Search Results

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

Medtronic Xomed, Inc.'s NIM™ Standard Reinforced and NIM CONTACT™ Reinforced Endotracheal Tubes are flexible, reinforced endotracheal tubes with inflatable cuffs. The NIM EMG ET Tubes are made from silicone elastomer. Each tube is fitted with electrodes on the main shaft, which are exposed only for a short distance, 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 cuff are manufactured from material that allows the tube to conform readily to the shape of the patient's trachea with minimal trauma to tissues.

The provided text describes a 510(k) premarket notification for the Medtronic Xomed, Inc. NIM Standard Reinforced EMG Endotracheal Tube and NIM CONTACT Reinforced EMG Endotracheal Tube. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a de novo device meets specific performance criteria through extensive clinical studies.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and a study proving a device meets them that one would find for a novel device or an AI/ML-based device seeking de novo authorization or PMA. Specifically, it lacks:

• A table of acceptance criteria and reported device performance: This document focuses on demonstrating equivalence to predicate devices, not on meeting predefined performance metrics for a novel technology.
• Sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or type of ground truth for a test set. These elements are typically found in studies designed to validate the performance of a diagnostic or therapeutic device against a gold standard, especially for AI/ML products.
• Sample size for the training set or how ground truth for the training set was established: This information is pertinent to machine learning models, which are not the subject of this 510(k) submission.

What the document does describe regarding "performance data" is limited to nonclinical testing for usability and labeling design validation to support substantial equivalence.

Here's an analysis of the "Performance Data" section based on the provided text:

1. Acceptance Criteria and Reported Device Performance:

The document does not present quantitative acceptance criteria for the device's technical or diagnostic performance in the way one would see for a novel medical device like an AI algorithm. Instead, the "acceptance" is tied to proving substantial equivalence to predicate devices. The performance data presented relates to usability and labeling effectiveness, which are indirectly linked to safety and effectiveness.

• Usability Goal: "The Anesthesiologist/Nurse Anesthetist shall be able to intubate the patient and maintain the airway without introducing any unrealized use errors or critical tasks."
• Critical Tasks: "Confirm the Critical tasks were completed without any unacceptable Use Error that may have resulted in unmitigated potential hazards."
• Risk Mitigations: "To show the risk mitigations were effective in regard to labeling and training."
• Labeling Design Validation User Need: "The product labeling was to be understandable and provide needed information for proper safe and effective use of the device."

Reported Performance:
"The results of these validations with the modified proposed labeling demonstrated that the usability goal was achieved, all critical tasks were completed without introducing any additional unmitigated hazards, the user need and risk control measures were met and the training mitigations proposed were effective."

2. Sample Sizes and Data Provenance:

The document mentions "Summative Usability Validation" and "Labeling Design Validation" but does not specify the sample size (e.g., number of users, number of simulated scenarios) used for these nonclinical tests.
The data provenance is implied to be from internal testing conducted by the manufacturer, Medtronic Xomed, Inc., as part of their 510(k) submission process. It is not retrospective or prospective clinical data in the typical sense. The country of origin of the data is not explicitly stated but is implied to be in the US, given the FDA submission.

3. Number of Experts and Qualifications:

The document refers to "Anesthesiologist/Nurse Anesthetist" as the target users for the usability testing. However, it does not specify the number of experts used in the usability or labeling validation studies, nor their specific qualifications (e.g., years of experience). These individuals would have served as the "test subjects" or "evaluators" for the usability study, not necessarily as "experts establishing ground truth" in a diagnostic context.

4. Adjudication Method:

The document does not mention any adjudication method. This is not relevant for the type of usability and labeling validation studies described. Adjudication is typically used in studies where multiple human readers or algorithms produce interpretations that need to be reconciled to establish a ground truth (e.g., for diagnostic accuracy studies).

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

No MRMC study was conducted or reported. The device is not an AI/ML diagnostic aid that assists human readers. It is an endotracheal tube with EMG monitoring capabilities. The "performance data" is purely for usability and labeling effectiveness, not comparative diagnostic accuracy for human readers with or without an AI.

6. Standalone Performance (Algorithm Only):

This section is not applicable. The device is a physical medical device (an endotracheal tube), not a software algorithm. Therefore, there is no "standalone performance" in the context of an algorithm's output.

7. Type of Ground Truth Used:

For the usability and labeling studies, the "ground truth" was essentially defined by the successful completion of critical tasks without unacceptable use errors and the understandability of the labeling, as determined by the study design and its evaluators. This is not "expert consensus," "pathology," or "outcomes data" in the clinical diagnostic sense. It's about demonstrating safe and effective interaction with the device.

8. Sample Size for the Training Set:

This is not applicable. The device is a physical product, not an AI/ML model that requires a training set.

