FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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 solid bony fusion and aid in the repair of bone fractures. LigaPASS system is indicated for 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 10 years of age and older, adult scoliosis, and kyphosis;
Spinal degenerative surgery, as an adjunct to spinal fusions;

Device Description

The LigaPASS connectors connect a rod to a vertebra. These connectors can independently tighten the rod and the bone anchor. The LigaPASS connectors are composed by a connector body, a rod set screw, a locking set screw for the band and a polyester band.

AI/ML Overview

The MEDICREA® INTERNATIONAL LigaPASS is a temporary orthopedic implant designed to provide stabilization during spinal fusion and aid in bone fracture repair. The submission details its substantial equivalence to predicate devices, focusing on the expanded indications for use to include idiopathic and neuromuscular scoliosis treatment in patients 10 years of age and older.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (LigaPASS)
Intended Use	- Temporary stabilization as a bone anchor during solid bony fusion development.

Aid in repair of bone fractures.
Spinal trauma surgery (sublaminar or facet wiring).
Spinal reconstructive surgery for spinal deformities (scoliosis, kyphosis, spondylolisthesis).
Spinal degenerative surgery (adjunct to spinal fusions).
Used with other titanium/cobalt chrome implants for "wiring" to secure attachment. | - Same as criteria, plus expanded indication for idiopathic and neuromuscular scoliosis in patients 10 years of age and older. |
| Materials | - Connector: Titanium alloy (ASTM F136 or ISO 5832-3).
Band: Polyethylene terephthalate (PET) and pure titanium (ASTM F67). | - LigaPASS connectors are made from titanium alloy conforming to ASTM F136 or ISO 5832-3.
The band is manufactured from polyethylene terephthalate (PET) and pure titanium conforming to ASTM F67. (Identical to predicate and other cleared MEDICREA products). |
| Design/Components | - Connector with polyester band.
To circle a vertebra as a bone anchor.
Connect to a Ø5.5mm or Ø6mm rod. | - Connectors with polyester band.
To circle a vertebra as a bone anchor.
Connect to a Ø5.5mm or Ø6mm rod.
The LigaPASS connectors are composed of a connector body, a rod set screw, a locking set screw for the band, and a polyester band. (Similar design and components to the predicate device).
No other changes in terms of design characteristics, principles of operation, packaging, sterility, or biocompatibility have undergone since the previous 510(k). |
| Mechanical Performance | - Meets ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model".
Meets ASTM F1798 "Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanism and Subassemblies Used In Spinal Arthrodesis Implants".
Comparable mechanical performance to predicate devices (Universal Clamp System K110348, LigaPASS K112736). | - Mechanical testing of LigaPASS implants was conducted following ASTM F1717 and ASTM F1798.
Data was compared to the mechanical performance of other cleared devices (LigaPASS, MEDICREA INTERNATIONAL, K112736).
Mechanical performance established via these cleared devices. |

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not specify a separate "test set" for performance evaluation in the context of clinical data. Mechanical testing was performed on LigaPASS implants, and data was compared to previously cleared devices (LigaPASS, MEDICREA INTERNATIONAL, K112736). No clinical studies were conducted for this submission.
Data Provenance: The document does not provide details on the specific number of units tested for mechanical performance, or any particular provenance for those tested units (e.g., country of origin). The comparison data is derived from previously cleared predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This is not applicable. No clinical studies were performed, and thus no expert-established ground truth for a clinical test set was required. The substantial equivalence claim is based on non-clinical (mechanical) testing and comparison to predicate devices, as well as material composition.

4. Adjudication Method for the Test Set

This is not applicable. As no clinical studies or human-in-the-loop evaluations were conducted, there was no need for an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is a medical implant, and its evaluation relies on non-clinical mechanical testing and comparison to predicate devices, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical medical implant (bone fixation cerclage), not an AI algorithm or software device. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

The primary "ground truth" for demonstrating acceptance was established by industry standards for mechanical testing (ASTM F1717, ASTM F1798) and the performance of legally marketed predicate devices. The material composition also relies on established standards (ASTM F136, ISO 5832-3, ASTM F67). There was no clinical ground truth (e.g., pathology, outcomes data) used as no clinical studies were conducted.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI/ML system that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, this question is not relevant.

Summary

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.