document. This device is a physical implant (sacroiliac joint fusion system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable to the device described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "clinical data" mentioned, the specific type of ground truth used is not specified. Given the nature of a fusion device, clinical outcomes data (e.g., pain reduction, fusion rates, functional improvement) would be expected, but no details are provided here.
8. The sample size for the training set
This information is not provided, and the concept of a "training set" is generally not applicable in the context of mechanical device testing or traditional clinical studies for implants, unless referring to a developmental or pilot phase, which is not detailed here.
9. How the ground truth for the training set was established
This information is not provided, and the concept of a "training set" ground truth is largely inapplicable here for the reason stated above.
§ 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.