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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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The Quantum Spinal System components are non-cervical spinal fixation devices intended for use as a pedicle screw system (T1 - S2), a posterior hook and sacral/iliac screw fixation system or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated 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), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

Not Found

This document describes the Quantum Spinal System, a medical device, and its regulatory clearance through the 510(k) pathway. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way that an AI/ML device submission would.

The provided text describes a traditional medical device (spinal fixation system) and its substantial equivalence to predicate devices, rather than an AI/ML device with performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested fields are not applicable to the information contained in the provided document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in a quantifiable way typical for AI/ML device performance. The document states:

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

• Not applicable / Not provided. This document describes a spinal implant, not a data-driven device that requires a "test set" in the AI/ML sense. The performance data refers to mechanical and material testing, not clinical data sets.

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

• Not applicable / Not provided. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts on a dataset. This information is not relevant to the clearance of a spinal implant.

4. Adjudication method for the test set:

• Not applicable / Not provided. Adjudication methods are used in AI/ML studies to resolve disagreements among experts in labeling data. This is not pertinent to the current device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable / Not provided. This device is a surgical implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not applicable / Not provided. There is no algorithm for this device.

7. The type of ground truth used:

• Not applicable / Not provided. The "ground truth" for a spinal implant's safety and effectiveness is established through engineering testing (e.g., biomechanical strength, material compatibility), pre-clinical studies, and clinical experience with similar predicate devices, rather than a "ground truth" for data labeling. The regulatory decision is based on substantial equivalence to predicate devices which have an established safety and effectiveness profile.

8. The sample size for the training set:

• Not applicable / Not provided. This device does not involve machine learning; therefore, there is no "training set."

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

• Not applicable / Not provided. As there is no training set for an AI/ML model, this question is not relevant.

In summary: The provided document is a 510(k) summary for a traditional medical device (spinal fixation system). The regulatory review for such devices focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through engineering performance data (e.g., mechanical testing conforming to ASTM standards), material safety, and similarity in design and intended use. The concepts of "acceptance criteria" and "study proving device meets acceptance criteria" for AI/ML devices, involving test sets, ground truth, experts, and reader studies, are not applicable to this type of traditional device clearance.

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