(66 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 Cynch System Visualif is a stand-alone device intended to be used with the two bone screws provided and the accompanying anterior cover plate. Should the physician choose to use fewer than the two screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided.
The Visualif System is part of the Cynch Spinal System and is available in various sizes to accommodate individual patient anatomy. The Visualif implant is a lumbar intervertebral body fusion device that is intended to be implanted singularly via an open anterior approach. Visualif is a stand-alone device intended to be used with two (2) bone screws provided and the accompanying anterior cover plate assembly. NOTE: The cover plate assembly and screws are part of the implant construct.
Addition of an ALIF version to the existing Cynch System is intended to provide surgeons with additional surgical approach options. There are no changes with respect to indications or intended use as compared to the Cynch Spinal System cleared previously via K090376.
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 subject device (Visualif - ALIF device) has similar technological characteristics as the predicate devices identified above (SpineSmith's Cynch System per K090376).
The provided text describes a medical device, the "SpineSmith Cynch Spinal System - Visualif Interbody Fusion Implant System," and its clearance process. However, it does not contain information about acceptance criteria in the typical sense for evaluating device performance in a clinical study (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" can be inferred from the non-clinical testing performed to establish substantial equivalence to a predicate device.
The study presented is a non-clinical testing study conducted to demonstrate substantial equivalence, not a clinical trial evaluating human performance or AI effectiveness.
Here's an breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
Since this is a non-clinical substantial equivalence study, the "acceptance criteria" are implied by the comparison to the predicate device's performance in mechanical tests. The reported device performance is that the subject device's results were "substantially equivalent" to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance equivalent to predicate in Static Compression (ASTM F2077-03) | Results demonstrated substantial equivalence to predicate device. |
| Performance equivalent to predicate in Dynamic Compression (ASTM F2077-03) | Results demonstrated substantial equivalence to predicate device. |
| Performance equivalent to predicate in Static Compression-Shear (ASTM F2077-03) | Results demonstrated substantial equivalence to predicate device. |
| Performance equivalent to predicate in Dynamic Compression-Shear (ASTM F2077-03) | Results demonstrated substantial equivalence to predicate device. |
| Performance equivalent to predicate in Subsidence (ASTM F2267-04) | Results demonstrated substantial equivalence to predicate device. |
| Performance equivalent to predicate in Expulsion (ASTM Draft Standard F-04.25.02.02) | Results demonstrated substantial equivalence to predicate device. |
| Performance equivalent to predicate in Wear Debris Characterization (ASTM F1877) | Results demonstrated substantial equivalence to predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of devices or tests. The document refers to "testing" being conducted in accordance with ASTM standards. For mechanical testing of medical devices, samples are typically tested until statistical significance is achieved or to meet the requirements of the specific ASTM standard. The exact number of samples (e.g., number of implants tested per condition) is not provided.
- Data Provenance: Not applicable in the context of geographical origin for mechanical testing. The testing was non-clinical (laboratory-based) as opposed to human or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. This was a non-clinical, mechanical testing study comparing a device to a predicate based on standardized ASTM test methods. No human experts were involved in establishing "ground truth" in the way they would for, say, image interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There was no "ground truth" established by human experts requiring adjudication in this type of mechanical testing study.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission concerns a physical medical implant (intervertebral fusion device) and involves non-clinical mechanical testing, not an AI-powered diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" in this context is the performance of the predicate device measured against established ASTM standards for mechanical properties. The goal was to show that the subject device's performance was "substantially equivalent" to that of the already cleared predicate device.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a non-clinical study for a physical implant, not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable, as there was no training set for an AI/machine learning model.
§ 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.