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The use of the SDC4K Information Management System with Device and Voice Control Package is to allow for voice control and remote control of medical device settings by surgeons or operating room personnel, thereby eliminating the need to manually operate those devices compatible with the SDC4K Information Management System with Device and Voice Control Package or to rely on verbal communication between the surgeon and other operating room personnel in order to adjust the surgical equipment. It also has additional digital documentation functionality capture, transfer, store and display medical device data (non-medical device function), which is independent of the functions or parameters of any attached Stryker device.

The SDC4K Information Management System with Device and Voice Control Package is a network compatible hardware platform that carries out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected endoscopic and general surgery devices both wired and wirelessly.

The SDC4K Information Management System with Device and Voice Control Package consists of the following components:

• 1. SDC4K Console which includes:
  • a) Class I Medical Device Data System (MDDS) functionality
  • b) Optional Device Control feature
  • c) Optional Voice Control feature
• 2. Device Control Package (software activation USB dongle and a handheld Infrared (IR) remote control)
• 3. Voice Control Package (software activation USB dongle and a wireless headset and base station)
• 4. Connected OR Spoke (Class I MDDS)

The SDC4K console carries out the Medical Device Data System (MDDS) functionalities (i.e. Class I device function or Non-medical function) and can be marketed as a standalone device. When upgraded with the Device Control and/or Voice Control package, the SDC4K Console extends its functionality to control compatible devices from its touchscreen graphical user interface (GUI), spoken commands via headset (voice control input), and an IR remote control or directional keypad from a camera head (device control input). The received user commands are then processed and communicated with the connected controllable devices, allowing the user to control the state, selection, and settings of those devices. In addition, the SDC4K Information Management System with Device and Voice Control Package also provides compatibility with the Connected OR Spoke (also referred to as "Spoke") which is a standalone Class I Medical Device Data System. Once the SDC4K is connected to the Spoke, Device Control can be extended to compatible devices connected to the Spoke.

The provided FDA 510(k) summary for the SDC4K Information Management System with Device and Voice Control Package outlines its performance data through various tests. However, it does not include a detailed table of acceptance criteria and reported device performance for specific functional metrics, nor does it describe a study design that would prove the device meets such criteria in terms of accuracy or clinical effectiveness.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Connected OR Hub with Device and Voice Control, K212055) by verifying compliance with recognized standards.

Here's an attempt to answer your questions based only on the provided text, highlighting what is included and what is explicitly not included:

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

The document provides a table of tests conducted and their outcomes, indicating "Pass" for each. These are related to safety, EMC, software validation, usability, and bench performance based on specifications and intended use. Specific quantitative performance metrics (e.g., accuracy, latency, success rate for voice control commands) against defined acceptance criteria are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any test sets mentioned (e.g., for usability or bench performance). It also does not mention data provenance, as the tests are primarily engineering and compliance-based rather than involving patient data or clinical studies. The document explicitly states: "the subject device does not require clinical studies to support the determination of substantial equivalence."

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

This information is not provided in the document. The tests described are largely against technical standards and internal specifications, rather than requiring expert consensus on a "ground truth" derived from clinical data.

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

Adjudication methods are not described, as the type of studies conducted (compliance and engineering tests) typically do not involve such processes.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned and is not applicable to this device, as it is an information management and control system, not an AI-assisted diagnostic or interpretative tool. The document states "the subject device does not require clinical studies to support the determination of substantial equivalence."

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

The device itself (SDC4K Information Management System with Device and Voice Control Package) includes human interaction (remote control, voice control, GUI). Therefore, a "standalone algorithm only" performance without human-in-the-loop is not directly relevant or described. The performance bench tests would assess the functionality of the system components and their integration, but not in a purely algorithmic, non-interactive context.

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

The concept of "ground truth" as typically understood in the context of diagnostic or AI performance evaluation (e.g., against pathology reports or clinical outcomes) is not applicable to the type of testing described. The "ground truth" in this context would be the successful execution of device commands, adherence to electrical safety, EMC, software, and usability standards, and meeting internal device input specifications.

