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RESPONSE™ Navigation Instruments are intended to be used during the preparation and placement of Response 4.5/5.0 and 5.5/6.0 Spine System pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic® StealthStation® S8 System (V1.2.0), 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The OrthoPediatrics RESPONSE™ Navigation Instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System to assist surgeons in precisely locating anatomical structures in open procedures for preparation and placement of pedicle screw system implants.

The RESPONSE™ Navigation Instruments include taps, probes, and drivers. The RESPONSE™ Navigation Instruments are to be used with the RESPONSE™ Spine System.

All instruments are made of stainless steel per ASTM F899. Taps range in size from Ø3mm to Ø8mm. The RESPONSE™ Navigation Instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic® StealthStation® Navigation System hardware and software.

The provided text describes a 510(k) premarket notification for the OrthoPediatrics RESPONSE™ Navigation Instruments. It does not present acceptance criteria or detailed study results in the format requested by the user.

The document states that the device was evaluated through:

• A detailed dimensional analysis and comparison with predicate devices.
• Testing per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems."

The specific parameters tested under ASTM F2554-18 are:

• Single point measurement accuracy
• Instrument axis rotation measurement accuracy
• Instrument angular position perpendicular to the system camera measurement accuracy
• Instrument angular position parallel to the system camera measurement accuracy
• Distance between points measurement accuracy

The conclusion states that "The results of this non-clinical testing together with the dimensional analysis and comparison show that performance of the RESPONSE™ Navigation Instruments is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance: While the tests performed (ASTM F2554-18 parameters) are listed, the specific acceptance criteria for each and the actual measured performance values are not disclosed in this document.
2. Sample size used for the test set and the data provenance: No sample sizes or details on data provenance (e.g., country of origin, retrospective/prospective) are mentioned for the non-clinical testing. This type of device (surgical instruments) typically undergoes lab testing rather than human clinical trials for substantial equivalence for this specific type of 510(k). The "test set" here refers to the instruments themselves, not a dataset of patient images or outcomes.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as this was non-clinical performance testing of physical instruments, not a study involving expert interpretation of medical images.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: Not applicable, as this is a navigation instrument, not an AI or imaging diagnostic device that would typically involve human readers.
6. If a standalone performance study was done: Yes, the described non-clinical testing of the instruments against a standard (ASTM F2554-18) can be considered a form of standalone performance evaluation for the device's functional characteristics. However, "standalone" in the context of AI often implies algorithm-only performance without human input, which isn't the primary focus here.
7. The type of ground truth used: The "ground truth" for this device's performance is established by the measurements and specifications defined in the ASTM F2554-18 standard for positional accuracy in computer-assisted surgical systems.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device (surgical navigation instruments) and details non-clinical laboratory testing rather than clinical study data involving AI algorithms or human interpretation of medical images.

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The FORTEZZA Spinal Stabilization System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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 stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor: pseudarthrosis; and/or failed previous fusion.

In addition, when used as a pedicle screw fixation system, the FORTEZZA Spinal Stabilization System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilum), who are having the device removed after the attainment of a solid fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the FORTEZZA Spinal Stabilization System are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The FORTEZZA Spinal Stabilization System is intended to be used with autograft and/or allograft. Pedicle screw fixation is limited to a posterior approach.

The FORTEZZA Spine Stabilization System consists of a variety of shapes and sizes of screws and 5.5 rods that can be rigidly locked in a variety of configurations, with each construct being tailor-made for the individual case. Fixation is provided via a posterior approach. The components are made from titanium alloy. Components of the system include straight and pre-bent rods, multi-axial screw.

This document is a 510(k) summary for the FORTEZZA Spinal Stabilization System, a medical device. It does not describe any clinical studies involving humans or AI. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical, bench testing.

Therefore, the requested information elements related to clinical studies, AI performance, ground truth, experts, and sample sizes for training/test sets are not applicable to this document.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a number of devices/tests, but implicitly refers to the number of samples required by ASTM F1717-14 for mechanical testing.
• Data Provenance: Not applicable for mechanical bench testing. The data is generated in a laboratory setting through controlled experiments.

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

• Not Applicable. No human experts were involved in establishing "ground truth" for these mechanical performance tests. The ground truth is determined by the physical properties and mechanical behavior of the device components under standardized test conditions specified by ASTM F1717-14.

4. Adjudication method for the test set

• Not Applicable. There is no adjudication method in the context of mechanical bench testing. Performance is measured against pre-defined engineering and material 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 document describes a medical device for spinal stabilization, not an AI-powered diagnostic or interpretive tool. No MRMC studies were conducted.

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

• Not Applicable. This document describes a physical medical device, not a software algorithm.

7. The type of ground truth used

• The "ground truth" for the performance testing is based on engineering and material science standards and measurements. Specifically, the device's mechanical properties (static compression bending, static torsion, fatigue compression bending) are measured and compared against the properties of a predicate device, as required by ASTM F1717-14 and FDA guidance.

8. The sample size for the training set

• Not Applicable. There is no training set in the context of this type of medical device submission (mechanical testing for substantial equivalence).

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

• Not Applicable. As there is no training set, there is no ground truth for a training set.

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