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The SPINEART® Navigation Instrument System reusable instruments are intended to be used during the preparation and placement of Spineart screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART® Navigation Instrument System reusable instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The SPINEART® Navigation Instrument System reusable instruments are surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants.

The SPINEART® Navigation Instrument System includes the following: Screwdrivers, Taps, Drills, and Drill Guides.

The SPINEART® Navigation Instrument System are to be used with the following Spineart Systems:

• ■Romeo® 2
  ▪Romeo® 2 MIS

▪Perla® Cervico-thoracic Fixation System

All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø4mm to Ø7.5mm for the Romeo® 2 systems and from Ø3mm to Ø4mm for the Perla system.

The SPINEART® Navigation Instruments are not compatible with implants from other manufacturers.

The SPINEART® Navigation Instrument System are designed for use only with Medtronic StealthStation Navigation System hardware and software.

The provided text describes the regulatory clearance for the "SPINEART® Navigation Instrument System" and includes information about its intended use, technological characteristics, and performance data. However, it does not describe a study to prove the device meets acceptance criteria in the format requested, particularly for an AI/algorithm-driven device with detailed metrics like sensitivity, specificity, or AUC based on expert reads.

The device described is a surgical navigation instrument system, which is a physical device used during surgery to assist in precisely locating anatomical structures. The performance data section refers to non-clinical testing such as connection, registration, simulated use, and accuracy testing, which are relevant to the physical instrument's functionality and compatibility, rather than the performance of an AI/algorithm in interpreting medical data.

Therefore, I cannot fulfill the request as framed, as the provided document details the clearance of a physical medical instrument, not an AI/algorithm, and the information required for AI acceptance criteria and study design (e.g., sample size for test/training sets, expert consensus for ground truth, MRMC studies) is not present.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Identical Technological Characteristics: Indications for use, materials, principle of operation, device technology, sizes, mechanical performance, packaging.
• Performance Data: Connection, registration, simulated use, and accuracy testing (per ASTM F2554-10) to ensure functionality and compatibility with the Medtronic StealthStation®.

To illustrate why I cannot answer the specific questions:

• 1. Table of acceptance criteria and reported performance: The document only mentions "accuracy testing per ASTM F2554-10" and states results "show that the performance...is sufficient for its intended use and is substantially equivalent." It doesn't provide specific numerical acceptance criteria (e.g., "accuracy > 95%") or reported performance values.
• 2. Sample sized for the test set and data provenance: Not applicable in the context of physical instrument testing. "Test set" here refers to the instruments themselves and their interaction, not a dataset for an AI.
• 3. Number of experts and qualifications: Not applicable. Ground truth for a physical instrument's accuracy is typically measured engineeringly, not through human expert interpretation of images.
• 4. Adjudication method: Not applicable.
• 5. MRMC comparative effectiveness study: Not applicable, as this is a physical instrument, not an AI assisting human readers.
• 6. Standalone (algorithm only) performance: Not applicable, as there is no standalone algorithm being evaluated in the document.
• 7. Type of ground truth: For a physical instrument, ground truth for accuracy testing would be engineering measurements against known standards, not expert consensus, pathology, or outcomes data in the sense of an diagnostic AI.
• 8. Sample size for the training set: Not applicable, as this is not an AI model.
• 9. How ground truth for training set was established: Not applicable.

In conclusion, the provided text describes the regulatory submission for a physical surgical instrument system, not an AI or algorithm. Therefore, the specific criteria and study design elements typically associated with AI/algorithm acceptance (e.g., sensitivity, specificity, expert consensus, MRMC studies) are not applicable and are not found in the document.

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The PERLA® posterior cervico-thoracic fixation system is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C 1 to C7) and the thoracic spine from Tl-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 PERLA® posterior cervico-thoracic fixation system is also intended to restore the integrity of the spinal column even in the 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 PERLA® posterior cervico-thoracic fixation system may be connected to the ROMEO® Posterior Osteosynthesis System with rod connectors. Transition rods may also be used to connect the PERLA® posterior cervico-thoracic fixation system to the ROMEO® Posterior Osteosynthesis System. Refer to the ROMEO® Posterior Osteosynthesis System package insert for a list of the ROMEO® Posterior Osteosynthesis System indications of use.

The Spineart Perla® system is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and the upper thoracic spine. Perla® system consists of a variety of shapes and sizes of rods, hooks, multi-axial screws, set screws, rod connectors and transverse connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The multi-axial screws are available with diameters 3.5mm and 4.0 mm with lengths ranging from 08 mm up to 52 mm. The purpose of this Special 510(k) application is to introduce an additional range of multi-axial screw with 4.5 mm diameter and lengths ranging from 08 mm up to 52 mm to the Perla® spinal system.

The provided document is a 510(k) summary for the SPINEART Perla® Posterior Cervico-Thoracic Fixation System. It describes a device modification, specifically the introduction of an additional range of multi-axial screws with a 4.5 mm diameter.

Here's an analysis of the acceptance criteria and study information, based solely on the provided text:

Key Takeaway: This 510(k) is for a modification to an existing device (Perla® Posterior Cervico-Thoracic Fixation System, cleared under K153386). The modification is the introduction of a new screw diameter (4.5mm). The submission leverages previous testing and an engineering analysis to demonstrate substantial equivalence, rather than conducting new performance studies for the specific modification. As such, the information you requested regarding acceptance criteria and performance data for a new study is largely not present for this specific submission because it was deemed unnecessary due to the nature of the modification.

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

Based on the provided document, there are no specific numeric acceptance criteria for device performance reported for this specific 510(k) submission (K190071). Instead, the submission relies on the existing performance data and acceptance for the predicate device (Perla® Posterior Cervico-Thoracic Fixation System, K153386).

The document states: "An engineering analysis was performed and determined the new 4.5 mm multi-axial screws do not constitute a new worst-case design in the Perla spinal system. No additional testing has been performed for the Perla® 4.5 mm multi-axial screws."

It then lists non-clinical tests that were conducted on the predicate devices:

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

As no new performance testing was conducted for the 4.5 mm multi-axial screws due to the engineering analysis, there is no "test set" and thus no sample size or data provenance specified for this particular modification. The previous testing for the predicate device would have had its own sample sizes, but those are not detailed here.

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

Not applicable, as no new clinical or performance test set (requiring expert ground truth) was performed for this specific 510(k) submission.

4. Adjudication method for the test set

Not applicable, as no new clinical or performance test set (requiring adjudication) was performed for this specific 510(k) submission.

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 device is a mechanical implant (spinal fixation system), not an AI-driven diagnostic or assistive device that would involve human readers.

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

Not applicable. This device is a mechanical implant.

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

Not applicable, as no new performance studies requiring ground truth were conducted for this submission. The "ground truth" for mechanical testing is the physical measurement against the standard.

8. The sample size for the training set

Not applicable, as no AI/algorithm is involved, and no new training set was mentioned for mechanical testing.

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

Not applicable, as no AI/algorithm is involved, and no new training set or corresponding ground truth establishment was discussed.

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