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The Huvex Interspinous Fusion System is a single-level, posterior, non-pedicle supplemental fixation device intended for use in the lumbar spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to the Huvex Interspinous Fusion System for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Huvex Interspinous Fusion System is intended for use at one level, in conjunction with autogenous bone graft, and not intended for stand-alone use.

The HUVEX Interspinous Fusion System consists of a left plate, a right plate, pin, bolt, inner cap, center bar, and set screw. Each of these components is provided in several sizes to allow for the construction of five different HUVEX Interspinous Fusion implant sizes. The left plate is provided assembled with the poly axial bar. The bar has a bone graft window to allow fusion between spinous process. Poly axial bar is also designed to fit the anatomical characteristics of the spinous process. The right plate is designed to be combined with left plate fixed to spinous process. Right plate contains a set screw to lock the right plate to the poly axial bar. The HUVEX Interspinous Fusion System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. In addition to the implants a set of reusable surgical instruments are provided. Both implant and instruments have trays that are used for handling and storage.

This is a 510(k) premarket notification for a medical device called the "Huvex Interspinous Fusion System." This document is a clearance letter from the FDA, and as such, it does not include the detailed study reports or acceptance criteria for the device's technical performance. Instead, it confirms that the FDA has found the device to be substantially equivalent to a previously marketed predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this specific submission (K223790).

Here's what the document does state regarding performance data and equivalence:

1. A table of acceptance criteria and the reported device performance

• No specific acceptance criteria or performance data are provided in this document directly from a study for device K223790.
• The document states: "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K162849."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable as no performance testing was conducted for K223790. The device is claimed to be identical to a previously cleared device (K162849).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as no performance testing was conducted for K223790.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as no performance testing was conducted for K223790.

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 device is a physical implant, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable as no performance testing was conducted for K223790.

8. The sample size for the training set

• Not applicable as no algorithmic training dataset is relevant for this physical implant.

9. How the ground truth for the training set was established

• Not applicable as no algorithmic training dataset is relevant for this physical implant.

Key takeaway from the document:

The FDA determined that the Dio Medical Huvex Interspinous Fusion System (K223790) is substantially equivalent to the Huvexel Co. Ltd. - Huvex Interspinous Fusion System (K162849). This determination is based on the claim that the current device is identical to the predicate device in its intended uses, indications, technological characteristics, and principles of operation. Therefore, no new performance testing was deemed necessary for this submission. The detailed performance data and acceptance criteria would have been part of the original K162849 submission.

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