(196 days)
The MC+ is indicated for use for partial replacement (i.e.: partial vertebrectomy) of a diseased vertebral body that has been resected or excised due to tumor or trauma/fracture in order to achieve anterior decompression of the spinal chord and neural tissues, and to restore the height of a collapsed vertebral body. The components are intended for use in pairs for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and are intended for use with supplemental internal fixation such as the Easyspine System to properly utilize this system.
The MC+ vertebral implants consist of a series of square and rectangular D-shaped implants. The device is used in pairs as a partial vertebral body replacement in the thoracolumbar spine (from T1 to LS). The device is offered in seven different configurations to better approximate the anatomical variation observed in different vertebral levels and/or patient anatomy. The LDR Spine USA. MC+ is comprised of a variety of components fabricated and manufactured from PolyEtherEtherKetone (PEEK) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. The upper surface of the implant is arched in the anterior/posterior direction for increased stability. Tantalum wire markers (ASTM F-560) are inserted into components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively. The device comes with optional anchoring clips made of titanium alloy.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the MC+ Partial VBR device.
Important Note: The provided document is a 510(k) Summary, which is a premarket notification to the FDA. It declares substantial equivalence to previously cleared devices. Unlike a PMA (Premarket Approval) submission, a 510(k) summary often references testing but does not typically include detailed reports of de novo clinical or performance studies with specific statistical acceptance criteria and results in the way you might expect for a novel device. The primary "proof" in a 510(k) is the demonstration of substantial equivalence to predicate devices, which implies that if the predicate devices were safe and effective, and the new device shares similar characteristics and performs similarly, it too can be considered safe and effective for its intended use.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type / Basis of Performance |
|---|---|---|---|
| Material Composition | PEEK compliant with ASTM F-2026; Tantalum with ASTM F-560; Titanium with ASTM F-136,92 | All implants made from implant grade PEEK (Optima LT) with tantalum alloy position markers and titanium alloy. Materials meet respective ASTM and ISO standards (e.g., PEEK Optima LT: USP Class VI, ASTM F-2026, ISO 10993; Tantalum: ASTM F-560, ISO 5832-3; Titanium: ASTM F-136,92, ISO 5832-3). | Material testing / Compliance with recognized standards |
| Mechanical Performance | Expected to perform in a manner equivalent to predicate devices. | "Fatigue and static testing is complete. Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device." | Bench testing (Fatigue and Static testing) against predicate device performance. |
| Sterility | Minimum Sterility Assurance Level (SAL) of at least 10^-6 for implants. | Implants supplied "STERILE" via radiation sterilization with a validated protocol meeting SAL of at least 10^-6. | Sterilization validation study. |
| Instrument Sterilization | Instruments supplied non-sterile; recommended steam autoclave cycle to achieve SAL of at least 10^-6. | Recommended sterilization process for instruments: Steam Cycle (Gravity), 270°F (134°C) Temperature, 18 minutes Exposure Time, achieving SAL of at least 10^-6. | Sterilization validation study. |
| Indications for Use | Partial replacement of diseased vertebral body (tumor/trauma/fracture) in thoracolumbar spine (T1-L5), using pairs, with supplemental internal fixation, to achieve anterior decompression and restore height. | Indications for Use are identical to predicate devices (CAS Spine Spacer System, Pioneer Vertebral Spacer, CPOD / LPOD VBR System, Ellys and Aurys VBR). | Comparison to predicate devices. |
| Design | Cage design. | Cage design. | Comparison to predicate devices. |
| Use with Bone Graft | Required. | Required. | Comparison to predicate devices. |
| Secondary Fixation | Required. | Required. | Comparison to predicate devices. |
| How Used | In pairs. | In pairs. (Note: Predicate devices vary, but MC+ is specifically for pairs). | Device design and intended use statement. |
Study Details (Based on the provided Summary)
Given this is a 510(k) submission, the provided summary does not detail full study protocols or results. The "study" mentioned is primarily focused on demonstrating substantial equivalence.
-
Sample size used for the test set and the data provenance:
- No specific sample size for a "test set" in the context of clinical performance is provided. The evaluation of mechanical performance (fatigue and static testing) would have used an engineering test sample, but the size is not specified.
- Data Provenance: Not applicable in the sense of patient data. The provenance for material and mechanical testing would be internal lab testing by LDR Spine USA or contracted labs. The basis for "equivalence" is comparison to predicates, meaning the clinical performance of the predicate devices is implicitly referenced.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a medical device for vertebral body replacement, and the "ground truth" for its performance is established through engineering principles and comparison to existing, legally marketed devices, not typically by expert consensus on a test set of images or clinical cases in a 510(k) summary.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical adjudication of a test set is mentioned or typically required for this type of 510(k) submission.
-
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 device is a physical implant, not an AI or imaging diagnostic tool. An MRMC study would be irrelevant.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical implant, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For material properties: Accepted industry standards (ASTM, ISO, USP).
- For mechanical performance: Engineering specifications and comparative mechanical performance to predicate devices.
- For indications/design: Direct comparison to legally marketed predicate devices, implying their established safety and effectiveness forms the "ground truth" for equivalence.
-
The sample size for the training set:
- Not applicable. No "training set" in the machine learning sense is relevant for this device.
-
How the ground truth for the training set was established:
- Not applicable.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.