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These cannulae are indicated for CPB procedures requiring delivery of cardioplegia in a retrograde direction through the coronary sinus for up to 6 hours in duration.

The Retrograde Coronary Sinus Perfusion Cannulae models in scope of this 510(k) consist of a wire-wound silicone cannula body with a beveled tip (6-Fr models have a non-wire wound cannula body). Two side holes are present near the tip. The back of the cannula body terminates in a locking female luer. A pressure monitoring line is an integral part of the cannula body, beginning at the tip and terminating in a locking female luer fitting or 3-way stopcock with a locking female luer fitting. An inflatable balloon is located at the distal beveled tip. The inflation assembly is located at the back of the cannula body and contains a female slip luer and a one-way valve assembly. Cannulae have a guidewire or solid stylet with a male luer handle or a TruTouch handle.

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The Stealth AXiS™ Surgical System is intended for precise positioning of surgical instruments and as an aid for precisely locating anatomical structures in open, minimally invasive, and percutaneous procedures. The Stealth AXiS™ Surgical System is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

The Stealth AXiS™ Surgical System is indicated for precise robotic positioning of surgical instruments or implants during orthopedic or neurosurgery. It may be used in open, minimally invasive, and percutaneous procedures.

The Stealth AXiS™ Surgical System, with the Stealth AXiS™ Spine clinical application, is intended for precise positioning of surgical instruments and as an aid for precisely locating anatomical structures in open, minimally invasive, and percutaneous procedures. Their use is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.

This can include procedures in adult patients, such as:
• Interbody device placement
• Pedicle screw placement
• Iliosacral screw placement

This can include the following spinal implant procedure in skeletally mature pediatric (adolescent) patients:
• Pedicle screw placement

The Stealth AXiS™ Surgical System is a computer-assisted surgery system that is composed of a platform, clinical application, surgical instruments, and a referencing system (which includes patient and instrument trackers). The system tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient. The Stealth AXiS™ Surgical System supports both optical and electromagnetic (EM) localization. Localization is also called navigation.

The Stealth AXiS™ Spine clinical application helps guide surgeons during spine procedures. Patient images can be displayed by the Spine clinical application from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display. The surgeon may also create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the clinical application displays how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, real-time positional information obtained through the Stealth AXiS™ Surgical System can serve to guide this judgment.

With the addition of the Stealth AXiS™ Autopilot to the Stealth AXiS™ Core, the Stealth AXiS™ Surgical System becomes a robotic-assisted surgery system.

Here's an analysis of the acceptance criteria and study information for the Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application, based on the provided 510(k) clearance letter:

Acceptance Criteria and Device Performance

Study Information

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

• AI-enabled Automatic Planning: Test data was strictly separated from training data by site and included scans stratified by surgical approach and vertebra. Specific sample size is not provided in the document.
• AI-enabled Automatic Spine Segmentation: Test data was separated from training data. Specific sample size is not provided in the document.
• General System Accuracy: "Under representative worst-case configuration..." Specific sample size (e.g., number of measurements, cadavers) and data provenance (e.g., country of origin, retrospective or prospective) are not provided in the document.
• Clinical Testing: A retrospective clinical evaluation of published literature was performed. Specific details on the number of studies or patients are not provided.

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

• AI-enabled Automatic Planning: The model compared candidate screw placements to "expert standards" and identified solutions aligned with "expert decisions." These expert placements were from "Surgical Support Technicians." The number of experts or specific qualifications are not explicitly stated beyond "Surgical Support Technicians."
• AI-enabled Automatic Spine Segmentation: Ground truth was "clinician-reviewed." The number of clinicians or their specific qualifications (e.g., radiologist with X years of experience) are not provided.
• General System Accuracy: Not applicable as ground truth for "accuracy" typically refers to physical measurements against a known standard.

