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The PASS LP Spinal System is a pedicle screw fixation system intended for 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), deformity or curvature (e.g., scoliosis, and/or lordosis), tumor, spinal stenosis, pseudarthrosis, or 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. Additionally, the system is intended to treat pediatic patients diagnosed with the following conditions: spondylolistis and fracture caused by tumor and/or trauma. The PASS LP Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The PASS LP 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, iliac screws, clamps, rods, nuts, rod plates and crosslink components. It can be used for single or multiple level fixations. Components are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 or cobalt-chromium molybdenum alloy Co-Cr28Mo6 that conforms to ISO 5832-12 and ASTM F1537.

A subset of PASS LP 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. The PASS LP components can be rigidly locked into a variety of configurations, with each construct being tailored made for the individual case.

The purpose of this submission is to extend to the PASS LP, with the addition of new components: 'Dominoes & Iliac Connectors'.

The provided document is a 510(k) summary for the Medicrea International S.A. PASS LP Spinal System, specifically for the addition of new components ('Dominoes & Iliac Connectors'). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel performance against acceptance criteria in the context of an AI/ML medical device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML product. Specifically:

• No AI/ML device: The PASS LP Spinal System is a physical spinal implant system, not an AI/ML-driven medical device.
• No acceptance criteria for AI/ML performance: The "acceptance criteria" discussed in the document relate to biocompatibility and mechanical engineering standards for physical implants (e.g., ASTM F1717-15, ISO 10993).
• No study demonstrating AI/ML performance: The document explicitly states "No clinical studies were performed" and "No animal studies were performed." The "performance data" section refers to engineering and biocompatibility testing of the physical components.
• No data provenance, expert panels, or MRMC studies: These concepts are relevant to the evaluation of AI/ML diagnostic or prognostic devices, which is not what this 510(k) submission addresses.

In summary, the provided text describes a medical device approval pathway for a physical orthopedic implant and does not contain any of the information requested about AI/ML device acceptance criteria or performance studies.

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