8. The sample size for the training set

This information is not applicable and not provided. The device is an information management and control system, not a machine learning or AI algorithm that relies on a "training set" for its core function (beyond potentially voice recognition models, which are likely integrated commercial solutions and their training data is not discussed here).

9. How the ground truth for the training set was established

This information is not applicable and not provided for the reasons stated in point 8.

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The Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing are used in conjunction with the CrossFlow Integrated Arthroscopy Pump (K123441) to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle, and wrist joint cavities during diagnostic and operative arthroscopic procedures.

The Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing (hereafter referred to as "proposed device") is an accessory to the FDA-cleared CrossFlow Integrated Arthroscopy Pump, cleared under K123441, which provides fluid to the surgical site. CrossFlow Day-Use Inflow Cassette Tubing includes an inflow cassette with spikes for irrigation fluid units and connector. The Patient-Use Tubing includes a connector that attaches the Patient-Use Tubing to Day-Use Tubing, and luer-lock connector that attaches the Patient-Use Tubing to an inflow cannula. The Stryker CrossFlow Day-Use Inflow Cassette Tubing is a 24-hour multi-patient device that remains in the arthroscopy pump throughout a day of cases (no more than 10 cases, 8 hours of active use, or 24 hours from the point of first use). Day-Use Inflow Cassette Tubing provides an alternate to complete replacement of the irrigation tubing after each patient. The backflow check valve of the Patient-Use Tubing prevents contaminated fluid from reaching the Day-Use Tubing and permits its use for a day of cases. Patient-Use Tubing is a single-use device that is discarded after every case.

The provided text describes the regulatory clearance for the Stryker® CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing. This device is an irrigation tubing set used during arthroscopic procedures. The documentation focuses on demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission.

The "acceptance criteria" and "device performance" in this context refer to the successful completion of various bench performance tests designed to ensure the safety and effectiveness of the device, particularly regarding its multi-patient use claim and prevention of cross-contamination.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly that the device "Pass"ed the test, indicating it met the design specifications and applicable standards. The specific quantitative acceptance criteria are not detailed in the provided summary but are generally implied by the nature of the tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of units tested) for each of the performance tests listed. It states that "Bench performance testing was conducted to ensure that the device functioned as intended and met design specifications and acceptance criteria based off of predicate data." It further indicates that "Full test summaries and results can be found in Section 18 - Performance Testing -Bench," but this section is not included in the provided text.

The data provenance is from bench testing conducted by the manufacturer, Stryker Corporation. It is retrospective in the sense that it's part of a submission for an already developed device. The country of origin for the data is implicitly the USA, where Stryker is headquartered and the submission was made.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for this device is established by engineering specifications, recognized standards (like ISO 10993-1, ISO 11135, ISO 10993-7), and the ability of the device to perform its intended function without failure, particularly regarding preventing contamination. There's no clinical trial or diagnostic outcome being assessed that would require expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical trials, especially for imaging or diagnostic devices, where multiple readers interpret data and a final "ground truth" decision is made through a consensus process. For bench testing of a medical device like an irrigation tubing set, the results are typically objectively measured against predefined engineering specifications (e.g., presence/absence of microbial growth, flow rate, pressure, integrity). There's no subjective interpretation requiring an adjudication process.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation where AI assistance could augment human reader performance. This device is a tubing set for arthroscopy, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device described is a physical medical device (tubing), not an algorithm or AI system. Therefore, standalone algorithm performance is not a concept related to this submission.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is based on predefined engineering specifications, recognized international standards (e.g., ISO for biocompatibility and sterilization), and objective physical/microbiological measurements. For instance:

• Microbial Ingress/Backflow Valve tests: Ground truth is the absence of microbial or viral breach.
• Biocompatibility: Ground truth is compliance with ISO 10993-1.
• Sterilization: Ground truth is achieving a sterility assurance level (SAL) of 10-6 and meeting ISO 10993-7 residuals limits.
• Functional tests (Regurgitation, Time to Close, General requirements): Ground truth is successful operation within design parameters.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical product and not an AI/algorithm-based device that would require a "training set" for machine learning.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above (not an AI/algorithm device).

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