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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), 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 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.

Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.

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

In addition, Synthes USS 6.0 mm 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. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.

The Synthes USS Connector is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are rod-to-rod connectors which can connect spinal rods of 5.5mm diameter. The rod-to-rod connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05).

This document describes the 510(k) summary for the Synthes USS Connector, a spinal fixation device. It details the device's intended use, indications for use, and performance data.

Here's an analysis of the provided information, framed as acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Study used to prove device meets acceptance criteria:

The study proving the device meets the acceptance criteria is described as non-clinical testing conducted according to ASTM F1717-10. This standard covers "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."

2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for the non-clinical testing (e.g., number of connectors tested). It only mentions "non-clinical testing."

Data Provenance: Not applicable, as this was non-clinical (mechanical) testing, not human-subject or clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurements, not by expert consensus.

4. Adjudication method for the test set
Not applicable. Adjudication methods are typically used for subjective assessments (e.g., image interpretation) or clinical outcomes, not for objective mechanical testing.

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 MRMC comparative effectiveness study was done. This document describes a spinal implant, not an AI-powered diagnostic or assistive device.

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, not an algorithm.

7. The type of ground truth used
The ground truth used for mechanical performance testing is the specifications and requirements outlined in ASTM F1717-10. The acceptance criterion for mechanical performance is that the device demonstrates mechanical characteristics (strength, fatigue resistance) that are "substantially equivalent" to predicate devices, as measured against the forces described in the ASTM standard.

8. The sample size for the training set
Not applicable. There is no concept of a "training set" for the mechanical testing of a physical medical device. This is not an AI/ML product.

9. How the ground truth for the training set was established
Not applicable, as there is no training set.

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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 3.5/6.0mm 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 5.5/6.0mm extension connectors, Matrix can be linked to the Synthes USS 6.0mm rod systems. 6.0/6.0mm extension connectors can be used to link all Synthes USS 6.0mm rod systems to one another.

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 6.0mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.

The Synthes USS Line Extension is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are in-line extension connectors which can connect spinal rods of the same or different diameters. The in-line extension connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05).

The document describes the K113149 510(k) submission for the Synthes USS Line Extension (connectors), which are non-cervical spinal fixation devices.

Here's an analysis of the provided text with respect to your questions:

1. Table of acceptance criteria and the reported device performance

Explanation: The acceptance criteria are implicitly met if the "non-clinical testing according to ASTM F1717-10 - static compression bending, static torsion, and dynamic compression bending - to determine that the Synthes USS Connector is substantially equivalent to the predicate devices identified" was successful. The document states that the testing was conducted "to determine" this, and the FDA's clearance implies the substantial equivalence was demonstrated.

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

The document does not explicitly state the specific sample sizes (number of devices tested) for the non-clinical tests. It refers to "non-clinical testing according to ASTM F1717-10". ASTM F1717-10 is a standard for testing spinal implant constructs, and it would specify the required number of samples for each test type. The data provenance is non-clinical, meaning it's from laboratory testing rather than human subjects. The country of origin for the data is not specified, but the firm (Synthes Spine) is located in West Chester, PA, USA.

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 this type of device and study. The "ground truth" for mechanical testing is based on the physical properties and performance measured against a standard (ASTM F1717-10), not on expert consensus or human interpretation.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies involving expert review of medical images or patient outcomes, not for mechanical bench testing.

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

This question is not applicable. MRMC studies are relevant for AI-powered diagnostic or interpretive devices that assist human readers (e.g., radiologists). This submission concerns a physical medical device (spinal connectors), not a diagnostic algorithm.

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

This question is not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

The ground truth used for these non-clinical tests is the performance metrics defined by the ASTM F1717-10 standard and the performance characteristics of the identified predicate devices. The new device's performance is compared against these established benchmarks to demonstrate substantial equivalence.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of mechanical bench testing for spinal implants. Training sets are relevant for machine learning or AI models.

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

This question is not applicable for the same reason as #8.

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