(86 days)
The GPS™, G Surgical Anterior Cervical Plate System is intended for use in anterior cervical decompression and fusion (ACDF) surgery at levels C2-C7. The system is indicated for temporary stabilization of the anterior spine during the development of cervical fusions in skeletally mature patients with the following indications:
- Degenerative Disc Disease (as defined by neck pain of the discogenic origin with . degeneration of disc confirmed by patient history and radiographic studies)
- Trauma (including fractures) .
- Tumors .
- Deformities or curvatures (including kyphosis, lordosis, or scoliosis) .
- Pseudarthrosis .
- . Failed previous fusion
- . Spondylolisthesis
- . Spinal Stenosis
The GPS™ G Surgical Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, bone screws, locking screws, and associated instruments. Fixation is provided by bone screws, of various lengths, inserted into the vertebral body of the cervical spine using an anterior approach. The GPS™ G Surgical Anterior Cervical Plate System implant components are made from titanium alloy described by ASTM F136 and supplied non sterile. Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the GPS ™, G Surgical Pedicle System implants.
The provided text describes the GPS™ G Surgical Anterior Cervical Plate System, an anterior cervical plate system intended for use in spinal fusion surgery. This submission is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than proving de novo safety and effectiveness through clinical trials.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal) | Reported Device Performance |
|---|---|
| Static Compression (ASTM F1717) | Adheres to ASTM F1717. The test results demonstrate the GPS™ G Surgical Anterior Cervical Plate System is safe and effective and adequate for the intended use. (Specific quantitative values are not provided in the summary). |
| Dynamic Compression (ASTM F1717) | Adheres to ASTM F1717. The test results demonstrate the GPS™ G Surgical Anterior Cervical Plate System is safe and effective and adequate for the intended use. (Specific quantitative values are not provided in the summary). |
| Static Torsion (ASTM F1717) | Adheres to ASTM F1717. The test results demonstrate the GPS™ G Surgical Anterior Cervical Plate System is safe and effective and adequate for the intended use. (Specific quantitative values are not provided in the summary). |
| Substantial Equivalence | Demonstrated through non-clinical testing comparing mechanical performance to predicate devices (K030866 Synthes CSLP, K000536 Synthes CSLP, K021461 Medtronic Atlantis Vision®). The results of non-clinical testing demonstrate that the mechanical performance of the GPS™ G Surgical Anterior Cervical Plate System is equivalent to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of devices tested. The document refers to "Performance testing... included static compression, dynamic compression and static torsion in accordance with ASTM F1717." ASTM F1717 specifies testing methodologies, including sample sizes (e.g., typically a minimum of 6 specimens per test condition for mechanical tests), but the exact number of units tested for this specific device is not disclosed in the summary.
- Data Provenance: The testing was "non clinical testing." The document does not specify the country of origin of the test data or the location where the testing was performed. It is retrospective in the sense that the testing was conducted on manufactured devices to assess their mechanical properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This device approval is based on non-clinical mechanical performance testing, not human interpretation of data where "ground truth" would be established by medical experts (e.g., radiologists). Therefore, this question is not applicable in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
- Not applicable. The "test set" here refers to the mechanical performance testing of the device itself, not to a set of medical images or patient cases requiring expert adjudication.
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
- No MRMC comparative effectiveness study was done. This 510(k) submission did not involve clinical testing or AI assistance. It focused on demonstrating substantial equivalence based on mechanical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No standalone algorithm performance study was done. This device is a surgical implant, not an AI or diagnostic algorithm.
7. The Type of Ground Truth Used
- For the mechanical performance testing, the "ground truth" is defined by the objective measurements obtained from standardized mechanical tests (static compression, dynamic compression, static torsion) as specified by ASTM F1717. The "truth" is whether the device's mechanical properties meet predefined acceptance criteria (implicitly, by being comparable to predicate devices and demonstrating safety and effectiveness for intended use) under these controlled testing conditions.
8. The Sample Size for the Training Set
- Not applicable. This device is a mechanical implant and does not involve machine learning or a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This device is a mechanical implant and does not involve machine learning or a training set.
§ 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.