(101 days)
The Anterior Lumbar Plate System is an anterior or antereolateral spinal fixation device indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels in the fusion of the lumbar or lumbosacral spine at levels L1 through S1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of solid spinal fusions in patients with degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma including fractures, tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis, spondyloysis, spondylolisthesis, stenosis and/or failed previous fusion.
The Biomet Anterior Lumbar Plate System consists of a titanium alloy plate and bone screws. The plates are available with two different lordotic curves for the lumbar or lumbosacral regions. Plates will be available in different lengths. The plates have threaded holes to accommodate bone screws, which will be available in different diameters and lengths.
This document is a 510(k) summary for the Biomet Anterior Lumbar Plate System, a medical device for spinal fixation. It establishes substantial equivalence to predicate devices based on technological characteristics and mechanical testing.
Here's an analysis of the provided text in relation to acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define "acceptance criteria" through numerical thresholds or specific performance metrics in the way a typical diagnostic device study would. Instead, the "acceptance criteria" for a 510(k) submission are implicitly met by demonstrating substantial equivalence to predicate devices.
-
Acceptance Criteria (Implicit for 510(k) via Substantial Equivalence):
- Similar intended use and indications.
- Similar technological characteristics.
- Similar principles of operation.
- No new issues of safety or effectiveness.
- Demonstrated mechanical performance equivalent to predicate devices.
-
Reported Device Performance:
- The Biomet Anterior Lumbar Plate System consists of a titanium alloy plate and bone screws.
- Plates are available with two different lordotic curves and different lengths.
- Screws are available in different diameters and lengths.
- The document states, "Based upon the mechanical testing, the Biomet Anterior Lumbar Plate is substantially equivalent for its intended use to other spinal systems currently on the market." This is the primary statement of its performance being "accepted" in the context of the 510(k) process.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document does not specify a "test set" in terms of patient data or a specific number of devices tested. The evaluation is based on "mechanical testing" of the device itself, likely involving a representative sample of plates and screws. The exact sample size for this mechanical testing is not provided.
- Data Provenance: Not applicable in the traditional sense of patient data. The "mechanical testing" would have been conducted by the manufacturer, Biomet Spine. No country of origin for this data is specified, but the applicant's address is Parsippany, NJ, USA. The testing would be prospective in the sense that it was performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This information is not provided and is generally not relevant for this type of device (spinal implant) in a 510(k) submission. The "ground truth" for a mechanical device is its physical and mechanical properties, assessed through standardized engineering tests, not expert interpretation of clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided and is not relevant. Adjudication methods are typically used in clinical studies involving interpretation of medical images or patient outcomes by multiple experts. For mechanical testing, the "adjudication" is generally based on objective measurements and comparison to predefined engineering standards or predicate device performance.
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
- No MRMC study was done. This document pertains to a physical medical device (spinal implant), not an AI/software device whose performance depends on human readers. Therefore, this section is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. This document is for a physical medical device, not a standalone AI algorithm. Therefore, this section is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance evaluation in the 510(k) process is its mechanical properties (e.g., strength, fatigue resistance, torsional stability) determined through standard engineering tests. These properties are then compared to those of legally marketed predicate devices to establish substantial equivalence. No clinical ground truth (like pathology or outcomes data) is explicitly mentioned for the 510(k) summary itself, as robust clinical trials are often not required for 510(k) clearance if substantial equivalence can be demonstrated through other means (like mechanical testing and comparison of design).
8. The sample size for the training set
- No training set is applicable or mentioned. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set mentioned or relevant for this type of device, the ground truth for it would not be established.
§ 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.