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

This is not applicable for the same reason as above.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, with performance data limited to nonclinical usability and labeling validation. It does not provide the details typically found in studies for novel diagnostic or AI/ML devices that aim to prove specific performance metrics against a clinical ground truth.

Ask a specific question about this device

The NIM™ surgeon control probes are indicated to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots via minimally invasive Transoral endoscopic thyroidectomy via vestibular approach - TOETVA.

The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.

The provided text is a 510(k) summary for a medical device (NIM™ 35cm long Surgeon Control Probe). It describes the device, its intended use, and why it is considered substantially equivalent to a predicate device. However, it does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device, as implied by the detailed questions (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance, etc.).

The "Performance Testing Discussion" section (Page 6) details typical engineering verification and validation tests for a physical medical device, such as electromechanical performance, sterilization validation, electrical safety, biocompatibility, stability, packaging performance, and usability testing. These are standard tests for hardware devices, not for assessing the performance of an AI model's diagnostic or predictive capabilities.

Therefore, I cannot provide a table of acceptance criteria for AI performance or answer most of the specific questions about the study proving the device meets AI-related acceptance criteria, as this information is not present in the provided document.

Here's what I can infer from the document regarding the performance testing that was conducted:

• Acceptance Criteria & Reported Performance: The document states that "Design performance testing was completed to ensure the functionality and intended use of the NIM™ 35cm long surgeon control probe was met in accordance with external standards, and device specifications via pre-defined acceptance criteria." It also notes that "This performance testing was used to support substantial equivalence, proving the subject device is as safe and effective as its predicate device." While specific numerical performance values against acceptance criteria are not provided, the conclusion is that the tests yielded "passing results" and demonstrated the device is "safe and effective."

  The performance tests listed are:

  • Electromechanical, dimensional, and visual design performance
  • Sterilization validation to ISO 11135:2014
  • Electrical safety & EMC testing to IEC 60601
  • Biocompatibility testing and risk analysis to ISO 10993-1:2018
  • Stability testing of proposed shelf life
  • Packaging performance of environmental conditioning to ISTA 3A and distribution simulation to ASTM D4169
  • Usability testing to IEC 62366-1:2015

• Sample Size for Test Set and Data Provenance: The document states "Bench engineering test samples were subjected to simulated real-life conditions during functional testing to establish baseline data and accelerated aging data." It does not specify the exact number of samples. Data provenance is not applicable in the sense of patient data; it's product performance testing.

• Number of Experts Used to Establish Ground Truth and Qualifications: This information is not relevant to the type of device and testing described. The "ground truth" for this device is established by engineering specifications, international standards, and physical measurements/tests.

• Adjudication Method: Not applicable for engineering performance testing of a physical device.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images/data. This device is a surgical nerve stimulating probe, not an image analysis or diagnostic AI.

• Standalone (algorithm only) Performance: Not applicable. There is no algorithm in the described function that operates standalone for diagnostic or predictive purposes. The "algorithm" here would literally be the electrical stimulation function itself, which is a physical property.

• Type of Ground Truth Used: For this device, the ground truth is based on engineering specifications, applicable international standards (e.g., ISO, IEC, ASTM), and established physical principles.

• Sample Size for Training Set: Not applicable. This document describes the validation of a physical medical device, not the training of an AI model.

• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is for a physical medical device (a surgical nerve stimulating probe) seeking 510(k) clearance based on substantial equivalence to a predicate device, supported by standard engineering performance and usability testing. It does not involve AI or an algorithm in the sense that would require the detailed AI-specific study information requested in your prompt.

Ask a specific question about this device

The NIM™ Surgeon Control Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

The NIMTM surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.

The provided document is a 510(k) premarket notification for the Medtronic Xomed, Inc. NIM™ Surgeon Control Probes. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance testing. However, it does not contain information about an AI/ML-based medical device study.

The document details safety and effectiveness testing for a physical medical device (nerve stimulator probes), not a software algorithm that performs diagnostic or prognostic tasks. Therefore, many of the requested elements (like "AI vs without AI assistance," "ground truth," "training set," "multi reader multi case study," etc.) are not applicable to the information contained in this FDA clearance letter.

Based on the provided text, here's what can be extracted and what information is missing/not applicable:

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

The document states that "Design performance testing was completed to ensure the functionality and intended use of the NIM™ Surgeon Control Probes was met in accordance with external standards, and device specifications via pre-defined acceptance criteria." It then lists the types of tests performed. It does not present a specific table with quantitative acceptance criteria and corresponding performance results. It generally states that the tests yielded "passing results."

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

• Sample Size for Test Set: The document mentions "Bench engineering test samples" but does not specify the sample size for any of the performance tests.
• Data Provenance: Not applicable in the context of this device's testing. The testing appears to be primarily lab-based engineering performance testing of physical prototypes, not data collection from patients or medical images. It's not a retrospective or prospective study on patient data.

