Search Results

The Articulator™ Arthroscopic Bur is indicated for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip, to provide abrasion, resection, debridement, and removal of bone and cartilage.

The Articulator Arthroscopic Bur can be used to abrade, cut and excise tissue and bone in arthroscopic surgeries.

The arthroscopic bur components include a bur attached to a constant velocity joint that is attached to a long rod rotating within a long hollow stainless steel housing. The bur is shielded on one side by its housing, allowing the bur to cut one structure while tissues on the opposite side of the shield are protected. A pushrod stabilizes the burr housing and holds the articulation into one of three preset flexion angles chosen by the user. A trigger mechanism on the proximal end of the bur allows the user to ergonomically flex and release the working angle of the bur with one hand. This system attaches to a motorized handpiece that drives the internal bur inside the outer housing and provides suction to pull the cut tissue away from the surgical site.

N/A

Ask a specific question about this device

Kyphoplasty Balloon Dilatation Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacrylate (PMMA) bone cements).

The proposed device, Kyphoplasty Balloon Dilatation Catheters are inflatable balloon catheters used in percutaneous kyphoplasty (PKP). It consists of Inner Stylet, Balloon Catheter, and polypropylene (PP) Protection tube. The radiopaque markers located at the balloon catheter tip to reflect the balloon position during positioning.

The proposed device, Kyphoplasty Balloon Dilatation Catheters are inflatable balloon catheters used in percutaneous kyphoplasty (PKP). It consists of Inner Stylet, Balloon Catheter, and polypropylene (PP) Protection tube. The device is made of PC, stainless steel, TPU, PE, Pebax and Pt/Ir.

The inner stylet is made from a stylet attached to a 6% Luer cap. The stylet enhances the stiffness of the balloon catheter to facilitate a smooth insertion of balloon catheter through the established working pathway during the percutaneous procedure. The PP Protection tube protects the balloon from damage during the production and packaging.

The balloon catheter is composed of six sections: Inflation Port, Stylet Port, Inner Tube, Outer Tube, Radiopaque Markers, Inflatable Component. The Stylet Port is used to provide a support for the Stylet. The Inflation Port provide an adapter for a balloon inflation Injector. The Inflatable Component plays a critical role in the procedure. The Inflatable Component is to restore the height of a compression-fractured vertebral body and also leave a cavity in the fractured area after the Inflatable Component deflation. The cavity is therefore to facilitate safer filling of the bone cement. The cavity in the fractured area left by the inflated balloon reduces the filling pressure of bone cement. This technology greatly reduces the risk of uncontrollable bone cement leakage and spread, and thus lowers complications and minimizes the risk of the procedure.

The radiopaque markers located at the balloon catheter tip to reflect the balloon position during positioning.

Kyphoplasty Balloon Dilatation Catheters are supplied sterilized, single-use.

There are generally two types of Kyphoplasty Balloon Dilatation Catheters, one is straight type which has a straight balloon catheter tip, and the other one is curved type which has a curved shape of tip of the balloon catheter. These catheters are available in different effective length. The detailed specifications are listed in Table 1.

N/A

Ask a specific question about this device

The TunnelVision Endoscopic Soft Tissue Release System is indicated for use in minimally invasive ligament or fascia release:

• Carpal tunnel release in the wrist
• Cubital tunnel release in the elbow

The HBL Blade Assembly is indicated for use with the TunnelVision Endoscopic Soft Tissue Release System, the 3M Agee Inside Job Carpal Tunnel Release System, or the MicroAire SmartRelease Endoscopic Soft Tissue Release System in minimally invasive ligament or fascia release:

• Carpal tunnel release in the wrist
• Cubital tunnel release in the elbow

Hand Biomechanics Lab's TunnelVision Endoscopic Soft Tissue Release System is a surgical system designed for minimally invasive soft tissue release procedures. The system includes the TunnelVision Endoscope, TunnelVision Handpiece, reusable manual surgical instruments (small and medium dilators, synovium elevator, coequal dilator), an instrument sterilization tray, and the HBL Blade Assembly.

