(94 days)
The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain 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 Coral™ Spinal System consists of a variety of shapes and sizes of screws, rods, hooks, cross-connectors, and connecting components. Coral™ Spinal System components can be rigidly locked creating a rigid construct for promoting fusion. Coral™ Spinal System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F67, ASTM F136, ISO 5832-3, and ISO 5832-2. Alternatively, the entire system may be made out of medical grade stainless steel described by such standards as ASTM F138, ISO 5832-1, and ISO 5832-9. Caution use of dissimilar metals, i.e. stainless steel and titanium must not be used in combination, but must be used independently.
The provided document is a 510(k) summary for the Coral™ Spinal System. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on mechanical testing. This document does not contain information typically found in a study proving a device meets acceptance criteria related to diagnostic accuracy or clinical performance.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving performance in the context of diagnostic or AI/ML device evaluation. The information provided is for a traditional medical device (spinal implant) where substantial equivalence is primarily demonstrated through mechanical testing and comparison to existing devices.
However, I can extract the information provided about the device's substantial equivalence and general description:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would be applicable to a diagnostic device or AI/ML system. Instead, it references substantial equivalence to predicate devices. For a spinal implant, this typically means demonstrating comparable mechanical properties and safety.
| Acceptance Criteria (Implied for Spinal Implant) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Devices | "Mechanical testing data under ASTM F-1717 was provided or referenced to demonstrate substantial equivalence." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided in the document as it refers to mechanical testing data, not a clinical or diagnostic performance test set.
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)
This information is not applicable and not provided. Ground truth in the context of diagnostic accuracy, clinical outcomes, or AI labeling is not relevant for the type of substantial equivalence demonstrated here (mechanical testing of a spinal implant).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. This is for an orthopedic implant, not an AI/ML-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The closest concept to "ground truth" here would be the established standards for mechanical testing (e.g., ASTM F-1717) and the characteristics of the predicate devices. The "ground truth" for the device's safety and effectiveness is inferred through its mechanical equivalence to devices already on the market.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/ML device.
Summary of why most fields are N/A:
The provided document is a 510(k) summary for a spinal surgical implant (Coral™ Spinal System). The primary method for demonstrating substantial equivalence for such devices is through mechanical testing against established standards (like ASTM F-1717) and comparison to legally marketed predicate devices. The request's questions are designed for evaluating diagnostic devices, particularly those that might use AI/ML, which involve clinical performance studies, ground truth establishment, expert review, and statistical measures like sensitivity and specificity. These concepts are not relevant to the information presented in this 510(k) filing for a spinal fixation system.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.