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The TDM SurgiTech TD-Wand is intended for use in procedures that require precise cuts where only light or no hemostasis is desired using the cut mode and procedures where a greater level of hemostasis is desired using the coag and blend modes.

TDM SurgiTech, Inc. ("TDMi")'s TD-Wand is a sterile, single use, disposable, monopolar device for use only with IEC 60601-1 certified electrosurgical units ("ESUs") that accept 3-pinned connectors. The TD-Wand combines blunt dissection with electrosection and electrocoagulation at its ceramic tip. The ceramic tip's bulbs provide blunt dissection capabilities between tissue planes similar to a cannula, bulbous scissors, or other blunt instrument. As such, initiation of the dissection path may be facilitated with the use of traditional surgical instruments. The device employs two types of recessed stainless steel electrodes that distribute electrosurgical current:
(1) For cutting, the Cutting Electrode is comprised of 3 segments protectively recessed between four ceramic bulbs at the axial tip. When activated, the Cutting Electrode, along its 3 recessed segments, distributes a cut or blended cut/coag waveform yielding a cutting effect that may also have a hemostatic effect depending upon the "blended" waveform chosen.
(2) For coagulation, the Coagulation Electrode, via the 7 termini protectively recessed atop the ceramic domes in the chevron shape, distributes coagulation waveforms producing a disbursed surface coagulation effect.

The provided text pertains to a 510(k) premarket notification for a medical device called the "TD-Wand," an electrosurgical cutting and coagulation device. The document summarizes the device, its indications for use, and the testing performed to demonstrate its substantial equivalence to a predicate device. However, it does not describe acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, or AUC) or a study proving the device meets such criteria related to AI/algorithm performance.

The testing described is primarily focused on mechanical integrity, electrical safety, thermal injury analysis, and biocompatibility, which are standard for electrosurgical devices but do not involve AI or algorithms that would have performance metrics like sensitivity, specificity, or human-in-the-loop improvements.

Therefore, many of the requested sections (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI performance) are not applicable or cannot be extracted from this document, as the device is not an AI-powered diagnostic tool.

Below is an attempt to address the relevant points based on the available information:

Acceptance Criteria and Study for TD-Wand (Electrosurgical Device)

The document describes engineering and biocompatibility testing for the TD-Wand, an electrosurgical device, to demonstrate its substantial equivalence to a predicate device, rather than performance criteria for an AI or diagnostic algorithm. Therefore, the requested information regarding AI-specific performance metrics, ground truth establishment, and expert involvement for diagnostic assessment is not present.

1. Table of Acceptance Criteria and Reported Device Performance

• Static Axial Compression results were evaluated.
• Dynamic Compression Bending results were evaluated.
  Conclusion: TD-Wand is substantially equivalent to the predicate device in mechanical integrity. |
  | Electrical Safety | Compliance with specified IEC/EN/ANSI/AAMI standards. | - Complies with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007), EN 60601-1:2006, ANSI/AAMI ES60601-1:2005 + A2.
• Tested to IEC/EN 60601-1-2 Third Edition (2007-03).
• Tested to IEC 60601-2-2: 2009. |
  | Thermal Injury | Thermal zones are substantially the same as or less substantial than those generated by the predicate and traditional paddle electrode. | Conclusion: Thermal zones of the TD-Wand were substantially the same and in many cases not as substantial as those generated by the predicate Epitome electrode and/or the traditional paddle electrode, regardless of tissue type or power setting. |
  | Biocompatibility | Compliance with ISO 10993 for various tests. | - Cytotoxicity (ISO 10993-5): Cell culture treated with test sample exhibited no reactivity (Grade 0).
• Sensitization (ISO 10993-10): Albino guinea pigs treated with test sample did not elicit a sensitization response (Grade 0).
• Intracutaneous Irritation Reactivity (ISO 10993-10): Rabbits treated with test samples were non-irritating (Less than 1.0 difference between test and control).
• Pyrogenicity (Materials Mediated Rabbit Pyrogen Test): Albino rabbits treated with test samples exhibited a negative response (Max Temperature Increase: 0.1°C), non-pyrogenic.
  Conclusion: Fully biocompatible in compliance with ISO 10993. |

Regarding AI-Specific Information:

Since this document describes an electrosurgical device and its safety/performance, not an AI or diagnostic algorithm, the following points are not applicable and cannot be answered from the provided text:

2. Sample size used for the test set and the data provenance: Not applicable, as this is not an AI diagnostic study. The testing refers to physical and biological tests, not data sets for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI diagnostics (e.g., expert consensus on medical images) is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) 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. The device is a surgical tool, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI performance. The "ground truth" for the device's testing relates to established engineering standards, biological responses, and comparison to a predicate device's physical attributes.
8. The sample size for the training set: Not applicable, as this is not an AI model.
9. How the ground truth for the training set was established: Not applicable.

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