The HBL Blade Assembly (Model CTR-455) was previously cleared under 510(k) K222490 for use with the 3M® and MicroAire® SmartRelease® systems. This submission expands indications for use to include compatibility with the TunnelVision platform. No changes were made to blade assembly materials, design, or sterilization method.

Reusable components (handpiece, endoscope, surgical instruments, sterilization tray) are supplied non-sterile, to be cleaned and steam sterilized by the end user. The HBL Blade Assembly is a sterile, gamma-irradiated, single-use device.

The subject device is comprised of two components:

1. TunnelVision Endoscopic Soft Tissue Release System – includes the endoscope, handpiece, manual surgical instruments, and sterilization tray. These components are reusable following validated cleaning and sterilization processes.
2. HBL Blade Assembly – a gamma-sterilized, single-use disposable device containing the cutting blade. The blade cuts in a retrograde direction to safely release the targeted soft tissue.

N/A

Ask a specific question about this device

The UltraGuideCTR® image guided soft tissue release system using real-time ultrasound visualization and guidance with integrated safety-engineered Sharps Injury Prevention is indicated for use in minimally invasive soft tissue release:

• Carpal tunnel release in the wrist

The UltraGuideCTR® image guided soft tissue release system with Sharps Injury Prevention feature is comprised of a disposable Handpiece with inflatable Balloons and a Blade assembly (UltraGuideCTR® device) that is utilized with Ultrasound imaging (continuous real-time Ultrasound visualization and guidance). The device is gamma sterilized and intended for single-use only.

Continuous real-time multi-planar ultrasound imaging throughout the procedure enables the user to visually identify pertinent anatomical structures of the hand and wrist and to visualize and navigate the device throughout the procedure. The device design and components enhance the echogenicity and visualization of the device and ensures the device is compatible with any musculoskeletal (MSK) Ultrasound system. The echogenic features of the device include:

• Inflatable Balloons located along the Shaft on either side of the Blade track, which, once inflated with saline, appear under Ultrasound as two dark circles.
• Metal Shaft/Tip of Blade - the Shaft, which houses the recessed blade at the distal Tip, appears as a bright echogenic line, with a visible notch indicating the point where the recessed Blade will be deployed from the Tip of the Shaft.
• After deployment, the Blade appears on Ultrasound as a bright star-shaped structure moving along the track in the Shaft.

Collectively, these echogenic features facilitate visualization and navigation of the device within the critical anatomy throughout the procedure.

The low-profile of the Tip allows the device to be inserted through a single, percutaneous incision in the proximal wrist flexor crease. The device is operated using an ergonomic Handle with separate controls to activate and inflate the integrated Balloons and actuate the Blade. The two inflatable Balloons are integrated on either side of the Blade track in the Shaft and once inflated, function as both anatomical guards and visual confirmation of desired device placement, as well as a safety mechanism before the Blade can be deployed from the Tip.

The Balloons are inflated in the intracarpal space of the carpal tunnel to create additional space and protect the surrounding anatomy while the Blade is actuated to transect the TCL. The design of the Blade includes a safety-engineered Sharps Injury Prevention feature. The Blade remains recessed in the Tip of the device until the Balloons are inflated using the Activation Lever on the Handle. Once the Balloon inflation/Blade interlock safety mechanism is released, the Blade Slider on the Handle is pulled back in a retrograde motion to actuate the Blade in a distal-to-proximal direction along the Blade track in the Shaft to transect the TCL. The Blade must be retracted into the fully recessed position in the Shaft before the Balloons are deflated, and the device is removed.

This integrated design of the Metal Tip/Shaft/Blade and Balloons serves to protect the surrounding anatomy during the palmar pressure that is applied to the device during the insertion, navigation, TCL transection, and removal of the device, and prevents deployment of the Blade prior to inflation and subsequent to deflation of the Balloons.

N/A

Ask a specific question about this device

The ELID (Endoscopic Less Invasive Decompression) system intended to provide lumbar decompression of the spine to treat various spinal condition(s) using minimally invasive techniques and instrumentation.

