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Phantom XL Insulated Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site, to assist in locating those nerves at risk during the surgical procedure.

TSI's Phantom XL Insulated Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. Phantom XL Insulated Dilators are available in monopolar configuration and four diameter sizes. They are supplied sterile, are non-pyrogenic, and are intended for single use only.

This document is a 510(k) premarket notification for a medical device called "Phantom XL Insulated Dilators". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific performance metrics like sensitivity, specificity, or AUC.

Therefore, the information you're requesting regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of typical AI/diagnostic device performance studies (which would involve metrics like sensitivity, specificity, human reader performance, etc.) is not applicable to this submission.

This submission focuses on engineering-level performance testing to demonstrate that changes made to the existing predicate device (Phantom XL Insulated Dilators, K140088) do not raise new questions of safety or effectiveness. The changes are minor:

• Change in packaging: from backer card/Tyvek pouch/Shelf Box to preformed tray sealed in Tyvek Lid placed in Shelf Box.
• Extended shelf life: from 2 years to 5 years.

The acceptance criteria and studies described relate to these specific physical changes and their impact on the device's ability to maintain sterility, packaging integrity, and functionality over its extended shelf life.

Here's a breakdown of the information provided, reframed to fit the context of this 510(k) submission:

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

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the way one might expect for a diagnostic or AI device (e.g., sensitivity > X%, specificity > Y%). Instead, it lists the types of changes made to the device and the standards/tests performed to ensure these changes do not negatively impact safety and effectiveness. The "acceptance criteria" are implied by compliance with the referenced ASTM, ISO, and AAMI standards. The "reported device performance" is that the device "demonstrates that the TSI Phantom XL Dilators are safe for use perform comparably to the predicate device that is currently marketed for the same intended use" after these tests.

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

The document does not specify exact sample sizes for each test listed (e.g., how many packages were tested for seal strength). The studies mentioned are engineering/bench tests on the device and its packaging components, not human subject studies. Therefore, "data provenance" in terms of country of origin or retrospective/prospective is not relevant here.

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

This is not applicable. The "ground truth" for this type of submission is defined by the technical specifications of the device and its packaging, and ensuring compliance with recognized industry standards (ASTM, ISO, AAMI). There is no "ground truth" to be established by medical experts (e.g., radiologists interpreting images) as this is not a diagnostic device with performance metrics relying on human interpretation. The testing is performed by engineers and technicians following standard protocols.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when there's ambiguity in establishing a ground truth (e.g., for disease diagnosis from images) or for resolving disagreements among multiple human readers. This submission describes physical and performance tests against standards, not diagnostic performance.

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 is not applicable. This device is a surgical instrument (an insulated dilator used for nerve stimulation/localization during spine surgery), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

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

This is not applicable. As stated above, this is a surgical instrument, not an algorithm or AI device.

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

The "ground truth" in this context is the compliance with established engineering and medical device standards (ASTM, ISO, AAMI). For example, for packaging, the "ground truth" is that the seal strength meets the requirements specified by ASTM F88, or that the sterility assurance level (SAL) meets the requirements of ANSI/AAMI ST67 after ethylene oxide sterilization. It's about meeting predefined technical specifications and standards, not a medical condition.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI or machine learning model. There is no "training set."

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

This is not applicable. As there is no training set for an AI or ML model, this question does not apply.

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