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

• Not applicable. This device is hardware for stimulating nerves, not an AI system requiring expert consensus for a "ground truth" diagnosis or image interpretation. The "ground truth" for this device's performance would be engineering specifications and standards.

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

• Not applicable. This study is not evaluating expert interpretation of medical data. Performance is evaluated against objective engineering standards and specifications.

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, this study was not conducted. The device is a surgical tool, not an AI software designed to assist human readers (e.g., radiologists) in interpreting cases.

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

• Not applicable. This is a physical device, not an algorithm. Its performance is inherent to its design and manufacturing.

7. The type of ground truth used:

• The "ground truth" for this type of device is compliance with established engineering and safety standards (e.g., IEC, ISO, ASTM) and the manufacturer's own pre-defined device specifications. It's not clinical diagnosis or outcomes data in the context of an AI study.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

• Not applicable. Because no AI/ML model training set is involved, this question is irrelevant to the provided document.

In summary: The provided FDA clearance letter is for a traditional hardware medical device (nerve stimulator probes) and describes its performance testing against engineering and safety standards to demonstrate substantial equivalence to predicate devices. It does not contain information related to the development or validation of an AI/ML-based medical device.

Ask a specific question about this device

The Nu Vent Eustachian Tube Dilation Balloon is indicated for use in patients 18 years and older who need treatment for persistent Eustachian tube dysfunction.

The NuVent™ Eustachian Tube Dilation Balloon is composed of a sterile, single use balloon handpiece and stopcock valve. The balloon is used in conjunction with the NuVent™ inflator, which is packaged with extension tubing to connect the inflator to the stopcock valve. The NuVent™ Inflator was cleared as a part of the NuVent™ EM Sinus Balloon Dilation System, 510(k) cleared under K132297.

A pre-angled flexible balloon section promotes easy access and insertion into the Eustachian tube from the nasal opening with the aid of endoscopic guidance. An atraumatic tip at the distal end of the flexible balloon section is meant to reduce the potential for risk of injury to the Eustachian tube and surrounding tissues during insertion. The rigid shaft and handle extending to the flexible balloon section provides stability and tactile feedback when moving the balloon through the nasal passages and into the Eustachian tube canal.

Mounted near the distal end of the balloon handpiece is a flexible balloon section. Once the balloon section is advanced into the target Eustachian tube the 6mm diameter/16 mm long rigid balloon is inflated using the separate NuVent™ inflator, expanding the Eustachian tube canal tissue and cartilage.

The provided text is a 510(k) Summary for the NuVent Eustachian Tube Dilation Balloon. This type of document is submitted to the FDA to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. The information supplied in this document focuses on mechanical and functional performance testing to prove substantial equivalence, rather than a clinical study evaluating the device's impact on human readers or clinical outcomes in the way a diagnostic AI device might be.

Therefore, many of the requested items (e.g., number of experts for ground truth, MRMC study, effect size of human improvement with AI, standalone performance, training set details) are not applicable to this type of device and the information provided in this 510(k) summary.

However, I can extract the acceptance criteria and performance data for the mechanical and functional tests that were performed to support the device's substantial equivalence.

Here's the information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document states that "All samples passed testing and met acceptance criteria." While the specific numerical acceptance criteria for each test are not explicitly detailed (e.g., "tensile strength must be > X N"), the general statement indicates that the device met pre-defined requirements for these performance characteristics. The table below lists the performance tests conducted, implying that the acceptance criterion for each was successful completion without failure, demonstrating performance comparable to or better than the predicate devices and ensuring safety and effectiveness.

Study Information Specifics:

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

   • The document states "All samples passed testing," but does not specify the sample size (N) used for each of the performance tests.
   • The data provenance is from non-clinical tests conducted by Medtronic Xomed, Inc. This testing is typically done in a lab setting, not on human subjects.
   • The data is prospective in the sense that the tests were designed and executed to evaluate the new device.

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

   • N/A. This device's testing involves mechanical and functional performance, not diagnostic interpretation requiring expert ground truth in the context of a medical imaging or AI study. The ground truth for these tests is based on engineering specifications and physical measurements/observations of device performance against predefined criteria.

3. Adjudication Method for the Test Set:

   • N/A. Since this involves mechanical/functional tests against engineering specifications, there is no "adjudication" in the sense of reconciling human expert opinions. Test results are objectively measured or observed.

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:

   • N/A. This device (Eustachian Tube Dilation Balloon) is not an AI-powered diagnostic tool, nor does it assist human readers in interpreting medical images. It is a surgical device.

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

   • N/A. This device does not have an "algorithm-only" performance component. It is a physical medical device.

6. The Type of Ground Truth Used:

   • The ground truth used for this type of device relies on engineering specifications, physical measurements, and adherence to established performance standards (e.g., ISO, ASTM, internal Medtronic criteria). For example, a "passed" result for tensile strength means it met a minimum force before breaking, or "passed" for inflation means it inflated to the specified dimensions without bursting within a given pressure range.

