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The Medyssey Navigation System is indicated for use during the preparation and placement of Medyssey screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Medyssey Navigation System is reusable and is specifically designed for use with the Medtronic Navigation StealthStation System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. Use of the Medyssey Navigation System is limited to use only with ILIAD™ Spinal Fixation System and Zenius™ Spinal Fixation System (including Hedjet and ARTeMIS pedicle screw systems).

Medyssey Navigation System is comprised of reusable instruments intended to be used in conjunction with the Medtronic StealthStation® Navigation System and its associated NavLock arrays to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. The Medyssey Navigation System is comprised of Bone Taps and Screw Drivers. These instruments are made of medical grade stainless steel. The Medyssey Navigation System is supplied clean and non-sterile, to be sterilized by the end user.

Here's an analysis of the provided FDA 510(k) clearance letter for the Medyssey Navigation System, focusing on the acceptance criteria and the study that proves the device meets those criteria.

Note: This document is a 510(k) clearance letter, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed study protocols, results, and statistical analyses typically found in a full submission. Therefore, some information, especially regarding specific numerical performance metrics, sample sizes for test sets, and detailed adjudication methods, is not explicitly stated in this high-level summary.

Acceptance Criteria and Device Performance

The provided document defines the acceptance criteria implicitly through "Performance Testing" which aims to demonstrate "substantial equivalence to the predicate instruments" and suitability for intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated. The document mentions "comparative dimensional analysis" and "performance testing" of the Medyssey Navigation System instruments. The specific number of instruments tested, or cases/measurements included in the accuracy and functionality testing, is not provided.
• Data Provenance: Not explicitly stated. The nature of the testing ("comparative dimensional analysis," "functionality, accuracy and compatibility with the Medtronic StealthStation® System") suggests laboratory and/or bench testing. There is no indication of clinical data from patients or a specific country of origin for the data beyond Medyssey Co, Ltd. being based in Korea. It appears to be a prospective test conducted for the purpose of this submission, based on physical and functional evaluation of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided in the document. The type of testing described (dimensional analysis, compatibility, reprocessing validations) typically relies on engineering and quality control measurements rather than expert human interpretation in the same way an AI diagnostic device would. If any expert evaluation was involved in assessing functionality or accuracy, it is not detailed.

4. Adjudication method for the test set

• This information is not provided in the document. Given the nature of the testing (dimensional analysis, compatibility, reprocessing), a formal adjudication method by multiple experts (like 2+1 or 3+1) is unlikely to be applicable in the same way it would for a clinical study involving subjective interpretations. The results would likely be based on objective measurement comparisons against specifications or predicate device data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was not done. The provided document describes engineering and performance testing to demonstrate substantial equivalence, not a clinical study involving multiple human readers assessing performance with or without AI assistance. The Medyssey Navigation System is an instrument; it's not an AI/software device that assists human interpretation of medical images or data.

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

• This question is not applicable as the Medyssey Navigation System is a surgical instrument. It is designed to be used with a human surgeon and the Medtronic StealthStation® Navigation System (which itself is a navigation tool, not an autonomous algorithm for diagnosis or treatment decision-making). The "algorithm only" concept does not apply here.

7. The type of ground truth used

• The "ground truth" for the performance testing appears to be based on:
  • Engineering Specifications/Standards: For dimensional analysis and compatibility with the Medtronic StealthStation.
  • Recognized Standards: For reprocessing validations (ANSI/AAMI ST98 and ISO 17665).
  • Predicate Device Data/Characteristics: For comparison to demonstrate substantial equivalence in terms of design, dimensions, materials, technology, and function.

8. The sample size for the training set

• This information is not applicable/not provided. The Medyssey Navigation System is a physical instrument, not a machine learning or AI model that requires a training set. The term "training set" is relevant for AI/ML algorithms.

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

• This information is not applicable/not provided for the same reasons as point 8.

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