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The ARx Modular 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 scollosis. 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 Modular 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 Modular Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.

The ARx Modular Spinal System consists of an assortment of rods, modular tulips, and offset connectors. The tulip head and taper lock are assembled during manufacturing to create the modular tulip assembly. The ARx Modular Spinal System implant components are made from titanium alloy (Ti- 6Al-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) per ASTM F1537.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the ARx Modular Spinal System components with components from any other system or manufacturer.

The provided text describes a 510(k) premarket notification for a medical device called the "ARx Modular Spinal System." This submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices based on design, materials, indications for use, and mechanical performance testing.

Crucially, this document does NOT describe the acceptance criteria or a study proving that an AI/algorithmic device meets these criteria. The device in question is a physical spinal implant system, not an AI or software as a medical device (SaMD).

Therefore, I cannot answer the requested questions about acceptance criteria for an AI/algorithmic device, sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these concepts are not applicable to the information provided in the document.

The document discusses:

• Device: ARx Modular Spinal System (spinal implant).
• Purpose: Posterior pedicle screw fixation for the spine.
• Materials: Titanium alloy and cobalt chrome.
• Testing: Mechanical performance testing (e.g., Static Axial Compression Bending Testing, Dynamic Compression Bending Testing) according to ASTM standards (F1717, F1798 & F5436-01) to demonstrate substantial equivalence to predicate devices.
• Conclusion: The device is substantially equivalent to predicate devices.

To answer your request, the provided input does not contain the information needed regarding acceptance criteria and performance studies for an AI/algorithmic medical device.

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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, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

The NAUTILUS Spinal System consists of an assortment of rods, screws, and cross connectors. The bone screw, head, and taper lock are assembled together during manufacturing to create the NAUTILUS Spinal System screw assembly component. The cross connectors are also assembled during manufacturing. Do not use any of the NAUTILUS Spinal System components with the components from any other system or manufacturer.

The NAUTILUS Spinal System is a medical device and its "acceptance criteria" and "study that proves the device meets the acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, rather than clinical performance metrics typical of AI/software devices. Therefore, the questions related to AI/software performance metrics (like sample size for test set, experts for ground truth, MRMC study, standalone performance) are not applicable in this context.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable: This is a mechanical device, not an AI/software device. There is no "test set" in the context of image analysis or algorithm performance. The data provenance would relate to the mechanical testing, which is performed in a laboratory setting. The document only states "Static compression, static torsion, and dynamic compression testing per ASTM F1717 was presented". The specific number of samples for each test type is not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not Applicable: There is no "ground truth" in the clinical or image analysis sense for this type of device submission. Substantial equivalence is established through comparison of design, materials, indications, and mechanical testing against recognized standards (ASTM F1717) and predicate devices.

4. Adjudication Method for the Test Set

• Not Applicable: See point 3.

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 a physical spinal system, not an AI or software device that assists human readers.

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

• Not Applicable: This is a physical spinal system; there is no algorithm or standalone performance in the context of AI.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable (in the conventional sense): The "ground truth" for this device's acceptance is its compliance with recognized mechanical testing standards (ASTM F1717) and its similarity in design, materials, and indications for use to already legally marketed predicate devices (CONQUEST Spinal System K080767, Pilot Spinal System K063601, ARX Spinal System K061600). The "truth" is established by showing it performs comparably and is structurally similar to devices already deemed safe and effective.

8. The Sample Size for the Training Set

• Not Applicable: There is no "training set" for this type of medical device submission.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable: See point 8.

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