(29 days)
The Tranquil-C™ Interbody System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 – T1. The Tranquil-CTM Interbody System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Tranquil-C™ Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
The Tranquil-C™ Interbody System is a cervical interbody fusion system. Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The implants are offered in various angles, widths, heights, and lengths to meet patient anatomy for the cervical spine. Implants are provided non-sterile or sterile via gamma irradiation. Instruments are provided clean and non-sterile for steam sterilization at the user's facility.
The purpose of this special 510(k) is to gain clearance for modifications to existing cervical implants and the size range offered.
The provided document is a 510(k) summary for the Nexus Spine Tranquil-C Interbody System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on clinical studies or performance objectives with measurable outcomes.
Therefore, the document does not contain the acceptance criteria or the study that proves the device meets specific acceptance criteria in the way you've described for a typical diagnostic or AI-driven device.
Here's why and what information is available:
- Device Type: The Tranquil-C Interbody System is an implantable medical device (intervertebral body fusion device) for spinal fusion surgery. Its "performance" is primarily assessed through mechanical and biocompatibility testing, and its safety and effectiveness are established by demonstrating substantial equivalence to predicate devices that have already proven safe and effective.
- 510(k) Process: A 510(k) submission aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and materials. If significant differences exist, performance testing (e.g., mechanical, biocompatibility) is conducted to ensure the new device is as safe and effective as the predicate.
- Lack of Clinical Study with Acceptance Criteria: The document explicitly states: "Engineering analysis has determined that the subject changes do not create a new worst case condition. Therefore, previously conducted testing remains applicable and no additional performance testing is required." This means no new performance study (e.g., a clinical trial comparing outcomes or an AI-specific validation study) was conducted for this specific 510(k) submission. The safety and effectiveness are inferred from the predicate devices and existing testing.
Consequently, I cannot fill out your requested table and information points as they are designed for a different type of device evaluation (e.g., diagnostic accuracy, AI performance).
However, I can extract what is relevant from the document regarding the device's assessment:
1. Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria (Implied): The implied acceptance criterion for a 510(k) is "substantial equivalence" to the predicate devices in terms of safety and effectiveness. This is typically met by demonstrating that the new device has similar technological characteristics, materials, and intended use as the predicate, and any differences do not raise new questions of safety or effectiveness.
- Reported Device Performance:
- Mechanical/Biocompatibility (Inferred from Predicate): The device is manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, indicating compliance with recognized standards for implantable materials. The document states "previously conducted testing remains applicable" from the predicate devices (Nexus Spine, LLC Tranquil Interbody System – K181483, K170297, Spinal Elements, Ventana™ C - K222833, Nexus Spine, LLC – Stable L and Stable C Interbody System – K232530). This implies the device, through its substantial equivalence, meets the mechanical and biocompatibility performance standards established by these predicate devices. The "performance" here refers to attributes like strength, fatigue resistance, and biological inertness, which are typically assessed through lab-based mechanical testing, not through diagnostic accuracy metrics of an AI.
2. Sample Size for Test Set and Data Provenance:
- Not applicable. This is not an AI/diagnostic device and no "test set" in that context was used for this submission. The evaluation relies on engineering analysis and comparison to predicate devices, not patient data from a test set.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable. Ground truth, in the context of expert consensus for diagnostic accuracy, is not relevant for this type of device submission. The "ground truth" for the device's safety and effectiveness is established through the regulatory clearance of its predicate devices and the robust engineering principles applied to its design and materials.
4. Adjudication Method:
- Not applicable. No adjudication of expert opinions on a test set occurred.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not a diagnostic device or product involving human readers interpreting images with or without AI assistance.
6. Standalone Performance:
- Not applicable. This is not an algorithm whose standalone performance would be evaluated.
7. Type of Ground Truth Used:
- Regulatory/Engineering Equivalence: The "ground truth" for this submission is the established safety and effectiveness of the legally marketed predicate devices, supported by engineering analysis that demonstrates the new device is as safe and effective despite minor modifications.
8. Sample Size for Training Set:
- Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How Ground Truth for Training Set was Established:
- Not applicable.
In summary: The provided FDA letter and 510(k) summary are for a traditional medical device (interbody fusion system) seeking market clearance via the substantial equivalence pathway, not a software-as-a-medical-device (SaMD) or AI-driven diagnostic. Therefore, the details about acceptance criteria and studies you've requested are not present because they are not typically required or relevant for this type of submission.
§ 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.