(100 days)
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:
- 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). - 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.
| Acceptance Criteria Category (Implied) | Specific Tests / Performance Reported |
|---|---|
| Device Control Functionality | SDC3 and Gateway Software Device Control Verification: Verified device/voice control of compatible devices via Gateway through SDC3's GUI, IR Remote, and supported Camera Head when devices are connected to Gateway. |
| Wireless Connectivity & Security | SDC3 and Gateway Connectivity Software Verification: Verified the compatibility of SDC3 with Universal Gateway System and the connection security between the SDC3 and the Universal Gateway System. |
| Software Network Security Verification: Verified network security features of the SDC3. | |
| Security Recommendation: User advised to use WPA2-Enterprise with AES encryption for Wi-Fi security. | |
| Wireless Co-existence & Latency | Wireless Co-existence Verification Test: Verified SDC3's ability to upload case data to an external server wirelessly under co-existence environment. |
| Benchmarking Test: Verified latency of wireless device control data transmission under co-existence environment, as compared to an identical wired system. Also verified the data accuracy in a non-coexistence environment. | |
| SDC3 and Gateway Accuracy and Reliability Coexistence Report: Verified accuracy and reliability of wireless device control data transmission under co-existence environment. | |
| QoS (Quality of Service): Wireless QoS needed for wireless device control is stated to be the same quality of service currently offered by wired device control; metrics considered included latency, data rate, accuracy, and communication reliability to achieve equivalent performance. | |
| Timing & Connection Reliability | Timing Test: Verified that the connection and disconnection times between the SDC3 and the Gateway meet the specification. |
| Design Validation | Validated expanded functionality of wireless device control to ensure defined user needs and intended use are met under simulated use conditions. |
| Electrical Safety & EMC | Conforms to ANSI/AAMI ES60601-1:2005 and IEC60601-1-2:2007. |
| Software Life Cycle Processes | Complies with IEC 62304:2006. |
Study Details (based on interpretation of provided text)
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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.
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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?").
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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.
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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.
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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.
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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.
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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.
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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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.