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The PERLA® TL system is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

• · degenerative disc disease;
• · spondylolisthesis;
• · fracture;
• · dislocation;
• scoliosis;
• · kyphosis;
• spinal tumor:
• · and failed previous fusion (pseudarthrosis).

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the PERLA® TL system is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used in conjunction with TEKTONA® HV US bone cement system, the PERLA®TL system is intended to restore the integrity of the spinal column even in the absence of fusion for a limited period of time, in patients whom life expectancy is of insufficient duration to permit achievement of fusion in advanced stage of thoracic and lumbar spine tumors. The PERLA®TL 35mm to 60mm lengths Screws augmented used with TEKTONA® HV US bone cement system are intended to be used at spinal levels where the structural integrity is not severely compromised.

TEKTONA® HV US Bone Cement is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

When used in conjunction with PERLA®TL system, TEKTONA® HV US Bone Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. PERLA®TL Screws augmented with TEKTONA® HV US Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The PERLA® TL System consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The PERLA® TL System is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537.

The PERLA® TL System is identical to the previously cleared version, however this submission includes the additional option to use bone cement with the fenestrated screws.

Mendec Spine HV System (TEKTONA HV US Bone Cement) is highly viscous, radio-opaque acrylic resins (PMMA based) for percutaneous vertebroplasty or kyphoplasty. Mendec Spine HV System holds the powder and liquid components separately within a closed syringe-like device that serves as a mixing chamber. The device is packaged in unitary PVC-blister with tray, sealed with Tyvek lid, which is placed in an aluminum bag. The device is sold disposable and sterile.

The provided FDA 510(k) summary (K230774) describes a medical device, the PERLA® TL System, and its use in conjunction with TEKTONA® HV US Bone Cement. However, this document does not contain acceptance criteria or a study describing the device's performance against such criteria for the PERLA® TL System with bone cement augmentation for thoracic and lumbar spine tumors.

The document states that:

"Bone cement usability testing (Usability Testing, Cement Injection Time Testing, and Cement Flow, Bolus Formation, and Screw Removal from Bone Cement Testing) was conducted to validate the use of the Perla® TL System used with bone cement."

And:

"The non-clinical tests performed by the company included bone cement usability testing and screw removal testing was conducted to validate the use of the Perla® TL System used with bone cement."

This indicates that testing was performed, but the details required to answer your specific questions (acceptance criteria, performance results, sample size, type of ground truth, expert qualifications, etc.) are not present in this document. The provided text focuses on establishing substantial equivalence to predicate devices based on indications, design, materials, manufacturing, and performance based on these "usability" and "screw removal" tests, but it does not quantify their results or define specific acceptance criteria they met.

Therefore, I cannot provide the requested table or detailed information about the study from the given text.

In summary, the provided document lacks the specific information about acceptance criteria and detailed study results that you are requesting.

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