(60 days)
The Idys®-C ZP 3DTi device is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one (1) or more levels from C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as radiculopathy and/or myelopathy with hemiated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The Idys®-C ZP 3DTi device must be used with the integrated fixation screws provided. The Idys@-C ZP 3DTi device must be filled with autograft bone graft and/or allogeneic bone graft composed of cancellous bone. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.
The Idys® C ZP 3DTi is designed for use as a cervical intervertebral body fusion device. The device is manufactured from medical grade Titanium alloy and must be filled with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The device has a shape which restores the intervertebral height and lordosis. The device contains one (1) slot to receive the bone graft to promote the fusion process between the endplates. The Idys® C ZP 3DTi is a standalone system intended to be used with two (2) bone screws, bone graft and requires no additional supplementary fixation. The Idys® C ZP 3DTi cages are made of compliant ASTM F3001 and ASTM F136 Titanium alloy and screws are made of ASTM F136 Titanium alloy.
This document is a 510(k) Summary for a medical device (Idys®-C ZP 3DTi), which is a premarket notification to the FDA. It declares substantial equivalence to existing devices rather than proving performance against specific acceptance criteria in a study. Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in the provided text.
The document primarily focuses on establishing substantial equivalence through:
- Indications for Use: Demonstrating similar intended uses to predicate devices.
- Technological Characteristics: Showing similar design and materials.
- Performance Data (Mechanical Testing, Biocompatibility, Sterility/Cleaning): Proving that the device meets established standards for safety and function, aligning with predicate devices.
Here's a breakdown of what is available concerning performance and testing, and where the requested information is absent:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance in the manner typically found in a clinical study. Instead, it refers to compliance with established standards and comparison to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: No changes to manufacturing/materials | Confirmatory testing per ISO 10993-5 and ISO 10993-11 had been performed. |
| Sterility: Success against standards | Sterilization validation per ISO 11137 successfully completed. |
| Cleaning: Acceptable residue limits | Cleaning validation per ISO 19227 showed acceptable limits of residues. |
| Mechanical Strength: Substantial equivalence to Idys™ C | Mechanical testing per ASTM F2077 and ASTM F2267 demonstrated substantial equivalence. This included static/dynamic axial compression, static/dynamic compression shear, subsidence, expulsion, and static torsion testing. |
This section does not provide specific numerical metrics or thresholds for "acceptance criteria" and "reported device performance," but rather states that the device met the requirements implied by the testing standards and showed equivalence to predicates.
Study Information (Based on Available Text)
- Sample size used for the test set and the data provenance: Not applicable/Not provided. The document describes mechanical and validation testing, not a clinical study with a "test set" of patients or data in the usual sense. The testing is for the physical device itself.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment with experts is relevant for diagnostic or AI-driven devices, which is not the case for this intervertebral fusion device.
- Adjudication method for the test set: Not applicable/Not provided.
- 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 implantable medical device, not an AI-driven diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device is compliance with engineering standards (e.g., ASTM, ISO) and comparison to the mechanical properties of an established predicate device. There is no biological or diagnostic "ground truth" in the clinical sense.
- The sample size for the training set: Not applicable/Not provided. This refers to a machine learning context, which is not relevant here.
- How the ground truth for the training set was established: Not applicable/Not provided.
In summary, the provided document is a 510(k) submission for an intervertebral body fusion device, focusing on substantial equivalence to predicate devices through technical and performance testing rather than clinical study results demonstrating efficacy against specific acceptance criteria for a diagnostic or AI-based device.
§ 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.