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510(k) Data Aggregation
(57 days)
The Facet FixxTM System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle. The Facet Fixx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following: Degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies, Degenerative disease of the facets with instability, Trauma (i.e. fracture or dislocation), Spondylolisthesis, Spondylolysis, Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity.
The Facet FixxTM System is a posterior facet spinal fixation system consisting of screws with and without washers. The cannulated screw is offered partially or fully threaded in various diameter and length combinations.
This device is a spinal fixation system, not an AI/ML device. Therefore, the questions related to AI/ML device performance and study design are not applicable. The provided text describes the device, its intended use, materials, and a comparison to predicate devices, focusing on mechanical performance.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Properties equivalent to predicate devices (Static and dynamic cantilever bending, axial pullout tests) | "The mechanical test results demonstrate the Facet FixxTM System to be substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of an algorithm. For mechanical testing, the number of samples tested for static/dynamic cantilever bending and axial pullout is not specified.
- Data Provenance: The mechanical testing was likely conducted in a laboratory setting, not with human patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. Mechanical testing involves objective measurements rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not an AI/ML device.
6. Standalone Performance Study:
- Not applicable. This is not an AI/ML algorithm. The performance established is the mechanical performance of the device itself.
7. Type of Ground Truth Used:
- Mechanical Testing Results: The "ground truth" here is the objective measurement of the device's mechanical properties (static and dynamic cantilever bending, axial pullout strength) against established ASTM standards (F2193 and F543) and comparable predicate devices.
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that uses a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
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(88 days)
The Discovery Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods:
Transfacet fixation - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.
Translaminar-facet fixation - The screws are inserted bilaterally through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet across the facet joint and into the inferior pedicle.
For both methods, this system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability
The Discovery Facet Screw Fixation System consists of screws and washers designed to compress bone grafts and/or fractures. The screws are intended only for use in combination with the washer. The system includes two screw styles: fully threaded and lag.
The DISCOVERY Facet Screw is a broad-headed screw that is designed to compact or stabilize adjacent facet articular processes to enhance spinal fusion and stability. The system is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle.
This section describes the acceptance criteria and the study conducted to demonstrate the performance of the DISCOVERY Facet Screw Fixation System.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document [K012773](https://510k.innolitics.com/search/K012773) describes the predicate device and the new device being submitted. It states that "Biomechanical testing, including static and fatigue 3-Point PERFORMANCE DATA: Bend Testing and Cantilever Testing, were conducted" (from Document 1, [K012773](https://510k.innolitics.com/search/K012773) page 2, "Biomechanical testing"). However, the specific acceptance criteria (e.g., minimum strength, fatigue cycles) and the quantitative reported device performance for these tests are NOT provided in the extracted text. The document primarily focuses on establishing "substantial equivalence" to predicate devices rather than detailing specific performance metrics against pre-defined acceptance criteria.
Therefore, the table below reflects the type of tests reported but cannot provide numerical acceptance criteria or performance due to the lack of this information in the provided input.
| Acceptance Criteria (Type) | Reported Device Performance |
|---|---|
| Static 3-Point Bend Test (e.g., strength) | Details not provided in the document. Biomechanical testing was conducted. |
| Fatigue 3-Point Bend Test (e.g., cycles) | Details not provided in the document. Biomechanical testing was conducted. |
| Cantilever Test (e.g., strength, cycles) | Details not provided in the document. Biomechanical testing was conducted. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Biomechanical testing, including static and fatigue 3-Point PERFORMANCE DATA: Bend Testing and Cantilever Testing, were conducted." The sample size used for these biomechanical tests is not specified in the provided text. The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is biomechanical testing of a medical device (screws and washers), not a study analyzing medical images or clinical data where expert consensus would typically establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for a biomechanical testing study. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of data (e.g., medical imaging) to resolve discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable as the study described is biomechanical testing of a medical device, not a study evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable as the study described is biomechanical testing of a medical device, not an evaluation of an algorithm's performance.
7. Type of Ground Truth Used
The ground truth for this type of study is typically established by engineering standards and physical measurements obtained from controlled laboratory conditions, using specialized testing equipment (e.g., material testing machines to measure load, displacement, and cycles to failure). The document does not explicitly state the specific standards used, but it refers to "Biomechanical testing."
8. Sample Size for the Training Set
This information is not applicable. Biomechanical testing of a physical device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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