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The hekaDrill system is intended for use in surgical procedures involving incision / cutting, removal, drilling and sawing of soft and hard tissue, bone and biomaterials. The system is specifically intended for use in Neurosurgical (Cranial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Stemotomy, and General Surgical Procedures.

The hekaDrill System consists of electric and pneumatic drill handpieces, a power console, footswitches, attachments, connection cables, irrigation tube kits, cutting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The console and footswitches are reusable and are not intended to be sterilised. The cutting tools and irrigation tube kits are provided sterile and are single use.

The hekaDrill device primarily consists of various components for surgical procedures involving cutting, drilling, and sawing of soft and hard tissues. The performance assessment focused on comparing the device's cutting performance, electrical safety, electromagnetic compatibility, and biocompatibility with predicate devices and relevant standards.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes for each performance test (e.g., number of cutting trials, number of biological samples). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective.

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 a "ground truth" in the traditional sense for the performance tests described. The assessment relied on objective measurements and comparisons against established standards and predicate device performance. For the biocompatibility tests, the "ground truth" is determined by the specific reaction observed (e.g., cytotoxicity, sensitization), not expert consensus on an image or diagnosis.

4. Adjudication Method for the Test Set:

Not applicable in this context. The performance tests involve objective measurements and comparisons to standards, not subjective interpretations requiring adjudication among experts.

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 hekaDrill is a surgical drill system, not an AI-powered diagnostic or assistive device that would involve human readers or image interpretation.

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

Not applicable, as this is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used:

For the performance tests:

• General Performance: The "ground truth" was established by comparing direct measurements of performance characteristics (vibration, noise, control, cutting effectiveness) against those same characteristics of a predicate device.
• Electrical Performance: The "ground truth" was the adherence to established international safety standards (IEC 60601-1:2005 and IEC 60601-1-2:2014).
• Biocompatibility: The "ground truth" was dictated by the specific biological responses observed in standardized tests, such as the absence of biological reactivity in cytotoxicity assays or no significant reaction in sensitization tests.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device. The concept of a "training set" is typically associated with machine learning or artificial intelligence models.

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

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

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The hekaDrill system is intended for use in surgical procedures involving incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone. The system is specifically intended for use in Neurologic and general surgical procedures.

The hekaDrill System consists of electric and pneumatic drill handpieces, a power console, footswitches, attachments, connection cables, irrigation tube kits, cutting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The console and footswitches are reusable and are not intended to be sterilised. The cutting tools and irrigation tube kits are provided sterile and are single use.

The provided text describes a 510(k) submission for the hekaDrill System. It includes details about performance testing, but it does not provide acceptance criteria in a quantitative format or a detailed study section with specific sample sizes, ground truth procedures, or expert involvement as requested.

However, based on the limited information available in the "Discussion of the Performance Testing" table, I can extract and infer some aspects related to acceptance criteria and reported device performance.

Here's an attempt to structure the answer based on the given information, with caveats about missing details:

Acceptance Criteria and Supporting Study for hekaDrill System

The K193630 submission for the hekaDrill System included performance testing to demonstrate the functionality and safety of the device compared to predicate devices. The following table summarizes the reported performance relative to general criteria.

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

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

• Sample Size: The document does not specify the sample sizes used for any of the performance tests. For instance, for "Cutting performance," it does not state how many devices were tested or how many cutting tasks were performed. For biocompatibility tests, the number of samples or specimens analyzed is not provided.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that these are bench and lab-based performance tests for a new device submission, they would typically be prospective studies conducted in a controlled lab environment by Zethon Ltd (a UK company) or its contracted testing facilities.

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

• This information is not provided in the document. The performance tests described (cutting performance comparison, electrical safety, EMC, biocompatibility) are primarily objective, quantitative measurements against established standards or predicate device performance, rather than requiring expert interpretation for ground truth.

4. Adjudication method for the test set:

• This information is not applicable/provided. The tests are objective measurements against standards or predicate performance, not subjective readings requiring adjudication for ground truth.

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. The device, hekaDrill System, is an electric cranial drill motor, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or assessment of AI assistance would not be relevant to this device.

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

• This information is not applicable. As stated above, the hekaDrill System is a surgical instrument, not an algorithm.

