Search Results

The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic 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, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are 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. LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System can be linked to the LnK Spinal Fixation System via rod to rod connector and transitional rod.

The LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation Systems are top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of poly screw, Reduction poly screw, partially screw, semireduction partially screw, straight rod, curved rod, transitional rod, set screw, hooks and accessories that can be used via an open surgical approach.

The provided text is a 510(k) summary for the LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily for mechanical performance and material compatibility, rather than the performance of an AI/ML powered medical device that would have specific acceptance criteria for algorithm performance.

Therefore, the information required to answer your specific questions about acceptance criteria for an AI/ML powered device and the study that proves the device meets the acceptance criteria (e.g., sample size for test set, expert qualifications, MRMC studies, standalone performance, ground truth establishment) is not present in this document.

This document describes a medical device, which is a spinal fixation system, and its premarket notification to the FDA. The "acceptance criteria" here refers to the FDA's regulatory acceptance for substantial equivalence, not performance metrics of a diagnostic or AI-powered analytical tool. The "performance testing" mentioned (Section 7) is mechanical testing to ensure the device components meet engineering and material standards, not the evaluation of an algorithm's accuracy or clinical utility.

In summary, this document does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML powered device.

Ask a specific question about this device

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.

Ask a specific question about this device

The PathLoc-C Posterior Cervical Fixation System is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-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 PathLoc-C Posterior Cervical Fixation 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.

The PathLoc-C Posterior Cervical Fixation System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of polyscrews, straight rods, curved rods and set screw that can be used via an open surgical approach.

The provided text describes a medical device, the PathLoc-C Posterior Cervical Fixation System, and its 510(k) summary for FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices through mechanical testing. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or human-in-the-loop performance for AI/ML device evaluation.

Therefore, I cannot provide the requested information from the given text. The document is a regulatory submission for a physical medical implant, not an AI/ML diagnostic or prognostic device that would involve the kind of performance studies, expert consensus, and ground truth establishment described in your prompt.

Ask a specific question about this device