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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."

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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.

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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.

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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 .
  • 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.

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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).

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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.

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TELIGEN Navigation Ready Instruments:

The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine.

The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. The navigation feature is used in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion.

TELIGEN Clear and TELIGEN Access Probe, when used with UNAS Navigation Rings, can be precalibrated with:

• · the VELYS Spine System using the VELYS Spine Instrument Arrays,
• · the Brainlab Navigation System using the UNAS Arrays.

TELIGEN Access Probe in conjunction with UNAS can also be manually calibrated with other navigation systems, using tracking arrays supplied by the navigation system manufacturer.

The TELIGEN Access Probe is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for location and identification during surgery.

Discectomy Navigation Ready Instruments:

The Discectorny Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures to facilitate disc space preparation, including discectomy or bony resection. These are indicated for use in surgical spinal procedures, in which:

• · the use of stereotactic surgery may be appropriate, and
  · reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy using a navigation system and associated navigation arrays.

These procedures include but are not limited to spinal fusion. The Discectomy Navigation Ready Instruments can be pre-calibrated with the VELYS Spine System (only for TELIGEN Graft Delivery Cannula and the curettes) as well as the Brainlab Navigation System.Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instruments, when used with UNAS, can be:

· pre-calibrated with the VELYS Spine System using VELYS Spine System Instrument Arrays,

• · pre-calibrated and/or manually calibrated with the Brainlab Navigation System,
  where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

TELIGEN Navigation Ready Instruments

TELIGEN Navigation Ready Instruments are part of TELIGEN Kits.

The TELIGEN Kits are sterile, single use kits intended for use in surgical spinal procedures allowing for access, visualization, discectomy, graft delivery, navigation and peripheral motor nerve stimulation.

The TELIGEN Kits include a camera, ports and port holder, TELIGEN Clear, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments. Additionally, the TELIGEN Procedure Kit Pro includes an Access Probe.

TELIGEN Access Probe and TELIGEN Clear are part of the DePuy Synthes Navigation Ready Instruments Portfolio and are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

Discectomy Navigation Ready Instruments

The Discectomy Navigation Ready Instruments are reusable instruments used for disc space preparation, including discectomy or bony resection. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS) and associated navigation arrays. For further details on UNAS, refer to the UNAS labeling.

Universal Navigation Adaptor Set

The Universal Navigation Adaptor Set (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments. The UNAS can only be used with the VELYS Spine System as well as Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes:

• Brainlab compatible UNAS Navigation Arrays,
• . VELYS Spine/Brainlab compatible Navigation Rings and
• Medtronic compatible Navigation Ring ST. ●

The Navigation Rings and Navigation Ring ST mate with compatible DePuy Synthes Navigation Ready Instruments. These instruments include implant site preparation and implant insertion instruments as well as access and discectomy instruments.

When the VELYS Spine/Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument:

• . VELYS Spine System Instrument Array can be attached and the instrument can be used with the VELYS Spine System as pre-calibrated instrument, or
• . UNAS Navigation Array can be attached and the instrument can be used with the Brainlab Navigation System as either a manually calibrated and/or pre-calibrated instrument.

When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation Navigation System.

This submission pertains to the TELIGEN System Navigation Ready Instruments, which include the TELIGEN Access Probe, TELIGEN Clear, TELIGEN Graft Delivery Cannula, and associated curettes, along with the Universal Navigation Adaptor Set (UNAS). The primary purpose of this 510(k) submission is to expand the compatibility of these instruments with the VELYS Spine System.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria in a tabular format. However, it states the following performance aspects were evaluated:

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

The document does not specify the exact sample size or number of "test cases" for the evaluations (Accuracy Verification, CAD Model Evaluation, Simulated Use Evaluation). It refers to "engineering analysis" and "simulated use evaluation" which typically involve a set of defined tests rather than a statistical sample size of patient data.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. Given the nature of the device (surgical instruments with navigation capabilities), the evaluations would likely be laboratory-based and simulated environments.

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

The document does not mention the use of experts to establish ground truth for the test set. The evaluations described (engineering analysis, meeting manufacturer's requirements, CAD model, simulated use) suggest a focus on design validation and performance specifications rather than clinical evaluation with expert-defined ground truth on patient data.

4. Adjudication method for the test set:

The document does not describe any adjudication method. This type of evaluation, for surgical instruments, typically relies on direct measurement and adherence to specifications rather than subjective expert assessment requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

No mention of an MRMC comparative effectiveness study, or any studies involving human readers, is found in the provided text. The device is a set of surgical instruments, not an AI diagnostic tool that would typically involve human reader studies.

6. Standalone (algorithm only without human-in-the-loop performance) Study:

Not applicable. The device is a set of physical surgical instruments with navigation capabilities, not a standalone algorithm. Its performance is intrinsically tied to its use by a surgeon within a navigation system.

7. Type of Ground Truth Used:

Based on the evaluation types:

• For Accuracy Verification and Navigation Systems Instrument Accuracy Requirements, the ground truth would be the established engineering specifications, dimensional tolerances, and the accuracy claims/requirements published by the navigation system manufacturers (e.g., VELYS Spine System, Brainlab, Medtronic StealthStation®).
• For CAD Model Evaluation, the ground truth would be the design specifications and theoretical performance derived from the CAD models.
• For Simulated Use Evaluation, the ground truth would be the defined objective criteria for successful surgical simulation (e.g., precise instrument placement, proper interaction with simulated anatomy).

