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The SDC3 is indicated for use with compatible endoscopic and general surgery devices. SDC3 can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope, or an 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 hysterectomy, laparoscopic and 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 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. SDC3 users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and urologists.

The Stryker SDC3 HD Information Management System with wireless device control capability (herein referred to as 'proposed device') consists of the following:

1. Stryker SDC3 HD Information Management System (SDC3) that consists of:
   a. A stand-alone console containing SDC3 software version 1.5 and above
   b. A device control package (contains optional software upgrade and a handheld Infrared (IR) remote control)
   c. A voice control package (contains optional software upgrade and a microphone/headset).
2. The Universal Gateway System (Gateway) (acts as a medium for transferring medical device and non-medical device data).

The proposed device is a modification of the Stryker SDC3 HD Information Management System (hereafter referred to as "predicate device", cleared under K121893) to add wired and wireless device control functionality via the Gateway. The wired device control feature (cleared under K121893) and the operating room documentation functionalities of electronically capturing, transferring, storing and displaying of medical device data (Class I device function) provided by the SDC3 remains the same compared to the predicate device. It should be noted that the device control functionality (both wired and wireless) of the proposed device only provides users with convenient, centralized control of connected (wired and wireless), compatible medical devices. The SDC3 accesses existing controls within each device and is secondary to the built-in control interface that is already on each device.

The provided text describes the Stryker SDC3 HD Information Management System with Wireless Device Control Capability (K160332), a modification of a predicate device (K121893) to add wired and wireless device control functionality via a Universal Gateway System. The document focuses on regulatory compliance and the safety and effectiveness of the new wireless functionality.

However, the document does not contain the level of detail requested for a typical study proving a device meets acceptance criteria, particularly for an AI/ML-based diagnostic device where performance metrics like sensitivity, specificity, or AUC are expected. This submission is for a device providing enhanced control and information management in a surgical setting, not a diagnostic or AI-driven decision-making tool. Therefore, the "acceptance criteria" and "device performance" are related to its functionality, reliability, and safety in controlling other medical devices and handling data, rather than diagnostic accuracy.

Here's an attempt to extract and interpret the information based on the provided text, acknowledging its limitations for the requested format:

Acceptance Criteria and Reported Device Performance

Given the nature of the device (a control and information management system with new wireless capabilities), the "acceptance criteria" are implied by the verification and validation activities described, focusing on functionality, safety, and reliability of the wireless communication and device control. No specific numerical thresholds (e.g., >90% accuracy) for clinical performance are applicable or provided.

Study Details (based on interpretation of provided text)

1. Sample size used for the test set and the data provenance:

   • The document does not specify a "test set" in terms of patient data or clinical images, as this is neither an AI/diagnostic device nor a device that processes such data for clinical output.
   • The testing described is focused on engineering verification and validation of the device's functionality, connectivity, security, and performance in various operational environments (e.g., co-existence with other wireless devices).
   • No information on data provenance (e.g., country of origin, retrospective/prospective) is applicable or provided, as no clinical data set is referenced for performance evaluation.

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

   • This question is not applicable. There is no "ground truth" to be established by clinical experts for the type of device tested. The "ground truth" for the tests performed would be the engineering specifications and expected functional behavior (e.g., "does the device turn on/off the connected medical device as commanded?", "is the wireless connection stable?").

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

   • Not applicable. No clinical test set requiring adjudication by multiple readers is mentioned.

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

   • No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. The Stryker SDC3 is a control and information management system, not a diagnostic tool.

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

   • This concept is largely not applicable in the context of this device. The core functionality is human-in-the-loop (surgeon/personnel controlling devices via SDC3). However, the "Benchmarking Test" did verify latency and data accuracy for wireless device control data transmission (algorithm/system performance) compared to a wired system, which could be considered a form of standalone performance evaluation for its wireless data transfer capabilities. The "SDC3 and Gateway Accuracy and Reliability Coexistence Report" also evaluated the system's performance in a standalone manner regarding its data transmission.

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

   • Not applicable in the clinical sense. The "ground truth" for the engineering performance tests performed would be defined by the device's design specifications and expected functional outcomes, verified through controlled experiments and measurements. For example, for the "Timing Test," the ground truth would be the specified connection/disconnection times.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML model that would typically have a "training set" of clinical data to learn from for diagnostic or predictive purposes. The software development follows a standard life cycle process (IEC 62304), which includes verification and validation but not machine learning training.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set (in the AI/ML sense) is mentioned or implied for this device.

