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The Wiltse System Is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 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 sacrum) with removal of the implants after the attainment of a solid fusion.

The Wiltse System is also intended for anterolateral screw fixation of the noncervical spine. Indications for this system include treatment of cases of spondylolisthesis, fracture, spinal stenosis, deformittes (including scollosis, kyphosis, and lordosis), tumor, pseudoarthrosis, and revision of failed previous fusion surgery. Other indications include degenerative lumbar scollosis, degenerative spondylolisthesis, and in spinal stenosis, where decompression is required.

Device Description

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AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "Wiltse System." This document primarily focuses on regulatory approval and indications for use, not on detailed acceptance criteria or a study proving device performance against such criteria.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) from the provided text.

The closest information provided is the "Indications For Use," which outlines the conditions and patient populations for which the device is intended. This is a regulatory statement about its intended application, not a performance metric.

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K Number

K990845

Device Name

MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15

Manufacturer

ADVANCED SPINE FIXATION SYSTEMS, INC.

Date Cleared

1999-04-13

(29 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K954770

Predicate For

N/A

Intended Use

The Varifix System with pedicle screw attachment is only indicated for patients with severe spondylolisthesis, grades 3 and 4, of the fifth lumbar-first sacral (L5-S1) joint. This indication is for those who are receiving fusions using autogenous bone graft only. The Varifix System is to be removed after the development of a solid fusion mass.

The Varifix System with sacral screws and sublaminar wiring and the Varigrip System are intended for treatment of cases of degenerative disc diseases (ddd is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiocraphic studies), soondylolisthesis, fracture, spinal stenosis, deformities (including scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and multi-operated back or revision of previous surgery. Other indications include degenerative lumbar scoliosis, degenerative spondylolisthesis, and in spinal stenosis, where decompression is required.

For indication other than severe spondylolisthesis (grade 3 or 4) at the L5-S1 vertebral joint this device in intended for sacral/iliac/lamina attachment only. The attachment points of the sacral screws are intended for the S1 or S2 locations. The sublaminar wire fixation levels range from L1 to L5. To facilitate fusion of the fifth lumbar-first sacral (L5-S1) the attachment points of the pedicle screws are limited to L3, L4, and L5 vertebrae. In addition, the titanium components are also intended for those individuals who have sensitivity to some of the elements present in stainless steel alloys. The Varigrip is intended to be attached to the non-cervical spine.

Device Description

Modification to K954770 - Varigrip device components numbered CGT-SL and CGT-SL-15

AI/ML Overview

This document is a 510(k) premarket notification from the FDA, specifically concerning a modification to the Varigrip device components. It does not contain information about acceptance criteria or a study proving device performance as typically expected for AI/ML medical devices.

Instead, this document is an approval letter based on "substantial equivalence" to a predicate device already on the market. This type of regulatory submission historically does not require the extensive performance testing and reporting that would lead to the information requested in your prompt.

Therefore, I cannot provide the requested table and details because they are not present in the provided text. The document's purpose is to grant market clearance, not to detail performance studies against predefined acceptance criteria for a novel device or software.