(38 days)
The Dogbone ACFS is indicated for trauma, deformity (lordosis and kyphosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), and spinal canal stenosis.
The Dogbone ACFS is indicated for stabilizing the spine from C2 to C7. Unicortical or bicortical fixation from the anterior face of the vertebral bodies may be employed using either the variable angle or fixed angle screws. This product may be employed as an internal fixation device during the time interval required for arthrodesis.
The Dogbone ACFS is a titanium alloy anterior cervical plate fixation system. Plates are pre-contoured in two planes, and come in a variety of lengths. Screws arc available in two diameters, several lengths, and two different styles; fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs combining elements of fixed and variable angle screws may be built also. Eight locking tingers circumferentially disposed around the rim of each screw hole engage the screw heads to provide mechanical resistance against screw back-out.
The provided text describes a medical device called the "Dogbone ACFS," a spinal intervertebral body fixation orthosis. However, the document is a 510(k) summary for regulatory clearance and does not contain information about acceptance criteria, a study demonstrating the device meets those criteria, or any of the detailed data provenance, expert involvement, or statistical analyses typically associated with such studies for AI/software-as-a-medical-device (SaMD) products.
The "Performance Data" section specifically states: "Non-clinical: Static and fatigue cantilever axial compression testing was performed. Properties of stiffness, strength, and fatigue life were characterized. Static torsion was also examined." This indicates engineering performance testing for a mechanical device, not a study evaluating an algorithm's performance.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document describes non-clinical engineering tests (stiffness, strength, fatigue life, static torsion) but does not define specific "acceptance criteria" (e.g., minimum stiffness values, maximum fatigue cycles) or quantitative "reported device performance" against those criteria. It only states that these properties were "characterized."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This information is relevant for studies involving data-driven algorithms (like AI/ML). The document describes mechanical testing, not a study involving a test set of 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)
- Cannot be provided. This is relevant for studies involving human interpretation or labeling of data for ground truth. The device is a physical implant, and its performance is assessed via mechanical testing, not expert consensus on data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. This is relevant for resolving discrepancies in expert labeling of ground truth in data-driven studies.
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
- Cannot be provided. This type of study is specific to AI/software that assists human readers/clinicians, which is not what the Dogbone ACFS is.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is relevant for AI-only devices. The Dogbone ACFS is a physical medical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No "ground truth" in the context of data labeling is mentioned. For mechanical devices, testing against engineering standards or established physical properties would be the equivalent.
8. The sample size for the training set
- Cannot be provided. No training set exists for this physical device.
9. How the ground truth for the training set was established
- Cannot be provided. No training set or associated ground truth is relevant here.
Summary of available information from the document that relates to performance:
The document describes non-clinical performance data for a physical spinal implant.
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Type of tests performed:
- Static cantilever axial compression testing
- Fatigue cantilever axial compression testing
- Static torsion testing
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Properties characterized:
- Stiffness
- Strength
- Fatigue life
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Study proving device meets acceptance criteria:
- No specific "study" in the sense of a clinical trial or AI performance validation is described. The "Performance Data" section indicates that these mechanical tests were performed and properties characterized. The implication for regulatory clearance (510(k)) is that these tests demonstrated the device's performance is substantially equivalent to a predicate device (Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)) and meets general safety and effectiveness requirements for its intended use. The 510(k) summary does not detail the specific test results or the acceptance criteria established for these mechanical properties.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.