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The LigaPASS™ system is an implant for use in orthopaedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and id in the repair of bone fractures. The indications for use are as follows:

· Spinal trauma surgery, used in sublaminar or facet wiring techniques;

· Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adults scoliosis and kyphosis;

· Spine degenerative surgery as an adjunct to spinal fusions.

· Intended for use with a posterior spinal instrumentation construct when ligamentation is needed.

The LigaPASS™ system may also be used in conjunction with other medical implants made of titanium or cobalt-chrome alloy whenever "wiring" may help secure the attachment of other implants.

The purpose of this submission is to expand the indications of the LigaPASS™ system to include the use with a posterior spinal instrumentation construct when ligament augmentation is needed.

The LigaPASS™ 2.0 Ligament Augmentation System provides surgeons the ability to mimic anatomical muscle and ligament functionality and stabilization between vertebrae that are collapsed during surgery before fusion. The LigaPASS™ 2.0 Ligament Augmentation System is designed to restore balance and stability as a complement to a posterior thoracolumbar fixation system. Ergonomic instrumentation provides smooth assembly with self-stabilizing tensioners and torque-limiting locking tools. The LigaPASS™ 2.0 Ligament Augmentation System consists of a polyester (PET) band and titanium alloy medial open connector with 2 set screws.

LigaPASS™ bands allow the surgeon to create a posterior vertebra anchorage without theuse of a pedicle screw or hook. Instead of a pedicle screw or hook, the LigaPASS™ bands are laced around the vertebra independently of the vertebra anatomy and then connected to a LigaPASSTM connector to make the rod-bone connection.

The LigaPASS™ 2.0 bands are comprised of a PET braid and pure titanium (T40) malleable leads at the ends of the bands. The malleable tips help the surgeon to lace the band around the vertebra. They can be bent by the surgeon to make it pass under and through the vertebral body easier.

The LigaPASS™ connectors allow surgeons to attach a rod to a vertebral body without the use of the pedicle. Instead of a pedicle screw, the LigaPASS™ connector use a facet band to make the rod-bone connection. The connectors are comprised of a connector body, a rod set screw, a locking set screw for the band and a polyester band. The body of these connectors is manufactured from titanium allov (Ti-6Al-4V). The part is compatible with any rods made of titanium or cobalt chromium alloys between diameters 5.5 mm and 6.0 mm.

The provided text is a 510(k) premarket notification decision letter and summary for the LigaPASS™ 2.0 Ligament Augmentation System. It does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria.

The document pertains to a physical medical device (ligament augmentation system) used in orthopedic surgery, not a diagnostic or AI-powered device. The "Performance Testing Summary" explicitly states:

"No additional bench or animal testing was completed for the purpose of this 510(k) submission. The non-clinical performance of the LigaPASS™ 2.0 Medial System has been validated through a series of 510(k) submissions (K172021, K173506). Clinical data published in the literature were provided to support the use of ligament augmentation with the LigaPASS™ system in adult spinal deformity surgery."

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from this document.

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The C-CURVE® Device is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate. The device is a stand-alone system when used C-Curve screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

MEDICREA® INTERNATIONAL S.A. C-CURVE® is composed of a cervical cage range stabilized by C-CURVE® screws. The titanium cage is composed of two pre-assembled components (the cage body and an expansion screw) that enable its expansion and adaptation of its lordotic angle. The cages are delivered individually and the screws are provided separately by two. The cages are available in different footprints and heights. These implants are designed to be inserted between two adjacent cervical vertebrae after removal of the disc. C-CURVE® is implanted by anterior approach. It is important to refer to the surgical technique and to the Instructions For Use (see paragraph «IMPLANT INSERTION», especially to use the two screws to stabilize the cage). C-CURVE® can be considered as a stand-alone cage if the two screws are used to stabilize the cage. If it is not the case, an additional fixation system must be added. Titanium cages & screws are manufactured in titanium alloy Ti-6Al-4V ELI conforming to ISO 5832-3 specifications and ASTM F136 specifications. Under no circumstances are the implants reusable.

The provided document is a 510(k) premarket notification for the C-CURVE device, an anterior cervical intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, material, and mechanical performance. The document does not contain acceptance criteria for device performance based on a clinical study of diagnostic accuracy or a human factors study related to AI/human interaction.

Therefore, I cannot provide information for many of the requested points, as they pertain to clinical or diagnostic performance studies that are not detailed in this regulatory submission.

However, I can extract information related to the non-clinical testing performed:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for the mechanical tests, but it does state that the tests "indicate that the product is mechanically equivalent to its predicates."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document details non-clinical mechanical bench testing. The "test set" would refer to the number of devices tested. The document does not specify the exact number of C-CURVE devices or predicate devices used for these tests. Data provenance is not applicable as this is bench testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the document describes non-clinical mechanical testing, not a study requiring expert readers to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the document describes non-clinical mechanical testing.

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 such study was conducted or reported in this document. This typically applies to AI/software as a medical device (SaMD) used for diagnostic purposes.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the document describes a physical intervertebral body fusion device and its mechanical performance, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical testing, the "ground truth" would be the established industry standards (ASTM F2077, ASTM F2267) and the mechanical performance of the legally marketed predicate devices.

8. The sample size for the training set

This is not applicable as the C-CURVE device is a physical implant, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable.

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