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The Pioneer LowTop Spinal Rod System components are non-cervical spinal fixation devices intended for use as an adjunct to fusion as a pedicle screw system (T1 - S2), a posterior hook and sacral/iliac screw fixation system or as an anterolateral fixation system (T8 - L5). Pedicle screw fixation is limited to skeletally mature patients. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthosis, and failed previous fusion.

The LowTop Spinal Rod System components are non-cervical spinal fixation devices. Materials used to manufacture the implants and instruments of this system are in conformance with ASTM Standard Specifications.

This document describes a medical device, the "LowTop Spinal Rod System," and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, many of the requested categories for AI/ML device evaluation (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment) are not applicable.

However, I can extract the acceptance criteria and the study type used to demonstrate equivalence for this specific device.

Acceptance Criteria and Study for LowTop Spinal Rod System

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 physical medical device, not an AI/ML algorithm. The "test set" in this context refers to the physical components being tested for mechanical properties, not a dataset for an algorithm. The testing would involve a sufficient number of samples to meet ASTM standards for mechanical testing, but a specific "sample size" in terms of clinical cases or data provenance is not relevant here.

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

• Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus or pathology is typically for diagnostic devices or AI/ML. For a spinal rod system, the "ground truth" would be the mechanical properties as defined by engineering standards (e.g., tensile strength, fatigue life), which are determined by laboratory testing, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a physical device undergoing mechanical testing, adjudication methods like 2+1 or 3+1 (common for expert consensus in medical imaging) are not relevant. Mechanical testing results are objectively measured against established ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. This is a physical medical device, not an AI-assisted diagnostic or treatment planning system that would involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• No. This is a physical medical device. The concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used:

• For the performance criteria: Engineering standards (ASTM standards) for material properties and mechanical performance.
• For the substantial equivalence determination: Comparison to the materials, performance, and indications for use of legally marketed predicate devices.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. This is a physical medical device.

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The Pioneer LowTop Spinal Rod System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudoarthrosis).

In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to S1) with removal of the implants after the attainment of a solid fusion.

Materials used to manufacture the implants and instruments of this system are in conformance with ASTM Standard Specifications.

The provided text is for a 510(k) premarket notification for a medical device (Pioneer LowTop Spinal Rod System) and does not describe an AI/ML device or its performance study. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets them.

The document discusses:

• Device name, classification, and intended use.
• Predicate devices.
• Material specifications.
• Performance data: "Testing per recognized ASTM standards was presented."
• Substantial equivalence determination based on comparisons to predicate devices.

It does not contain any information about:

• Acceptance criteria in the context of an AI/ML device.
• Reported device performance of an AI/ML system.
• Sample sizes for test sets or data provenance for AI/ML.
• Experts for ground truth, adjudication methods, or MRMC studies.
• Standalone AI algorithm performance.
• Ground truth types for AI/ML.
• Training set size or ground truth establishment for a training set.

Ask a specific question about this device