(377 days)
The Small PLATEAU Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft and a supplemental internal spinal fixation system.
The Small PLATEAU 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 Polyetheretherketone (PEEK-OPTIMA LT1) with radiographic markers. The implant is hollow to permit packing with 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.
The provided text describes the 510(k) submission for the Plateau-C Spacer System, a medical device. This is a premarket notification for a medical device seeking substantial equivalence to existing devices, not a study evaluating AI performance. Therefore, many of the requested fields related to AI, ground truth, experts, and human reader performance are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate devices & standards) | Reported Device Performance (Plateau-C Spacer System) |
|---|---|
| Biocompatibility: Meet ISO 10993 standards for implantable contact > 30 days. | PEEK-OPTIMA (material) has proven biocompatibility for implantable contact greater than 30 days to the ISO 10993 standard. Independent laboratories performed relevant ISO 10993 testing. Invibio (material manufacturer) has Device Master Files (MAF 1209) with ISO 10993 testing and extensive data. Life Spine has access letters to these files. |
| Biomechanical Performance: Substantial equivalence to predicate devices under ASTM F2077 and F2267. This includes: | The Small PLATEAU Spacer System demonstrated substantial equivalence to the predicate devices through biomechanical testing. Tests performed on 14mm x 14mm, 7 implants (optimal size to match predicate testing) included: Static axial compression, static expulsion, static subsidence, static torsion, dynamic axial compression, and dynamic torsion. The "worst case construct" (14x14mm, 7 implants with worst-case wall thickness) was tested. Test results indicate substantial equivalence. |
| - Static axial compression | Performed, results led to substantial equivalence finding. |
| - Static expulsion | Performed, results led to substantial equivalence finding. |
| - Static subsidence | Performed, results led to substantial equivalence finding. |
| - Static torsion | Performed, results led to substantial equivalence finding. |
| - Dynamic axial compression | Performed, results led to substantial equivalence finding. |
| - Dynamic torsion | Performed, results led to substantial equivalence finding. |
| Indications for Use: | "Spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. To be used in patients who have had at least six weeks of non-operative treatment, with autogenous bone graft and a supplemental internal spinal fixation system." This matches the predicate devices in the equivalency section. |
Study Proving Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a biomechanical testing study conducted in accordance with ASTM (American Society for Testing and Materials) standards ASTM F2077 and F2267.
2. Sample size used for the test set and the data provenance
- Sample Size: 7 implants of 14mm x 14mm (this was determined to be the optimal and worst-case size for testing).
- Data Provenance: The biomechanical testing was performed at Empirical Testing, an independent testing facility. The report number is #199-534806-115. No country of origin is explicitly stated for Empirical Testing, but the submission is to the U.S. FDA, implying a U.S.-based or recognized facility. This was a prospective test designed to evaluate the physical properties of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is Not Applicable (N/A). This submission is for a physical medical device (intervertebral spacer) based on material biocompatibility and biomechanical performance, not an AI or diagnostic device that requires expert-established ground truth on patient data. The "ground truth" here is the physical performance against established engineering standards.
4. Adjudication method for the test set
This section is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving human interpretation or AI output. This study involved objective biomechanical testing where metrics are measured directly against standards.
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
This section is Not Applicable (N/A). This is not an AI-assisted diagnostic device, so no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is Not Applicable (N/A). This is not an algorithm or AI device.
7. The type of ground truth used
The "ground truth" for this device's performance is based on:
- Biocompatibility Standards: Adherence to ISO 10993 standards.
- Biomechanical Performance Standards: Adherence to ASTM F2077 and F2267 mechanical testing standards.
- Predicate Device Performance: The biomechanical results were compared against the known performance characteristics of the legally marketed predicate devices to establish substantial equivalence.
8. The sample size for the training set
This section is Not Applicable (N/A). This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This section is Not Applicable (N/A). As there is no training set, there is no ground truth to establish for it.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.