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The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannulated form to accommodate patient anatomy. The three design types of the subject device are: 1. Standard Thread Screw (with and without slots) 2. Lag Screw (with and without slots) and 3. Washer Screw (with slots)

This appears to be an FDA 510(k) clearance letter and a 510(k) summary for the UNITY Sacroiliac Joint Fixation System. This type of documentation permits a device to be legally marketed, but it typically does not contain detailed information about the acceptance criteria and study results in the way you've requested for proving a device meets acceptance criteria, especially regarding AI or diagnostic performance studies.

The document states: "The UNITY Sacroiliac Joint Fixation does not create a new worst case for device performance; additional testing is not needed." This is a key statement indicating that the device is cleared based on substantial equivalence to an existing predicate device, not on new clinical performance data demonstrating its effectiveness in a traditional clinical trial or AI performance study.

Therefore, I cannot provide the requested information from this document. The questions you've asked (sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) are common for AI/diagnostic device clearances, but this particular device is a fixation system (essentially, screws for the sacroiliac joint), which falls under a different regulatory pathway.

To directly answer your points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The device is cleared based on equivalence to a predicate, not performance against specific criteria.
2. Sample sized used for the test set and the data provenance: Not applicable. No new test set data for performance was generated as per the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The UNITY Sacroiliac Joint Fixation System is indicated for use in skeletally mature patients for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The UNITY Sacroiliac Joint Fixation System consists of screws designed to enhance sacroiliac joint fusion. The UNITY Sacroiliac Joint Fixation System is offered in various diameters, lengths, and three screw types in cannualated form to accommodate patient anatomy. The three design types of the subject device are:

1. Standard Thread Screw (with and without slots)
2. Lag Screw (with and without slots) and
3. Washer Screw (with slots)

The provided text is a 510(k) premarket notification for the UNITY Sacroiliac Joint Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the way a diagnostic AI might.

Therefore, many of the requested fields regarding acceptance criteria and study details for an AI-based device are not directly applicable or available in this document. The document describes mechanical performance testing and biocompatibility.

Here's an analysis based on the provided text:

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

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

The document does not specify the exact sample sizes used for the mechanical tests. It states that "Three motion and stress tests were performed" and lists four tests, implying a set of samples for each test type. The data provenance is implied to be from the manufacturer (Huvexel Co., Ltd. in South Korea) through their testing activities. The nature of these tests (mechanical stress and motion) is inherently prospective as new devices would be manufactured and tested.

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)

This field is not applicable. The device is a physical implant, not a diagnostic AI system requiring expert interpretation for ground truth. The "ground truth" for the mechanical performance is defined by the standards and the physical properties observed during testing.

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

This field is not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for mechanical device testing. The assessment of mechanical performance is based on adherence to engineering standards and observed physical behavior.

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

This field is not applicable. The UNITY Sacroiliac Joint Fixation System is a physical implant, not an AI-assisted diagnostic tool.

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

This field is not applicable. The device is a physical implant, not an algorithm.

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

For biocompatibility, the ground truth is established by referencing the prior FDA clearance of the Rexious Spinal Fixation System (K111362) which used similar materials, manufacturing processes, and sterilization. This is a form of historical data/pre-established safe use.

For mechanical testing, the ground truth is established by engineering standards (ASTM F2193-14 and ASTM F543-17) which define acceptable ranges and behaviors for the specified tests. The "functioned as intended" and "stability observed as expected" implies meeting these standards.

8. The sample size for the training set

This field is not applicable. The device is a physical implant, not an AI model requiring a training set.

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

This field is not applicable. The device is a physical implant, not an AI model.

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