(59 days)
The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended to be used with the screws provided and requires no additional supplementary fixation.
The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. It is to be used in patients who have had at least six weeks of non-operative treatment. This device is intended to be used with autogenous bone graft.
The Pro-Link® Ti Stand-Alone Cervical Spacer System is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium (Ti 6Al-4V ELI). The implant is hollow to permit packing with autogenous bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to prevent rotation and/or migration. The implant has two pockets to permit placement of titanium bone screws (Ti 6Al-4V ELI) through the interbody to provide internal fixation. The implant also has one central threaded hole to permit the insertion of a titanium lock plate (Ti 6A1-4V ELI) to prevent screw back out.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Pro-Link Ti Stand-Alone Cervical Spacer System components with components from any other system or manufacturer. The PRO-LINK Ti Stand-Alone Cervical Spacer System components should never be reused under any circumstances.
The provided document, an FDA 510(k) premarket notification letter, describes the "Pro-Link® Ti Stand-Alone Cervical Spacer System." However, it does not contain the specific information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria.
This document is a regulatory clearance for a medical device (an intervertebral body fusion device), stating that it is substantially equivalent to legally marketed predicate devices. It focuses on:
- Device Name: Pro-Link® Ti Stand-Alone Cervical Spacer System
- Regulation Information: Classification, product code, regulation number.
- Indications for Use: Spinal fusion in skeletally mature patients with degenerative disc disease (DDD) at one disc level (C2-T1), used with provided screws and autogenous bone graft, after six weeks of non-operative treatment.
- Device Description: Material (titanium Ti 6Al-4V ELI), design features (hollow for bone graft, superior/inferior teeth, pockets for bone screws, threaded hole for lock plate).
- Technological Characteristics & Material: Stating substantial equivalence to predicates in design, materials, indications for use, and sizing. It specifically mentions the use of implant grade (Ti-6AL-4V) Titanium alloy according to F136, same as predicate devices.
- Performance Data: States that "Engineering rationales and FEA were provided to demonstrate the substantial equivalency." This refers to in silico (computational) analysis rather than clinical or human reader studies.
- Substantial Equivalence Conclusion: Confirms substantial equivalence based on indications for use, design, function, materials used, and mechanical performance.
Therefore, it is not possible to fill out the table or answer most of your detailed questions based on the provided text, as this type of information is typically found in the full 510(k) submission or associated test reports, which are not included here.
Here's what can be inferred or stated as "not applicable/not found" based on the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. | The document states "Engineering rationales and FEA were provided to demonstrate the substantial equivalency." This implies mechanical performance criteria were met, but specific thresholds are not detailed here. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not applicable. This document refers to engineering rationales and FEA (Finite Element Analysis) for substantial equivalence, not human clinical test sets.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No human test set or ground truth establishment by experts is described for performance evaluation in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No human test set is described.
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
- No. This is a spinal implant, not an AI diagnostic device. MRMC studies are not relevant for this device type.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The performance data mentioned refers to engineering rationales and Finite Element Analysis (FEA), typically comparing mechanical properties to established safety standards or predicate device specifications.
8. The sample size for the training set
- Not applicable. No "training set" in the context of machine learning or clinical trials is mentioned. The device's design is based on engineering principles and comparison to predicate devices, not iterative training.
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.