(129 days)
Ti-Largo™ Cervical Interbody Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Ti-Largo™ Cervical Interbody Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T 1 disc levels using autograft bone. Ti-Largo™ Cervical Interbody Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
FloSpine Ti-Largo™ Cervical Interbody Cages are keystone shaped devices that have a central lumen and smaller graft windows throughout the structure of the implant. The implants are additively manufactured (ADM) using grade 23 titanium alloy powder per ASTM F3001. The implants are provided sterile (gamma radiation, 25 kGy minimum dose), are intended for single use only, and should not reused under any circumstances. Components from this system should not be used in conjunction with components from other company products.
Ti-Largo™ Cervical Interbody Cages are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine. The Ti-Largo™ Cervical Interbody System was developed for anterior cervical fusion with implants available in keystone shaped footprints ranging in size between 11 x 14mm and 16 x 18mm, thickness ranging from 5 to 14mm in 1 mm increments, 7degree lordosis for all sizes, and 0-degree lordosis for the smallest and largest sizes. The surface texture of the 3D structure of the implants resists expulsion forces.
The provided text does not contain information about acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/ML medical device. Instead, it is a 510(k) summary for the FloSpine Ti-Largo™ Cervical Interbody System, which is a physical medical device (an intervertebral body fusion device made of titanium alloy).
Therefore, I cannot provide the requested information regarding AI/ML device performance, ground truth, expert adjudication, or training/test set sample sizes, as these concepts are not applicable to the presented document.
The document discusses performance data for the physical interbody system, which includes mechanical and sterilization testing to demonstrate substantial equivalence to predicate devices.
Here's what I can extract regarding the physical device's performance data:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests conducted but does not explicitly state the numerical acceptance criteria for each test or the specific reported device performance values (e.g., actual compression strength in Newtons or number of cycles to failure). It simply states that the outcomes met "all acceptance criteria."
| Test Category | Test Standard/Type | Reported Performance |
|---|---|---|
| Mechanical Testing | Static Compression | Met acceptance criteria |
| Dynamic Compression Fatigue | Met acceptance criteria | |
| Static Torsion | Met acceptance criteria | |
| Dynamic Torsion Fatigue | Met acceptance criteria | |
| Static Expulsion | Met acceptance criteria | |
| Subsidence | Met acceptance criteria | |
| Wear Debris Analysis | Met acceptance criteria | |
| Sterilization | Gamma Radiation (SAL 10⁻⁶) | Validated based on VDmax method (ANSI/AAMI/ISO 11137-1 and 11137-2) |
2. Sample size used for the test set and the data provenance: Not applicable. These are mechanical and sterilization tests, not studies on 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 and expert adjudication are not relevant for mechanical and sterilization testing of a physical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI/ML product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to mechanical and sterilization testing.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 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.