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The Premier is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1): 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; and failed previous fusion (pseudoarthrosis).

The purpose of this 510(k) is to make modifications to the previously cleared Premier Spinal System (K160320). The changes include modifications to the implants, surgical instruments, indications and labeling. The Premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, iliac screw, domino connector, lateral connector and hooks.

It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Allov for Surgical Implant Applications, which are widely used for surgical implants with wellknown biocompatibility.

The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The provided text does not describe an AI medical device or a study proving its acceptance criteria. Instead, it is an FDA 510(k) clearance letter for a Premier Thoracolumbosacral pedicle screw system, which is a physical orthopedic device used in spinal surgeries.

Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth related to an AI device. The document focuses on regulatory clearance for a medical implant and mentions conformance to ASTM standards and ISO guidelines for sterilization, not AI performance metrics.

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The Premier is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft.

The premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, domino connector, lateral connector and hooks. It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

This document is a 510(k) summary for the "Premier" pedicle screw spinal system. It does not describe an AI/ML powered medical device or a study involving human readers or AI assistance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics.

Therefore, the requested information regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document.

The document indicates "No clinical study is included in this submission" (Page 6). The acceptance criteria and the study that proves the device meets them are based on non-clinical tests verifying design specifications and compliance with ASTM F 1717-13 as detailed in the "Non-Clinical Test Conclusion" section (Page 6).

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to non-clinical mechanical testing, not a test set for an AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on the performance according to established ASTM standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is for mechanical testing, not clinical data adjudication.

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: No, an MRMC study was not done. The device is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: No, this is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical tests, the "ground truth" is defined by the performance parameters and failure criteria established within the ASTM F 1717-13 standard. For material, it's compliance with ASTM F136-13. For sterilization, it's compliance with ISO 17665-1: 2006.

8. The sample size for the training set: Not applicable. There is no training set for this type of device (spinal implant).

9. How the ground truth for the training set was established: Not applicable. There is no training set.

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