(112 days)
The Transom™ is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Transom™ Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Transom™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Associated instruments are available to facilitate the implantation of the device. The Transom™ Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136.
The provided document describes a 510(k) premarket notification for the Transom™ Cervical Plate System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets new acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth for an AI/CADe device is not applicable to this document.
Here's a breakdown based on the information provided and what is typically expected from a 510(k) submission for a spinal implant:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria (Mechanical Testing):
- The acceptance criteria for a 510(k) for a spinal implant typically involve demonstrating that the new device performs at least as well as or better than the predicate device in specific mechanical tests. The document states the Transom™ was tested for:
- Static axial compression bending per modified ASTM F1717-13
- Static torsion per modified ASTM F1717-13
- Dynamic axial compression bending fatigue per modified ASTM F1717-13
- The implicit acceptance criterion is that the new device's performance in these tests is comparable to or exceeds that of the predicate devices (Tempus™ Cervical Plate System, Orthofix Anterior Cervical Plating System) to ensure it is "sufficient for its intended use" and "substantially equivalent." Specific numerical acceptance thresholds are not provided in this summary but would be part of the full submission.
- The acceptance criteria for a 510(k) for a spinal implant typically involve demonstrating that the new device performs at least as well as or better than the predicate device in specific mechanical tests. The document states the Transom™ was tested for:
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Reported Device Performance:
- The document states: "The results of this non-clinical testing show that the strength of the Transom™ is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
- Specific quantitative results (e.g., maximum load, fatigue cycles to failure) are not included in this summary. These would be detailed in the full performance data section of the 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable in the context of this document. This document describes mechanical (non-clinical) testing of a physical implant, not a study involving human data or an AI algorithm. The "test set" here refers to physical samples of the device and predicate devices used in laboratory testing. The sample size would be the number of physical implants tested for each condition, which is not specified in this summary. Data provenance for mechanical testing is generally about the testing facility and methodology rather than patient origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the sense of expert consensus on patient data (e.g., radiology reads, pathology), is not relevant for this type of mechanical device testing. The "ground truth" for mechanical testing is established by standardized testing protocols (e.g., ASTM F1717-13) and precise measurement instruments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used to resolve discrepancies among human readers or experts when establishing ground truth for clinical data. This is not pertinent to mechanical testing.
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
- Not Applicable. MRMC studies are clinical studies, often used for diagnostic imaging devices or AI-assisted diagnostic tools. This submission is for a physical spinal implant and does not involve human readers interpreting images, nor does it concern AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Testing Results against Predicate Performance: The "ground truth" for this submission is the performance of the predicate devices as established through historical mechanical testing and clinical use, and the new device's conformity to relevant ASTM standards. The comparison is against established benchmarks for similar spinal implants' mechanical properties.
8. The sample size for the training set
- Not Applicable. "Training set" refers to data used to train an AI algorithm. This device is a physical implant, not an AI system.
9. How the ground truth for the training set was established
- Not Applicable. As above, no AI training set is involved.
Summary of what is provided from the perspective of a 510(k) for a physical device:
The document emphasizes that the Transom™ Cervical Plate System shares "nearly identical technological characteristics" with its predicate devices, including:
- Indications for Use
- Materials of manufacture (titanium alloy conforming to ASTM F136)
- Sterilization method
- Structural support mechanism
The key "study" mentioned is the non-clinical mechanical testing (static axial compression bending, static torsion, dynamic axial compression bending fatigue) performed according to modified ASTM F1717-13. The conclusion is that these tests demonstrate the strength of the Transom™ is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The predicates are listed as the Tempus™ Cervical Plate System (K131374, K120515) from Neurostructures, Inc. and various Anterior Cervical Plating System models from Orthofix (K974885, K012184, K030595, K050892, K100614).
§ 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.