7. The Sample Size for the Training Set:

   • N/A. There is no "training set" in the context of this device's mechanical and functional testing, as it is not an AI/machine learning model.

8. How the Ground Truth for the Training Set was Established:

   • N/A. This question pertains to AI/machine learning model development, which is not relevant to the type of device and testing described in this 510(k) summary.

Ask a specific question about this device

The NIM Vital™ System is intended for locating and monitoring, including stimulation, of cranial, spinal, peripheral motor and mixed motor-sensory nerves and registering EMG responses during surgery.

The NIM Vital™ System may be used for EMG monitoring in surgical procedures including: Intracranial, Extracranial, Intratemporal and surgeries associated with the Neck, Spine, Thorax, and Upper and Lower Extremities.

The NIM Vital™ is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation.

The NIM Vital™ system is an electromyography (EMG) monitor for intraoperative use during surgeries in which a motor or motor-sensory nerve is at risk. The NIM Vital™ records EMG activity from the muscles innervated by the affected nerve. The system assists in early nerve identification by providing the surgeon with tools to help locate and identify the particular nerve at risk within the surgical field. The system monitors EMG activity from the muscles innervated by the nerve at risk, alerting the surgeon when a particular nerve has been activated. Nerve monitoring involves measuring and displaying amplitudes of EMG responses as well as the latency (delay) between the stimulus and the EMG response. The system also allows an option for Automatic Periodic Stimulation (APS), allowing for EMG monitoring, nerve activity trending and alerts.

This information is used throughout the procedure to determine and/or change surgical strategy in order to promote the best outcome for the patient by preserving nerve function. In addition, intraoperative monitoring can help verify the integrity of the nerve throughout the procedure.

NIM Vital™ system provides detailed intraoperative nerve condition information to inspire surgical strategy and help improve patient outcomes.

Proprietary technology notifies user in real time of nerve condition - visually and audibly. NIM Nervassure™ continuous monitoring technology provides real-time feedback on nerve function so surgeons can adjust course, if necessary, during thyroid surgery and other procedures affecting head and neck nerves.

NIM NerveTrend™ EMG reporting enables nerve condition tracking throughout a procedure, even when using intermittent nerve monitoring.

During both continuous and intermittent trending, green, yellow and status bars provide visual information and their associated tones provide audible cues to users of current nerve function and EMG trends.

NIM Vital™ nerve condition information can be captured in a single, meaningful snapshot.

The following components of the NIM Vital™ Nerve Integrity Monitoring System including mechanical, electrical and software design are subject of this 510(k) submission:

NIM Vital™ Console
NIM Vital™ Console controls the functions of the system:

• Interacting with users via touch screen graphic user interface
• Setting parameters for nerve stimulations
• Executing stimulation procedures
• Processing and displaying EMG responses
• Notifying users about events by issuing audio signals
• Interfacing with Patient Interface unit
  NIM Vital™ Patient Interface
  Under control of NIM Vital™ Console
• Generating stimulation signals
• Receiving and processing EMG responses
• Connecting with Console wirelessly or via cable

NIM Vital™ Accessories:

• Cables allow connection between components of the system
• Cart provides housing for the component of the system and allows easy movement of the Console within the Operating Room
• Adaptors allow use of predicate NIM 3.0 System disposables with subject NIM Vital System

The NIM Vital™ System uses sterile disposables that were developed and cleared for use with the predicate device NIM™ 3.0 and are not subject of this 510(k) submission:

• Disposables:
• Electrodes stimulation electrodes, return electrodes, Automatic Periodic Stimulation (APS) electrodes
• Incrementing Probes

In addition, NIM Vital™ System is using a Mute Probe - a non-sterile component of NIM™ 3.0 System to detect activation of electrocautery devices during surgical procedures.

The provided text is a 510(k) summary for the Medtronic NIM Vital Nerve Integrity Monitoring System. This document focuses on demonstrating substantial equivalence to a predicate device (NIM 3.0), rather than proving stand-alone performance or clinical effectiveness through a comparative effectiveness study. Therefore, specific details about acceptance criteria for a new clinical claim, or the methodologies of studies designed to prove such claims, are not present.

However, based on the provided document, we can interpret acceptance criteria and "proof" in the context of a 510(k) for device modifications. The "proof" here is that the modified device, NIM Vital, performs equivalently to the predicate device, NIM 3.0, and adheres to relevant safety and performance standards.

Here's an attempt to answer your questions based solely on the information available in the provided document, acknowledging the limitations for a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this 510(k) are implicitly tied to demonstrating substantial equivalence to the predicate device (NIM 3.0) and compliance with relevant safety and performance standards. The "reported device performance" is framed as the NIM Vital meeting or exceeding the predicate's capabilities and all specified standards.

