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The ARx Spinal System, is intended for posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the ARx Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the ARx Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.

The ARX Spinal System consists of screws and longitudinal rods intended to provide temporary stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The ARX Spinal System consists of an assortment of rods and screws. The bone screw, head, and taper lock are assembled together during manufacturing to create the ARX Spinal System screw assembly component. The ARX Spinal System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537. Do not use any of the ARX Spinal System components with the components from any other system or manufacturer.

The provided text describes the 510(k) premarket notification for the ARx Spinal System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through materials and mechanical performance testing, rather than an AI/ML product. Therefore, much of the requested information regarding AI/ML device acceptance criteria and study details (like sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided document.

The document primarily addresses the mechanical and material characteristics of the ARx Spinal System.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this specific device (ARx Spinal System) are implicitly tied to the performance standards outlined in ASTM F1717 for pedicle screw systems, and the reported device performance is that it met these mechanical tests and demonstrated substantial equivalence to predicate devices. However, no specific numerical acceptance thresholds or detailed performance figures are provided in this summary.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML device. For mechanical testing, the "sample size" would refer to the number of physical devices tested, which is not specified in the document.
• Data Provenance: Not applicable in the context of an AI/ML device. This submission is about a physical spinal implant.

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

• This is not applicable as the device is a physical pedicle screw system, not an AI/ML diagnostic tool requiring expert interpretation for ground truth.

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

• Not applicable for a physical device's mechanical testing.

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 as this is not an AI-assisted diagnostic device.

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

• Not applicable as this is a physical medical device, not an algorithm.

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

• The "ground truth" for this device would be established by established engineering principles and the performance standards outlined in ASTM F1717 for spinal implant mechanical characteristics. There isn't a "diagnostic ground truth" in the typical AI/ML sense.

8. The sample size for the training set

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

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

• Not applicable.

Summary of what the document DOES provide:

• Device Name: ARx Spinal System
• Device Type: Thoracolumbosacral Pedicle Screw System (physical implant)
• Regulation Number: 21 CFR 888.3070
• Regulatory Class: Class II
• Product Code: NKB
• Indications for Use: Posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ilium) in skeletally mature and pediatric patients (adolescent idiopathic scoliosis). Adjunct to fusion for stabilization and immobilization in acute/chronic instabilities or deformities.
• Materials: Titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (Co-28Cr-6Mo).
• Performance Data: Tested according to ASTM F1717 (Static Axial Compression Bending, Static Torsion & Dynamic Compression Testing) to demonstrate substantial equivalence to predicate devices.
• Predicate Devices: Life Spine Nautilus (K123373), Stryker Xia 3 Spinal System (K142381), Life Spine AR CoCr Pedicle Screw System (K200070).

In conclusion, the provided FDA clearance letter and 510(k) summary are for a traditional, physical medical device (spinal implant) and therefore do not contain the details typically required for an AI/ML-based device regarding acceptance criteria, study design, and ground truth establishment.

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Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The NAUTILUS Spinal System, when properly used. is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system. the NAUTILUS Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and axial and offset connectors. The bone screw. head, and taper lock are assembled together during manufacturing to create the NAUTILUS Thoracolumbar Spinal System screw assembly component. The cross, axial, and offset connectors are also assembled during manufacturing. The NAUTILUS Thoracolumbar Spinal System implant components are made from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136. Do not use any of the NAUTILUS Thoracolumbar Spinal System components with the components from any other system or manufacturer.

The provided text describes the 510(k) Summary for the NAUTILUS Spinal System. This document is for a medical device (spinal implant system) and does not contain information about an Artificial Intelligence (AI) device or its performance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The document explicitly states that the device is made from titanium alloy and concerns mechanical fixation for spinal fusion.

Here's why the requested information cannot be extracted from the provided text:

• No AI Device: The NAUTILUS Spinal System is a physical medical device (implants, screws, rods) made of titanium alloy. It is not an AI-powered diagnostic or assistive device.
• Performance Data Type: The "Performance Data" section specifically mentions "Dynamic compression testing per ASTM F1717" to demonstrate substantial equivalency, which are mechanical tests for physical implants, not AI algorithm performance metrics.
• No AI-related Criteria: The document does not discuss metrics like accuracy, sensitivity, specificity, AUC, or other parameters typically used to evaluate AI device performance.
• No "Ground Truth" for Algorithms: The concept of "ground truth" (expert consensus, pathology, outcome data) as it relates to training or testing an AI algorithm is not applicable to a physical spinal implant system.

In summary, the provided content is a regulatory submission for a non-AI medical device, and thus does not contain the information necessary to answer your questions about AI device acceptance criteria and studies.

Ask a specific question about this device