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

• AI-enabled Automatic Planning: Decision-making relies on the AI model identifying solutions similar to "expert decisions," with clinical users having full control to review, modify, or override. This implies an expert review step but does not specify a formal adjudication method like N+1.
• AI-enabled Automatic Spine Segmentation: Ground truth was "clinician-reviewed." This implies review, but a formal adjudication method (e.g., majority vote, consensus) is not specified.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• A formal MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance is not explicitly mentioned for either AI feature. The AI features are described as aids where the human user retains ultimate control. The document focuses on the standalone performance of the AI components and system accuracy rather than direct human performance improvement.

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

• AI-enabled Automatic Planning: The model outputs screw placement recommendations. While clinical users can modify these, the performance evaluation likely assesses the accuracy of the AI’s initial recommendations against expert standards, suggesting a standalone component to its evaluation.
• AI-enabled Automatic Spine Segmentation: Model performance was evaluated by comparing "AI-generated segmentations to clinician-reviewed ground truth," which indicates a standalone evaluation of the algorithm's segmentation output.
• General System Accuracy: Yes, the "3D positional accuracy" and "trajectory angle accuracy" are standalone performance metrics for the device.

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

• AI-enabled Automatic Planning: "Expert standards" and "expert decisions" from "Surgical Support Technicians." This indicates expert consensus or labeled data from experts.
• AI-enabled Automatic Spine Segmentation: "Clinician-reviewed ground truth." This implies expert review or consensus.
• General System Accuracy: Ground truth for physical accuracy studies is typically established through high-precision metrology or physical measurements against a known standard, often in a lab setting, but not explicitly stated here.

7. The sample size for the training set:

• AI-enabled Automatic Planning: "expert screw placements from Surgical Support Technicians." Specific sample size is not provided.
• AI-enabled Automatic Spine Segmentation: "internal and public datasets." Specific sample size is not provided.

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

• AI-enabled Automatic Planning: Ground truth was established from "expert screw placements from Surgical Support Technicians," implying that these technicians provided the optimal screw placements used to train the model.
• AI-enabled Automatic Spine Segmentation: Ground truth was established using "internal and public datasets," with the implication that these datasets contained accurately segmented vertebrae, likely performed by clinicians or experts. The statement "clinician-reviewed ground truth" for validation suggests a similar approach for training data.

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The EMG Tube is indicated for use where continuous monitoring of the nerves supplying the laryngeal musculature is required during surgical procedures. The EMG tube is not intended for postoperative use.

The Medtronic NIM Essence™ EMG Endotracheal Tube (ETT) is a flexible, reinforced PVC endotracheal tube with an inflatable cuff. FPC (Flexible Printed Circuit) is attached and wrapped around the main shaft of the endotracheal tube, and silicone cover tube overlays on the FPC. The FPC electrodes are exposed only for a short distance, approximately 30 mm, slightly superior to the cuff. The electrodes are designed to make contact with the laryngeal muscles around the patient's vocal cords to facilitate electromyographic (EMG) monitoring of the laryngeal musculature during surgery when connected to an EMG monitoring device. Both the tube and the cuff are manufactured from material that allows the tube to readily conform to the shape of the patient's trachea with minimal trauma to tissues. The NIM Essence™ EMG Endotracheal Tube is packaged as a sterile single-use device.

The Medtronic NIM™ 3.0 (cleared via K083124 on February 27, 2009) and NIM Vital™ (cleared via K200759 on October 28, 2020) nerve monitors are the recommended EMG monitors for use with the EMG Endotracheal Tube. All references to connections and technical specifications for EMG monitor contained in the instructions are made with references to the NIM™ family of devices. Medtronic recommends that the user consult the NIM™ User's Guide for determining proper settings of the NIM™ console and instructions for intraoperative EMG monitoring and motor nerve location and stimulation.

The NIM Essence™ EMG Endotracheal Tube is Type BF applied part.

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SmartGuard Technology:
SmartGuard technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically adjust the delivery of basal insulin and to automatically deliver correction boluses based on sensor glucose (SG) values.

