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When intended to promote fusion of the occipitocervical spine, the cervical spine, and the upper-thoracic spine (Occiput-T3), the PASS OCT Spinal System is intended for:

• Degenerative Disc Disease (DDD): neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.
• Spondylolisthesis
• Spinal Stenosis
• Trauma (i.e. Fracture or Dislocation)
• Atlanto/axial fracture with instability
• Revision of previous cervical spine surgery
• Tumors
  Occipital Plates / Occipital Bone Screws / Hooks:
  The occipital plates, occipital bone screws, and hooks are intended to provide stabilization and to promote fusion in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, the occipital bone screws are limited to occipital fixation only.
  The use of the occipital plate requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.
  Hooks and rods:
  The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
  Polyaxial screws/Connectors:
  The use of the polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) for anchoring the OCT construct, and are not intended to treat thoracic conditions. The polyaxial screws are not intended to be placed in the cervical spine.
  The PASS OCT Spinal System can also be linked to the PASS LP® Spinal System using the dual diameter rod.

The PASS OCT Spinal System is a posterior system, which consists of a variety of shapes and sizes of rods, hooks, polyaxial screws, occipital plates, occipital bone screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations. See package insert of the system for labeling limitations.
The implants are manufactured from titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications and in PEEK OPTIMA LT1 conforming to ASTM E2026 specifications.

The PASS OCT Spinal System is a spinal fixation device. No AI/ML components are mentioned in the provided text. The device's substantial equivalence to predicate devices was determined through non-clinical testing.

Here's the information based on the provided text, focusing on the mechanical performance of the device rather than AI/ML related criteria:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance: The document does not specify a "test set" in the context of AI/ML. The performance data presented is for non-clinical (mechanical) tests. The sample sizes for these mechanical tests are not explicitly stated. Data provenance is not applicable in the context of device mechanical testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this device's performance is established by mechanical testing standards, not expert clinical interpretation.
3. Adjudication method for the test set: Not applicable. Mechanical testing is typically evaluated against defined scientific standards and acceptable ranges, not human adjudication.
4. 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 device is a physical spinal fixation system, not an AI/ML diagnostic or assistive tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical spinal fixation system and does not contain an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is established by mechanical testing standards (e.g., ASTM F2706-08) and FDA guidance for spinal systems, which define acceptable physical properties and performance under various loading conditions.
7. The sample size for the training set: Not applicable. This device is a physical spinal fixation system; there is no training set as would be used for an AI/ML algorithm.
8. How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.

Conclusion from non-clinical data: MEDICREA® INTERNATIONAL PASS OCT Spinal system is substantially equivalent to several predicate devices (SUMMIT System, Mountaineer OCT Spinal System, Vertex Reconstruction System, and PASS 2 Spinal System) in terms of intended use, materials, design, mechanical safety, and performance. The device is considered safe and effective.

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The PASS LP Spinal Systems include a pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine:

• Fractures
• Dislocation
• Failed previous fusion (Pseudoarthrosis)
• Spinal stenosis
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Spinal deformations such as scoliosis or kyphosis.
• Loss of stability due to tumors.

The PASS LP Spinal Systems are also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The PASS LP also include hooks and rods and sacralitiiac screws indicated for degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal deformities or curvatures (i.e., scollosis, kyphosis, and/or lordosis), turnor, stenosis. pseudoarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allografi and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, illac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-SAI-4V ELI) that conforms to ASTM F136 or cobalt-chromiummolybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. Similarly to the PASS LP implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case.

Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy

Function: The PASS LP was developed as an implant:

• To provide immobilzation and stabilization of posterior spinal segments
• to augment the development of a solid spinal fusion
• to provide stability to ease fusion
• to be mechanically resistant to allow the fusion of the operated level

The provided text describes a 510(k) summary for the MEDICREA® INTERNATIONAL PASS LP Spinal System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of features, rather than a study proving the device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested elements regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to the non-clinical tests performed to demonstrate mechanical equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The "test set" in this context refers to mechanical testing of components, not a clinical data set. The document states "mechanical testing... was conducted following the ASTM F1717" and "additional components... tested following the ASTM F1798". No specific sample size (number of constructs tested) is provided in the summary.
• Data Provenance: Not applicable in the context of clinical data. The mechanical tests were performed on the device components.

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

• Number of Experts: Not applicable. Ground truth, in the clinical sense, is not established for mechanical testing.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable for 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

• MRMC Study: No. The document explicitly states: "No clinical studies were performed." This is a regulatory submission for a medical device implant, not an AI diagnostic device.

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

• Standalone Performance: No. This device is a spinal implant, not an algorithm.

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

• Type of Ground Truth: For the mechanical performance, the "ground truth" is adherence to established ASTM standards (ASTM F1717 and ASTM F1798) and comparison to the mechanical performance of previously cleared devices. This is a technical/engineering "ground truth," not a clinical one.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no AI component or machine learning model described as part of this device or its evaluation.

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

• Ground Truth for Training Set Establishment: Not applicable. There is no AI component or machine learning model described.

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