Search Results

The ENNOVATE Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities.

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation)
4. Spinal Stenosis.
5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor.
7. Pseudoarthrosis, and
8. Failed previous fusion

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This system includes polyaxial screws of varying diameters and lengths, rod-to-rod and cross connectors of various styles and lengths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ISO 5832-3.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's polyaxial screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature.

This document describes a spinal system, not a device that would typically have acceptance criteria and performance metrics in the way an AI/ML or diagnostic device would. This is a 510(k) premarket notification for a medical device called the "ENNOVATE Spinal System," which is a metallic implant system for spinal fusion.

The document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing novelty or specific performance criteria like sensitivity, specificity, or accuracy for a diagnostic tool.

Therefore, many of the requested categories are not applicable to this type of device and regulatory submission. I will explain why each category is not applicable and what information is provided in the document.

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

• Not Applicable. For a spinal implant system like the ENNOVATE Spinal System, "acceptance criteria" are typically related to mechanical and material performance standards, not diagnostic accuracy or clinical outcomes in the same way as an AI/ML device. The "performance" reported is compliance with these standards through mechanical testing.

Note: The document states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the guidance 'Spinal System 510(k)s May 3, 2004' was completed where applicable." This indicates that the device met the performance requirements outlined in these guidance documents, primarily through mechanical testing to demonstrate substantial equivalence.

The following sections are NOT APPLICABLE because this document describes a physical spinal implant system, not a diagnostic AI/ML device requiring clinical performance evaluation with ground truth.

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

• Not Applicable. This is a mechanical device, not an AI/ML diagnostic. No 'test set' of clinical data for diagnostic performance is described. The 'test set' here refers to physical devices tested in a lab.

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. Ground truth, in the context of expert review, is for diagnostic devices or AI, not for mechanical spinal implants.

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

• Not Applicable. Adjudication methods are relevant for clinical endpoints or diagnostic interpretations, not for mechanical testing of an implant.

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 specific to AI/ML diagnostic tools, not an orthopedic implant.

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

• Not Applicable. This is specific to AI/ML diagnostic tools.

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

• Not Applicable. Ground truth refers to the definitive determination of a condition for diagnostic purposes. For a spinal implant, the "truth" is whether it meets engineering specifications and functions mechanically as intended.

8. The sample size for the training set

• Not Applicable. This is for AI/ML models. No training set is involved for this mechanical device.

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

• Not Applicable. As above, no training set or ground truth in this context.

Ask a specific question about this device

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 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/5.5 mm tapered rods, 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 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.

This is an addition to Synthes' existing non-cervical spinal fixation devices intended for 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). The current system is comprised of monoaxial and polyaxial screws, rods, locking caps, transverse bars and connectors. The additional locking cap in this submission is manufactured of cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08).

The provided text describes a 510(k) Summary for a medical device called the "Synthes Matrix System," which is an addition to an existing line of non-cervical spinal fixation devices. The document explicitly states that clinical data and conclusions were NOT needed for this device. This means that the information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets is not available in this document because a clinical study was not performed or deemed necessary for this 510(k) submission.

The acceptance criteria and proof of meeting them are based on non-clinical performance data (bench testing), which demonstrated equivalence or superiority to predicate devices.

Here's a breakdown of the available information:

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

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

• Sample Size for Test Set: Not specified. (Refers to mechanical testing specimens, not human subjects or a data set for an AI model).
• Data Provenance: Not applicable in the context of human data. The data comes from bench testing of the device components.

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

• Experts: Not applicable. Ground truth for mechanical testing is established by engineering specifications and direct measurement, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. This is mechanical bench testing, not a clinical study requiring adjudication of diagnostic outcomes.

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

• MRMC Study: No. This device is a spinal implant, not an AI or diagnostic imaging device. No human reader studies were performed or relevant.

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

• Standalone Performance: Not applicable. This is a physical medical device (spinal implant), not an algorithm or AI.

7. The type of ground truth used

• Ground Truth: For mechanical testing, the ground truth is based on the physical properties and performance characteristics defined by engineering standards (e.g., ASTM F1717-11a) and compared against the performance of legally marketed predicate devices.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. There is no AI model or learning algorithm mentioned or relevant to this device.

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

• Ground Truth for Training Set: Not applicable. There is no AI model or learning algorithm mentioned or relevant to this device.

In summary, this 510(k) submission relied on non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices, and explicitly stated that clinical data was not required. Therefore, all questions pertaining to clinical study design, human data, expert review, and AI model specifics are not addressed by the provided document.

Ask a specific question about this device