(184 days)
Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intervertebral body devices intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on the posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by history and radiographic studies. Talos®-C (HA) Cervical IBF Devices are intended to be used with autologous bone graft to facilitate fusion.
Non-operative treatment prior to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) weeks.
Talos®-C (HA) Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation.
The Talos® -C (HA) Cervical Intervertebral Body Devices (Talos®-C (HA) Cervical IBF Devices) are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C (HA) Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, tantalum markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.
The provided document is a 510(k) summary for a medical device called Talos®-C (HA) Cervical Intervertebral Body Fusion Devices. This type of regulatory filing demonstrates substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed results for sensitivity, specificity, and other performance metrics typically associated with AI/software devices.
Therefore, the requested information elements related to AI device performance are not applicable and cannot be extracted from this document. This document focuses on the mechanical and material equivalence to a predicate device, as well as the indications for use.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or AUC as one would expect for an AI device. Instead, the acceptance criteria for this 510(k) submission are implied to be the successful demonstration of substantial equivalence to the predicate device, particularly in terms of mechanical function and properties.
The reported device performance is that the Talos®-C (HA) Cervical IBF Devices are equal in mechanical function and properties to the predicate device, thereby establishing equivalency in safety and effectiveness.
| Acceptance Criteria (Implied for 510(k) Mechanical Equivalence) | Reported Device Performance |
|---|---|
| Exhibit similar mechanical function and properties to the predicate device. | The Talos®-C (HA) Cervical IBF Devices were found to be equal in mechanical function and properties to the predicate device (K122850: Meditech Advisors, LLC Talos®-C Cervical Intervertebral Body Fusion Devices). |
| Pass tests according to ASTM 2077 (static compression, compression shear, torsion, dynamic compression, dynamic compression shear, dynamic torsion) and ASTM 2267 (subsidence testing). | The device successfully underwent testing according to ASTM 2077 (static compression, compression shear and torsion tests, dynamic compression, compression shear and torsion tests) and ASTM 2267 (subsidence testing). |
| Maintain mechanical integrity after simulated aging. | Simulated aging was performed, and the device was subjected to additional dynamic compression and torsion tests in accordance with ASTM 2077, implying successful performance post-aging. |
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 non-clinical mechanical testing of physical devices (implants), not a study involving patient data. Therefore, the concept of "sample size for the test set" in the context of patient data, data provenance, retrospective/prospective study, or country of origin is not applicable. The "test set" here refers to the physical devices manufactured and tested. The document does not specify the number of individual implants tested in each mechanical test, but it refers to standard ASTM methods, which typically involve a specified number of samples for statistical validity.
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 ground truth for mechanical testing is established by the physical measurements and standards defined in the ASTM test methods, not by expert human interpretation of data like in medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as it pertains to human interpretation of data, which is not what this document describes.
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. This submission is for mechanical spinal implants, not an AI device or software that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on established engineering standards and physical measurements from mechanical testing (e.g., force, displacement, cycles to failure) as defined by ASTM 2077 and ASTM 2267.
8. The sample size for the training set
This is not applicable. The device is not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. The device is not an AI or machine learning model.
§ 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.