7. The type of ground truth used:

• For the General Performance (Cutting performance), the ground truth was based on a comparison to a predicate drill system (Midas Rex Drill Systems), implying the predicate's performance served as a benchmark for "equivalent or better."
• For Electrical Performance and Electromagnetic Compatibility, the ground truth was adherence to international consensus standards (IEC 60601-1:2005 and IEC 60601-1-2:2014, respectively).
• For Biocompatibility, the ground truth was established by recognized biocompatibility testing methods (e.g., L929 MEM Elution for cytotoxicity, Kligman Maximization for sensitization, etc.) where specific biological responses or lack thereof (e.g., "Non-cytotoxic," "Non-sensitizer") define compliance.

8. The sample size for the training set:

• This information is not applicable/provided. The device is a surgical instrument, not a machine learning algorithm that requires a training set.

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

• This information is not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.

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The Midas Rex™ attachments and dissecting tools for Mazor are indicated for the incision/cutting, drilling, burring, and removal of hard tissue and bone in open and minimally invasive spine procedures.

Computer-assisted surgery and its associated applications are intended as an aid for locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition for which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure, such as a long bone or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

Midas Rex™ attachments and surgical dissecting tools for Mazor are intended for the incision/cutting, drilling, burring, and removal of hard tissue and bone. The subject instruments are designed to be utilized through a cannula, for use with the Mazor X Stealth Edition™ system in open and minimally invasive spine procedures.

The subject devices perform the intended function as part of the existing Medtronic Midas Rex TM surgical drill systems which consist of the subject attachments and dissecting tools, electric and pneumatic drill handpieces and system accessories.

The provided text describes the acceptance criteria and a study for the "Midas Rex Attachments and Dissecting Tools" which are intended for surgical navigation.

Here's the detailed information based on your request:

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document indicates that "Navigational Accuracy Analysis" was performed, which "Provides confirmation that the subject devices satisfy the necessary navigational accuracy requirements." However, the specific sample size used for this test set is not explicitly mentioned in the provided text.

Regarding data provenance, the study appears to be an internal performance verification study conducted by Medtronic Powered Surgical Solutions (MPSS) to demonstrate the device's adherence to specified accuracy metrics. The data would therefore be prospective in the context of this regulatory submission, generated specifically for the purpose of demonstrating substantial equivalence. The document doesn't specify the country of origin of the data beyond the manufacturer's location in Fort Worth, Texas.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the navigational accuracy analysis. The "Navigational Accuracy Analysis" is likely a technical measurement against a known reference, rather than an expert-adjudicated ground truth like in image interpretation studies.

4. Adjudication method for the test set

No adjudication method (e.g., 2+1, 3+1, none) is mentioned or implied for the navigational accuracy analysis. This type of test typically involves direct measurement against a known physical standard or simulated environment, rather than expert consensus on subjective interpretations.

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 multi-reader multi-case (MRMC) comparative effectiveness study was done, as this device is a surgical tool with navigation capabilities, not an AI-assisted diagnostic or interpretive system involving human readers. The device itself provides assistance to the surgeon in locating anatomical structures.

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

A standalone performance evaluation was conducted for the device's navigational accuracy. The "Navigational Accuracy Analysis" measured the device's performance (Mean Positional Error and Mean Trajectory Error) against predefined acceptance criteria, independent of a human operator actively engaged in a clinical task. This assessment is purely about the device's technical specifications.

7. The type of ground truth used

For the "Navigational Accuracy Analysis," the ground truth is based on technical specifications and precision measurements. The comparison is against a known, presumably highly accurate, reference or measurement standard that determines what constitutes "0 mm error" and "0 degrees error." It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic device.

8. The sample size for the training set

The provided document describes a medical device (surgical tools with navigation) and its substantial equivalence submission, not a machine learning or AI model that requires a training set. Therefore, there is no mention of a "training set sample size."

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

As mentioned above, this device is not an AI/ML model and therefore does not have a "training set" or a corresponding "ground truth for the training set" in the context of typical AI/ML development.

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The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software.
The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic EEG, laser tissue ablation, etc.).
The Midas Rex™ Legend™ depth stop attachment and tools are incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

Stealth Autoguide™ System: The Stealth Autoguide System is a robotic positioning and guidance system intended to interpret navigation tracker coordinates and surgical plan coordinates from the StealthStation to robotically position and orient instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments to pre-defined plans.
Midas Rex™ Legend™ Depth Stop System: The Midas Rex™ Legend™ Depth Stop System consists of a Depth Stop Attachment and specific surgical dissecting tools that will be used in conjunction with the Stealth Autoguide System to create cranial access holes for neurosurgical procedures.

