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510(k) Data Aggregation
(65 days)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5/6.0mm parallel connectors, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems.
When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mm tapered rods. Matrix can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System.
In addition, Synthes USS 6.0mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.
The Synthes CoCr and Cp Ti-3 Rods are an addition to Synthes' existing posterior thoracolumbar spine systems. These are 6.0mm diameter rods that will be used with Synthes Pangea polyaxial screws and locking caps.
The rods are comprised of commercially pure titanium grade 3 (Cp Ti-3) and Cobalt Chrome Molybdenum (Co-28CR-6Mo) ASTM F67 and ASTM F1537, the same as the predicate device.
The provided document describes the Synthes Pangea System, which includes CoCr and Cp Ti-3 Rods. The study conducted to prove the device meets acceptance criteria is a non-clinical performance test.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Results) |
|---|---|
| Static compression bend in accordance with ASTM F1717 - 04/09 | The conclusions drawn from testing demonstrate that the CoCr and Cp Ti-3 Rods are substantially equivalent to the predicate devices identified. (Specific numerical data or thresholds are not provided in this summary.) |
| Static torsion in accordance with ASTM F1717 - 04/09 | The conclusions drawn from testing demonstrate that the CoCr and Cp Ti-3 Rods are substantially equivalent to the predicate devices identified. (Specific numerical data or thresholds are not provided in this summary.) |
| Dynamic compression bend in accordance with ASTM F1717 - 04/09 | The conclusions drawn from testing demonstrate that the CoCr and Cp Ti-3 Rods are substantially equivalent to the predicate devices identified. (Specific numerical data or thresholds are not provided in this summary.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided summary. The document states "Synthes conducted the following non-clinical testing," but does not mention the number of rods or test articles used.
- Data Provenance: The study was a non-clinical (laboratory) test. Therefore, there is no patient data or geographical origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this submission. The "ground truth" for this device's acceptance was established through non-clinical mechanical testing based on ASTM standards, not through expert review of clinical cases.
4. Adjudication method for the test set
This information is not applicable to this submission as the "test set" involved mechanical laboratory testing, not human interpretation or adjudication of clinical data.
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
An MRMC comparative effectiveness study was not done. This device is a spinal implant system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for device performance was established through mechanical testing standards (ASTM F1717 - 04/09). The performance of the rods (static compression bend, static torsion, dynamic compression bend) was measured against the requirements of this standard to demonstrate substantial equivalence to predicate devices.
8. The sample size for the training set
This information is not applicable. This device is a physical medical implant and does not involve a "training set" in the context of machine learning or algorithms. The testing described is verification and validation testing for a manufactured product.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, there is no "training set" for this type of device.
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