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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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When intended to promote fusion of the cervical spine and the thoracic spine (C1 - T3), the S4 Spinal System is intended for the following;

• DDD (Neck pain pf discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spinal stenosis
• Fracture/dislocation
• Failed previous fusion
• Tumors

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.

The use of the polyaxial screws is limited to placement in T1 - T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

The S4 Spinal System consists of 3.5mm rods in 6 lengths, thin and thick lamina hooks, 3.5 The 64 Opinal System of various lengths and a cross connector. The S4 Spinal System is manufactured from Titanium forged alloy Ti6Al4V.

The S4 Spinal System is a medical device for spinal fusion. The 510(k) summary provided does not contain explicit acceptance criteria or the details of a study proving the device meets said criteria in the format requested. Instead, it indicates that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices - The Basic Elements' was completed where applicable."

Therefore, I cannot provide a direct answer to your request in the specified format from the provided text excerpt. The document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a detailed performance study with acceptance criteria.

However, I can extract information related to what aspects were considered for the 510(k) clearance, which implicitly implies that the device is expected to meet the performance standards set by the predicate devices.

Here's an analysis based on the provided text:

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

This information is not explicitly provided in the given text. The document states that "All required testing per [guidance document] was completed where applicable." This implies that standard tests relevant to orthopedic devices were performed, but the specific acceptance criteria for each test and the numerical performance results are not detailed.

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

This information is not provided in the given text. The document refers to "testing" but does not specify the sample sizes or the nature of the data (e.g., in vitro, in vivo, clinical trial, retrospective, prospective, country of origin).

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

This information is not provided in the given text. Since the document does not describe a clinical study with a "test set" requiring ground truth established by experts, this detail is absent.

4. Adjudication method for the test set:

This information is not provided in the given text. As there is no described clinical study, an adjudication method for a test set is not mentioned.

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 information is not provided in the given text. The S4 Spinal System is a mechanical implant, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant to this device and is not mentioned.

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

This information is not provided in the given text. As the device is a spinal implant, the concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.

7. The type of ground truth used:

This information is not explicitly provided in the given text. Given that the clearance is based on substantial equivalence to predicate devices and adherence to general guidance for orthopedic devices, the "ground truth" would likely be derived from established biomechanical testing standards, material property tests, and the clinical history and performance of the predicate devices.

8. The sample size for the training set:

This information is not provided in the given text. The concept of a "training set" is typically associated with machine learning or AI algorithm development, which is not applicable to this device as described.

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

This information is not provided in the given text, for the same reason as point 8.

Summary of available information regarding performance:

• Performance Data: "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." This indicates that the device underwent mechanical and material testing to demonstrate its safety and effectiveness, consistent with regulatory requirements for similar orthopedic implants.
• Substantial Equivalence: The S4 Spinal System is deemed substantially equivalent in design to the following predicate devices:
  • Nex-Link Spinal System (K031985)
  • Vertex Spinal System (K042789, 042524)
  • Summit Spinal System (K013222, K030103, K041203)

This means that the S4 Spinal System's performance characteristics are considered comparable to these cleared devices, implying that it meets similar performance expectations and safety profiles. The specific "acceptance criteria" for the S4 Spinal System would therefore align with those established for its predicate devices and the relevant FDA guidance.

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