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The BRIDALVEIL Occipital Cervical Thoracic System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine from TI-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions ( e.g., pseudarthrosis ); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The BRIDALVEIL Occipital Cervical Thoracic System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the BRIDALVEIL Occipital Thoracic System may be connected to the OLYMPIC Posterior Spinal Fixation System rods and connectors. Transition rods with differing diameters may also be used to connect the BRIDALVEIL Occipital Cervical Thoracic System to the OLYMPIC Posterior Spinal Fixation System. Refer to the OLYMPIC Posterior Spinal Fixation System package insert for instructions for use and indications for use.

The BRIDALVEIL Occipital Cervical Thoracic System is a spinal fixation system intended to stabilize the uppermost portion of the spine during the fusion process. The system contains a wide variety of implants and instruments which allows for the transition across multiple spinal segments: Occipital Plate with Screws, Cervical Polyaxial Screws, Laminar Hooks, Cross Connectors, Rod Connectors, and Rods manufactured from Ti6Al4V ELI (ASTM F136) and cobalt chrome alloy (ASTM F1537).

The provided text describes the regulatory clearance for the BRIDALVEIL Occipital Cervical Thoracic System, a spinal fixation system. It does not detail acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML device.

This document is a 510(k) premarket notification for a traditional medical device (spinal fixation system), not an AI/ML device. Therefore, the details requested in the prompt, such as reported device performance, sample size for test sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for the training set, are not applicable in the context of this submission.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Intended Use: Providing immobilization and stabilization of spinal segments as an adjunct to fusion for various conditions (traumatic fractures/dislocations, instability, tumors, degenerative disease, etc.) in the craniocervical junction, cervical spine (C1-C7), and thoracic spine (T1-T3). It also mentions restoring spinal column integrity for a limited time in advanced stage tumor patients.
• Design: The system includes occipital plates with screws, cervical polyaxial screws, laminar hooks, cross connectors, rod connectors, and rods.
• Materials: Ti6Al4V ELI (ASTM F136), cobalt chrome alloy (ASTM F1537), Elgiloy CoCrNi alloy (ASTM F1058), and Nitinol #1 (ASTM E2063).
• Mechanical Safety and Performance: Evaluated through non-clinical bench testing.

Here's the information extracted from the document, framed in the context of a traditional medical device submission, rather than an AI/ML one:

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

For this traditional medical device (BRIDALVEIL Occipital Cervical Thoracic System), "acceptance criteria" revolve around demonstrating substantial equivalence to predicate devices through conformity to recognized standards for mechanical performance and material properties. "Reported device performance" is derived from the results of these non-clinical tests meeting the requirements of those standards.

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

• Sample Size for Test Set: Not applicable in the context of human data. The "test set" here refers to physical specimens of the device components tested in a laboratory setting. No human patients or retrospective/prospective data were used for performance evaluation.
• Data Provenance: The data provenance is from non-clinical bench testing conducted in a laboratory. The specific country of origin of the lab is not stated in the provided text.

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 this context refers to the defined parameters and performance standards derived from the ASTM standards for mechanical testing. These standards are established by expert committees in engineering and materials science, but individual experts are not "adjudicating" a test set as they would for clinical images or diagnoses.

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

• Not applicable. There's no human adjudication process described for the mechanical test results; rather, the results are compared against predefined criteria within the ASTM standards.

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 not an AI/ML device, and no MRMC studies or human reader performance evaluations were conducted.

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

• Not applicable. This is not an AI/ML device. The "standalone performance" is the mechanical testing of the device itself against engineering standards.

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

• For this device, the "ground truth" (or reference for evaluation) is established through recognized industry standards for mechanical testing of spinal implants (e.g., ASTM F1717, ASTM F2706, ASTM F1798). The device's performance is compared against the requirements and typical performance of predicate devices as measured under these standardized conditions.

8. The sample size for the training set

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

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

• Not applicable. This is not an AI/ML device.

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The GSO PCT Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. It is intended to be used as a temporary construct that assists normal healing and is not intended to replace normal body structures. The GSO PCT Spinal System should be removed after fusion.

The GSO PCT Spinal System is intended to promote fusion of the cervical spine and cervico-thoracic junction (C1-T3), and is indicated for the following:

1. Degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
2. Spondylolisthesis
3. Spinal stenosis
4. Fracture or dislocation
5. Revision of previous cervical or cervico-throracic spine surgery
6. Tumors

The use of multi-axial pedicle screws is limited to placement in the upper thoracic spine (T1-T3) for the purpose of anchoring the construct. The multi-axial pedicle screws are not intended to be placed in the cervical spine.

The GSO PCT Spinal System consists of rods, screws, hooks, and connecting components that can be locked rigidly into various configurations to build a spinal construct specific to the needs of each individual patient. The implants are attached to the spine posteriorly by means of screws and/or hooks joined with rods. Cross connector components are used to attach two rods in parallel. The GSO PCT Spinal System can be installed with any suitable instrumentation.

The GSO PCT Spinal System components are manufactured from CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136. Devices are available in various diameters, lengths and sizes.

This appears to be a 510(k) premarket notification document for a spinal implant system, not an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device performance and testing (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

However, I can extract information related to the acceptance criteria and the study performed to demonstrate "device meets acceptance criteria" in the context of a traditional medical device (spinal implant).

Acceptance Criteria and Reported Device Performance for GSO PCT Spinal System

Study Details (Non-AI/ML Medical Device)

• Sample sized used for the test set and the data provenance: Not applicable. For this type of device, mechanical testing is done on device samples, not patient data sets.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert clinician consensus.
• Adjudication method for the test set: Not applicable.
• 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 not an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.
• The type of ground truth used:
  • For mechanical strength: Engineering standards (ASTM F1717) and physical measurements.
  • For substantial equivalence: Comparison against legally marketed predicate devices based on indications, design, and materials.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary of the Study:

The primary study conducted for the GSO PCT Spinal System was non-clinical mechanical testing.

• Study Type: Mechanical performance testing.
• Methodology: The testing was conducted according to ASTM F1717. ASTM F1717, "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model," typically evaluates the static and fatigue strength of spinal implant constructs under various loading conditions (e.g., compression, torsion, bending) to ensure they can withstand the anticipated physiological stresses without failure.
• Results: The mechanical testing demonstrated that the GSO PCT Spinal System possesses "sufficient strength for its intended use."

Additionally, the submission relies on demonstrating substantial equivalence to existing legally marketed devices (Mountaineer OCT Spinal System, Altius OCT System, and OASYS System). This comparison serves as a form of "study" to support the safety and effectiveness by showing similarity in:

• Indications for Use
• Design
• Materials of construction (CP Titanium conforming to ASTM F67 and Ti-6A1-4V Titanium alloy conforming to ASTM F136).

Clinical Testing: The document explicitly states: "Clinical testing was not necessary to demonstrate the substantial equivalence of the GSO PCT Spinal System to the predicate devices." This is common for 510(k) submissions where substantial equivalence can be established through non-clinical data and direct comparison to predicates.

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