The ELID (Endoscopic Less Invasive Decompression) System consists of instrumentation intended to aid the user in completing steps necessary to perform lumbar decompression. Instruments include a bone needle, flat blade dilator, dilator tubes, and rongeurs. Instruments in the ELID (Endoscopic Less Invasive Decompression) System are supplied non-sterile, reusable, and manufactured from aluminum per ASTM B211, Nitinol per ASTM 2063, or stainless steel per ASTM A564.

The provided text is a U.S. FDA 510(k) Clearance Letter and a 510(k) Summary for the ELID (Endoscopic Less Invasive Decompression) System. While it describes the device, its indications for use, technological characteristics, and a list of performance tests conducted, it does not provide specific acceptance criteria or detailed study results that demonstrate the device meets those criteria.

The "Performance Data" section states that certain tests were conducted and their results "show that the strength of the ELID (Endoscopic Less Invasive Decompression) System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." However, it does not quantify this performance, nor does it specify the acceptance criteria for each test.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance. The document only lists the types of tests performed (Cleaning Validation, Sterilization Validation, Biocompatibility, Usability Testing, Particulate Analysis) but doesn't provide the detailed results or the specific quantitative acceptance thresholds for these tests.
• Sample sizes used for the test set and the data provenance. The document mentions "test modes" but does not detail the sample sizes for these tests or the origin of any data (e.g., human or ex-vivo samples, country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth establishment. This type of information is typically relevant for AI/ML-based devices relying on expert annotations, which is not clearly indicated as a component of the ELID system described. The ELID system seems to be a set of physical surgical instruments.
• Adjudication method. Similar to the point above, this is generally for AI/ML performance evaluation against expert ground truth.
• MRMC comparative effectiveness study. This is typically for AI/ML devices assisting human readers/interpreters, which doesn't seem to be the primary function of the ELID system.
• Standalone performance. This again relates to AI/ML algorithms. The ELID system appears to be a set of manual surgical instruments.
• Type of ground truth used. For an AI/ML device, this could be expert consensus, pathology, or outcomes data. For the ELID system, ground truth would likely refer to engineering specifications and performance evaluations for mechanical properties, biocompatibility, etc. The document does not specify this in detail.
• Sample size for the training set. Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.
• How the ground truth for the training set was established. Not applicable.

In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence based on a set of non-clinical performance tests, but it does not disclose the detailed quantitative acceptance criteria or the specific results of these tests, nor does it describe AI/ML related study methodologies like those you've requested. The "Performance Data" section only states that the results "show that the strength... is sufficient for its intended use and is substantially equivalent."

Ask a specific question about this device

The HydroCision SpineSite System is intended to be used as a single-use endoscopic video camera in a variety of endoscopic diagnostic and surgical procedures for spine applications. The device is also intended to be used as an accessory for microscopic surgery.

The HydroCision SpineSite System is comprised of (i) sterile disposable endoscope and (ii) reusable Video Processing Unit (VPU). The HydroCision SpineSite System provides illumination, image processing and digital documentation for endoscopic procedures. The HydroCision SpineSite System is not suitable for use in the MR environment.

The SpineSite Endoscope provides distal LED illumination via LEDs surrounding a high-resolution video sensor. The SpineSite Endoscope contains a working channel for the passage of micro instrumentation to the surgical site. The SpineSite Endoscope is provided sterile, via ethylene oxide sterilization.

The SpineSite Endoscope is designed to be connected to the SpineSite VPU via a proprietary edge card connector which provides power to the endoscope and supports video processing capability. The SpineSite VPU is powered via connection to an external wall outlet via a 12V power adapter.

The provided text is a 510(k) clearance letter and a 510(k) summary for the HydroCision SpineSite System. It details the device's indications for use, its components, and various non-clinical performance tests conducted to meet regulatory requirements. However, this document does not contain any information about a study proving the device meets specific acceptance criteria related to its performance in a clinical or AI-assisted context.

