(172 days)
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. The indications for use include the following applications:
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Spinal trauma surgery, used in sublaminar, or facet wiring techniques;
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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;
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Spinal degenerative surgery, as an adjunct to spinal fusions;
The LigaPASS system may also be used in conjunction with other medical implant grade 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. Components in this connector are manufactured from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136, pure titanium that conforms to ASTM F67 and Polyethylene Terephthalate (PET).
The purpose of this submission is 1) to introduce the LigaPASS 2.0 XS Connector which accommodates a 4.5mm rod and 2) to modify the LigaPASS indications to align with those of its primary predicate.
This document is a 510(k) premarket notification for the LigaPASS bone fixation cerclage device. The device is a "temporary implant for use in orthopedic surgery" intended for "temporary stabilization as a bone anchor during the development of solid bony fusion and [to] aid in the repair of bone fractures."
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a structured table with quantifiable thresholds that the device had to meet to be accepted. However, it states that the device was deemed "substantially equivalent" to predicate devices based on:
- Mechanical testing: "The tests performed on the LigaPASS 2.0 XS connector (axial and torsional grip, and static and dynamic band tension according to ASTM F1798) indicate that the product is as mechanically sound as other devices commercially available." This implies that the performance in these mechanical tests met or was comparable to the performance of the predicate devices.
- Biocompatibility: "The LigaPASS 2.0 XS is made from the same materials as its predicates." This implies that it met the same biocompatibility standards as the predicate devices.
Since specific numerical acceptance criteria and a table of reported performance against those criteria are not provided, we can infer the acceptance was based on comparability to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the mechanical testing. The tests conducted were "axial and torsional grip, and static and dynamic band tension according to ASTM F1798." These are in-vitro mechanical tests, not tests on biological samples.
- Data Provenance: The data provenance is from laboratory mechanical testing of the device components. It is not listed as retrospective or prospective patient data, nor does it refer to a specific country of origin of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. The "ground truth" for mechanical testing is established by engineering specifications and recognized ASTM standards (F1798), not by expert consensus in clinical interpretation.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to clinical review processes for establishing ground truth in image interpretation or clinical outcomes, which is not relevant to mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable as the device is a physical medical implant, not an AI algorithm. The performance evaluation was mechanical testing of the device itself.
7. Type of Ground Truth Used
The ground truth used for performance validation was based on established ASTM F1798 standards for mechanical testing of spinal devices and the comparative performance of legally marketed predicate devices.
8. Sample Size for the Training Set
This question is not applicable. The device is a physical implant, not an AI algorithm, so there is no "training set" in the machine learning sense. The "training" in mechanical design would involve iterative testing and refinement, but a specific "training set" of data for an algorithm is not relevant here.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above (not an AI algorithm).
§ 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.