(147 days)
The Tranquil™ Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion.
The Tranquil™ Cervical Interbody System is intended for spinal fusion procedures at one level in the cervical spine (C3 to C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The cervical device is to be implanted via an open, anterior approach and packed with autogenous bone. The cervical device is to be used in patients who have had six weeks of non-operative treatment. This device system is intended for use with supplemental internal fixation systems.
The Tranquil™ Lumbar Interbody System is intended for use at either one level or two contiguous levels (12-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. The patients may have had a previous nonfusion spinal surgery at the involved level(s). The device is intended to be used with supplemental internal fixation systems.
The Tranquil Interbody System is made of Ti-6Al-4V ELI. The implant is offered in various angles, widths, heights, and lengths to meet patient anatomy for both cervical and lumbar spine. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
This document is a 510(k) premarket notification for the "Tranquil Interbody System," a spinal implant, and primarily focuses on establishing substantial equivalence to previously cleared devices rather than providing a detailed study of its performance against specific acceptance criteria for a novel AI/software component. Therefore, much of the requested information regarding AI device performance metrics, sample sizes for training/test sets, expert qualifications, and ground truth establishment is not present in this regulatory submission.
However, based on the provided text, here's what can be extracted and inferred regarding performance data and acceptance criteria relevant to the physical device:
The document states that "Verification activities based on ASTM F2077, ASTM F2267 and expulsion testing were performed. The mechanical testing demonstrated the device can be expected to perform in a manner substantially equivalent to the predicates listed above."
This indicates that the acceptance criteria for this medical device are based on demonstrating mechanical equivalence to existing, legally marketed predicate devices, as per the specified ASTM standards and additional expulsion testing. The "reported device performance" is that it met these criteria, demonstrating substantial equivalence.
Here's a breakdown of the information you requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on standards/comparison) | Reported Device Performance |
|---|---|
| Mechanical performance as per ASTM F2077 | Demonstrated substantial equivalence to predicate devices. |
| Mechanical performance as per ASTM F2267 | Demonstrated substantial equivalence to predicate devices. |
| Expulsion resistance | Demonstrated substantial equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in the provided text. Mechanical testing typically involves a set number of physical samples, but the exact quantity is not detailed here.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. This refers to mechanical testing data, which is generated in a lab setting rather than clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. For a physical device undergoing mechanical testing, "ground truth" as it pertains to expert consensus on clinical findings is not relevant. The "ground truth" would be the measured physical properties and performance against specified standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies to resolve discrepancies among human readers or evaluators of clinical data. Mechanical testing results are typically objective measurements.
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 physical interbody fusion device, not an AI/software medical device. Therefore, MRMC studies and AI-assisted human reader performance improvements are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document pertains to a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For mechanical testing, the "ground truth" would be the objective measurements of material properties and structural integrity against defined engineering standards (ASTM F2077, ASTM F2267) and the performance of the predicate devices. There is no clinical "ground truth" like pathology or outcomes data presented for this specific premarket notification, as it focuses on substantial equivalence of the device's design and mechanical properties.
8. The sample size for the training set:
- Not applicable / Not specified. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is involved.
Key takeaway from the document:
The Nexus Spine Tranquil Interbody System established its acceptance criteria and met them by demonstrating substantial equivalence in its mechanical performance (material properties, design, and structural integrity via ASTM F2077, ASTM F2267, and expulsion testing) to existing predicate devices. This type of regulatory submission (510(k)) primarily relies on this comparison rather than extensive de novo clinical trials or AI/software performance 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.