The provided text describes the Medtronic Stealth Autoguide System and Midas Rex Legend Depth Stop System. It includes information on performance testing for the Stealth Autoguide System, but lacks specific details on acceptance criteria and a study to prove the device meets all acceptance criteria in a comprehensive format. It also doesn't contain the requested information about training sets, expert ground truth development, MRMC studies, or standalone performance.

However, based on the provided text, I can extract the following information concerning the performance testing for the Stealth Autoguide System's accuracy:

Acceptance Criteria and Reported Device Performance for Stealth Autoguide™ System

Details of the Accuracy Study:

1. Sample size used for the test set and the data provenance: The document states that performance was determined using "overall end-to-end worst-case system level accuracy testing which incorporated clinically relevant anatomical phantoms." Further specifics about the sample size (e.g., number of phantoms, number of measurement points per phantom) and data provenance (e.g., country of origin, retrospective or prospective) are not provided in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document. The accuracy testing seems to be based on direct physical measurements against defined targets on phantoms rather than expert interpretation of images.

3. Adjudication method for the test set: This information is not provided. Given the nature of the accuracy testing (physical measurements), traditional adjudication methods for image interpretation would likely not apply.

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: This information is not provided. The assessment described is a technical accuracy validation of the device's navigation and positioning capabilities, not a study involving human readers or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Stealth Autoguide™ System" is described as a "robotic positioning and guidance system" and the accuracy validation focuses on its "performance in 3D positional accuracy" and "trajectory angle accuracy." This implies standalone technical performance testing of the system's ability to achieve planned trajectories, before a human surgeon uses it to guide instruments. The system is designed to "robotically position and orient instrument holders or tool guides," suggesting its core function is algorithm-driven positioning. However, the evaluation here focuses on the accuracy of the guidance provided, which would then be utilized by a surgeon.

6. The type of ground truth used: The ground truth for the accuracy study was established by defining "clinically relevant anatomical phantoms" and measuring the device's "performance in 3D positional accuracy" and "trajectory angle accuracy" against the known positions and trajectories on these phantoms. This is a phantom-based measurement ground truth.

7. The sample size for the training set: This information is not provided. The document describes an accuracy validation study, not the development or training of an AI algorithm.

8. How the ground truth for the training set was established: This information is not provided, as details about a training set are not included in the document.

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The Elite and Heavy Duty Attachments are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE) console and electric and pneumatic motors. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otothinolaryngology; Craniofacial; Dental; and Endoscopic applications.

The specific applications include Craniotomy, Laminotomy, Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.

When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, splitting, fragmenting, extracting, removing, drilling, and reaming. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, smoothing or shaping of metal, and removing/rounding sharp edges.

The Stryker Elite and HD Attachments are used within a system consisting of a variety of devices, including a console, powered motors, and cutting accessories. The attachments connect to the motors and the cutting accessories to complete the system for physician use. The Stryker Elite and HD Attachments are offered for prescription use only. The Elite and HD Attachments are intended to serve as interfaces between powered motors and cutting accessories for the purposes of:

• Cutting bone, bone cement, and teeth;
• Placing or cutting screws, metal, wires, pins, and other fixation devices; and
• Providing a location for the user to hold and grip the device system. ●

The Elite and HD Attachments are provided in straight and angled configurations. The subject Elite Attachments are offered in the following lengths: 7cm, 12cm, 17cm, and 20cm. The Stryker HD Attachments are offered in the following lengths: 9cm and 14cm. The Elite and HD Attachments are powered by, and compatible with, the Stryker electric and pneumatic motors. The attachments are also used with the cutting accessories (burs). All the attachments demonstrate a rotary mode of action by transmitting torque.

The Elite and HD Attachments are made of stainless steel (SST). The attachments display a color band on the outer surface. The color bands serve to enhance the distinction of attachment and cutting accessory compatibility.

The purpose of this submission is to gain clearance for colorant band modification for the Subject Device Attachments color band that exceeds the threshold as per FDA Guidance, "Deciding When to Submit a 510(k) for a Change to an Existing Device".

The provided text is a 510(k) summary for the Stryker Elite and Heavy Duty (HD) Attachments, focusing on a colorant band modification. This document does not contain the detailed acceptance criteria or the study results for the original device's performance, but rather for the modification.