The "Performance Testing" section lists only non-clinical tests:

• Biocompatibility per ISO 10993-1
• Design verification/validation to mechanical and optical specifications
• Electrical, Mechanical and Thermal (EMT) safety testing per IEC 60601-1, IEC 60601-2-18
• Human Factors/ Usability per IEC 60601-1-6
• Electromagnetic compatibility testing per IEC 60601-1-2
• Software validation

The "Substantial Equivalence Summary" focuses on comparing the HydroCision SpineSite System to its predicate device (Arthrex Nanoscope System) on aspects like intended use, technological design, sterilization, electrical safety, materials, and technical features (optical resolution, field of view, depth of field, etc.). It states: "The safety and effectiveness of the HydroCision SpineSite System are adequately supported by the non-clinical performance data, substantial equivalence information, and comparison of design characteristics provided within this premarket notification."

Therefore, based solely on the provided text, I cannot answer the specific questions related to acceptance criteria and a study proving the device meets those criteria, particularly those concerning:

1. A table of acceptance criteria and reported device performance (in a clinical/AI context).
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study (AI vs. human).
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The device described is an endoscopic video camera system, not an AI-powered diagnostic device, which is what the questions regarding "AI assistance," "effect size," "standalone algorithm performance," and "training set" typically refer to. The document suggests a traditional medical device clearance based on substantial equivalence and non-clinical performance testing for a physical device, not an AI/ML algorithm.

Ask a specific question about this device

Indications remain unchanged from pre-pandemic COVID-19 vaccines for use in individuals 6 months of age and older.

HPE 8570B 50 Ohm Programmable Step Attenuator, DC to 18 GHz

This FDA clearance letter for the Arthrex Spine Endoscope (K243602) does not contain information about the development and validation of an AI/ML device. Instead, it describes a traditional medical device submission for an endoscope.

The letter explicitly states on Page 6: "The Arthrex Spine Endoscope did not require animal testing or human clinical studies to support the determination of substantial equivalence." and "All verification activities were successfully completed to confirm the subject device meets product requirements and design specifications established for the device." This indicates that the clearance was based on non-clinical bench testing and comparison to a predicate device, typical for traditional medical devices, rather than a novel AI/ML algorithm requiring extensive clinical validation with ground truth, expert readers, and comparative effectiveness studies.

Therefore, I cannot extract the requested information about acceptance criteria and study proving an AI/ML device meets those criteria from this document. The document pertains to a physical endoscope, not an AI/ML system.

If you have a different document pertaining to an AI/ML medical device, please provide it, and I will do my best to extract the requested information.

Ask a specific question about this device

The VECTR - Video Endoscopic Carpal Tunnel Release System is in minimally invasive ligament or fascia release surgeries, such as:

· Carpal tunnel release in the wrist

· Cubital tunnel release in the elbow

The VECTR – Video Endoscopic Carpal Tunnel Release System is composed of a handpiece (5200-01) and a proprietary tablet (5200-90). The handpiece is an arthroscopic unit with an integrated surgical knife. It is intended for minimally invasive ligament or fascia release in endoscopic carpal tunnel release (ECTR) surgery. The proprietary tablet is a registered class I medical device that is commercially available.

The handpiece is a single-use disposable device that combines the traditional manual surgical knife with an arthroscope all in one. It is fully integrated into a single unit and consists of a functional tip (surgical knife), live-action camera, light, cannula, and cord to connect to the proprietary tablet. The surgical knife can be used to sever tendons, ligaments, or fascia in the joints or limbs and is able to be protracted or retracted via a slide switch on the side of the handpiece.

During procedures, surgeons will introduce the device through incisions made in the patient's wrist. Once inside, the camera and light are used to visualize the surgical environment on the proprietary tablet. Once the surgeon has maneuvered the device into the desired location, the blade can be actuated and the ligament can be cut. Once cut, the surgeon will withdraw the blade and remove the device.

The provided text does not contain information about acceptance criteria for the VECTR - Video Endoscopic Carpal Tunnel Release System, nor does it detail a study proving the device meets specific acceptance criteria in the manner requested. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria performance, sample sizes, ground truth, expert qualifications, adjudication, or MRMC studies.

