(203 days)
Talos® Intervertebral Body Fusion Devices:
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 autograft comprised of cancellous and/or corticocancellous bone graft.
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 in the lumbosacral spine. The Talos®-A, Talos®-L, Talos®-T are intended to be used with supplemental fixation.
Talos®-C Cervical Intervertebral Body Fusion Devices:
The Talos®-C Cervical Intervertebral Body Fusion Device is an intervertebral body device intended for use in sketally mature patients with Degenerative Disc (DDD) of the cervical spine at one level from C2-T1. Cervical degenerative disc disease is defined as intractable radior 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 Cervical IBF Devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
Non-operative treatment prior to treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implanted via an open anterior approach. Talos®-C Cervical IBF Devices are also to be used with supplemental fixation.
Talos®-C (HA) Cervical Intervertebral Body Fusion Devices:
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 radior 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 autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
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® IBF Device is made of polymer, polyetheretherketone (PEEK). The Talos® IBF Device is available in four configurations: Talos®-P, 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® – 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 Talos®-C Cervical Intervertebral Body Devices (Talos®-C Cervical IBF Devices) are made of the polymer, polyetheretherketone (PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C 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, titanium markers at the opposite ends are offered which allows the Talos®-C Cervical IBF Device radiological confirmation for proper positioning.
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, titanium markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.
This document is a 510(k) premarket notification for Meditech Spine, LLC's Talos® Intervertebral Body Fusion Devices. It focuses on changes to previously cleared devices, specifically the addition of allograft bone options and a change in marker material for cervical devices.
Based on the provided text, the device itself (hardware) has not undergone changes, but the submission is for modifications to the indications for use concerning bone graft material and material change for radiopaque markers. Therefore, the acceptance criteria and study information relate to demonstrating that these proposed changes do not introduce new safety or effectiveness concerns, and that the device remains substantially equivalent to its predicate devices.
Here's the breakdown of the requested information based solely on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative table format for device performance (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are implicitly that the modified indications and marker material do not increase risk and maintain substantial equivalence to the predicate devices. The "reported device performance" is framed in terms of clinical outcomes from published literature for similar devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary from clinical literature) |
|---|---|
| No new risks or safety/effectiveness concerns introduced by using allograft for bone fusion. | "Published clinical outcomes demonstrated that the use of allograft in interbody fusion procedures to treat patients with degenerative disc disease as defined above poses no new risks to patients." |
| No new risks or safety/effectiveness concerns introduced by changing marker material from tantalum to titanium in cervical devices. | "Titanium is biocompatible material and commonly used. The cervical predicate is an intervertebral body fusion device that uses titanium markers." The technological characteristics are identical to the predicate devices in terms of intended use and design, and the indications for use are similar. |
| Substantial Equivalence to Predicate Devices. | "The Talos® Intervertebral Body Fusion Devices... have identical intended use, technological characteristics, design, and principles of operation as their predicate devices; as well as similar indications for use. The proposed devices will have Titanium markers instead of tantalum, which is the same as the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated as a specific number of patients or cases. The document refers to "Published retrospective clinical data" rather than a newly conducted study by the submitter.
- Data Provenance: "Published retrospective clinical data for lumbar and cervical intervertebral body fusion devices similar to the Talos® Intervertebral Body Fusion Devices..." No specific country of origin is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. As the clinical data referenced is "published retrospective clinical data," details about expert review for ground truth within those studies would not typically be part of this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as it refers to existing published literature rather than a new study with a specific adjudication protocol.
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
- MRMC study done? No. This document is for intervertebral body fusion devices, not an AI-assisted diagnostic tool for which an MRMC study would be relevant.
- Effect size of human reader improvement with AI? Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study done? No. This document is for intervertebral body fusion devices, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document references "published clinical outcomes" for similar devices. This implies that the "ground truth" for the effectiveness of allograft in fusion procedures would be based on clinical outcomes data (e.g., fusion rates, patient reported outcomes, absence of complications) from those retrospective studies.
8. The sample size for the training set
The concept of a "training set" is not applicable here as this is not an AI/ML device being developed or validated. The document refers to existing published clinical literature.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device, and no "training set" in that context is referenced. The "ground truth" in the context of the referenced clinical literature would have been established through standard clinical follow-up and evaluation methods of the respective studies.
§ 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.