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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 3.5/6.0 mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm Systems. 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. When used with the 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems.

When used with the 3.5/6.0 mm and 4.0/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5/5.5 mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be lined to the Matrix System.

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors.

Synthes USS

• 6.0 mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
• 5.5 mm Rod System: Matrix
• 5.0 mm Rod System: USS Small Stature

CerviFix

• 3.5 mm Rod Systems: CerviFix, Axon, Synapse
• 4.0 mm Rod System: Synapse

The Synthes Matrix System is an addition to Synthes' existing posterior thoracolumbar spine systems. The Matrix System consists of a family of non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2), posterior hook fixation (T1-L5) or anterolateral fixation (T8-L5). The implants include pedicle bone screws, polyaxial pedicle screws, monoaxial pedicle screws, polyaxial heads, reduction screws, reduction heads, locking caps, transconnectors, transverse bars, rods and hooks. The implants are primarily manufactured from titanium (ASTM F67 - 06), titanium alloy (ASTM F1295 - 05), cobalt-chromium-molybdenum alloy (ASTM F1537 - 08) or nitinol (ASTM F2063 - 05), similar to the predicates.

The subject of this submission is the addition of transverse bars and tapered rods.

The document describes the Synthes Matrix System, a spinal fixation device. The study provided focuses on non-clinical performance testing rather than clinical trials with human subjects or AI performance.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Synthes conducted the following non-clinical testing..." but does not detail the number of units tested for each type of test.
• Data Provenance: The testing was non-clinical, conducted by Synthes. It does not involve human subjects, so concepts like country of origin or retrospective/prospective don't apply in the medical imaging sense.

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

• This question is not applicable to the provided document. The study is a non-clinical, mechanical performance test, not a study evaluating human judgment or diagnostic accuracy. The "ground truth" here is compliance with ASTM standards, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set

• Not applicable. As noted above, this is a mechanical performance test, not a study involving human readers or adjudicators of medical 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

• No. This is a non-clinical performance study of a spinal fixation device, not a study involving AI or human readers of medical images.

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

• No. This is a non-clinical performance study of a spinal fixation device, not an algorithm.

7. The type of ground truth used

• The "ground truth" implicitly used for this non-clinical testing is the mechanical performance requirements specified in ASTM F1717–09 standards for static compression bend, static torsion, and dynamic compression bend testing. The device's performance was compared against these established industry standards and against predicate devices.

8. The sample size for the training set

• Not applicable. This is a non-clinical performance study of a physical device, not an AI algorithm that requires a training set.

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

• Not applicable for the same reason as point 8.

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When used as a posterior pedicle screw fixation system, the Synthes Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-pedicle screw fixation system, the Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System is also intended for scoliotic, or kyphotic deformities (such as scoliosis, Schevermann's disease); degenerative disk disease (back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), and fractures of the posterior thoracolumbar spine (levels 74-S2). In addition, when using the parallel rod connector, the USS can be connected to the Posterior Cervical/Thoracic Hook/Rod System.

The overall levels of fixation are T4-S2.

The Synthes Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System currently consists of rods, hooks, clamps and screws. These components were previously cleared in K951626, K951794, K962608, K963045, K963357, and K964416. This 510(k) submission is extending the region of the posterior spine in which the USS hook and rods may be used (i.e., from T8-S2 to T4-S2). In addition to these components Synthes is adding a new parallel rod connector. The connector is intended to allow a rod (3.5mm) to rod (6mm) connection with the Posterior Cervical/Thoracic Hook/Rod System.

The provided text describes a medical device, the SYNTHES Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System, and its regulatory clearance. However, it does not contain information typically found in a study proving a device meets acceptance criteria, particularly for an AI/ML-driven device.

The document is a 510(k) summary and an FDA clearance letter for a spinal fixation system, focusing on substantial equivalence to previously cleared devices rather than a performance study with specific acceptance criteria as you've outlined.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance studies, which are not detailed here for this type of medical device clearance.

Here's a breakdown of what can be inferred or determined from the text, and what cannot:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for this document. This document describes mechanical testing for physical characteristics of a medical implant, not a clinical study involving a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No expert review of a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set requiring expert adjudication is 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

• Not applicable. This device is a physical spinal implant, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This device is a physical spinal implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the mechanical testing, the "ground truth" would be the standards set by ASTM F1717 for static and fatigue performance, against which the device's physical performance was measured.
• For the substantial equivalence determination, the "ground truth" is the performance and safety profiles of the predicate devices (Liberty Posterior Spinal System K964254 and Titanium Spinal Rod System K970635).

8. The sample size for the training set

• Not applicable. This document does not describe a machine learning training set.

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

• Not applicable. This document does not describe a machine learning training set or its ground truth establishment.

In summary: The provided text is a regulatory submission for a physical medical device. It demonstrates compliance through mechanical testing against industry standards (ASTM F1717) and substantiates equivalence to previously cleared predicate devices. It does not involve clinical performance studies with patient data, human reader evaluations, or AI/ML components as implied by the structure of your questions.

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