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The Synthes USS (including Matrix, USS Side-Opening, USS Dual-Opening, USS Small Stature (which includes small stature and pediatric patients), USS VAS variable axis components, USS Fracture, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Polyaxial, USS liiosacral, and ClampFix) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), a posterior hook fixation system (T1-L5), or as an anterolateral fixation system (T8-L5). Pedicle scew fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated as an adjunct to fusion 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), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, 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 3.5/6.0-mm parallel connectors, the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, and ClampFix), can be linked to the CerviFix 3.5 mm Systems (including CerviFix, Axon, and Synapse). In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems (including CerviFix, Axon, and Synapse). When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Polyaxial, USS Hibsacral, and ClampFix).

In addition, Synthes USS (including USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Fracture, Polyaxial, USS Iliosacral, and ClampFix) can be interchanged with all USS 6.0 mm ods and transconnectors.

Device Description

The Synthes Matrix MIS Rods are spinal rods to be used as part of the Synthes Matrix System of posterior pedicle screw fixation implants. The titanium rods are available straight or curved in two bend radii and a range of lengths. The Synthes Matrix MIS rods are to be implanted via a minimally invasive approach.

The Synthes Matrix MIS Rods are intended to be used with the Synthes Matrix System Implants. The Synthes Matrix Implants consist of a family of non-cervical spinal fixation devices intended for use as a posterior pedicle screw fixation system (T1-S2), posterior hook fixation system (T1-L5) or anterolateral fixation system (T8-L5).

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Synthes Matrix MIS Rods," a spinal rod system. It is important to note that this document is for a physical medical device, not an AI/ML-driven device or software. Therefore, the questions related to AI/ML performance metrics, ground truth, experts, and training sets are not applicable to this submission.

The acceptance criteria and supporting study are described in terms of non-clinical performance to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate devices in design	The Synthes Matrix MIS Rods are modifications to the design of predicate devices but are substantially equivalent in design.
Substantial equivalence to predicate devices in function	The Synthes Matrix MIS Rods are modifications to the surgical technique of predicate devices but are substantially equivalent in function.
Substantial equivalence to predicate devices in material	The Synthes Matrix MIS Rods utilize materials that are substantially equivalent to those of predicate devices (titanium rods mentioned, which is common for spinal implants).
Substantial equivalence to predicate devices in intended use	The Synthes Matrix MIS Rods have an intended use that is substantially equivalent to predicate devices. The document details indications for use such as posterior pedicle screw fixation, posterior hook fixation, and anterolateral fixation for various spinal conditions.
Non-Clinical Performance demonstrating substantial equivalence	"The information provided demonstrates that the Synthes Matrix MIS Rods are substantially equivalent to the predicate devices." (Exact tests are not detailed in this summary, but would typically include mechanical testing, biocompatibility, and sterilization validations for physical implants).
Clinical performance (Not required for this device)	"Clinical data and conclusions were not needed for this device."

2. Sample sized used for the test set and the data provenance

Not Applicable: This is a physical medical device. The "test set" would refer to non-clinical performance testing of the device hardware. The document states "The information provided demonstrates that the Synthes Matrix MIS Rods are substantially equivalent to the predicate devices," implying successful completion of required non-clinical tests, but it does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for these engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: As a physical medical device, there is no "ground truth" established by experts in the context of an AI/ML system's diagnostic or predictive performance. Substantial equivalence for this type of device is determined by comparing its technical characteristics and performance to legally marketed predicate devices, typically through engineering and biocompatibility testing, not expert consensus on data interpretation.

4. Adjudication method for the test set

Not Applicable: There is no adjudication method for a "test set" in the context of an AI/ML system. The assessment for this physical device relies on engineering tests and regulatory review against predicate devices.

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 physical spinal rod system, not an AI-assisted diagnostic or treatment device. Therefore, MRMC studies and "human readers improving with AI" are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This is a physical medical device, not an algorithm or software.

7. The type of ground truth used

Not Applicable: For this physical device, "ground truth" in the AI/ML sense (e.g., pathology, outcomes data) is not used. The "truth" for this device's acceptance is its demonstrated substantial equivalence to predicate devices through non-clinical performance data (e.g., mechanical strength, biocompatibility).

8. The sample size for the training set

Not Applicable: This is a physical medical device; there is no training set as would be used for an AI/ML model.

9. How the ground truth for the training set was established

Not Applicable: There is no training set or associated ground truth for this physical medical device.

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