Here's an overview of the information that is available in the provided text, categorized as much as possible according to your request, but highlighting the absence of the specific details you're looking for:

1. Table of Acceptance Criteria and Reported Device Performance

• Not available in the provided text. The document describes a series of non-clinical tests conducted (sterility, package stability, shelf life, biocompatibility, EMC, electrical/mechanical/thermal safety, and bench testing) to support substantial equivalence. However, it does not specify quantitative acceptance criteria for each of these tests, nor does it present the results in a comparative table format against such criteria. It generally states that the device "performs the intended functions as designed" and "is substantially equivalent."

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified for any of the non-clinical tests. The document mentions "nonclinical testing provided," "testing completed," or "testing referenced," but does not give numerical sample sizes for these tests.
• Data Provenance: The data described are from non-clinical tests performed by Rafael Medical Devices, LLC, and referenced standards. This indicates the testing was conducted in a controlled environment, likely by the manufacturer or contracted labs, rather than being derived from patient data (retrospective or prospective). The geographical origin of the testing is not specified beyond the company's location (Newark, NJ, USA).

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

• Not applicable. This information is relevant for studies involving human interpretation or clinical outcomes. The provided text details non-clinical laboratory testing.

4. Adjudication method for the test set

• Not applicable. Adjudication is typically associated with clinical studies or expert review of data where discrepancies might arise. The non-clinical tests described would follow standardized protocols without an adjudication process in this context.

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

• Not applicable. The VECTR system is a physical surgical device (handpiece with integrated camera and knife) and proprietary tablet, not an AI or software-based diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

• Not applicable. As noted above, the device is not an algorithm, but a surgical instrument with integrated video capabilities. The "standalone" performance here refers to the device itself performing its intended functions (e.g., blade deployment, video output, safety features), which was assessed through bench testing as described.

7. The type of ground truth used

• For the non-clinical tests, the "ground truth" would be established by the specifications and validated methodologies of the referenced standards (e.g., ISO, ASTM, ANSI, AAMI, USP). For example:
  • Sterility: Absence of viable microorganisms, confirmed by biological indicators and bioburden testing according to AAMI/ISO 11135, ISO 11138, ISO 11737.
  • Package Stability: Maintenance of seal integrity and protection against shipping hazards, evaluated against ASTM standards (D5276-19, D642-20, D999-08, D4728-17, D6344-04).
  • Biocompatibility: Absence of toxicological effects (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity) as defined by ISO 10993 series and USP <151>.
  • EMC: Compliance with immunity and emission levels as per IEC 60601-1-2.
  • Electrical, Mechanical, Thermal Safety: Adherence to safety requirements outlined in ANSI/AAMI ES60601-1, ISO 14971, and IEC 60601-2-18.
  • Bench Testing (functionality): Device specifications for parameters like blade deployment, insertion force, blade height, sharpness, deflection, and video output, verified through direct measurement.

8. The sample size for the training set

• Not applicable. This device is a surgical instrument, not a machine learning model, so there is no "training set."

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

• Not applicable. As there is no training set for a machine learning model, this question is not relevant.

In summary, the provided document focuses on non-clinical testing to demonstrate substantial equivalence of a physical medical device. It does not contain the specific details regarding acceptance criteria, clinical study design, or AI performance metrics as requested.

Ask a specific question about this device

The MIDASVu is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.

MIDASVu is an advanced imaging system comprised of sterile, single-use scopes (0° and 30° viewing angle) and a reusable tablet. The scopes include camera and image capture features with LED light source. The distal tip of the scopes contains the camera, illumination, and imaging optics. The scopes are available in three lengths: 60mm, 90mm, and 120mm. The scopes and tablet work in concert as a system to acquire, display and record an intra-articular image as well as store images and video taken during the procedure.

The provided text is a 510(k) summary for the MIDASVu device. It primarily discusses the device's substantial equivalence to a predicate device based on non-clinical testing. It does not include information about acceptance criteria for an AI/ML-based device, nor does it detail a study proving such a device meets acceptance criteria. The MIDASVu is described as an "advanced imaging system" and an "arthroscope," which implies a hardware device for visualization, not an AI/ML diagnostic or assistive tool.

