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The Midas Rex MR8 Depth Stop attachment and tools are indicated for the 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.

The Midas Rex MR8 Depth Stop attachment and tools are intended to create a cranial access hole of a known diameter and depth.

This document (K213454) is a 510(k) premarket notification for a medical device and, as such, does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study that proves the device meets those criteria.

Specifically, this submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a comprehensive study protocol and results for a new device's performance against specific acceptance criteria. The document states that "The changes from the predicate, do not raise any new issues of safety and effectiveness" and that "The following testing was conducted to demonstrate that the modifications to the subject devices are as safe and effective as the predicate." This implies that the focus was on validating that the changes did not degrade performance, and the existing predicate device's performance serves as the benchmark.

Therefore, many of the questions asked cannot be directly answered from the provided text.

Here's an attempt to extract what is available and explain what is missing:

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

The document does not provide a table of acceptance criteria and reported device performance in the way you've requested. Instead, it describes a comparison to a predicate device to demonstrate substantial equivalence. The "performance" is primarily implied by the claim that the technological characteristics are similar and that conducted testing (Product Life Verification, Summative Validation, Biocompatibility Testing) supports the functionality, integrity, and safety and effectiveness for its intended use, making it "as safe and effective as the predicate."

The closest thing to "acceptance criteria" discussed are the aspects compared to the predicate, as shown in the table on pages 5-6. However, these are comparative features, not quantified performance criteria with acceptance thresholds.

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

The document mentions "Product Life Verification," "Summative Validation," and "Biocompatibility Testing." However, it does not specify sample sizes for any of these tests, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) for a mechanical device modification, these would likely be engineering and bench testing, not clinical studies in the typical sense.

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 testing described (Product Life, Summative Validation, Biocompatibility) are typically engineering validation tests, not clinical studies requiring expert ground truth in the context of diagnostic AI.

4. Adjudication method for the test set

This information is not provided. As above, the described testing types do not typically involve adjudication methods for "ground truth" derived from expert consensus.

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 study was done or mentioned. This device is a surgical drill accessory, not an AI software/diagnostic device.

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

Not applicable. This device is a mechanical surgical tool component, not an algorithm.

7. The type of ground truth used

The concept of "ground truth" in the way it's typically applied to AI or diagnostic studies (expert consensus, pathology, outcomes data) is not relevant or discussed for this type of mechanical device submission. The "ground truth" for this device would be established by engineering specifications, material properties, and mechanical performance tests.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/machine learning product that requires a training set.

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

Not applicable. As above, this is a mechanical device.

Summary of Findings from the Document:

The K213454 submission demonstrates substantial equivalence primarily by:

• Comparing the subject device's features and intended use to a legally marketed predicate device (K191597).
• Highlighting that the differences are minor (e.g., extended depth setting, minor tool head geometry, new user task, compatibility with MR8 system) and do not raise new safety or effectiveness concerns.
• Stating that risk management (ISO 14971:2019) was conducted and found no new risks.
• Reporting that specific engineering tests were conducted: "Product Life Verification," "Summative Validation," and "Biocompatibility Testing," which "demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use."

The document's purpose is to show that the modified device is "as safe and effective" as the already cleared predicate, rather than to establish new, distinct performance criteria and demonstrate achievement of those from scratch.

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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-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.

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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 Electric Drill System is a electrically operated surgical instrument system. The electric 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 Electric Drill System is indicated for the incision / cutting, removal, drilling, 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 Electric Drill System consists of an electric Integrated Power Console, Electric Foot Control unit with Y-Splitter, Connection Cables, Irrigation/Cooling Sets including a remote Irrigation Control Unit, and various Electric Handpieces and/or electric motors and Attachments to drive various Surgical Dissecting Tools. The Integrated Power Console device of the Electric Drill System can also function as an endoscope lens cleaning system.

Thank you for providing the detailed documentation for the Medtronic Powered Surgical Solutions. However, after careful review, I must inform you that the provided information does not contain the specific details required to complete your request for acceptance criteria and a study proving a device meets those criteria.

The document is a 510(k) premarket notification for an Electric Drill System. While it discusses the device's indications for use and compares it to predicate devices, it primarily focuses on demonstrating substantial equivalence to previously cleared devices.

Here's why the requested information is not available in the provided text:

• Acceptance Criteria for Device Performance: The document does not explicitly state quantitative or qualitative "acceptance criteria" for the device's performance that would typically be associated with a new or significantly modified device needing to demonstrate its capabilities against specific benchmarks. The focus is on demonstrating that the device performs similarly to previously cleared devices for its expanded indications.
• Study Proving Device Meets Acceptance Criteria: Consequently, there is no detailed study described that proves the device meets such acceptance criteria. The performance testing sections (9.12) describe a "Clinical Literature Review" and "Cadaveric Testing."
  • The Clinical Literature Review supports the use of the system for expanded indications, but doesn't quantify device performance against specific targets.
  • The Cadaveric Testing states that "The Medtronic Electric Drill System is acceptable for its intended use in various surgical procedures," which is a qualitative conclusion rather than a demonstration against defined acceptance metrics. There are no details about what was measured, how it was measured, or what values would be considered acceptable.

