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The LigaPASS is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of a solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:

• 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, adult scoliosis, and kyphosis; -Spinal degenerative surgery, as an adjunct to spinal fusions.

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 LigaPASS System connects a rod to a vertebral body using a specific type of connector and a flexible band. This connector can independently tighten the rod and the bone anchor. It is comprised by a connector body, a rod set screw, a locking set screw for the band and a polyester band.

The purpose of this submission is 1) to introduce the LigaPASS 2.0 Medial Connector and 2) to introduce the LigaPASS 2.0 Medial Open Connector.

MATERIALS: Components in this connector are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136, pure titanium that conforms to ASTM F67 and Polyethylene Terephthalate (PET).

The provided document is a 510(k) summary for the LigaPASS system, which describes its indications for use, materials, and substantial equivalence to previously cleared devices. It is for a bone fixation cerclage device, not an AI/ML device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies, which are typical for AI/ML device approvals, is not present in this document.

The document states:

• No additional mechanical testing. Finite element analysis and device descriptive information were sufficient to establish the substantially equivalent mechanical performance of the subject components.

This indicates that a study with explicit acceptance criteria for device performance, as would be expected for a novel AI/ML device, was not conducted or required for this submission. The evaluation was based on similarity to existing devices and existing mechanical data for those predicate devices.

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The PASS LP Spinal Systems include a pedicle system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of thoracic, lumbar, and sacral spine:

• Fractures
• Dislocation
• Failed previous fusion (Pseudoarthrosis)
• Spinal stenosis
• Degenerative spondylolisthesis with objective evidence of neurological impairment
• Spinal deformations such as scoliosis or kyphosis.
• Loss of stability due to tumors.

The PASS LP Spinal Systems are also indicated for pedicle screw fixation 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 PASS LP also include hooks and rods and sacralitiiac screws indicated for degenerative disc disease (ddd) 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 deformities or curvatures (i.e., scollosis, kyphosis, and/or lordosis), turnor, stenosis. pseudoarthrosis and failed previous fusion.

Except for rod plates, when used for posterior non-cervical pedicle screw fixation in pediatric patients, the PASS LP Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PASS LP Spinal System is intended to be used with allografi and/or autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP Spinal System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine.

The system consists of pedicle screws, hooks, sacral plates, illac screws, clamps, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-SAI-4V ELI) that conforms to ASTM F136 or cobalt-chromiummolybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP Spinal System components may be used for posterior pedicle screw fixation in pediatrics cases. These constructs may be comprised of a variety of shapes and sizes of rods, hooks, sacral plates, iliac screws, clamps, nuts and crosslink components. Similarly to the PASS LP implants used in adult case, these components can be rigidly locked into a variety of configurations, with each construct being tailored-made for the individual case.

Materials: Titanium alloy and Cobalt-chromium-molybdenum alloy

Function: The PASS LP was developed as an implant:

• To provide immobilzation and stabilization of posterior spinal segments
• to augment the development of a solid spinal fusion
• to provide stability to ease fusion
• to be mechanically resistant to allow the fusion of the operated level

The provided text describes a 510(k) summary for the MEDICREA® INTERNATIONAL PASS LP Spinal System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of features, rather than a study proving the device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested elements regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to the non-clinical tests performed to demonstrate mechanical equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not applicable. The "test set" in this context refers to mechanical testing of components, not a clinical data set. The document states "mechanical testing... was conducted following the ASTM F1717" and "additional components... tested following the ASTM F1798". No specific sample size (number of constructs tested) is provided in the summary.
• Data Provenance: Not applicable in the context of clinical data. The mechanical tests were performed on the device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable. Ground truth, in the clinical sense, is not established for mechanical testing.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable for 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

• MRMC Study: No. The document explicitly states: "No clinical studies were performed." This is a regulatory submission for a medical device implant, not an AI diagnostic device.

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

• Standalone Performance: No. This device is a spinal implant, not an algorithm.

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

• Type of Ground Truth: For the mechanical performance, the "ground truth" is adherence to established ASTM standards (ASTM F1717 and ASTM F1798) and comparison to the mechanical performance of previously cleared devices. This is a technical/engineering "ground truth," not a clinical one.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no AI component or machine learning model described as part of this device or its evaluation.

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

• Ground Truth for Training Set Establishment: Not applicable. There is no AI component or machine learning model described.

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