(198 days)
The KMTI Tesera-k SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1. KMTI Tesera-k SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation.
The KMTI Tesera-k SC System is a stand-alone system when used with the locking bolt and bone screws provided and requires no additional supplemental fixation. When used as a stand-alone system, the cages require the use of two (2) bone screws and the locking bolt.
When used without the locking bolt and two screws, the KMTI Tesera-k SC System is a non-standalone system and requires additional supplemental fixation cleared by the FDA for use in the cervical spine to augment stability and may only be used at one level.
The Tesera-k SC System (Tesera-k SC) is a spinal fusion system consisting of additively manufactured interbody devices and machined titanium bone screws and cage lock. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tesera-k SC implants are available in a variety of lordosis and footprint options with a superior and inferior porous face and internal lattice structure to offer increased capacity for bone growth.
The Tesera-k SC cages are additively manufactured then machined from Titanium alloy (Ti-6Al-4V) per ASTM F2924 or are additively manufactured from Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, and the bone screws and cage locks are machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The Tesera-k SC System may be implanted as a standalone with two internal fixation screws and the cage lock and without supplemental fixation or may be implanted as a non-standalone system without the internal fixation screws or cage lock but with FDA-cleared supplemental fixation.
The provided FDA 510(k) clearance letter for the Tesera-k SC System focuses on the substantial equivalence of an intervertebral body fusion device. Crucially, as this is a medical device clearance, the performance data provided relates primarily to mechanical testing of the device's structural integrity and does not involve clinical studies with human subjects or AI algorithms to interpret medical images.
Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone algorithm performance, AI training set details) are not applicable to this type of device clearance and the information provided.
Based on the provided document, here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance letter mentions the following non-clinical performance tests. It states that the "results of this non-clinical testing show that the strength of the Tesera-k SC System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." However, specific numerical acceptance criteria and precise reported device performance values are not detailed in this public summary document. The document only lists the types of tests performed.
| Acceptance Criteria (Not explicitly stated numerically, but implied by "sufficient for intended use" and "substantially equivalent") | Reported Device Performance (Not explicitly stated numerically, but implied by "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices") |
|---|---|
| Mechanical Performance (Implied acceptance criteria: meet or exceed predicate device performance for intended use) | "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." (Specific numerical results are not provided in this summary.) |
| Dynamic axial compression (per ASTM F2077) | Passed (implied) |
| Dynamic compression shear (per ASTM F2077) | Passed (implied) |
| Dynamic torsion (per ASTM F2077) | Passed (implied) |
| Tensile Strength (per ASTM F1147) | Passed (implied) |
| Shear Fatigue (per ASTM F1160) | Passed (implied) |
| Abrasion (per ASTM F1978) | Passed (implied) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in this context. The testing involved mechanical evaluation of the device as a physical product, not an AI algorithm on a dataset.
- Data Provenance: Not applicable for AI data. The "performance data" refers to the results of standardized mechanical tests on the device, not clinical data or image data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the clearance is for a physical medical device (intervertebral fusion device), not an AI/software device that requires expert-established ground truth on medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This question is not applicable for the same reasons as #3.
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 question is not applicable as the clearance is for a physical medical device, not an AI/software device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the clearance is for a physical medical device, not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This question is not applicable. For this type of device, "ground truth" relates to the physical and material properties meeting engineering specifications and clinical performance criteria established through mechanical testing and comparison to predicates, rather than a diagnostic 'ground truth' from human interpretation or pathology.
8. The sample size for the training set
- This question is not applicable as the clearance is for a physical medical device, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable for the same reasons as #8.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study that proves the Tesera-k SC System meets acceptance criteria consists of a series of non-clinical mechanical tests designed to assess the device's structural integrity, durability, and resistance to various forces it would encounter in its intended use. These tests were conducted according to recognized ASTM standards.
The specific tests performed were:
- Dynamic axial compression per ASTM F2077
- Dynamic compression shear per ASTM F2077
- Dynamic torsion per ASTM F2077
- Tensile Strength per ASTM F1147
- Shear Fatigue per ASTM F1160
- Abrasion per ASTM F1978
Conclusion of the Study:
The document states that "The results of this non-clinical testing show that the strength of the Tesera-k SC System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the device successfully met the performance benchmarks implicitly required for devices of its type and demonstrated equivalent or superior performance to the predicate device, K223105 (Tesera-k SC System by Kyocera Medical Technologies, Inc.). The overall technological characteristics and mechanical performance data led to the conclusion of substantial equivalence.
§ 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.