(120 days)
The Talos™ IBF Device is an intervertebral body device intended for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Talos™ IBF devices are intended to be used with autologous bone graft to facilitate fusion. The Talos™ IBF device is to be used in patients who have had six months of non-operative treatment.
Talos™ IBF devices are to be implanted via a direct posterior, transforaminal, lateral or anterior approach. The Talos™-P device is implanted in pairs, while the Talos™-A, Talos™-L and Talos™-T devices may be implanted singly or in pairs in the lumbosacral spine. The Talos™-A, Talos™-L, Talos™-P, and Talos™-T are intended to be used with supplemental fixation.
The Talos™ IBF Device is made of PEEK-OPTIMA®. Talos™ IBF Device is available in four The configurations: Talos™-P, Talos™-T, Talos™-L, and Talos™-A. The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos™-P and Talos™-L are rectangular devices and the Talos™-T and Talos™-A 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 allow the Talos™ IBF radiological confirmation for proper positioning.
The provided text describes a 510(k) premarket notification for the "Talos™ Intervertebral Body Fusion (IBF) Device." It outlines the device's description, intended use, and indicates its conformance to specific guidance documents and mechanical testing standards. However, the document does not contain information regarding a study that assesses the device's performance against specific acceptance criteria in terms of clinical outcomes, diagnostic accuracy, or comparative effectiveness (e.g., with human readers, for an AI device).
The "Performance Data" section explicitly states: "Talos™ IBF devices conforms to Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices, June 12, 2007. Mechanical testing was conducted per ASTM F 2077-03 and ASTM F 2267-04." This indicates that the performance data for this device relates to mechanical testing standards, not a clinical or AI-related performance study as typically described by the provided questions.
Therefore, many of the requested fields cannot be filled as they pertain to a type of study not present in the given text.
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by document) | Reported Device Performance (from document) |
|---|---|
| Conformance to Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices, June 12, 2007 | Talos™ IBF devices conforms to Class II Special Controls Guidance Document: Intervertebral Body Fusion Devices, June 12, 2007. |
| Compliance with ASTM F 2077-03 (Standard Test Method for Intervertebral Body Fusion Device Static Compressive Mechanical Testing) | Mechanical testing was conducted per ASTM F 2077-03. (Implies compliance/satisfaction) |
| Compliance with ASTM F 2267-04 (Standard Test Method for Measuring Load-Displacement Properties of Spine Constructs in Compression and Shear) | Mechanical testing was conducted per ASTM F 2267-04. (Implies compliance/satisfaction) |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes mechanical testing, not a clinical or AI performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for clinical or diagnostic performance is not mentioned. Mechanical testing standards dictate the "ground truth" through specified methodologies and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This pertains to clinical or diagnostic assessment, not mechanical testing.
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 device is an intervertebral body fusion device, not an AI or diagnostic imaging device. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This pertains to AI devices. The Talos™ IBF Device is a physical implant.
7. The type of ground truth used
For mechanical testing, the "ground truth" is defined by the objective measurements and parameters specified in the ASTM standards (F 2077-03 and F 2267-04). These standards dictate the conditions, methods, and acceptance criteria for evaluating the mechanical properties of the device.
8. The sample size for the training set
Not applicable. This pertains to AI/machine learning. The document describes a physical medical device.
9. How the ground truth for the training set was established
Not applicable. This pertains to AI/machine learning.
§ 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.