Therefore, I cannot populate all sections of your request comprehensively. However, I can provide information based on what is available regarding the modification to the device.

Here's a breakdown of the available information and what is missing:

Description of Acceptance Criteria and Study for Colorant Band Modification

The submission concerns a modification to the colorant band on the Stryker Elite and Heavy Duty (HD) Attachments. The primary purpose of this 510(k) is to gain clearance for this specific modification which "exceeds the threshold as per FDA Guidance, 'Deciding When to Submit a 510(k) for a Change to an Existing Device'". The underlying assumption is that the original device, without this specific color band modification, has already met its acceptance criteria through prior submissions (e.g., K143320).

The study performed here specifically addresses the safety and effectiveness of the new colorant band material and colorant.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated for bench testing, colorfastness, or durability tests for the specific modification. Biocompatibility testing was "adopted from K143320," implying reliance on prior data. The context suggests that the testing was performed on representative samples of the modified attachments.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, it is a prospective laboratory-based study for the modification.

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

• Not Applicable. This submission focuses on engineering bench testing and biocompatibility for a material change, not on diagnostic performance where expert ground truth would typically be established.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is for engineering and material testing, not clinical diagnosis.

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

• No. This is not a diagnostic device or an AI-assisted device, so MRMC studies are not relevant. This is for a surgical instrument attachment.

6. Standalone Performance (Algorithm Only without Human-in-the-loop)

• Not Applicable. This device is a mechanical surgical attachment, not an algorithm.

7. Type of Ground Truth Used

• Bench Testing Results and Biocompatibility Standards. The "ground truth" for this modification's safety and effectiveness is established by meeting predefined engineering performance specifications and biological safety standards (ISO 10993-1, FDA Guidance) through laboratory testing.

8. Sample Size for the Training Set

• Not Applicable. This is not a machine learning device that requires a "training set."

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

• Not Applicable. As above, no training set is relevant here.

Summary of what the document confirms about the modification:

• The change is related to the color band material and colorant.
• The indications for use, intended use, operating principles, energy source, and functional outputs remain unchanged from the predicate device (K143320).
• Bench testing (colorfastness, durability) was performed and met acceptance criteria.
• Biocompatibility evaluation was performed, including chemical characterization (ICP-MS) and toxicological risk assessment, following established standards (ISO 10993-1, FDA Guidance). This biocompatibility testing was adopted from the predicate K143320, suggesting the new material passed similar or identical tests as the previous material.
• No animal or clinical testing was required for this specific modification.
• The conclusion is that the device, with the modification, is as safe and effective as the predicate device.

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The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery 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 a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

The Stealth-Midas MR8 consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation in conjunction with the StealthStation S8 System and the Integrated Power Console (IPC). The system allows the navigation of a selection of currently available surgical dissecting tools. The navigated handpieces are provided non-sterile and are reusable. The associated attachments are provided non-sterile and are reusable. The associated surgical dissecting tools and MR8 ClearView burs are provided sterile and are single-use.

This document describes the premarket notification (510(k)) for the Medtronic Stealth-Midas MR8 System. The information provided outlines the device, its intended use, and comparative testing to establish substantial equivalence to predicate devices. However, the document does NOT contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics in the format requested. The document primarily focuses on establishing substantial equivalence based on technological characteristics and functional testing, not a formal clinical efficacy or diagnostic performance study with specific quantitative acceptance criteria typically seen for AI/ML-driven devices.

Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, effect sizes, standalone performance, type of ground truth) are not explicitly present in the provided text. The device described is a surgical instrument with navigation capabilities, not an AI/ML-driven diagnostic or prognostic tool.

Despite this, I will describe what is present and indicate what is missing based on the prompt's requirements.

Device Name: Stealth-Midas MR8 System
Device Type: Stereotaxic Instrument (Surgical Navigation System with Drill)

The provided document describes the Stealth-Midas MR8 System, which combines an electric and pneumatic drill handpiece with an optical navigation tracker for computer-assisted surgery. The purpose of the 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to prove the device meets specific quantitative performance acceptance criteria in the context of an efficacy study as might be conducted for an AI/ML diagnostic algorithm.

Here's a breakdown of the requested information based on the provided document:

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

The document focuses on "Navigational Accuracy Analysis" as a key performance test.

