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510(k) Data Aggregation
(205 days)
The Plateau-LO Spacer System
The Plateau-LO Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
The Plateau-LO Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from PEEK (Polyetheretherketone) with tantalum markers. The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau-LO Spacer System components with components from any other system or manufacturer. The Plateau-LO Spacer System components should never be reused under any circumstances.
This document describes the regulatory approval of "The Plateau-LO Spacer System," an intervertebral body fusion device. The information provided is for a 510(k) premarket notification and focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than a detailed clinical study demonstrating device performance against specific acceptance criteria in the way one might expect for a diagnostic AI device.
Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of regulatory submission and the information available. The document is primarily concerned with proving the new device is as safe and effective as existing, legally marketed devices.
Here's an attempt to address your request based on the provided text, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
The document does not present specific quantitative acceptance criteria or reported device performance in the way a diagnostic AI device study would. Instead, it relies on demonstrating "substantial equivalence" to predicate devices based on design, materials, indications for use, and mechanical performance.
| Criterion Type | Acceptance Criteria (Not explicitly stated as numerical targets) | Reported Device Performance (Summary of evidence presented) |
|---|---|---|
| Design Equivalence | The Plateau-LO Spacer System's design should be comparable to the predicate devices. | The document states: "The Plateau-LO Spacer System is substantially equivalent to the predicate systems in terms of design..." It is fabricated from PEEK with tantalum markers and is hollow for bone graft. Similar to common intervertebral fusion devices. |
| Material Equivalence | Materials used should be comparable and possess similar biocompatibility and mechanical properties to the predicate devices. | The document states: "...materials used..." are substantially equivalent to the predicate systems. Specifically, it's made from PEEK (Polyetheretherketone) with tantalum markers, which are standard materials for such implants. |
| Indications for Use | The intended use should be the same as or very similar to the predicate devices. | The document states: "...indications for use..." are substantially equivalent to the predicate systems. The intended use is for spinal fusion in skeletally mature patients with degenerative disc disease (DDD) at L2-S1, possibly with Grade 1 spondylolisthesis, after 6 months of non-operative treatment, used with autogenous bone graft and a supplemental internal spinal fixation system. This matches typical indications for such devices. |
| Mechanical Performance | The mechanical strength and stability (e.g., resistance to expulsion) should be equivalent to or better than the predicate devices, ensuring safety and efficacy in vivo. | Data presented included "Engineering rationale, finite element analysis and expulsion testing." These studies aimed to "demonstrate the substantial equivalency of The Plateau-LO Spacer System" in terms of mechanical performance compared to the predicate devices. Specific numerical results are not provided in this summary. |
| Functional Equivalence | The device should perform its intended function (facilitating intervertebral fusion) similarly to the predicate devices. | The document states: "...function..." is substantially equivalent to the predicate systems. Its design (hollow for bone graft, teeth on surfaces) supports its function to promote fusion and prevent migration, consistent with predicate devices. |
| Sizing Equivalence | The range of available sizes should be comparable to the predicate devices to accommodate various patient anatomies. | The document states: "...sizing" is substantially equivalent to the predicate systems. It's noted that the implant is "available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient." |
| Biocompatibility (Implicit) | Materials should be biocompatible for implantation in the human body. | Though not explicitly stated as a criterion, using PEEK, a common and well-established biocompatible material for implants, implies that biocompatibility was confirmed or established through a history of safe use of similar materials in predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document is a 510(k) summary, which typically relies on non-clinical performance data (bench testing, engineering analysis) and comparison to predicate devices, rather than a clinical "test set" from patient data.
- Sample Size for Test Set: Not applicable in the context of clinical patient data. The "test set" (if we consider it as the subject of the performance data) would be the physical devices used in the engineering rationale, finite element analysis, and expulsion testing. The specific number of devices tested is not mentioned.
- Data Provenance: The studies mentioned (engineering rationale, finite element analysis, expulsion testing) are typically conducted in a laboratory setting by the manufacturer (Life Spine Inc.). No "country of origin of data" for clinical patient data is relevant here. The studies would be considered prospective in terms of how the tests were designed and executed on the device prototypes/samples.
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 is not applicable. "Ground truth" in the sense of expert consensus on clinical findings is not established for this type of submission. The ground truth here is derived from engineering principles, material science, and established acceptable performance limits for intervertebral fusion devices, as demonstrated through bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no clinical "test set" requiring adjudication by clinical experts as this is not a diagnostic device and no clinical data review is described.
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 device is a surgical implant, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this submission is established by:
- Engineering principles and material science: For the design, materials, and mechanical properties.
- Regulatory standards and guidance: For what constitutes "substantial equivalence" for intervertebral body fusion devices.
- Performance of predicate devices: The established safety and effectiveness of the legally marketed predicate devices serve as the benchmark.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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