Therefore, the requested information regarding acceptance criteria, performance studies of an AI/ML device, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device is not present in the provided document. The document focuses on demonstrating substantial equivalence to a predicate hardware device through non-clinical performance and safety testing (electrical safety, EMC, biocompatibility, software validation for functionality, and cybersecurity for the embedded software of the hardware device, not for an AI/ML component).

Ask a specific question about this device

Connected OR Hub with Device and Voice Control:
The use of the Connected OR Hub with Device and Voice Control 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 Connected OR Hub with Device and Voice Control 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 to electronically 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.

SDC4K Information Management System with Device and Voice Control:
The use of the SDC4K Information Management System with Device and Voice Control 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 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 to electronically 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 Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control are network compatible hardware platforms that carry out Medical Device Data System (MDDS) functionalities and allows the user to control the state, selection, and settings of compatible connected devices both wired and wirelessly.

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

• 1. Base Console which includes:
  • a) Medical Device Data System (MDDS) functionalities
  • b) Optional Device Control feature
  • c) Optional Voice Control feature
  • d) Optional Video Image Processing (VIP) 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. Video Image Processing package (software activation USB dongle)
• 5. Connected OR Spoke (MDDS)

The provided FDA 510(k) summary for the Stryker Connected OR Hub with Device and Voice Control and SDC4K Information Management System with Device and Voice Control describes the acceptance criteria and the study that proves the device meets them. However, it does not involve an AI system for diagnostic or prognostic purposes, but rather a control system for medical devices. Therefore, some of the requested information regarding AI-specific criteria (like effect size of AI assistance for human readers, ground truth type for training, etc.) is not applicable.

Here's an analysis based on the available information:

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

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of a dataset for an AI model. Instead, it refers to various engineering and validation tests. The "Performance - Bench" tests would have involved specific test cases and scenarios, but the sample size (number of tests, number of voice commands, etc.) is not explicitly detailed. The provenance is internal to Stryker's development and validation processes. Given the nature of software and hardware validation, these tests are typically conducted in a controlled environment as part of the manufacturing and R&D process.

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

This information is not explicitly provided in the document. For non-AI device validation, "ground truth" is typically established by engineering specifications, recognized standards (e.g., IEC, AAMI), and user needs. The validation process would involve qualified engineers and testers to confirm the device performs according to these pre-defined specifications. For "Usability," expert users (e.g., surgeons, OR personnel) or human factors engineers would likely be involved, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set

The document does not describe an adjudication method in the context of multiple observers or interpretations for a test set, as would be common for AI performance evaluation. For the various "Pass" results, internal validation protocols and test reports would have been followed, likely involving engineering review and sign-off based on predefined success criteria for each test.

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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a control system (voice and remote control) for other medical devices and not an AI diagnostic or prognostic tool that assists human readers in interpreting medical images or data.

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

The device's core functionality involves control of medical devices, including "voice control of medical device settings." While this incorporates voice recognition, it's not a standalone AI algorithm for medical diagnosis or interpretation. The "Voice Recognition Performance" was tested, implying a standalone evaluation of this component, but it's part of a human-in-the-loop control system. The other listed tests (Electrical Safety, EMC, etc.) are inherent to the device's standalone hardware and software performance.

7. The type of ground truth used

The ground truth for this device's validation is based on:

• Recognized Standards: e.g., IEC 60601-1 for electrical safety, IEC 60601-1-2 for EMC, AAMI TIR69 for wireless technology, IEC 62304 for software, IEC 62366-1 for usability.
• Device Input Specifications: Internal engineering requirements for video compatibility, environmental robustness, voice recognition accuracy, and overall system design.
• User Needs and Intended Uses: The device must meet the functional requirements for surgeons and operating room personnel to control medical devices effectively and safely.

8. The sample size for the training set

This information is not provided. For the voice recognition component, a training set would have been used to develop the voice models. However, the document does not specify its size or characteristics, as it's not the primary focus of the 510(k) summary for this type of device.

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

Not explicitly stated. For the voice recognition feature, the ground truth for training would typically involve a large dataset of spoken commands, explicitly transcribed and labeled, to train the voice recognition model to accurately identify the intended commands. This process is standard for developing speech recognition systems.

Ask a specific question about this device