(123 days)
The VariSync Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The VariSync Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The VariSync Spacer is to be filled with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. These devices are intended to be used with supplemental fixation such as the Zavation VariSync Plate, Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems. When used with the VariSync Plate, the assembly takes on the indications of the VariSync Spacer, with the VariSync Plate acting as the supplemental fixation.
The VariSync Plate is an anterior, cervical fixation device available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates are made from titanium alloy, as specified in ASTM F136. The Screws for use with the VariSync Plates are manufactured from titanium alloy, as specified in ASTM F136.
VariSync Spacers are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and footprints to fit the anatomical needs of a wide variety of patients. These devices are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The VariSync Spacers are manufactured from radiolucent PEEK polymer, with tantalum markers, as specified in ASTM F2026 and F560.
The provided document is a 510(k) premarket notification for the Zavation VariSync Plate System & VariSync Spacer System. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance study results like those expected for novel device approval or AI-based software.
Therefore, many of the requested details, such as specific acceptance criteria in numerical terms, sample sizes for test sets (as these are not clinical studies for efficacy in the same way), number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance details, training set information, or how ground truth was established for training sets, are not applicable to this type of submission.
Instead, the document highlights mechanical testing to show that the new device performs similarly to existing, legally marketed predicate devices.
Here's an breakdown of the information that is available in the provided text:
1. A table of acceptance criteria and the reported device performance:
The document does not present a table of specific numerical acceptance criteria (e.g., "Accuracy > 90%"). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through mechanical testing. The reported performance is that the "mechanical test results demonstrated that the Zavation VariSync Plate System and The VariSync Spacer System is substantially equivalent to the predicate devices."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance similar to predicate devices in mechanical tests | Demonstrated substantial equivalence to predicate devices via mechanical test results |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "test set" in the context of clinical or AI studies. For mechanical testing, the "sample size" would refer to the number of devices or constructs tested. This detail is not provided in the summary.
- Data Provenance: The mechanical testing was performed in accordance with recognized ASTM standards (F2077, F2267, F1717). The location or specific laboratory where these tests were conducted is not mentioned. This is not a human data provenance (e.g., country of origin, retrospective/prospective) but rather a lab-based, engineering testing provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context refers to the physical properties and performance characteristics determined by standardized mechanical tests, not expert medical opinion on a dataset.
4. Adjudication method for the test set:
- Not applicable. The "ground truth" for mechanical testing is derived from the results of the standardized tests themselves, not through expert adjudication.
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:
- Not applicable. This is a medical device for spinal fusion, not an AI software device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
- Mechanical Performance Data: The "ground truth" is established by the results of standardized mechanical tests (ASTM F2077, ASTM F2267, ASTM F1717) designed to assess the strength, stability, and other physical properties of intervertebral body fusion devices and spinal implant constructs.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of AI or machine learning for this type of device submission. The device's design is based on engineering principles and similarity to predicate devices.
9. How the ground truth for the training set was established:
- Not applicable. As there's no training set, there's no ground truth for it.
In summary:
The provided document describes a traditional 510(k) submission for a physical medical device (spinal implantation system). The "study" mentioned is mechanical testing performed according to ASTM standards. The purpose of this testing is to demonstrate that the various components of the Zavation VariSync Plate System and VariSync Spacer System perform mechanically in a way that is substantially equivalent to legally marketed predicate devices, thereby establishing their safety and effectiveness for their intended use. This is a crucial distinction from AI/Software as a Medical Device (SaMD) clearances which would typically involve the types of detailed data analysis and ground truth assessment you've inquired about.
§ 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.