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The Stryker SDC3 HD Information Management System (SDC3) is intended for use with compatible endoscopic and general surgery devices. SDC3 can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope, or an 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 hysterectomy, 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 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. SDC3 users are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, and urologists.

The Stryker SDC3 HD Information Management System (referred to as "SDC3 system" in the following sections) is a medical device that allows the surgeon to control the state, selection, and settings of any compatible device attached to it. It also has operating room documentation functionalities (Class I device function) to electronically capture, transfer, store and display medical device data independently of the functions or parameters of any connected medical device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stryker SDC3 HD Information Management System:

Summary of Acceptance Criteria and Device Performance (Limited Information Provided)

The document provides very high-level information about "performance testing" but does not detail specific acceptance criteria values or specific device performance results in a quantitative manner. The acceptance criteria are broadly described as being in accordance with "internal design specifications" and "applicable performance standards." The reported performance is generally stated as "conforms" or "successfully passed."

Detailed Study Information:

The document describes various performance tests conducted, but it does not present a typical clinical study or a study specifically designed to establish acceptance criteria with quantitative outcomes. Instead, it refers to internal verification and validation activities.

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified. The document mentions "verification/validation testing" and "simulated use testing," but does not provide any sample sizes in terms of number of users, cases, or data points used for these tests.
   • Data Provenance: Not specified. Given that these are internal verification and validation tests, the data would likely originate from Stryker's internal testing environments. It's not a retrospective or prospective clinical study on patient data.

2. 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 specified. The document does not describe a process of establishing ground truth by external experts for a clinical test set. The ground truth for internal performance testing would be defined by engineering specifications and expected behavior.

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

   • Not applicable/Not specified. This type of adjudication method is used in studies involving human reviewers and ambiguous cases, which is not described here.

4. 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 MRMC comparative effectiveness study was done or reported in this document. The SDC3 system is an information management and control system, not an AI-assisted diagnostic tool for "human readers." Its purpose is to control other surgical devices and manage documentation.

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

   • The document describes "system level testing and simulated use testing" which implies testing the algorithm's performance in isolation or in simulated environments. However, the term "standalone" performance usually refers to diagnostic algorithms operating without human intervention for decision-making. In the context of a control and information management system, the "standalone" performance would be its ability to accurately execute commands, capture data, and maintain system integrity, which is implicitly covered by the various verification/validation tests mentioned (voice recognition, device control, digital documentation). No specific "standalone" study is detailed with quantitative results.

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

   • The term "ground truth" as typically used in medical AI studies (e.g., for disease detection) is not directly applicable here. For the types of tests described (voice recognition, device control, digital documentation), the "ground truth" would be established by:
     • Voice Recognition: Correct interpretation of spoken commands based on predefined linguistic models.
     • Device Control: Accurate and timely execution of commands to connected devices as per specifications.
     • Digital Documentation: Correct capture, storage, transfer, and display of data as per functional requirements and data integrity standards.
     • Electrical Safety/EMC: Compliance with the pass/fail criteria of the relevant IEC standards.
     • Software Validation: Adherence to software requirements specifications and absence of bugs, verified by unit, integration, and system-level tests.

7. The sample size for the training set:

   • Not applicable/Not specified. The document does not describe the use of machine learning that would require a distinct "training set." While voice recognition technology does involve training, the details of such a training set are not provided in this 510(k) summary, which focuses on validation of the final product.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified. As no training set is described for the device's functionality, the method for establishing its ground truth is also not provided.

Conclusion based on the provided text:

The provided document, a 510(k) summary, primarily seeks to establish substantial equivalence to a predicate device (Stryker SIDNE™ System). It details various engineering verification and validation activities rather than a clinical study with quantitative acceptance criteria and performance metrics. The focus is on demonstrating that the device conforms to internal specifications and relevant industry standards (e.g., ISO, IEC), and that any differences from the predicate device do not raise new questions of safety or effectiveness. Specific numerical acceptance criteria, clinical study designs, expert ground truth establishment, or sample sizes for testing beyond general statements of "verification/validation testing" are not included in this summary.

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