Since explicit quantifiable acceptance criteria for clinical performance (e.g., sensitivity, specificity for a diagnostic claim) are not provided for a new functionality, the table below reflects the criteria regarding technical and safety performance equivalence as presented in the 510(k) summary.

Note on "Proof": For a 510(k) submission, "proof" of meeting acceptance criteria is primarily demonstrated through verification and validation (V&V) testing, compliance with recognized standards, and a comparison to a legally marketed predicate device to show substantial equivalence. The document repeatedly states that "All testing passed" and "Test results indicated that NIM Vital System complies with the applicable standards."

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

The document describes bench testing and comparative design verification testing to demonstrate equivalence, but it does not specify "sample sizes" in the context of clinical patient data. The tests performed are primarily engineering and system-level tests:

• Test Set (for comparative design verification): Not applicable in terms of patient sample size. The "test set" would be the NIM Vital system components compared against the NIM 3.0 system. The comparison involved specific functionalities (e.g., electrode impedance checking, monitoring during cautery, recording responses, APS monitoring).
• Data Provenance: Not applicable. This is not a study based on human patient data. The "data" comes from the results of various engineering and functional performance tests conducted on the device itself. The document explicitly states:
  • "Animal testing data were not submitted with this 510(k)."
  • "Clinical testing was not submitted in this 510(k)."

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. Since no clinical testing or human data review was performed for this 510(k) submission, there were no experts used to establish ground truth in the traditional sense of medical image interpretation or clinical diagnosis.
• The "ground truth" for the engineering and performance tests is defined by the technical specifications, design requirements, and recognized industry standards (e.g., IEC standards for electrical safety, EMC, software). Compliance is assessed against these predefined technical benchmarks, not clinical expert consensus.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring adjudication by medical experts. The V&V testing involved engineering and quality control procedures to verify that the device performed according to its specifications and compared equivalently to the predicate.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. The document explicitly states: "Clinical testing was not submitted in this 510(k)." Therefore, no MRMC study was conducted to assess improvement in human reader performance with AI assistance (as the device is not an AI-based diagnostic tool) or other clinical outcomes.

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

• Not applicable. The NIM Vital is a medical device for nerve monitoring, not a standalone algorithm. Its performance is inherent in its hardware, software, and functional operation. The "performance testing" described (Electrical Safety, EMC, Software, Bench Performance, Comparative Design Verification) can be considered "standalone" in the sense that they evaluate the device's technical capabilities in isolation.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is primarily technical specifications, engineering design requirements, and recognized industry standards (e.g., IEC 60601 family of standards for medical electrical equipment).
• For the comparative design verification, the predicate device (NIM 3.0) and its established performance served as a "gold standard" for functional equivalence.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set of data. The device's functionality is based on established electrophysiological principles and hardware/software design.

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

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

Ask a specific question about this device

Sharpsite™ AC Rigid Endoscope: The Sharpsite™ AC Rigid Endoscopes are intended for use in surgical imaging in otolaryngology and Head and Neck procedures. including thinology and endoscopic plastic and reconstructive surgery.

Sharpsite™ AC Sterilization Tray: Sharpsite™ AC Endoscope Sterilization Tray is intended to provide a specific configuration to hold, organize and protect Sharpsite™ AC Rigid Endoscope during their transport, storage and sterilization prior to use in surgical procedures.

The Sharpsite™ AC endoscopes are rigid rod lens endoscopes for imaging and are available in diameters from 2.7 mm to 4.0 mm and in angles of view of 0, 30, 45 and 70 degrees. These endoscopes are reusable, autoclavable instruments and are provided non-sterile.

The Sharpsite™ Rigid Ear, Nose and Throat (ENT) endoscopes provide access and allow observation during otolaryngology and head and neck procedures. The device consists of rigid rod inserted into body orifice. The endoscope includes an optical system to visualize the image by direct view or with use of a camera. The endoscopes are provided non-sterile and can be reused by multiple methods as mentioned in the IFU. Each Sharpsite™ endoscope is fitted with a commercially available removable light port adapter for use with different manufacturers light cables.

Sharpsite™ AC Endoscopic sterilization tray is a container which is a reusable device that includes a base and lid. It is a single level thermoplastic instrument case designed to hold Sharpsite™ AC Rigid Endoscopes. The Sharpsite™ tray is specifically configured to organize, store, protect, transport and sterilize Sharpsite™ AC Rigid Endoscopes for use in surgical procedures.

The provided text is a 510(k) summary for the Medtronic Sharpsite™ AC Rigid Endoscope and Sharpsite™ AC Endoscope Sterilization Tray. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for device performance in the context of an AI/ML-driven medical device.

The information requested in the prompt, specifically regarding acceptance criteria for device performance and the study proving it, is typically associated with AI/ML-based diagnostic or prognostic devices, or devices with complex functional output that requires rigorous validation against ground truth.

