(22 days)
When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).
When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis)
When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions using autogenous bone graft only, having the device fixed or attached to the lumbar and sacral spine, having the device removed after the development of a solid fusion mass. Screw fixation is limited to L3 and below.
Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis).
The SCS Claris Extended OmniAxial Connectors are available in two sizes (medium and long) and are used to connect the rods and screws of the SCS Claris Spinal System.
Here's an analysis of the provided FDA 510(k) summary, focusing on your requested acceptance criteria and study information.
It's important to note that the provided document is a 510(k) summary for a medical device (spinal system components), not an AI/software as a medical device (SaMD) submission. Therefore, many of your questions related to AI-specific studies (e.g., sample size for training set, MRMC studies, ground truth for AI) are not applicable to this type of submission. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use for mechanical orthopedic implants.
Acceptance Criteria and Device Performance (Not Applicable for this device type)
For mechanical medical devices like the SCS Claris Spinal System Extended OmniAxial Connectors, the "acceptance criteria" are generally related to demonstrating substantial equivalence to a previously cleared predicate device. This is achieved through comparisons of:
- Indications for Use: Must be identical or very similar.
- Technological Characteristics: Materials, design principles, manufacturing methods, and fundamental operating mechanisms must be similar.
- Performance Data: Often involves mechanical testing (e.g., fatigue, static strength) to show that the new device performs at least as well as, or better than, the predicate device under similar conditions.
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format, nor does it provide a "reported device performance" in the way you might find for a diagnostic or AI device. Instead, it states the conclusion of substantial equivalence. The "study" mentioned is the comparison itself.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Implied from 510(k) Conclusion) |
|---|---|
| Indications for Use: Identical or substantially similar to predicate device. | "Substantially equivalent... based upon equivalence in indications/intended use." (Identical) |
| Technological Characteristics: | |
| - Materials: Identical to predicate device. | "manufactured from titanium alloy (ASTM F136 / ISO 5832-3)." (Matches predicate) |
| - Basic Design: Similar to predicate device. | "basic design" (Similar) |
| - Manufacturing Methods: Similar to predicate device. | "manufacturing methods" (Similar) |
| - Interconnection Mechanism: Similar to predicate device. | "interconnection (attachment) mechanism" (Similar) |
| Performance (Mechanical Testing - inferred): New device performs at least as well as predicate. | Not explicitly detailed in the summary, but implied by the successful 510(k) clearance, meaning testing (if required) showed acceptable performance relative to the predicate. |
Detailed Study Information (Where Applicable for K021919 submission):
For this specific 510(k) submission (K021919), the "study" is the demonstration of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical "test sets" for diagnostic or AI devices. For mechanical performance testing, the "sample size" would refer to the number of devices tested to demonstrate mechanical equivalence. This detail is not provided in the summary but would have been part of the full 510(k) submission.
- Data Provenance: Not applicable in the context of clinical "data provenance." Mechanical testing data is generated in a lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable: This submission does not involve clinical ground truth established by experts for a diagnostic or predictive task. The "ground truth" for a mechanical device is its physical properties and mechanical performance.
4. Adjudication Method for the Test Set
- Not Applicable: There is no "adjudication method" in the clinical sense for this type of device submission.
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: This is a mechanical device, not an AI/SaMD.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a mechanical device, not an AI/SaMD.
7. The Type of Ground Truth Used
- Mechanical Properties and Performance: The "ground truth" for this device is its material composition (titanium alloy as per ASTM F136 / ISO 5832-3) and its mechanical performance characteristics (e.g., fatigue strength, static strength) as demonstrated through engineering testing. This "ground truth" is compared against industry standards and the predicate device's established performance.
8. The Sample Size for the Training Set
- Not Applicable: This is a mechanical device, not an AI/SaMD. There is no "training set" in the machine learning sense. The "training" for such a device is its design, engineering specifications, and manufacturing process.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: Similar to point 8, there's no "training set" or "ground truth for a training set" as understood in AI/SaMD. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory standards for spinal implants.
§ 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.