(134 days)
The LigaPASS is a temporary implant for use in orthopedic surgery on skeletally mature patients. 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 surgery, used in sublaminar, interspinous, or facet wiring techniques; Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as scoliosis, kyphosis, spondylolisthesis;
Spinal degenerative surgery, as an adjunct to spinal fusions;
The LigaPASS may also be used in conjunction with other medical implants made of titanium or chrome cobalt alloy whenever "wiring" may help secure the attachment of other implants.
The LigaPASS connector connects a rod to a vertebra. This connector can independently tighten the rod and the bone anchor. The LigaPASS connector is composed by a connector body, a rod set screw, a locking set screw for the band and a polyester band.
The provided text describes the LigaPASS device, a temporary orthopedic implant, and its 510(k) summary for FDA approval. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the testing standards and the comparison to predicate devices, rather than explicitly stated numerical targets. The reported performance is a qualitative statement of equivalence.
| Acceptance Criteria Category | Specific Criteria (Implicitly from ASTM Standards) | Reported Device Performance |
|---|---|---|
| Material/Design | Comparable to predicate device | "substantially equivalent" |
| Intended Use | Same as predicate device | "same intended use" |
| Indications for Use | Substantially similar to predicate device | "substantially similar indications for use" |
| Technological Characteristics | Substantially similar to predicate device | "substantially similar technological characteristics" |
| Principles of Operation | Substantially similar to predicate device | "substantially similar principles of operation" |
| Static Torsion Performance | Meeting or exceeding predicate device's performance under ASTM F1717 | "The results of these tests indicate that the LigaPASS is equivalent to predicate devices." |
| Static Compression Bending Performance | Meeting or exceeding predicate device's performance under ASTM F1717 | "The results of these tests indicate that the LigaPASS is equivalent to predicate devices." |
| Dynamic Compression Bending Performance | Meeting or exceeding predicate device's performance under ASTM F1717 | "The results of these tests indicate that the LigaPASS is equivalent to predicate devices." |
| Static Tension Performance | Meeting or exceeding predicate device's performance under ASTM F1798 | "The results of these tests indicate that the LigaPASS is equivalent to predicate devices." |
| Dynamic Tension Performance | Meeting or exceeding predicate device's performance under ASTM F1798 | "The results of these tests indicate that the LigaPASS is equivalent to predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for the non-clinical tests (e.g., how many LigaPASS devices were tested for each scenario). The tests were conducted according to ASTM standards, which would typically specify minimum sample sizes, but these details are not provided in the summary.
- Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no information about country of origin for the data, nor whether it was retrospective or prospective, as these terms typically apply to clinical studies involving human patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device's performance is established through physical mechanical testing against recognized industry standards (ASTM F1717 and ASTM F1798) and comparison to a legally marketed predicate device, not through expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable, as the evaluation is based on objective mechanical testing results against standardized criteria, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical orthopedic implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is primarily:
- Mechanical Performance Data: Conformance to established ASTM standards (ASTM F1717 and ASTM F1798) for static and dynamic properties of spinal implants.
- Substantial Equivalence to a Predicate Device: The performance and characteristics of the LigaPASS were compared to the Universal Clamp System (K060009), a legally marketed predicate device, to demonstrate that it is "substantially equivalent" in terms of safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a physical product, not an AI model.
§ 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.