The device described here, the Sharpsite™ AC Rigid Endoscope, is a rigid rod lens endoscope used for surgical imaging. Its primary function is to provide visualization. The "testing" section (page 7) refers to cleaning and sterilization validations, biocompatibility assessment, and states that "Additional bench, animal or clinical testing was not required to establish substantial equivalence." This indicates that the substantial equivalence argument relies on the similarity of the device's technological characteristics and intended use to a previously cleared predicate device (K965233).

Therefore, I cannot extract the requested information from the provided text because it does not describe an AI/ML-driven device's performance validation. The document is about establishing substantial equivalence for a non-AI/ML optical imaging tool and its sterilization tray.

If this were an AI/ML device, the acceptance criteria and study details would be presented very differently, focusing on metrics like sensitivity, specificity, AUC, human reader agreement, and the methodology for establishing ground truth for AI model training and testing.

Ask a specific question about this device

The EM Sinus Dilation System is intended for use in conjunction with the Medtronic Computer-Assisted Surgery System during sinus procedures when surgical navigation or image-guided surgery may be necessary. When used concomitantly, these systems may be used to

• locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia; or
• locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically altered to facilitate dilation of the sinus ostia.

The Medtronic computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use 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 the skull, can be identified relative to a CT- or MR-based model, or digitized landmarks of the anatomy.

The system and its associated applications should be used only as an adjunct for surgical quidance. They do not replace the surgeon's knowledge, expertise, or judgment.

The NuVent™ EM Sinus Dilation System comprises sterile, single-use instruments that combine electromagnetic (EM) "plug and play" tracking capability with the pathway expansion effects of balloon dilation technology and an inflator. Each of the three types of sinus seekers (frontal, maxillary and sphenoid) has a unique shape and angle that allows for entry into the sinus outflow tract. The inflator consists of a plunger, barrel and extension tube.

Each sinus seeker is intended for use in conjunction with the Fusion software on a Medtronic computer-assisted surgery system. Inside each sinus seeker is an EM tracker. The emitter on the EM Computer-Assisted Surgery System generates a low-energy magnetic field to locate the tracker mounted inside of the sinus seeker. The software displays the location of the sinus seeker's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the sinus seekers balloon can be inflated with saline solution by using the inflator to expand the outflow of the targeted sinus.

The provided text describes a 510(k) premarket notification for the NuVent EM Sinus Dilation System. This device is an ear, nose, and throat (ENT) manual surgical instrument used in conjunction with a computer-assisted surgery system for sinus procedures. The submission seeks to expand the indications for use to include procedures on scarred, granulated, or previously surgically altered tissue, and also to explicitly state facilitating "dilation of the sinus ostia" in the indications.

The submission does not contain acceptance criteria for specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be expected for a diagnostic or AI-driven device. This is primarily because the device is a surgical instrument for physical manipulation and guidance, not a diagnostic tool that produces classification or quantitative results.

The "study" described is a clinical study to support the expanded indications, focusing on the safe and intended performance of the device in a specific patient population, not on meeting predefined statistical performance thresholds for an AI algorithm.

Based on the provided text, here is the information requested, with "N/A" where the information is not applicable to this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a surgical instrument and not an AI or diagnostic device, the "acceptance criteria" discussed are related to the broader concepts of "substantial equivalence," "performance as intended," and "no new safety concerns." There are no quantitative performance metrics like sensitivity or specificity.

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

• Sample Size (Test Set): Not explicitly stated as a number of "subjects." The text mentions "subjects with scarred, granulated or previously surgically altered tissue were enrolled and treated in at least one frontal, sphenoid, or maxillary sinus." The exact number of subjects is not provided in this excerpt.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

N/A. This is a study to demonstrate the performance and safety of a surgical instrument in a clinical setting, not a study involving expert-derived ground truth for diagnostic accuracy. The "truth" is whether the device could be used as intended without issue and without new safety concerns, as observed by the operating surgeons. Though not called out explicitly regarding "ground truth," the study involved "surgeons" performing procedures.

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

N/A. This type of adjudication is not applicable to a clinical study evaluating the performance and safety of a surgical instrument. The study was described as "non-randomized, non-blinded, single arm."

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

N/A. This device is a surgical instrument assisted by a computer navigation system, not an AI-assisted diagnostic imaging interpretation tool. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant.

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

N/A. The device is a physical surgical instrument that functions "in conjunction with the Medtronic Computer-Assisted Surgery System." It is inherently a "human-in-the-loop" device as it aids the surgeon, rather than performing tasks autonomously.

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

The "ground truth" implicitly assessed was clinical outcome and observed safety/performance during live surgical procedures. The clinical study evaluated whether the device "performed as intended and did not raise new safety concerns" in patients with the expanded indications.

