(254 days)
The Ion Facet Screw System is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following:
• Spondylolisthesis
- · Spondylolysis
· Pseudoarthrosis or failed previous fusions which are symptomatic
· Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facet with instability
The system is intended for use with bone graft material.
The Ion Facet Screw System contains various sized facet screws for bilateral stabilization of the facet joints from levels C2 through S1, inclusive. The system is supplied with various orthopedic instruments that assist the user in implanting a titanium facet screw into the facets to fixate the facet joint. There are various facet screw sizes available for implanting to accommodate a range of facet joint sizes and geometries.
The provided text is a 510(k) Premarket Notification from the FDA regarding the Ion Facet Screw System. This document clears the device for market based on substantial equivalence to existing predicate devices.
**Crucially, this document does not contain information about acceptance criteria for device performance studies or the studies themselves for a new device. Instead, it demonstrates substantial equivalence to previously cleared devices through non-clinical performance data and a comparison of technological characteristics. **
Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies in the way you might expect for a novel device undergoing clinical trials or rigorous standalone algorithm evaluation.
Here's what I can extract based on the provided text, and where I must state that the information is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this 510(k) clearance. The document asserts substantial equivalence based on a comparison to predicate devices, rather than establishing new acceptance criteria for a novel device's clinical performance. The "performance data" listed are for non-clinical aspects.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Conformance to ISO 10993-1:2018 | Met: "Biocompatibility per ISO 10993-1:2018" |
| Sterilization Validation: Conformance to ISO 17665-1:2006/(R) 2013 | Met: "Sterilization validation per ISO 17665-1:2006/(R) 2013" |
| Mechanical Static and Dynamic Testing: Conformance to ASTM F543, ASTM F1264, and ASTM F2193 | Met: "Mechanical static and dynamic testing per ASTM F543, ASTM F1264, and ASTM F2193." |
| V/V Mechanical and Safety Testing: (Specific criteria not detailed in document) | Met: "V/V Mechanical and Safety Testing" |
Note: These are non-clinical performance data points demonstrating the device's fundamental characteristics and safety, not clinical efficacy or diagnostic accuracy.
2. Sample Size Used for the Test Set and Data Provenance
Not provided. This document does not describe a clinical test set in the traditional sense for evaluating device performance against a ground truth. The "test set" here refers to the materials and conditions used in the non-clinical tests listed above.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not provided. This information would be relevant for studies involving expert consensus on medical image interpretation or clinical outcomes, which is not the type of study described in this 510(k) clearance document.
4. Adjudication Method
Not provided. Adjudication methods are typically used when multiple experts review cases to establish a ground truth, which is not applicable to the non-clinical tests mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not performed/Not applicable. The document focuses on demonstrating substantial equivalence to predicate devices, not on showing human readers improve with AI assistance. The Ion Facet Screw System is a physical medical device, not an AI or diagnostic software.
6. Standalone Performance Study (Algorithm Only)
Not performed/Not applicable. As a physical medical device (facet screws), there is no 'algorithm-only' standalone performance study.
7. Type of Ground Truth Used
For the non-clinical performance data:
- Biocompatibility: Reference standards from ISO 10993-1.
- Sterilization: Reference standards from ISO 17665-1.
- Mechanical Testing: Reference standards from ASTM F543, ASTM F1264, and ASTM F2193.
- V/V Mechanical and Safety Testing: Implied internal company safety and mechanical specifications.
There is no clinical ground truth established or used in this document for the device's efficacy, as this is a 510(k) clearance for substantial equivalence.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a training set of data.
9. How Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
Summary Explanation:
The provided document, an FDA 510(k) clearance letter, states that the Ion Facet Screw System is "substantially equivalent" to legally marketed predicate devices. This means that new clinical studies demonstrating the device's performance against specific acceptance criteria (as you might expect for a novel drug or a truly new device with an unknown risk profile) were not required or performed for this clearance. Instead, the manufacturer provided non-clinical performance data (biocompatibility, sterilization, mechanical testing) and compared the technological characteristics and indications for use to existing, cleared devices. The FDA then determined that these comparisons sufficiently demonstrate that the new device is as safe and effective as the predicate devices.
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