(210 days)
The Tyber Medical Interbody Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Cervical System Indications
The Tyber Medical Cervical Interbody Systems System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.
The Tyber Medical Interbody System, manufactured from PEEK-Optima®. consist of implants available in various foot prints, heights and lordlotic configurations with an open architecture to accept packing of autograft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device comes in a PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on the superior and inferior surfaces.
The provided text describes a 510(k) premarket notification for the TYBER MEDICAL Interbody System. This is a medical device submission, and the focus of the "study" described is primarily non-clinical mechanical testing, not a clinical study involving human subjects or AI performance. Therefore, many of the requested criteria, particularly those related to AI algorithm performance, expert consensus, and ground truth for training/test sets, are not applicable to this type of submission.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Mechanical Testing | |
| Static Compression (per ASTM F2077) | "Non-clinical mechanical testing was performed consisting of Static and Dynamic Compression, Torsion, Compression-Shear per ASTM F2077." (Implied to have met the standard, as the conclusion states substantial equivalence.) |
| Dynamic Compression (per ASTM F2077) | "Non-clinical mechanical testing was performed consisting of Static and Dynamic Compression, Torsion, Compression-Shear per ASTM F2077." (Implied to have met the standard, as the conclusion states substantial equivalence.) |
| Torsion (per ASTM F2077) | "Non-clinical mechanical testing was performed consisting of Static and Dynamic Compression, Torsion, Compression-Shear per ASTM F2077." (Implied to have met the standard, as the conclusion states substantial equivalence.) |
| Compression-Shear (per ASTM F2077) | "Non-clinical mechanical testing was performed consisting of Static and Dynamic Compression, Torsion, Compression-Shear per ASTM F2077." (Implied to have met the standard, as the conclusion states substantial equivalence.) |
| Subsidence Testing (per ASTM F2267) | "Additionally, Subsidence Testing per ASTM F2267 and Expulsion testing was performed." (Implied to have met the standard, as the conclusion states substantial equivalence.) |
| Expulsion testing | "Additionally, Subsidence Testing per ASTM F2267 and Expulsion testing was performed." (Implied to have met the standard, as the conclusion states substantial equivalence.) |
| Coating Characterization | |
| Static Shear (per ASTM F1044) | "The coating characterization tests include Static Shear per ASTM F 1044, Static Tension per ASTM F 1147, and Abrasion per ASTM F 1978." (Implied to have met the standard, as the conclusion states substantial equivalence.) |
| Static Tension (per ASTM F1147) | "The coating characterization tests include Static Shear per ASTM F 1044, Static Tension per ASTM F 1147, and Abrasion per ASTM F 1978." (Implied to have met the standard, as the conclusion states substantial equivalence.) |
| Abrasion (per ASTM F1978) | "The coating characterization tests include Static Shear per ASTM F 1044, Static Tension per ASTM F 1147, and Abrasion per ASTM F 1978." (Implied to have met the standard, as the conclusion states substantial equivalence.) |
| Overall Equivalence | "All data indicates the device is substantial equivalence to the predicate systems." |
| "The Tyber Medical Interbody System is substantially equivalent to its predicate devices. This conclusion is based upon indications for use, materials, design, test data and principles of operation." |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not explicitly stated. The "test set" refers to the mechanical specimens used for non-clinical testing. The number of specimens for each test standard (ASTM F2077, F2267, F1044, F1147, F1978) would typically be defined within those standards, but the specific counts are not provided in this summary.
- Data provenance: Non-clinical mechanical testing data. There is no information about country of origin, retrospective or prospective nature as it pertains to clinical data, because this is not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This submission does not involve an AI algorithm or an expert review for ground truth on patient data. The "ground truth" here is the performance of the mechanical device against established ASTM standards.
4. Adjudication method for the test set
- Not Applicable. See point 3. Mechanical testing results are typically evaluated against pre-defined thresholds specified in the ASTM standards, not through expert adjudication in the traditional sense of clinical data.
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 hardware medical device (interbody fusion system), not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device. No algorithm was involved.
7. The type of ground truth used
- Engineering/Mechanical Standards: The "ground truth" for this device's performance is its ability to meet the specified requirements and performance characteristics outlined in the ASTM international standards (ASTM F2077, F2267, F1044, F1147, F1978) for intervertebral body fusion devices and implant coatings. This demonstrates substantial equivalence to predicate devices, not clinical efficacy or diagnostic accuracy.
8. The sample size for the training set
- Not Applicable. This is a hardware medical device. There is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.