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The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. Procedures for use on bone are often in orthopedics, dental, oral surgery, maxilliofacial, plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal.

The endoscopic applications with TPS include use of the SES Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.

The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal. The endoscopic applications with TPS include use of the SE5 Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.

The provided text describes the Stryker HERMES-Ready™ Total Performance System, but it does not contain a study that proves the device meets specific acceptance criteria related to its performance characteristics.

Instead, the document primarily focuses on:

• Premarket Notification (510(k)) Summary: This outlines the device's intended use, its substantial equivalence to previously cleared devices, and general information required for FDA submission.
• Regulatory Classification: It details the device's classification and the regulatory controls it falls under.
• Voluntary Standards: It lists the voluntary standards (e.g., IEC 601-1, UL 2601-1) that the device will be designed and tested to. This indicates the intent to meet certain safety and performance benchmarks, but not the results of such testing or specific acceptance criteria.
• Indications for Use: This section describes the medical procedures and applications for which the device is intended.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the given text. The document confirms the device's regulatory clearance based on substantial equivalence, but it does not elaborate on specific performance testing results or a study proving its acceptance criteria have been met.

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The Stryker Endoscopy Medical Video Camera System is intended for endoscopic camera use in a variety of endoscopic surgical procedures including orthopedic, laparoscopic, urologic, sinuscopic, plastic and as an accessory for microscopic surgery. Sterilization of the camera head and cable is required before use. The new Stryker camera will be capable of interfacing with the Hermes Operating Room Control Center (K973700) voice-activated system, with no impact on normal camera system operation.

The Stryker Endoscopy 3-Chip Medical Video Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery where-ever a laparoscope/endoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic & thorascopic anterior spinal fusion. anterior cruciate ligament reconstruction, knee arthroscopy, shoulder arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis. internal mammary ariery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The Stryker Medical Video Camera System consists of a camera control unit (CCU) and a camera head with an integral cable that connects to the CCU.

The System is AC powered and is designed to meet international medical device standards (IEC 601-1, UL 2601, & CSA 22.2) to provide safe operation and eliminate or minimize the risk of fire, electrical shock, and electromagnetic interference that may be associated with it.

The provided text is a 510(k) premarket notification for the Stryker Endoscopy Model 888 Video Camera. It focuses on establishing substantial equivalence to a predicate device based on intended use and technical characteristics, rather than presenting a formal study with acceptance criteria and performance metrics in the way a clinical study for a drug or a novel AI diagnostic would.

Therefore, many of the requested categories are not applicable or not explicitly stated in this type of submission.

Here's a breakdown based on the information available:

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

Important Note: This 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device. This process typically relies on comparing intended use, technological characteristics, and performance data if available, to show that the new device is as safe and effective as the predicate. It does not usually involve setting new, independent acceptance criteria and then conducting a novel study against those criteria in the same way a new drug or a novel AI algorithm might. The "performance" here is largely inferred from the equivalence claim and compliance with relevant standards.

Regarding the specific study questions:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  • Not applicable / Not explicitly stated. This document does not describe a clinical performance study with a test set of data. The "study" mentioned is the comparison for substantial equivalence.
• 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)
  • Not applicable / Not explicitly stated. No ground truth establishment by experts for a test set is described.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • Not applicable / Not explicitly stated. No test set requiring annotation or adjudication is mentioned.
• 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
  • No. This is a hardware device (video camera), not an AI-powered diagnostic. An MRMC study is not relevant to this submission.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • No. This is a hardware device; standalone algorithm performance is not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
  • Not applicable / Not explicitly stated. For a medical video camera, ground truth typically relates to image quality and functionality, which would be assessed through technical specifications and usability evaluations, rather than a clinical ground truth like pathology for a diagnostic device.
• 8. The sample size for the training set
  • Not applicable / Not explicitly stated. No training set for an algorithm is relevant to this submission.
• 9. How the ground truth for the training set was established
  • Not applicable / Not explicitly stated. No training set is relevant.