Other "performance testing" mentioned includes:

• CAD Model Evaluation: Verified that CAD models are accurately reflected in the application software. (No quantitative acceptance criteria or reported performance given beyond "verified").
• Formative Usability: Confirmed users can follow the navigated workflow and assemble the device. (No quantitative acceptance criteria or reported performance given beyond "confirmed").
• Summative Testing: Confirmed users can safely and effectively use the Stealth-Midas MR8 navigated drill handpiece with the StealthStation S8 software. (No quantitative acceptance criteria or reported performance given beyond "confirmed").

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 for Test Set: Not specified in the provided document. The document refers to "Accuracy validation testing" but does not detail the number of tests performed or the nature of the samples (e.g., phantom, cadaver, pre-clinical/clinical data).
• Data Provenance: Not specified. It can be inferred that testing was conducted internally by Medtronic, but no country of origin or whether it was retrospective/prospective is mentioned.

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

• This information is not provided in the document. The accuracy testing refers to comparing the device's measured accuracy against a predicate device's established accuracy requirements. It's likely that "ground truth" for navigational accuracy pertains to physical measurements using precision instruments, not expert-derived labels.

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

• This information is not provided and is generally not applicable to the type of engineering/physical accuracy testing described for a surgical navigation system. Adjudication methods are typically used for establishing ground truth in image interpretation or clinical outcomes, which is not the primary focus of the performance tests detailed here.

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 MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for AI-assisted diagnostic tools, not for a surgical drill and navigation system like the Stealth-Midas MR8. The device assists surgeons in locating anatomical structures, but it does not analyze images or provide diagnoses that human "readers" would interpret.

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

• The concept of "standalone performance" for an algorithm is not applicable in the context of this device. The Stealth-Midas MR8 System is an instrument that functions in conjunction with a human surgeon and the StealthStation S8 System. Its "performance" is inherently linked to its ability to accurately track and display the position of surgical tools relative to patient anatomy, as used by a human, rather than an independent algorithmic output. The "Navigational Accuracy Analysis" seems to be a form of standalone technical performance assessment of the navigation component.

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

• The ground truth for the "Navigational Accuracy Analysis" would likely be physical measurements from a highly accurate measurement system (e.g., optical tracking system with known fiducials, coordinate measuring machine) in a controlled laboratory setting, rather than expert consensus, pathology, or outcomes data. The document implies a technical performance measurement against established benchmarks, not a clinical outcome.

8. The sample size for the training set

• Not applicable / Not provided. The Stealth-Midas MR8 System is a mechanical and optical medical device, not an AI/ML system that requires a "training set" in the computational sense. The device's design and operating parameters are based on engineering principles and validated through testing, not machine learning.

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

• Not applicable / Not provided. As the device is not an AI/ML system, there is no "training set" or corresponding ground truth establishment process in the way it's understood for AI/ML.

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The Medtronic MR8 Drill System is incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

Additionally, the MR8 Drill System is indicated for the incision/cutting, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

• Lumbar Microdiscectomy
• Lumbar Stenosis Decompression
• Posterior Lumbar Interbody Fusion (PLIF)
• Transforaminal Lumbar Interbody Fusion (TLIF)
• Anterior Lumbar Interbody Fusion (ALIF)
• Direct Lateral Interbody Fusion (DLIF)

The Midas Rex MR8 ClearView Tools are used only in conjunction with the MR8 Drill System to perform as intended. Please refer to the Midas Rex MR8 Drill System and associated User's Guides for the Indications of Use.

The Medtronic MR8TM Drill System is comprised of both Electric and Pneumatic powered, rotary cutting handpieces, attachments, surgical dissecting tools, and accessories designed to remove soft and hard tissue, bone, and biomaterials during various surgical procedures. The surgical dissecting tools are provided sterile and are single use, while the rest of the system components are provided non-sterile and are reusable.

The Midas Rex™ MR8TM ClearView™ Tools are designed to interface with Midas Rex™ MR8 Drill System motor to support bone and tissue removal during surgical procedures. The Midas Rex™ MR8™ ClearView™ Tools are part of a larger portfolio of tools and accessories designed to be used with the Midas Rex™ MR8 System/Platform.

This document describes the Medtronic MR8 Drill System and Midas Rex MR8 ClearView Tools. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance claims against specific acceptance criteria. Therefore, the information provided primarily compares the device to existing predicate devices.