SmartGuard technology is intended for the management of Type 1 diabetes mellitus in persons 7 years of age and older, and Type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.

SmartGuard technology is intended for single patient use and requires a prescription.

Predictive Low Glucose Technology:
Predictive Low Glucose technology is intended for use with compatible integrated continuous glucose monitors (iCGM), compatible Medtronic continuous glucose monitors (CGM), alternate controller enabled (ACE) pumps, and digitally connected devices to automatically suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.

Predictive Low Glucose technology suspends and resumes insulin delivery in Manual mode. Manual mode contains a bolus calculator that calculates an insulin dose based on user-entered data.

Predictive Low Glucose technology is intended for the management of type 1 diabetes mellitus in persons 7 years of age and older, and type 2 diabetes mellitus in persons 18 years of age and older requiring insulin.

Predictive Low Glucose technology is intended for single patient use and requires a prescription.

Device Description for SmartGuard Technology

SmartGuard Technology, also referred to as the Advanced Hybrid Closed Loop (AHCL) algorithm, is a software-only interoperable automated glycemic controller (iAGC) intended to adjust basal insulin delivery and perform automatic correction boluses based on user-entered inputs and sensor glucose (SG) values obtained from a compatible integrated continuous glucose monitor (iCGM) or an interoperable Medtronic continuous glucose monitor (CGM). SmartGuard Technology is embedded within the firmware of a compatible alternate controller enabled (ACE) pump, which functions as the host device.

The ACE pump receives SG data from compatible CGM/iCGM devices via Bluetooth Low Energy (BLE) and also collects user inputs through the ACE pump (for pumps that have a screen) or the MiniMed App (for screenless pumps). The AHCL algorithm does not directly communicate with CGMs/iCGMs; instead, the ACE pump transmits CGM/iCGM data and user-entered inputs to the AHCL algorithm and receives the algorithm's output commands.

In SmartGuard Mode, the AHCL algorithm uses adaptive control to adjust insulin delivery every five (5) minutes based on SG values. It delivers an auto basal insulin dose to maintain user-selectable targets of 100, 110, or 120 mg/dL, supports a temporary target of 150 mg/dL for up to 24 hours, and can automatically deliver correction boluses when appropriate.

Meal boluses are the responsibility of the user. The AHCL algorithm includes an integrated bolus calculator that determines user-initiated meal bolus doses based on available SG information, carbohydrate input, and other patient parameters.

The AHCL algorithm is a software-only device with no user interface. All therapy settings, user interactions, and AHCL-related alerts or alarms are managed through the compatible ACE pump or the MiniMed App. An optional App Manager device with the MiniMed App pre-installed is available as an alternative to a user's personal mobile device.

Device Description for Predictive Low Glucose Technology

Predictive Low Glucose Technology, also referred to as the Predictive Low Glucose Management (PLGM) algorithm, is a software-only interoperable automated glycemic controller (iAGC) that is intended to automatically suspend delivery of insulin when sensor glucose (SG) values fall below or are predicted to fall below predefined threshold values based on user-entered inputs. The PLGM algorithm is embedded within the firmware of a compatible alternate controller enabled (ACE) pump, which functions as the host device.

The ACE pump receives SG data from a compatible integrated continuous glucose monitor (iCGM) or interoperable Medtronic CGM via Bluetooth Low Energy (BLE) and collects user-entered inputs through the ACE pump (for pumps that have a screen) or the MiniMed App (for screenless pumps). The PLGM algorithm does not directly communicate with CGM/iCGM devices; instead, the ACE pump transmits CGM/iCGM data and user inputs to the algorithm and receives the resulting suspend and resume commands. PLGM functionality is available only in Manual mode. In this mode, users are responsible for all basal and bolus insulin delivery, including user-defined basal rate patterns and user-initiated boluses, with optional use of the bolus calculator and the max bolus limit feature. When enabled, the PLGM algorithm may suspend insulin delivery for a minimum of 30 minutes and up to 2 hours based on current or predicted SG values and will automatically resume delivery when criteria are met or when the maximum suspend duration is reached. Users may also manually resume delivery at any time.