8. The sample size for the training set

N/A. This submission describes a modification to an existing surgical device. There is no mention of an algorithm or AI model that would require a "training set."

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

N/A. As there is no training set for an algorithm, this question is not applicable.

Ask a specific question about this device

The ALAR™ Nasal Valve Stent is intended for use in supporting the lateral nasal wall during the post-operative healing period following nasal valve surgery. This procedure may be performed independently or in conjunction with other procedures such as septoplasty and turbinoplasty in order to address nasal obstruction.

The ALAR™ Nasal Valve Stent supports and immobilizes intranasal tissues and cartilage during the post-operative healing period following intranasal and nasal valve surgery.

The elliptically shaped fluoroplastic stent is approximately 20 mm long and 16 mm wide. Slits symmetrically spaced along the stent's lateral edges allow for left and right nostril usage. The suture and needle attached to the stent provide stent anchoring and hold cartilage plates stable during post-operative healing.

The provided document is a 510(k) premarket notification for the ALAR™ Nasal Valve Stent. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy.

The "Discussion of the Performance Testing" section (page 4) states: "Testing was completed to ensure the functionality and compatibility with the identified Medtronic Xomed products. Test samples were subjected to simulated real-life use conditions during functional testing. All function testing passed the test specifications and acceptance criteria for the bench top engineering studies. A biocompatibility assessment, sterility adoption, transportation and shelf life/aging testing was also conducted Additional bench, animal or clinical testing was not required to establish substantial equivalence."

This indicates that engineering studies were performed to confirm functionality and compatibility, and these studies had "test specifications and acceptance criteria." However, these specific criteria and the detailed results are not provided in this document. The focus of this 510(k) summary is on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and existing predicate testing, rather than presenting a performance study with detailed clinical or diagnostic metrics.

Therefore, I cannot populate the requested table and answer many of the questions because the necessary information is not present in the provided text. The device is a physical medical device (stent), not an AI/algorithm-based diagnostic device, so many of the questions pertinent to AI performance metrics (like MRMC studies, standalone algorithm performance, training/test set details, ground truth for AI) are not applicable or detailed in this context.

Here's what can be inferred or stated based on the provided text, and what cannot:

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

Missing Information: The document does not provide the specific numerical or qualitative "acceptance criteria" for functionality, biocompatibility, sterility, etc., nor does it provide the detailed "reported device performance" metrics against those criteria. It only states that testing passed the internal specifications.

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

• Sample Size: Not specified. The document refers to "test samples" for "bench top engineering studies," but the number of samples is not mentioned.
• Data Provenance: Not applicable in the context of clinical/patient data, as these were bench-top engineering studies. The studies were likely conducted internally by Medtronic Xomed Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is a physical stent, and the evaluation mentioned consists of engineering studies (biocompatibility, functional testing, etc.), not a diagnostic test with a "ground truth" established by medical experts in the typical sense of evaluating diagnostic accuracy.

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

• Not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple readers. The described tests are bench-top engineering studies.

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. This is not an AI/diagnostic device.

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

• No. This is not an AI/diagnostic device.

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

• Not applicable in the context of clinical "ground truth" for diagnostic performance. Ground truth in the engineering studies would refer to established physical, chemical, or mechanical standards and specifications.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable.

Ask a specific question about this device

The XPS Nexus™ System is indicated for the incision/cutting, removal and drilling of soft and hard tissue and bone in head and neck/ENT, oral/maxillofacial and plastic/reconstructive/aesthetic surgical procedures.

The XPS Nexus™ System is a powered microdebrider and drill system that removes soft tissue, hard tissue and bone during surgical procedures. The system consists of a power control console, a foot control unit and assorted hand-pieces to drive various burs, blades, drills, rasps and cannulas. Hand-piece options include the StraightShot® M2 Microdebrider, the StraightShot® M4 Microdebrider and the Indigo® Otology Drill. The power control console also includes integrated irrigation pump for irrigation of blades and burs. Optional accessories include an IV pole to hold a bag(s) of irrigation solution as well as a carrying case.

The provided document is a 510(k) summary for the Medtronic Xomed, Inc. XPS Nexus System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the device is not an AI/ML powered device, and the information requested (acceptance criteria, study details, sample sizes, expert involvement, etc., in the context of an AI/ML device) is not directly applicable or available in this document.

However, I can extract the types of testing performed and the standards met, which serve as "acceptance criteria" for this conventional medical device's safety and performance in the context of a 510(k) submission.

Here's a breakdown of the available information, reframed to address the spirit of your request where possible, but highlighting that this is not an AI/ML device study:

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

For a conventional medical device like the XPS Nexus System, "acceptance criteria" typically refer to compliance with recognized standards for safety and fundamental performance. The reported "device performance" in a 510(k) for such a device is demonstrated by meeting these standards and showing equivalence to predicate devices.

