(7 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 herniated 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 and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. The Idys®-C ZP 3DTi device is to be implanted via an open, anterior approach.
The Idys® C ZP 3DTi device consists of a cervical intervertebral body fusion system. The device is manufactured from medical grade Titanium alloy and is to be used with autograft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone graft. 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 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. It is essential to insert implants with instrumentation specifically designed for this purpose.
The Idys® C ZP 3DTi device consists of cages and screws, as well as associated surgical instruments.
This document describes the regulatory clearance of a medical device and, as such, focuses on substantial equivalence rather than a clinical study evaluating an AI device's performance against acceptance criteria. Therefore, most of the requested information regarding AI device performance (like MRMC studies, standalone performance, ground truth, and training set details) is not applicable or cannot be extracted from this type of document.
The document primarily discusses the Idys® C ZP 3DTi intervertebral body fusion device and its substantial equivalence to a legally marketed predicate device (IDYS® C ZP 3DTi, K212562). The "Performance Data" section specifically details non-clinical testing for the screws of the device.
Here's the breakdown of the information that can be extracted or commented on, based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for clinical efficacy. Instead, it refers to non-clinical testing to demonstrate substantial equivalence for the screws' mechanical properties. The acceptance is based on the subject device performing at least as well as the predicate device.
| Acceptance Criteria (Implied for Screws) | Reported Device Performance |
|---|---|
| Axial pullout load (per ASTM F543) | "The results of this non-clinical testing show that the subject Idys® C ZP 3DTi is substantially equivalent to legally marketed predicate device." (This implies the subject device met or exceeded the performance of the predicate device in axial pullout). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in terms of number of screws or tests, but it refers to "the subject Idys® C ZP 3DTi screws".
- Data Provenance: The testing is "non-clinical testing," implying laboratory-based mechanical testing, not human-derived patient data. Therefore, country of origin or retrospective/prospective does not apply in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving expert-established ground truth for clinical outcomes or image interpretation. It's a mechanical performance test.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations.
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 document pertains to a physical medical device (intervertebral fusion system), not an AI-based diagnostic or assistive software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as it's not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate device, against which the subject device's performance (e.g., axial pullout load) is compared to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable, as this is not an AI device that requires a training set.
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.