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The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SES Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump. and the Stryker Total Performance System (endoscopy port only). It can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic symph node dissection, laparoscopically assisted hysterectomy, laparoscopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization in indicated and examination of the evacuated chamber during performance of valve replacement. The users of the HERMES ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

The HERMES Operating Room Control Center is a computer-driven system whose basic function is offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control.

The intent of the HERMES OR Control Center is to allow for simplified and more direct control of medical device settings by the physician, thereby eliminating the necessity of using the various interfaces existing on the Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump and the Stryker Total Performance System (endoscopy port only) in the Operating setting, or relying upon verbal communications between the surgeon and other personnel in the operation room in order to adjust surgical equipment.

The HERMES™ Operating Room Control Center is a computer-driven system that allows surgeons to control medical device settings using voice commands.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

This 510(k) summary does not include a table of specific acceptance criteria with corresponding device performance metrics (e.g., accuracy, precision, sensitivity, specificity). Instead, it primarily focuses on demonstrating that the HERMES™ Operating Room Control Center conforms to established safety and electrical standards.

The document lists the following standards to which the device was designed and tested:

Study Details:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics in the way one might expect for diagnostic AI or imaging devices.

1. Sample size for the test set and data provenance:
   The document does not specify a "test set" in the context of clinical performance data (e.g., patient data, image dataset). The testing refers to compliance with electrical and safety standards. Therefore, information on sample size and data provenance for a test set in the traditional sense is not applicable or provided.

2. Number of experts used to establish the ground truth for the test set and qualifications:
   Not applicable, as the provided document focuses on compliance with engineering and safety standards, not on clinical performance or diagnostic accuracy that would require expert-established ground truth.

3. Adjudication method for the test set:
   Not applicable, for the reasons stated above.

4. Multi-reader multi-case (MRMC) comparative effectiveness study:
   No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This device is an operating room control system for device settings, not a diagnostic or AI-assisted interpretation tool that would typically involve MRMC studies.

5. Standalone (algorithm only without human-in-the-loop performance) study:
   While the system operates on voice control, the "standalone" performance isn't described in terms of a clinical outcome or diagnostic accuracy. Its performance is measured by its ability to reliably and correctly interpret voice commands to adjust device parameters according to the surgeon's intent, and its compliance with safety standards. The document doesn't provide specific data on voice recognition accuracy or response time for device control.

6. Type of ground truth used:
   The "ground truth" for this device's performance testing revolved around engineering standards and functional requirements. For example, whether it correctly changed a setting when a specified voice command was given, or if it met electromagnetic compatibility limits. It is not expert consensus, pathology, or outcomes data in the clinical sense.

7. Sample size for the training set:
   This information is not provided. If a voice recognition component involves machine learning, there would typically be a training set, but this detail is absent from the summary.

8. How the ground truth for the training set was established:
   Not provided. This detail would only be relevant if the device incorporated advanced AI/ML for voice recognition requiring specific training data and ground truth labeling, which is not elaborated upon in this 1999 document.

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