1. Table of Acceptance Criteria & Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" for the overall device in the typical sense of a clinical trial or performance study with defined thresholds. Instead, it details performance testing conducted for the Midas Rex MR8 ClearView Tools to ensure functionality with the MR8 Drill system and comparability to predicate devices. The "acceptance criteria" for this testing appear to be qualitative (e.g., "similar and/or better," "same or more," "below the burn threshold").

No additional testing was performed on the MR8 Drill System itself as there were no design changes to it for this submission. The Midas Rex MR8 ClearView Tools are the new elements being evaluated for their compatibility and performance within the existing MR8 Drill System.

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

The document does not specify the sample size for the individual performance tests (Tool Chatter and Hand Vibration, Irrigation Rate vs IPC Setting, Thermal Performance)conducted on the Midas Rex MR8 ClearView Tools.

The provenance of the data is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that this is a 510(k) submission for a medical device by Medtronic, a US-based company, it is highly likely that the testing was conducted under standard quality systems and engineering practices, likely within a controlled laboratory environment. The tests appear to be engineering/bench testing rather than clinical studies with human subjects.

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

This information is not applicable to the type of testing described. The tests are engineering performance tests, not clinical evaluations requiring expert interpretation of ground truth (e.g., diagnosis from medical images).

4. Adjudication Method for the Test Set:

This information is not applicable. The tests are objective, quantitative measurements or qualitative observations during engineering performance testing, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This information is not applicable. The device described is a surgical drill system and associated tools, not an AI-assisted diagnostic or interpretative system.

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

This information is not applicable. This is not an AI-driven device or algorithm. The performance evaluation focuses on the mechanical and operational characteristics of the surgical tools.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests effectively refers to the physical and functional parameters of the device as designed and expected, as well as established safety thresholds (e.g., burn threshold for thermal performance). It's based on engineering specifications and safety standards relevant to surgical instruments.

8. The Sample Size for the Training Set:

This information is not applicable. No "training set" is mentioned as this is not a machine learning or AI-driven device.

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

This information is not applicable. As there is no training set mentioned, there is no ground truth established for one.

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The ELAN 4 Air Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

The ELAN 4 Air Motor System is a pneumatic motor system that can be used with any sterile, pressurized gas (usually nitrogen). The system consists of several components such as wall adaptors, foot pedals, and handpieces. The foot pedal has the ability to connect various handpieces with integrated motors that contain attachments such as burrs, saw blades, and drills. The system allows for high-speed dissection at up to 80.000 RPM while also allowing low speed cutting between 1.000 and 20.000 RPM. The speed and rotation direction of the handpieces can be controlled via the foot pedal.

The provided text is a 510(k) summary for the ELAN 4 Air Motor System, a pneumatic cranial drill motor. It does not describe a study involving an AI or algorithm-based device, human readers, or a test set with expert ground truth establishment. Instead, it describes a medical device (a surgical drill) and its performance validation through design verification and biocompatibility testing.

Therefore, I cannot answer your request as the information you've asked for (acceptance criteria for an AI/algorithm, sample size for AI test and training sets, expert consensus for ground truth, MRMC study, etc.) is not contained within the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices (other surgical drills) based on:

• Indications for Use: The ELAN 4 Air Motor System is intended for high-speed cutting, sawing, and drilling of bone in various surgical fields.
• Technological Characteristics: Comparison of components, power source (pneumatic vs. electric), operating speeds, rotation, materials, and control mechanisms.
• Performance Data (Design Verification): Functional testing to ensure the device performs as intended and safely meets specifications over time. These tests are explicitly listed as "Pass: All requirements met."
• Biocompatibility: Confirmation that materials used are safe for patient contact.

To reiterate, the provided text does not describe the kind of study you are asking about, which typically pertains to diagnostic or assistive AI software rather than mechanical surgical instruments.

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The Medtronic MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

The MR8 Drill System consists of electric and pneumatic drill handpieces, attachments, surgical dissecting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The surgical dissecting tools are provided sterile and are single use.

The document provided is a 510(k) summary for the Medtronic MR8 Drill System. It describes the device, its intended use, and comparison to predicate devices, along with a summary of performance testing. However, it does not provide the detailed acceptance criteria and study information typically found in a clinical study report for an AI/ML medical device. The MR8 Drill System is a surgical drill, not an AI/ML device.