8. Sample Size for the Training Set:

Not applicable. The device is a set of physical surgical instruments, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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The Tricera™ Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Tricera™ Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Tricera™ Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.

The device description and principles of operation for the modified devices are equivalent to the device description of the predicate devices cleared per Primary Predicate-K233493 and additional predicate-K162770. A brief device description of the subject devices is provided in the table below.

The provided document is a 510(k) premarket notification letter from the FDA regarding the Tricera™ Arthroscopic System. It states that the device has been determined to be substantially equivalent to previously marketed predicate devices.

Crucially, this document is an administrative letter of substantial equivalence for a medical device (an arthroscopic system) and not an AI/ML-enabled medical device.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets AI/ML-specific acceptance criteria (such as performance metrics for an algorithm, ground truth establishment, training/test set details, MRMC studies, etc.) is not applicable to this document's content.

The document describes a physical medical device (an arthroscopic system) and its accessories, including fluid management, shaver blades, and RF probes, used for orthopedic and arthroscopic procedures. The "performance data" mentioned (Section 8) refers to testing related to packaging, verification and validation, shelf life, and electromagnetic compatibility (EMC), which are standard for physical medical devices and do not involve AI/ML performance metrics.

In summary, because this is not an AI/ML device, I cannot provide the requested information related to AI/ML acceptance criteria and studies.

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The Vertos Medical mild Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.

The Vertos Medical mild Device Kit is a sterile, single-use device. The mild Device is composed of surgical tools consisting of one each of the following components: mild Initiator, mild Access Auger, mild Bone Rongeur, and mild Tissue Sculpter. The mild Initiator is pre-assembled for convenience and includes: the mild Trocar and Handle, mild Portal, mild Portal Grip, and mild Depth Guide. The mild Device Kit is utilized for tissue access, retraction, and resection within the lumbar spine via a minimally invasive posterior approach. The procedure is conducted percutaneously with the mild Tissue Sculpter and Bone Rongeur, placed through an introducer cannula, the mild Portal.

This document is a 510(k) Pre-market Notification for a medical device, specifically the Vertos mild Device Kit. It explicitly states that the device is a set of specialized surgical instruments and not an AI or software-driven diagnostic tool.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/software performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) is not applicable to this submission.

The "Performance Tests" section (VII) outlines the types of testing conducted for this surgical instrument kit, which focus on mechanical performance, safety, and sterility.

Here's a breakdown of the information that is present, aligning with the actual content provided:

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

The document doesn't provide a table with specific numerical acceptance criteria and reported performance values for each criterion. Instead, it states that the device "met all predetermined acceptance criteria" for various performance tests. The performance is described qualitatively:

The following criteria are NOT applicable or NOT detailed in the provided document, as it pertains to a surgical instrument kit, not an AI/software device:

• Sample sized used for the test set and the data provenance: Not applicable in the context of AI/software test sets. The cadaveric testing implies a "sample size" of cadavers, but the number is not specified.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a surgical instrument is its mechanical function and safety, not diagnostic accuracy.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, ground truth is established through engineering and biocompatibility standards, and cadaveric performance, not medical consensus reads or pathology.
• The sample size for the training set: Not applicable (no AI/software training set).
• How the ground truth for the training set was established: Not applicable (no AI/software training set).

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The Digital ClarusScope System and Digital NeuroPEN System are intended for accessing and visualizing the spinal nerve roots, foramina, intervertebral disc, and surrounding tissues of the spine during discectomy procedures, bone and osteophyte removal, and procedures associated with ruptured or herniated discs.

The Digital ClarusScope System and Digital NeuroPEN System are spinal endoscopes which provide a light source, camera, and HDMI output for visualization. Irrigation is provided for flushing during the procedure. The working channel facilitates the use of tools necessary for spinal procedures (Digital ClarusScope versions only). The Digital ClarusScope and Digital NeuroPEN are intended to be used with the non-sterile, reusable Clarus Digital Control Module with standard HDMI video output. The proximal end of the Digital ClarusScope and Digital NeuroPEN terminate in two fittings: the endoscope connector attaches to the Clarus Digital Control Module, which interfaces to a standard off-the-shelf HDMI video monitor which is not provided by Clarus and is not part of this 510(k) application; the other fitting is an irrigation extension tube with a female Luerlock connector.

The provided text is a 510(k) summary for the Clarus Medical Digital ClarusScope System and Digital NeuroPEN System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain information regarding specific performance acceptance criteria or detailed study results for proving the device meets these criteria. It lists various tests performed (e.g., performance testing, sterility, biocompatibility, electrical safety) but does not provide quantitative results, sample sizes, ground truth establishment, or details about expert involvement that would be needed to fill out the requested table and answer the study-related questions.

Therefore, I cannot populate the table or answer the specific questions about the study design as the information is not present in the provided document.

A 510(k) summary typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed report of clinical or non-clinical trials with specific performance metrics against pre-defined acceptance criteria. While it mentions system verification and validation through "performance testing," "simulated use test," etc., it does not disclose the details of these tests in a way that would allow for a comprehensive answer to your request.

Based on the provided text, I can only state that the information required to answer your questions is not available.

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