(141 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:
-Spinal trauma, used in sublaminar, or facet wiring techniques
-Spinal reconstruction 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 to introduce the LigaPASS 2.0 Band - B08110005 and the LigaPASS 2.0 Dual Band - B08110010.
MATERIALS: Components in these bands are manufactured from pure titanium that conforms to ASTM F67 and biocompatible Polyethylene Terephthalate (PET).
Function: The LigaPASS spinal system was developed as an implant:
• To provide temporary stabilization as bone anchor during the development of solid bony fusion.
• To aid the repair of bone fracture.
This document is a 510(k) summary for the Medica International's LigaPASS additional components (LigaPASS 2.0 Band - B08110005 and LigaPASS 2.0 Dual Band - B08110010). It focuses on establishing substantial equivalence to previously cleared LigaPASS devices (K172021). The information provided primarily pertains to the design and material comparisons, and non-clinical testing. It does not include data from a study that typically measures specific performance metrics against pre-defined acceptance criteria in the context of medical device AI or diagnostic accuracy, nor does it involve human readers, ground truth establishment by experts, or training/test sets for an algorithm.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert qualifications, and AI-related studies are not applicable to the content of this 510(k) summary.
However, I can extract the relevant information from the provided text regarding the non-clinical testing and the basis for substantial equivalence.
Here's an interpretation based on the provided document, acknowledging the limitations:
This document is a 510(k) Summary, which aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. In such cases, the "acceptance criteria" are generally that the new device performs at least as well as, or is technologically similar to, the predicate device in terms of safety and effectiveness, supported by non-clinical (and sometimes clinical) data. There isn't a table of numerical "acceptance criteria" against which a new device's performance is explicitly measured in the way one might expect for a diagnostic or AI-driven device's sensitivity/specificity.
The "study" undertaken here is a comparative analysis and non-clinical testing to demonstrate substantial equivalence.
1. A table of acceptance criteria and the reported device performance
As this is a 510(k) for device modifications (additional components to an existing system) and not a novel diagnostic AI product, there aren't explicit numerical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity). The "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, particularly regarding material properties and mechanical performance.
| Acceptance Criteria Category | Specific Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Same as predicate device (materials, manufacturing) | Met (same materials and similar manufacturing processes as predicates) |
| Mechanical Performance | Mechanically equivalent to predicate device (e.g., static traction) | Met (LigaPASS 2.0 Dual Band – B08110010 showed mechanical equivalence to predicates in static traction testing) |
| Intended Use | Same as predicate device | Met (intended uses are identical to predicate devices) |
| Material Composition | Same as predicate device | Met (PET & Pure titanium (T40) conforming to ASTM F67 for both new components and predicates) |
| Technological Characteristics | Similar to predicate device (number of braids, braid shape, tips) | Met (as detailed in the comparison table on page 5) |
2. Sample size used for the test set and the data provenance
For the mechanical testing:
- Sample Size: Not explicitly stated in terms of number of units tested, but the document refers to "the LigaPASS 2.0 Dual Band – B08110010" being tested. Typically, mechanical tests would involve a statistically relevant number of samples, but this specific number is not provided in the summary.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is non-clinical laboratory testing, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a mechanical implant, not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" requiring adjudication by experts in this context.
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
Not applicable. This is not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For mechanical non-clinical testing, the "ground truth" is typically the physical and material properties measured against established engineering standards (e.g., ASTM F67 for titanium, NF EN ISO 13934-1 for static traction) and comparison to the predicate device's known performance.
8. The sample size for the training set
Not applicable. This is a mechanical implant, not an AI-driven device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.