The PLGM algorithm is a software-only device with no user interface. All therapy settings, user interactions, and PLGM-related alerts or alarms are managed through the compatible ACE pump or the MiniMed App. An optional App Manager device with the MiniMed App pre-installed is available as an alternative to a user's personal mobile device.

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The Infinity™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3. These devices are to be used with autograft and/or allograft.

• Traumatic spinal fractures and/or traumatic dislocations.
• Instability or deformity.
• Failed previous fusions (e.g. pseudarthrosis).
• Tumors involving the cervical spine.
• Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT rods. In order to achieve additional levels of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package insert, Vertex™ Reconstruction System, and PASS OCT Spinal System package inserts for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

Medtronic Navigated Reusable Instruments for use with StealthStation™ and IPC™ POWEREASE™ Systems

Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

Stealth™ Spine Clamps

When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:

• The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
• The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
• The Stealth™ spine clamps are indicated for skeletally mature patients.

Infinity™ OCT System

The Infinity™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case.

The Infinity™ OCT System is fabricated from medical grade titanium alloy and medical grade cobalt chromium. Medical grade titanium alloy and medical grade cobalt chromium may be used together. Never use titanium alloy and/or cobalt chromium with stainless steel in the same construct. No warranties, expressed or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

To achieve best results, do not use any of the Infinity™ OCT System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another Medtronic document. As with all orthopedic and neurosurgical implants, Infinity™ OCT System components should never be reused under any circumstances.

Medtronic Navigated Referencing Devices

Medtronic navigated referencing devices provide rigid fixation to patient anatomy and enables the assembly of a patient reference frame. Various types of instruments are available including spine referencing clamps and associated connections to maintain compatibility with current spine reference frames.

Medtronic navigated referencing devices are compatible with various Medtronic spinal implant systems including Medtronic computer assisted surgery systems, including, but not not limited to, StealthStation™ and/or Mazor™ systems, and Medtronic navigation reusable instruments. These instruments are also compatible with Medtronic's IPC™ Powerease™ System when connected to the Powerease™ Driver.

Medtronic navigated referencing devices are supplied as non-sterile reusable instruments. All devices should be cleaned and sterilized before use.

Medtronic navigated referencing devices are manufactured from a variety of materials commonly used in orthopedic and neurological procedures, which meet applicable national and/or international standards. These instruments may be shipped in accessories. Accessories include cases, trays, lids, caddies, and modules fabricated from a variety of materials, which meet national and international standards, and are commonly used to enclose, protect, and organize Medtronic orthopedic and neurological reusable instruments.

Medtronic Reusable Instruments and Accessories

Reusable instruments are manufactured from a variety of materials commonly used in orthopedic and neurological procedures, which meet applicable national and/or international standards. These instruments may be shipped in Medtronic Transportation/ Sterilization Cassettes. The Medtronic Transportation/Sterilization Cassettes are designed to be used in conjunction with a legally marketed, validated, and FDA-cleared sterilization wrap to allow steam sterilization of non-sterile devices.

Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials, which meet national and international standards, and are commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation Sterilization Cassettes are intended for transport of non-sterile loads.

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The device is indicated for temporary use during the creation of anastomosis for medical conditions requiring beating heart coronary artery bypass procedures.

The disposable intracoronary shunts consist of a flexible tube. Both ends of the tube feature a teardrop shaped tip made from radiopaque material with 14 mm between the ends. Tip diameters range from 1.00 mm to 3.00 mm. A tether with a tag made of radiopaque material is permanently attached to the shunts. These devices are sterile, nonpyrogenic, disposable and intended for single use only. They are sterilized using ethylene oxide and are categorized as external communicating devices, with limited contact (<=24 hours) circulating blood contact.

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