Search Results

The Spinal Fixation System 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 levels of fixation are T8 - S1.

The Spinal Fixation System consists of screws, rods, transverse bar assembly, set screws. It is made of titanium Alloy (Ti6AI4VELI), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Vanadium 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 10th 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 a medical device (Spinal Fixation System) and outlines its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria related to a diagnostic or AI-assisted system's performance, as the request implies.

The document discusses substantial equivalence for a spinal fixation system, which is a medical implant, not an imaging or diagnostic device. The "acceptance criteria" discussed are related to performance testing verifying the physical properties and safety of the implant, not the diagnostic accuracy of an algorithm.

Therefore, I cannot provide the information requested based on the provided text. The prompt asks for details about a study proving a device meets acceptance criteria, specifically on aspects like sample size, ground truth, expert adjudication, MRMC studies, and training set details, which are relevant to diagnostic or AI-based devices. The provided document concerns a physical implant called a "Spinal Fixation System" and its regulatory clearance via a 510(k) submission, demonstrating substantial equivalence to a predicate device based on material, intended use, and mechanical testing.

The document does not contain information about:

1. A table of acceptance criteria for diagnostic performance.
2. Sample sizes for test sets in a diagnostic context.
3. Number of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. Types of ground truth (expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

Instead, the document focuses on:

• Device Description: Made of titanium alloy, non-sterile, sterilized via autoclave.
• Intended Use: Posterior, non-cervical, pedicle fixation for specific spinal conditions.
• Technological Characteristics Comparison: Comparing the subject device (Spinal Fixation System) to a predicate device (General Spinal System K122994) in terms of product code, regulation, intended use, material, test items (static compression bending, static torsion, dynamic compression bending), test standard (ASTM F1717), how supplied, sterilization method, single use, and prescription/OTC use.
• Performance Data: Mentions "sterility and performance testing" and "Test data and report information are included in this submission," but does not detail the specific acceptance criteria or results of these tests in the provided text. These tests would typically involve mechanical strength, fatigue, and material biocompatibility, not diagnostic accuracy.

To answer your question, information relevant to diagnostic or AI-assisted devices would need to be present in the provided text, which it is not.

Ask a specific question about this device