(43 days)
The Cynch System is indicated 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.
Cynch is curved to allow for medial-lateral placement of the device, and is available in two footprints (25mm and 30mm) with a 5° lordosis in various heights. Cynch is hollow to allow for the placement of autograft bone, and has large anterior graft windows to facilitate fusion. There are teeth on the superior and inferior surface of the device to provide increased stability and inhibit movement of the implant.
This 510(k) summary describes a spinal implant device and focuses on establishing substantial equivalence for market clearance, rather than presenting a study with specific acceptance criteria related to device performance in a clinical context.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantial equivalence to predicate devices | Mechanical test results demonstrate that the Cynch System is substantially equivalent to the predicate. |
| Indications for Use | Matching predicate device indications | The Cynch System's indications for use are aligned with predicate intervertebral body fusion devices. |
| Design Characteristics | Comparable design features to predicates | Cynch is described with features (curved, two footprints, 5° lordosis, hollow, graft windows, teeth) that are functionally comparable to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not describe a clinical "test set" in the context of human subjects or a dataset for evaluating an AI/software device. The primary evaluation is mechanical testing and comparison to predicate devices. Therefore, these categories are not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as there is no mention of a test set with ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an AI/software device, and no human-reader study is mentioned.
6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)
Not applicable, as this is a physical medical device (spinal implant), not a software or AI algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context is the established mechanical performance and safety profile of legally marketed predicate devices. The Cynch Spinal System aims to demonstrate equivalence to these established devices through mechanical testing and design comparison.
8. Sample Size for the Training Set
Not applicable, as this is not an AI/software device that undergoes a "training set" process.
9. How the Ground Truth for the Training Set Was Established
Not applicable. The "ground truth" for comparison is based on the previously cleared predicate devices and their compliance with FDA regulations.
Summary of the Study and Acceptance Criteria:
The "study" described in the provided text is a 510(k) premarket notification aiming to demonstrate substantial equivalence to legally marketed predicate devices.
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Acceptance Criteria: The primary acceptance criterion is substantial equivalence to the identified predicate devices (LT-CAGE®, BAK® Cage, RAY® Threaded Fusion Cage, Lumbar I/F Cage). This means the device must be as safe and effective as a legally marketed device. This equivalence is primarily assessed through:
- Mechanical Test Data: The device must perform comparably in mechanical testing to the predicate devices. The text states: "Mechanical test results demonstrate that the Cynch System is substantially equivalent to the predicate."
- Indications for Use: The device's intended use must be the same as or comparable to the predicate devices. The indications provided are consistent with those typically found in lumbar intervertebral fusion devices.
- Technological Characteristics: The design, materials, and operational principles must be sufficiently similar to the predicate devices. The device description details aspects like its curvature, footprints, lordosis, hollowness for autograft, graft windows, and teeth for stability, implying comparison to similar features in predicates.
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Study That Proves the Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is the set of mechanical tests performed on the Cynch System, along with a comparison of its design features and indications for use against the predicate devices. The 510(k) submission itself is the document that presents this evidence to the FDA. The FDA's issuance of the 510(k) clearance signifies their agreement that substantial equivalence has been demonstrated. The provided text, however, does not include the detailed results or methodology of these mechanical tests, only the summary statement that they demonstrate substantial equivalence.
§ 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.