(73 days)
The Cynch System is indicated for intervertebral body fusion of the lumbar spine, from L2 to SI, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The SpineSmith Cynch System is offered in two (2) configurations of various sizes. The configurations are designed based on indicated spinal implant level and surgical approach. The system consists of the Cynch TLIF device for transforaminal lumbar approach and the Cynch PLIF/T-PLIF device, which may be implanted via a posterior lumbar bi-lateral approach or transverse lumbar approach. The Cynch System implants are manufactured from PEEK Optima LT1 and contain three (3) radiopaque tantalum markers to assist the surgeon with proper placement of the device.
The Cynch System implants are hollow to allow for the placement of autograft bone, and have large anterior graft windows to facilitate fusion. There are teeth on the superior and inferior surface of the implants to provide increased stability and inhibit movement of the implant. The implants have horizontal grooves to locate the implant holder superior/inferior and rotationally. Additionally, a cross-bar is provided to minimize buckling during insertion.
The provided document describes the SpineSmith Cynch Spinal System, an intervertebral body fusion device. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical mechanical testing.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Regulations/Standards) | Reported Device Performance (from Non-Clinical Testing) |
|---|---|
| Static Compression Performance (per ASTM F2077-03) | Substantially equivalent results to predicate devices |
| Dynamic Compression Performance (per ASTM F2077-03) | Substantially equivalent results to predicate devices |
| Subsidence Performance (per ASTM F2267-04) | Substantially equivalent results to predicate devices |
| Expulsion Performance (per ASTM Draft Standard F-04.25.02.02) | Substantially equivalent results to predicate devices |
Explanation: The "acceptance criteria" here are defined by the referenced ASTM standards, which specify methods and requirements for evaluating the mechanical properties of intervertebral body fusion devices. The reported "device performance" indicates that the SpineSmith Cynch Spinal System achieved "substantially equivalent results" when tested according to these standards, meaning its mechanical performance was comparable to the predicate devices which have already been deemed safe and effective.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "non-clinical tests" and "results" but does not quantify the number of units tested for each mechanical assessment.
- Data Provenance: Not applicable in the context of clinical data provenance (country of origin, retrospective/prospective). These are non-clinical mechanical tests conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This is a mechanical device, and "ground truth" for its performance is established through adherence to standardized engineering tests (ASTM standards) rather than expert consensus on clinical interpretation or outcomes.
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, the "test set" refers to mechanical properties evaluated against engineering standards. There is no human adjudication process involved in interpreting these test results beyond ensuring adherence to test protocols and data analysis.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a mechanical device, and an MRMC study is relevant for evaluating diagnostic or imaging devices where human readers interpret medical images. This document describes non-clinical mechanical tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance: The "ground truth" for demonstrating the safety and effectiveness of the Cynch System is its ability to perform equivalently to predicate devices when subjected to established mechanical testing standards (ASTM F2077-03, ASTM F2267-04, ASTM Draft Standard F-04.25.02.02).
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.