Therefore, many of the requested sections below, such as details on AI performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, and MRMC studies, are not applicable to this submission. The information provided primarily focuses on the substantial equivalence of a physical surgical device.

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the performance tests in the same way typical for AI/ML performance, but rather states the criteria implicitly by comparing to predicate devices or conformity to standards.

Regarding AI/ML Specific Information (Many are Not Applicable to this Device):

This device is a surgical drill system, a physical medical device, and not an AI/ML-driven diagnostic or therapeutic device. Therefore, the following sections are largely not applicable based on the provided FDA submission summary.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" for this device involved physical product testing and cadaveric use. Specific sample sizes for the cadaveric study are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of AI/ML ground truth. For the cadaveric study, professional users (surgeons/medics) would have evaluated the device, but specific numbers and qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device and study.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the cadaveric use, the "ground truth" would be the subjective and objective assessment of the device's performance and acceptability by the users during surgical simulation. For other tests, it's conformance to technical specifications and safety standards.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

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The Pneumatic Drill System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Additionally, the Pneumatic Drill System is incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

• Lumbar Microdiscectomy
• Lumbar Stenosis Decompression
• Posterior Lumbar Interbody Fusion (PLIF)
• Transforaminal Lumbar Interbody Fusion (TLIF)
• Anterior Lumbar Interbody Fusion (ALIF)
• Direct Lateral Interbody Fusion (DLIF)

The Pneumatic Drill System is a pneumatically powered high-speed drill system consisting of a choice of various Pneumatic Handpieces (comprising of a High Pressure and Exhaust Hose, and Handpiece) equipped with a foot or finger controller, Pneumatic Foot Control Unit, Surgical Dissecting Tools, System Accessories, and where applicable, Attachments to support various Surgical Dissecting Tools, and System Accessories.

The provided text describes a 510(k) premarket notification for a surgical drill system. This type of submission is for establishing substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a study with quantifiable performance metrics. Therefore, many of the requested categories are not applicable or cannot be extracted directly from this document.

However, I can provide information based on the typical content of a 510(k) summary regarding performance claims and testing.

Here's an analysis of the provided information relative to your request:

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

This document does not provide a table of acceptance criteria with corresponding performance metrics in the way one might expect for an AI/CAD diagnostic device. The "performance" described is largely functional and safety-based, focused on equivalence to predicate devices and suitability for expanded indications.

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

• Test Set (Cadaveric Testing): The document mentions "Users evaluated the acceptability of the subject drill system to its intended use on a variety of procedures using cadavers." However, the specific sample size of cadavers used is not provided.
• Data Provenance: Not specified, but likely from a laboratory or clinical setting where cadaveric studies are conducted. It would be considered prospective for the purposes of evaluating the device for expanded indications.

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)

• The document states "Users evaluated the acceptability...". The number and specific qualifications of these "users" (likely surgeons or medical professionals) are not provided. Their role was to evaluate the acceptability of the drill system, which serves as the "ground truth" for its functional performance in a surgical simulation.

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

• The document does not describe a formal adjudication method (like 2+1 or 3+1) for the cadaveric testing. The phrase "Users evaluated the acceptability" suggests a direct evaluation by the involved parties, but no specific adjudication process is detailed.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/CAD systems that assist human readers in tasks like image interpretation. This submission is for a surgical drill system, which does not involve "human readers" in the context of image interpretation.

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

• No, a standalone AI algorithm performance study was not done. This device is a physical surgical instrument, not an AI algorithm. Its performance is intrinsically linked to human-in-the-loop operation by a surgeon.

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

• For the cadaveric testing: The "ground truth" was established by the evaluation and assessment of the surgical performance and acceptability by the "users" (presumably surgeons) during simulated surgical procedures on cadavers. This would fall under a form of expert assessment/consensus regarding functional performance and safety.
• For the clinical literature review: The "ground truth" was based on existing published clinical evidence regarding the safe and effective use of drill systems.

8. The sample size for the training set

• Not applicable. This document describes a physical surgical device, not an AI model that requires a training set.

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

• Not applicable. As above, no training set for an AI model is involved.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence for a physical surgical device and its suitability for expanded indications through functional testing and literature review, rather than quantifiable performance metrics typical of AI or diagnostic devices. Therefore, many of the specific questions about AI study design and ground truth establishment for AI models are not relevant to this document.

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