(49 days)
The Steerable Plateau TI 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. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone 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 Steerable Plateau TI 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 titanium alloy (Ti-6AI-4V ELI) described by ASTM F136. 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 Steerable Plateau TI components with components from any other system or manufacturer. The Steerable Plateau TI components should never be reused under any circumstances.
The provided document is an FDA 510(k) clearance letter and summary for a medical device called "Steerable Plateau TI," an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study involving AI or human readers.
Therefore, many of the requested details about acceptance criteria, performance in a clinical setting, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies are not applicable or not available in this document. The document describes mechanical performance testing, but not clinical performance with human operators or AI.
However, I can extract information related to the device itself and its mechanical testing.
1. A table of acceptance criteria and the reported device performance
Based on the document, the acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices in mechanical testing standards. The reported performance refers to successfully meeting these standards for the tests conducted.
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | ASTM F2077 (includes): | Demonstrate performance comparable to or exceeding predicate devices within specified limits for intervertebral body fusion devices. | Successfully tested according to ASTM F2077. |
| - Static Compression | Performance data not numerically detailed, but implies successful completion. | ||
| - Static Compression Shear | Performance data not numerically detailed, but implies successful completion. | ||
| - Dynamic Compression | Performance data not numerically detailed, but implies successful completion. | ||
| - Dynamic Compression Shear | Performance data not numerically detailed, but implies successful completion. | ||
| ASTM F2267 (includes): | Demonstrate performance comparable to or exceeding predicate devices within specified limits for intervertebral body fusion devices. | Successfully tested according to ASTM F2267. | |
| - Static Expulsion | Performance data not numerically detailed, but implies successful completion. | ||
| - Subsidence | Performance data not numerically detailed, but implies successful completion. | ||
| Material Equivalence | ASTM F136 | Device material (Ti-6Al-4V ELI) must conform to ASTM F136. | Fabricated from Ti-6Al-4V ELI as described by ASTM F136. |
| Design/Function | N/A | Design and function comparable to predicate devices. | Stated to be substantially equivalent in design and function to predicate devices. |
| Indications for Use | N/A | Indications for Use must be substantially equivalent to predicate devices. | Stated to be substantially equivalent in indications for use to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes mechanical testing of the device, not a clinical study with a "test set" of patient data in the context of AI or human reading. Therefore, this information is not applicable in the sense of a clinical study.
For mechanical testing, the "samples" would be the manufactured devices themselves. The document does not specify the number of devices tested for each mechanical test. The provenance would be the laboratory where the tests were performed; this is not specified but would typically be an in-house lab or a contracted testing facility.
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. The document does not describe a study involving expert readers or ground truth establishment for patient data. It describes mechanical performance testing of an implantable device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The document does not describe a study involving adjudication of clinical results.
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 is not applicable. The document describes an intervertebral body fusion device and its mechanical testing, not an AI-assisted diagnostic tool or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The document describes an implantable medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for mechanical testing is defined by the physical laws and engineering standards (ASTM F2077, ASTM F2267). The device's performance against these standards constitutes the "truth" being assessed for substantial equivalence.
8. The sample size for the training set
This is not applicable. The document does not describe an AI device with a training set.
9. How the ground truth for the training set was established
This is not applicable. The document does not describe an AI device with a training set or its ground truth establishment.
§ 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.