(44 days)
These Systems are intended for the following:
Hooks, Plate/Rods, Plates, Rods and Screws
When intended to provide stabilization as an adjunct to fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix, Axon; OC Fusion and Synapse Systems are indicated for skeletally mature patients using allograft and/or autograft for the following:
- Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with . degeneration of the disc as confirmed by patient history and radiographic studies)
- . Spondylolisthesis
- Spinal stenosis .
- Fracture/dislocation .
- Atlantoaxial fracture with instability .
- Occipitocervical dislocation .
- Revision of previous cervical spine surgery .
- Tumor .
When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.
Hooks and Rods
The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws and Transverse Bars
The rods, clamps, screws, nuts, variable axis screws, locking screws and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (TI-T3).
The use of these screws (3.5 mm. 4.0 mm and 4.5 mm cancellous and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.
The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm paralle1 connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks; 4.2 mm screws, and the 5.0 mm/6.0 mm parallel connector.
Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.
The Synapse System is a hook and pedicle screw spinal system which is designed to provide spinal fixation to allow for stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Synapse System is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Axon System and Cervifix System also included in the indications for use statement are additional hook and pedicle screw spinal systems. These systems consist of anchors including bone screws, pedicle screws and hooks: interconnection mechanisms including locking screws, set screws, parallel rod connectors, clamps, transverse bars, rod collars and nuts; longitudinal members including rods and rod/plates; and transverse connectors including transconnectors. These system components are implanted using class I surgical instruments.
This document describes a 510(k) premarket notification for the Synapse System, specifically focusing on proposed curved rods. It is a submission intended to demonstrate substantial equivalence to previously cleared devices, rather than a study proving performance against acceptance criteria for a novel device.
Therefore, many of the requested categories for a study proving device performance are not applicable (N/A) in this context, as this submission primarily relies on a "rationale" comparing the new components to existing ones, rather than new performance testing.
Here's an analysis based on the provided text, addressing your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Conformance: Curved rods manufactured from Ti-6A1-7Nb (TAN), conforming to ASTM F-1295-11 and ISO 5832-11. | The proposed curved rods are manufactured from the same material, titanium aluminum niobium (Ti-6A1-7Nb (TAN)), as the previously cleared Synapse System curved rods. The material conforms to ASTM F-1295-11 and ISO 5832-11. |
| Technological Characteristics: Indications for use, intended use, and technological characteristics (design, material) of proposed curved rods are the same as, or similar to, predicate devices. | The indications for use, intended use and technological characteristics, such as design and material, of the proposed curved rods are the same as, or similar to, those of the predicate devices from the Synapse System, Sierra™ System and Altius™ OCT System. |
| Performance Testing: (Implied: No new performance testing required if substantial equivalence is based on existing data/rationale). | A rationale is provided in place of performance testing for the proposed curved rods. (This indicates that the "performance criteria" were met by demonstrating equivalence rather than actual new testing.) |
2. Sample size used for the test set and the data provenance
- Sample Size: N/A. No new test set involving patient data or specimens was described. The submission relies on a "rationale" for equivalence to predicate devices.
- Data Provenance: N/A. No new data from a test set (e.g., country of origin, retrospective/prospective) is presented. The "performance data" section explicitly states "A rationale is provided in place of performance testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. As no new test set data requiring ground truth establishment was presented, this is not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set requiring expert adjudication was described.
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
- N/A. This device is a spinal fixation orthosis (physical implant system), not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical implant, not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No new ground truth establishment was described, as the submission focused on comparing the new components to established predicate devices based on design, materials, and existing performance data (implied from the predicates).
8. The sample size for the training set
- N/A. No training set for an algorithm was involved; this is a physical medical device.
9. How the ground truth for the training set was established
- N/A. No training set or associated ground truth was established for this submission.
Summary of the Submission's Approach:
The K133698 submission for the Synapse System (specifically, proposed curved rods) is a substantial equivalence (SE) submission. This means the applicant demonstrated that the new device components (curved rods) are as safe and effective as a legally marketed predicate device.
Instead of conducting new performance studies, the manufacturer provided a "rationale" arguing that:
- The materials (Ti-6A1-7Nb (TAN)) are identical to those used in previously cleared components.
- The technological characteristics (design, intended use, indications for use) of the proposed curved rods are the same or similar to predicate devices (Synapse System, Sierra™ System, Altius™ OCT System).
This approach is common in 510(k) submissions where modifications to existing devices are minor and do not raise new questions of safety or effectiveness. The FDA's clearance (as indicated in the letter dated January 16, 2014) confirms their agreement that the device is substantially equivalent to predicates.
§ 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.