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

This information is not provided in the document. The document describes engineering and regulatory compliance testing rather than clinical or AI/ML performance testing involving patient data. For electrical, EMC, software, and general performance testing, a "sample size" of patient data is not applicable. The samples would be the device units tested, but the number is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. "Ground truth" established by experts is relevant for AI/ML diagnostic or prognostic devices that interpret medical data. This device is a surgical drill system; its "ground truth" relates to its mechanical and electrical function as per engineering specifications, not expert interpretation of medical images or patient outcomes.

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

This information is not applicable and not provided. Adjudication methods like 2+1 are typically used in clinical studies or AI/ML evaluations where there's disagreement among human readers or between AI and human readers. This document details engineering compliance testing.

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

This information is not applicable and not provided. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical drill and does not involve "human readers" interpreting data with or without AI assistance.

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

This information is not applicable and not provided. This device is a physical surgical tool and does not involve a standalone algorithm for performance evaluation in the context of AI.

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

For this device, the "ground truth" would be established by engineering specifications, validated test methods (e.g., measuring power output, torque, temperature, electrical leakage), and compliance with the recognized consensus standards listed (e.g., IEC 60601 series). It's a functional "ground truth" based on physics and engineering, not medical interpretation or pathology.

8. The sample size for the training set

This information is not applicable and not provided. Training sets are used for machine learning models. This is a conventional medical device.

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

This information is not applicable and not provided.

Ask a specific question about this device

When inserted through a myringotomy, a ventilation tube provides a passageway for movement of air between the auditory canal and the middle ear. The unobstructed passageway may also allow a means of drainage of fluids resulting from acute or chronic otitis media from the middle ear into the auditory canal. In addition, surgical placement of ventilation tubes also provides a means of equalizing air pressures between the outer ear and the middle ear and continued ventilation to prevent fluid accumulation within the middle ear.

The surgeon must use medical judgment and consider the patient's medical history prior to a decision to surgically insert a ventilation tube. Pathologic conditions for which ventilation tubes are indicated include but not limited to:

• Chronic otitis media with effusion characterized as serous, mucoid, or purulent
• Recurrent acute otitis media which fails to respond satisfactorily to alternative therapies
• A patient with a history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus
• Atelectasis resulting from retraction pocket of the tympanic membrane or eustachian tube dysfunction

Medtronic® Xomed® Ventilation (tympanostomy) Tubes are small tubular implants available in a variety of biocompatible materials including silicone elastomer, fluoroplastic. C-FLEX® TPE. stainless steel and titanium. Numerous designs and sizes are available with single or multiple flanges to satisfy various surgical techniques for insertion and to facilitate short or long-term communication of the auditory canal with the middle ear. Some tubes are fitted with semi-permeable membranes intended to allow free passage of air while preventing movement of fluids into the middle ear.

The provided text describes a 510(k) premarket notification for "Ventilation (Tympanostomy) Tubes" by Medtronic Xomed, Inc. This submission is for consolidating previously cleared and preamendment ventilation tubes and claims substantial equivalence to predicate devices. As such, it does not contain information about a study to prove acceptance criteria for a new device or algorithm performance.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this document. This submission relies on the existing clearance and established performance of the predicate devices.

Here's a breakdown of what can be extracted and what cannot:

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

• Not Applicable. This submission is for devices that have already been cleared or were preamendment devices, meaning their performance and safety were established previously. No new performance acceptance criteria or study results are presented in this document. The document asserts "same" for all comparative characteristics with existing predicate devices.

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

• Not Applicable. No new test set or data provenance is mentioned as no new performance testing was conducted for this 510(k). The document states, "The Ventilation (Tympanostomy) Tubes did not undergo any design changes as a result of this submission. Therefore no additional bench, animal or clinical testing is required."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No test set or ground truth establishment relevant to the performance of a new device is mentioned.

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

• Not Applicable. No test set or related adjudication method is mentioned.

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. This is not an AI device, and no MRMC study was conducted or referenced for this submission.

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

• Not Applicable. This is not an AI/algorithm device.

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

• Not Applicable. No new ground truth for performance evaluation is mentioned. The clearance is based on substantial equivalence to predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/algorithm device and thus has no training set.

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

• Not Applicable. This is not an AI/algorithm device and thus has no training set or associated ground truth establishment.

Summary of Relevant Information from the Document:

The document focuses on demonstrating substantial equivalence to existing predicate devices. The key argument is that the proposed Ventilation (Tympanostomy) Tubes are identical in intended use, indications for use, technological characteristics, and principle of operation to 12 previously cleared predicate devices.

Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the "acceptance criteria" appear to be meeting the characteristics of the predicate devices, thereby establishing substantial equivalence. The reported "performance" is implicitly that these devices function identically to the legally marketed predicates.

Ask a specific question about this device