(83 days)
The Unity LX™ Anterolateral Lumbar Plate Fixation System is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine (L1-L5) above the bifurcation of the vascular structures. When properly used, this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include:
Degenerative disc disease (defined as back pain of discogenic origin with 1) degenerative disc confirmed by history and radiographic studies)
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- Pseudoarthrosis
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- Spondylolysis
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- Spondylolisthesis
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- Fracture
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- Neoplastic disease
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- Unsuccessful previous fusion surgery
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- Lordotic deformities of the spine
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- Idiopathic thoracolumbar or lumbar scoliosis
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Deformities (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or mvelomenigocele
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Neuromuscular deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with pelvic obliquity
The Unity LX Anterolateral Lumbar Fixation Plate consists of:
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- A base plate
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- A cover plate with locking setscrew
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- Bone screws
The provided text describes a 510(k) summary for the Blackstone Medical's Unity LX™ Anterolateral Lumbar Plate Fixation System. This is a medical device application for a spinal fixation system, which is typically cleared based on substantial equivalence to existing predicate devices, rather than a study with acceptance criteria in the manner of an AI/ML device.
Therefore, the information requested for AI/ML device performance (like sample size, ground truth, expert qualifications, etc.) is not applicable to this 510(k) summary. The "acceptance criteria" for this device are met by demonstrating substantial equivalence to predicate devices through mechanical testing.
Here's an interpretation based on the provided document:
Acceptance Criteria and Device Performance (in the context of a 510(k) for a physical medical device)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Similar Intended Use: The device should have the same intended purpose as legally marketed predicate devices. | The Unity LX Anterolateral Lumbar Plate Fixation System is indicated for use as an anteriorly or anterolaterally placed supplemental fixation device for the lumbar region of the spine (L1-L5) to provide temporary stabilization until solid spinal fusion develops. This is the same intended use as the predicate devices: Blackstone Medical, Inc. Unity™ Anterior Lumbar Plate Fixation System (K043548) and Synthes Anterior Tension Band System (K022791). |
| Similar Indications for Use: The conditions for which the device is used should be similar to those of predicate devices. | The Unity LX system's specific indications include Degenerative disc disease, Pseudoarthrosis, Spondylolysis, Spondylolisthesis, Fracture, Neoplastic disease, Unsuccessful previous fusion surgery, Lordotic deformities of the spine, Idiopathic thoracolumbar or lumbar scoliosis, Deformities associated with deficient posterior elements, and Neuromuscular deformity associated with pelvic obliquity. These mirror the indications of the predicate devices, confirming similar indications for use. |
| Similar Technological Characteristics: The design, materials, and operating principles should be similar to predicate devices, with any differences addressed. | The Unity LX Anterolateral Lumbar Fixation Plate consists of a base plate, a cover plate with a locking setscrew, and bone screws. The document states that the Unity LX and its predicates have "similar technological characteristics and principles of operation." The only technological differences are "minor dimensional characteristics" which were addressed. |
| No New Issues of Safety or Effectiveness: Any minor differences in design or technology must not raise new questions of safety or effectiveness compared to predicate devices. | "These differences [minor dimensional characteristics] do not present any new issues of safety or effectiveness, therefore, the Unity LX Anterolateral Lumbar Fixation Plate is substantially equivalent to its predicate devices." This statement directly addresses this criterion. |
| Mechanical Testing Demonstration: For physical devices, mechanical testing is used to affirm that the device performs equivalently to predicate devices under relevant conditions. | "Mechanical testing of the Blackstone Medical Unity LX Anterolateral Lumbar Fixation Plate System was conducted which demonstrates that the system is substantially equivalent to predicate devices..." This confirms that mechanical testing was performed to support the claim of substantial equivalence. |
2. Sample size used for the test set and the data provenance
- Not Applicable: This is a physical medical device, not an AI/ML system. "Test set" in the context of AI/ML refers to data used to evaluate the algorithm's performance. For this device, "testing" refers to mechanical stress and durability tests on physical prototypes/samples of the device itself. The document does not specify the number of individual devices or components tested, nor details on data provenance (country of origin, retrospective/prospective) for mechanical testing, as these are not standard reporting requirements for 510(k) summaries of this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: There is no "ground truth" established by human experts in the AI/ML sense for this physical device. The "truth" is determined by established engineering standards and material science principles during mechanical testing.
4. Adjudication method for the test set
- Not Applicable: No adjudication method is described as there is no "test set" in the AI/ML sense, nor a need for human expert consensus on interpretations. Mechanical test results are objective measurements against predefined engineering specifications.
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 a physical spinal implant, not an AI/ML diagnostic or assistive tool. MRMC studies are designed for evaluating the performance of imaging modalities or interpretation systems by human readers, often with and without AI assistance. This concept does not apply to a spinal fixation plate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to the performance of an AI algorithm. The device is a physical implant.
7. The type of ground truth used
- Engineering Standards and Reference Data: For this type of device, the "ground truth" for evaluating performance during mechanical testing would be established engineering standards, material properties, and comparison data from predicate devices. The goal is to show the new device performs within acceptable parameters and is at least as safe and effective as existing legally marketed devices.
8. The sample size for the training set
- Not Applicable: This is specific to AI/ML devices. There is no "training set" for a physical medical device.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set, this question is not relevant.
§ 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.