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510(k) Data Aggregation
(66 days)
The Facet Fixation System is indicated for the posterior surgical treatment of any or all of the following at the C2 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.
When properly used, facet screws will provide temporary stabilization as an adjunct to spinal bone grafting processes.
The US Spine Facet Fixation System consists of two implantable components, the screw in various lengths and an optional washer. Both components are made from implant grade wrought Titanium 6-Aluminum 4-Vanadium (Ti6Al4V) alloy.
The provided text describes a medical device, the "US Spine Facet Fixation System," and its 510(k) submission. However, it does not include information about a study based on AI/ML.
Here's a breakdown of the requested information based on the provided text, with "N/A" indicating information not present:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device needed to achieve) | Reported Device Performance (What the device actually achieved) |
|---|---|
| Provide temporary stabilization as an adjunct to spinal bone grafting processes when properly used. | Biomechanical testing (static and fatigue 3-Point Bend Testing and Cantilever Testing) performed. The specific results of these tests showing that it meets the criteria are not detailed in the provided text. The text only states that testing was performed. This performance data was deemed sufficient for substantial equivalence to predicates. |
Missing Information: The specific quantitative acceptance criteria (e.g., "withstanding X N of force for Y cycles") and the actual quantitative results achieved by the device are not provided in this summary. It only states that testing was performed.
Study Details (Focusing on AI/ML, which is not present)
2. Sample size used for the test set and the data provenance
N/A - The document describes biomechanical testing, not a study involving a test set of data for an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This is not an AI/ML study.
4. Adjudication method for the test set
N/A - This is not an AI/ML study.
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
N/A - This is not an AI/ML study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is not an AI/ML study.
7. The type of ground truth used
N/A - The performance data is based on biomechanical testing of the physical device. For a physical device, the "ground truth" would be objective measurements from these tests and observation of the device's physical integrity and stability under load.
8. The sample size for the training set
N/A - This is not an AI/ML study.
9. How the ground truth for the training set was established
N/A - This is not an AI/ML study.
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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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