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The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera, Quantum 5000 Light Source, Stryker SE5 Shaver and WOM 20L Insufflator. It can be used in where nasopharyngoscopy, ear endoscopy, and sinuscopy a laparoscopy, general laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic repair, laparoscopic cholecystectomy, laparoscopic hernia laparoscopic surgeries are ymph node dissection, laparoscopically assisted laparoscopic pelvic appendectomy, hysterectomy, laparoscopic & thorascopic 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 is indicated and examination of the evacuated cardiac 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 robotic 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 and WOM 20L Insufflator 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 provided document is a 510(k) summary for the HERMES OR Control Center System. This document focuses on the regulatory aspects and the intended use of the device, rather than detailed performance study results with specific acceptance criteria.

Based on the information available, a table of acceptance criteria and reported device performance cannot be fully constructed in the manner requested, as the document does not contain clear, measurable acceptance criteria or detailed study results beyond a statement of functional test requirements.

However, I can extract and infer some information related to the device's testing and regulatory approval based on the text:

Missing Information:
Many of the requested data points (sample size for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth used) are not available in this 510(k) summary document. This document is a regulatory submission summary and typically does not include the detailed raw data or study methodologies to that extent.

Available/Inferred Information from the Document:

1. Acceptance Criteria and Reported Device Performance:

   The document mentions "HERMES System Functional Test Requirements" as a standard the device was designed and tested to. However, the specific criteria within those requirements and the numerical performance results are not detailed in this summary. The only "performance" discussed is the intended function of the device: to offer voice control for medical device settings, simplifying control and eliminating the need for verbal communication with other personnel or direct interaction with individual device interfaces.

The Study that Proves the Device Meets Acceptance Criteria:

The document broadly states that the device "is designed and tested to the following Computer Motion and voluntary standards," and lists several standards (IEC 601-1, UL 2601-1, EMC Directive, etc.) in addition to "HERMES System Functional Test Requirements."

• The term "study" in the context of clinical performance demonstrating quantitative improvements (e.g., accuracy, efficiency) is not explicitly detailed with methodologies or results in this summary.
• The primary evidence of "safety and effectiveness" for this 510(k) submission appears to be based on substantial equivalence to an existing predicate device (HERMES Operating Room Control Center and Accessories K973700). This means the FDA determined the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness. This often relies on meeting recognized consensus standards for safety and performance, and demonstrating that the new device functions similarly to the predicate.

Given this context, the document doesn't describe a specific, detailed study with quantitative performance results against explicit acceptance criteria in the way one might expect for a novel diagnostic algorithm. Instead, it attests to design and testing according to established engineering and regulatory standards, and relies on the concept of substantial equivalence.

Specific Requested Information (and why it's mostly unavailable from this document):

2. Sample size used for the test set and the data provenance: Not mentioned. This would typically be found in detailed verification and validation reports, not a 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. Such details are usually part of a clinical validation study.
4. Adjudication method: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. This type of study is more common for diagnostic imaging AI. For a control system, "effectiveness" might be measured in terms of time savings, error reduction, or surgeon satisfaction, but such a study is not described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not directly applicable or mentioned. This device is a human-in-the-loop system (voice control by a surgeon). Any standalone performance would be about the voice recognition accuracy and system response, which isn't detailed.
7. The type of ground truth used: Not explicitly stated for performance testing. For a control system, ground truth might relate to whether commands were accurately interpreted and executed, or whether the system successfully integrated with and controlled the indicated medical devices. This would be part of functional testing.
8. The sample size for the training set: Not mentioned. AI/ML models usually require training sets; while this device uses voice control, it's not described as a deep learning AI in the modern sense. It's more of a robotic control system with voice interface.
9. How the ground truth for the training set was established: Not mentioned.

In summary, this 510(k) notification focuses on the regulatory requirements for showing substantial equivalence and compliance with engineering standards for a medical device. It does not provide the kind of detailed clinical or algorithm performance study description (with specific acceptance criteria, sample sizes, expert qualifications, etc.) that would typically be associated with modern AI/ML device submissions, especially those involving image analysis or diagnostic applications. The "study" here is primarily composed of general design and testing to established standards to ensure safety and functional requirements, leading to a determination of substantial equivalence.

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