(230 days)
When intended to promote fusion of the occipito-cervico-thoracic region of the spine (occiput-T3) in skeletally mature patients, the Lanx Posterior Cervicothoracic Spinal Fixation System is indicated for the following:
- Degenerative Disc Disease (as defined by neck and back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- . Spondylolisthesis
- . Spinal Stenosis
- . Trauma/Fracture/Dislocation
- Atlanto-Axial Fracture with Instability .
- . Occipito-Cervical Dislocation
- Failed Previous Fusion .
- . Tumor
The use of occipital bone screws is limited to placement in the occiput only.
The use of polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The purpose of this 510(k) submission is to add a head-to-head cross connector and additional longitudinal rods and polyaxial pedicle screws. The modified system has the same intended use and fundamental scientific technology as the previously-cleared system.
Both the modified and predicate Lanx Posterior Cervicothoracic Spinal Fixation System consist of various screws, hooks, plates, rods, connectors, etc. that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion. The system components can be assembled in a variety of configurations, with the anchors and connectors rigidly locked to the rod, allowing the surgeon to tailor the construct to the particular needs of the patient,
Both the modified and predicate Lanx Posterior Cervicothoracic Spinal Fixation System implants are fabricated from medical grade titanium alloy per ASTM F136. The modified Lanx Posterior Cervicothoracic Spinal Fixation System implants are manufactured using the same manufacturing processes, and are passivated and anodized in the same manner as the implants in the predicate Lanx Posterior Cervicothoracic Spinal Fixation System.
The provided text describes a 510(k) premarket notification for a medical device (Lanx Posterior Cervicothoracic Spinal Fixation System) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving a device meets specific clinical acceptance criteria.
Therefore, many of the requested categories are not applicable to this type of regulatory submission, as it deals with mechanical performance and equivalence, not clinical efficacy or diagnostic accuracy.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance for Lanx Posterior Cervicothoracic Spinal Fixation System (K100888)
This submission is a 510(k) for adding a head-to-head cross connector, additional longitudinal rods, and polyaxial pedicle screws to an existing spinal fixation system. The primary goal is to demonstrate substantial equivalence to the predicate device (K092656), not to prove the device meets new, independent clinical performance acceptance criteria. The "acceptance criteria" here are implicitly related to the mechanical performance of the modified system being comparable to the predicate device, as tested by specific ASTM standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implicit) | Specific Test/Standard | Reported Device Performance / Outcome |
|---|---|---|
| Mechanical Strength | Static and dynamic axial compression bending (in accordance with ASTM F1717) | Modified device performed as intended. Results compared to predicate system. |
| Mechanical Strength | Static and dynamic torsion testing (in accordance with ASTM F1717) | Modified device performed as intended. Results compared to predicate system. |
| Mechanical Strength | Axial grip testing (in accordance with ASTM F1798) | Modified device performed as intended. Results compared to predicate system. |
| Mechanical Strength | Cantilever bending testing (in accordance with ASTM F1798) | Modified device performed as intended. Results compared to predicate system. |
| Substantial Equivalence | Comparison of mechanical properties to predicate device | Mechanical testing demonstrated comparable mechanical properties to predicate. |
| Functionality | Meeting intended use | Modified device functioned as intended. |
| Safety and Effectiveness | No new issues raised by modifications | Modifications do not raise new issues of safety or effectiveness. |
| Material Equivalence | Fabricated from medical grade titanium alloy per ASTM F136 | Implants are fabricated from the same material as the predicate. |
| Manufacturing Equivalence | Same manufacturing processes, passivation, and anodization as predicate | Implants are manufactured, passivated, and anodized in the same manner as predicate. |
Study Proving Device Meets Acceptance Criteria:
The study was a series of mechanical performance tests conducted to characterize the modified Lanx Posterior Cervicothoracic Spinal Fixation System and compare it to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as numerical values for each test. The text mentions "the modified and predicate systems" were tested, implying a sufficient number of samples for each configuration to satisfy the ASTM standards.
- Data Provenance: Not specified. This would typically be internal laboratory data generated by the manufacturer or a contracted testing facility. Given the regulatory context, it would be considered prospective for the purposes of this submission (i.e., tests specifically performed to support this submission). Country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This is a mechanical testing study, not a study involving human interpretation or ground truth established by experts in a clinical context. The "ground truth" is defined by the physical properties and performance metrics specified by the ASTM standards.
4. Adjudication Method for the Test Set:
- Not Applicable. Mechanical testing results are objective measurements from instruments; they do not involve human adjudication in the sense of reconciling subjective opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is a mechanical performance study, not a clinical or comparative effectiveness study involving human readers or cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is a physical medical device (spinal fixation system), not an algorithm or AI software.
7. The Type of Ground Truth Used:
- For the mechanical tests, the "ground truth" is defined by the metrics and pass/fail criteria established by the referenced ASTM standards (F1717 and F1798). The performance of the predicate device also serves as a comparative "truth" against which the modified device is evaluated for substantial equivalence.
8. The Sample Size for the Training Set:
- Not Applicable. This is a physical device where "training sets" are not relevant in the way they are for AI/machine learning algorithms. Instead, the design and manufacturing processes are likely informed by prior engineering principles and data from similar devices.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As above, the concept of a "training set" with established ground truth does not apply to this type of mechanical device submission. The design and testing methodologies are based on established engineering principles and industry standards (ASTM).
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.