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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.

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