Search Results

The ELLIPSE® Occipito-Cervico-Thoracic Spinal System is intended to be used in skeletally mature patients as an adjunct to fusion using autograft or allograft, for stabilization of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) for the following conditions: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, atlanto/axial fracture with instability, occipitocervical dislocation, revision of previous cervical spine surgery, and tumors.

The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine. Occipital bone screws are limited to occipital fixation; they are not intended for fixation of the posterior cervical spine.

The ELLIPSE® Occipito-Cervico-Thoracic Spinal System 3.5mm rods can also be linked to rod systems ranging in diameter from 3.2mm to 6.5mm, including the PROTEX® CT or PROTEX®, REVERE®, or BEACON® Stabilization Systems, using corresponding connectors.

The ELLIPSE® Occipito-Cervico-Thoracic Spinal System consists of 3.5mm jointed, straight and pre-bent rods, tapered rods, polyaxial screws, hooks, locking caps, t-connectors, lateral connectors, parallel connectors, in-line connectors, rodto-rod connectors, rod extension clamps and occipital plates. CAPITOL ™ screws and rods are also available as components of the ELLIPSE® system. The implants are composed of titanium alloy (per ASTM F136, F1472, or F1295), stainless steel (per ASTM F138) or cobalt chromium molybdenum allov (CoCr) (per ASTM F1537). Due to the risk of galvanic corrosion following implantation. titanium alloy or CoCr implants should not be connected to stainless steel implants.

The provided text describes a 510(k) submission for the ELLIPSE® Occipito-Cervico-Thoracic Spinal System, specifically for additional implants. This document details the device, its intended use, and the performance data that demonstrates its substantial equivalence to predicate devices, rather than a clinical study evaluating the device against specific acceptance criteria for a diagnostic or AI-driven system.

Therefore, many of the requested categories in your prompt are not applicable to this type of medical device submission (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size).

However, I can extract the information relevant to the performance data provided:

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: Not specified in the document. Mechanical testing typically uses predefined samples for each test type, but the exact numbers are not reported here.
• Data Provenance: Not applicable in the context of mechanical testing. The "data" are the results of physical tests conducted on the device components.

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

• This is not applicable as the "ground truth" for mechanical performance is established by standardized test methods and physical measurements, not by expert consensus on clinical data.

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

• Not applicable as this is not a diagnostic device relying on expert adjudication.

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 spinal implant system, not a diagnostic imaging or AI system intended to assist human readers.

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

• Not applicable. This is a physical medical device.

7. The type of ground truth used

• The "ground truth" for mechanical testing is defined by the objective physical measurements obtained from tests conducted according to recognized industry standards (ASTM F1717, ASTM F1798) and FDA guidance for spinal systems.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as Mechanical testing.

• Tests Conducted: Static and dynamic compression bending (in accordance with ASTM F1717), static torsion (in accordance with ASTM F1798), and axial gripping capacity (in accordance with the "Guidance for Industry and FDA Staff. Guidance for Spinal System 510(k)s," May 3, 2004).
• Conclusion: "Performance data demonstrate substantial equivalence to the predicate devices." The document states that the ELLIPSE® Additional Implants "are as safe, as effective, and perform as well as or better than the predicate devices."
• Predicate Devices: ELLIPSE® Occipito-Cervico-Thoracic Spinal System (K090565 & K110963), PROTEX® CT Cervicothoracic Spinal System (K050391 & K081906), REVERE® Stabilization System (K061202 & K122226), Blackstone™ Ascent® Posterior Occipital Cervico-Thoracic System (K080394).

Ask a specific question about this device

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput-T3), the Ascent POCT System is indicated for:
a) degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
b) spondylolisthesis;
c) fracture/dislocation;
d) spinal stenosis;
e) atlanto-axial fracture with instability:
f) occipito-cervical dislocation;
g) tumors;
h) revision of previous cervical spine surgery

The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (T1-T3) for the treatment of thoracic conditions only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (T1-T3). The hooks are intended to be placed from C1 to T3. The Songer Cable (titanium) System to be used with the Ascent Posterior Occipital Cervical Thoracic System allows for wire/cable attachment to the posterior cervical spine.

The Ascent Posterior Occipital Cervical Thoracic System can also be linked to the Orthofix Spinal Fixation System using the Ascent Axial or Parallel Rod Connector.

The Ascent® POCT System is a temporary, multiple component system comprised of a variety of non-sterile, single use components made of Titanium and Cobalt Chrome allov that allow the surgeon to build a spinal implant construct. The system design is intended to promote immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical and for upper thoracic spine. Ascent POCT System consists of an assortment of rods, setscrews, cross connectors, axial connectors, lateral offset adapters, multi-axial screws, hooks, plates, bone screws, and Songer Cables. Ascent POCT system can also be linked to Orthofix Spinal Fixation System (SFS) using the Ascent Axial or Parallel Rod Connector or Transition Rods.

The provided document is a 510(k) Premarket Notification for the Orthofix Ascent POCT System, a spinal fixation system. It describes the device, its intended use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. This type of regulatory submission typically focuses on mechanical and material testing for medical devices, rather than AI/ML algorithm performance studies. As such, the specific information requested about AI/ML acceptance criteria and studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable to this document.

However, I can extract information related to the performance data presented in the document, which pertains to the mechanical performance of the device components.

Acceptance Criteria and Device Performance (Mechanical)

The acceptance criteria for the Orthofix Ascent POCT System are based on demonstrating substantial equivalence to predicate devices through mechanical testing in accordance with ASTM F2706-08 standards.

Study Proving Device Meets Acceptance Criteria:

The study conducted was a series of non-clinical mechanical tests to evaluate the physical performance of the Orthofix Ascent POCT System components (specifically the new rods).

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

   • The document does not explicitly state the number of samples (e.g., number of rods tested) for each characteristic. It refers to "Test results," implying that multiple samples were likely tested as per ASTM F2706-08 standards.
   • Data Provenance: The tests were conducted internally by Orthofix Inc. or contracted to a testing facility. The document doesn't specify the country of origin data beyond the submitter's address in Lewisville, TX, USA. These are laboratory-based, prospective tests for this specific submission.

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

   • Not applicable. For mechanical tests of this nature, "ground truth" is established by the standardized testing protocols (ASTM F2706-08). Expertise would lie in the engineers or technicians performing and interpreting the mechanical tests according to the standard.

3. Adjudication method for the test set:

   • Not applicable. The "adjudication" in this context refers to whether the test results meet the predefined criteria of the ASTM standard and demonstrate substantial equivalence. This is typically a pass/fail determination based on quantitative measurements against thresholds defined by the standards or comparison with predicate device performance.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, this type of study is not applicable to the mechanical testing of a spinal fixation device. MRMC studies are typically used to evaluate the performance of diagnostic imaging or AI systems read by multiple human readers.

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

   • No, this is not applicable as the submission is not for an algorithm or AI system.

6. The type of ground truth used:

   • For mechanical testing, the "ground truth" is generally the physical properties and performance of the device components as measured by calibrated equipment and according to established engineering standards (ASTM F2706-08). The benchmark for acceptance is the performance of the predicate devices.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML study; therefore, there is no "training set."

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

   • Not applicable.

Ask a specific question about this device