Therefore, I cannot provide the requested table or detailed information regarding sample sizes, data provenance, ground truth establishment, or specific performance metrics from the provided document.

The document's purpose is to establish substantial equivalence based on comparable performance and indications for use, rather than to present a de novo study with explicit acceptance criteria for a new device's performance.

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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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The Stealth-Midas System is indicated for the drilling, burring and removal of hard tissue and bone in spinal 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 System consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation with the StealthStation System. 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 document provided describes the Stealth-Midas System, a medical device intended for spinal surgical procedures, and lists some performance testing. However, it does not contain the requested detailed acceptance criteria or a comprehensive study report with specific performance metrics such as sensitivity, specificity, or reader improvement. The information available is limited to a summary of performance testing and a declaration of substantial equivalence to predicate devices.

Based on the provided text, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance (Based on available information):

Missing Information/Not Provided in the Document:

1. Detailed Acceptance Criteria and Specific Performance Results: While categories of testing are mentioned, the document lacks specific quantitative acceptance criteria (e.g., "accuracy must be within X mm") and the exact numerical results obtained from the tests. For example, for "Navigation Accuracy Analysis," it only states "Confirmed navigated instrument accuracy," without providing the actual accuracy achieved.

2. Sample Size used for the test set and data provenance: The document mentions "testing was completed" but does not specify the sample size for any of the tests (e.g., number of instruments tested for navigation accuracy, number of users for usability, number of cases/models for CAD evaluation). It also does not mention data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.

4. Adjudication method for the test set: Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no indication that an MRMC study was conducted, nor is there any mention of an effect size for human reader improvement with or without AI assistance. The device is a navigated surgical instrument, not an AI-assisted diagnostic tool, so such a study would likely not be relevant or performed in this context.

6. Standalone Performance: The document does not describe a "standalone (i.e., algorithm only without human-in-the-loop performance)" study. The device is described as an aid for surgery, implying human interaction.

7. Type of ground truth used: For the navigation accuracy, the ground truth would likely be a precisely measured physical reference. For CAD model evaluation, the ground truth would be the original CAD models. For usability, the ground truth would be successful task completion and user feedback against predefined usability goals. These are not explicitly detailed in the document.

8. Sample size for the training set: The document does not refer to any AI/ML models that would require a "training set." The device described is a navigated surgical instrument, not an AI-driven diagnostic or predictive system in the context of what would typically have a "training set" of data.

9. How the ground truth for the training set was established: Not applicable, as no training set for an AI/ML model is indicated.

Summary of the Study (Based on available information):

The document refers to "Performance Testing" which was "completed to ensure the functionality and compatibility with the identified Medtronic products." This testing primarily focused on:

• Navigation Accuracy Analysis: To confirm that the addition of the passive optical tracker to the drill handpieces resulted in accurate navigation of the instruments. The document states, "Navigational accuracy testing confirms that the subject navigated drill system is as accurate as the predicate navigated Vertex Select instruments."
• CAD Model Evaluation: To verify that the CAD models used by the application software accurately reflected the physical design.
• Formative Usability: To confirm that users could effectively follow the navigated workflow and properly assemble the device.

The overall conclusion drawn from this testing and comparison was that the "Stealth-Midas System has been shown through comparison and testing to be substantially equivalent to the identified predicate devices." This implies that the performance results met the standards set by the predicate devices, though specific quantitative measures are not provided.

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The Medtronic Midas Rex MR7 System is a pneumatically operated surgical instrument system. The pneumatic motors provide 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.

The Midas Rex MR7 Pneumatic High Speed System includes a pneumatic motor; either the MR7 option which is foot controlled or the MR7t option which is finger controlled. A coaxial hose system, designed with an inner high-pressure supply hose located within an exhaust hose, connects the motor to the foot controller. One end of the coaxial hose system is permanently attached to the motor. The inner high-pressure hose supplies the compressed gas to the internal components of the motor. The outer hose captures the exhausted gas from the internal components of the motor and transports this exhaust gas to the diffuser section of the lubricant diffuser cartridge located on the foot control end of the hose at floor level. This self-contained lubricant/diffuser system consists of two components; a permanently attached receptor base on the foot control connector section of the hose and a disposable lubricant/diffuser cartridge. The cartridge provides two functions; the lubrication for the internal components of the motor and the capture of the exhausted gas from the motor. the foot or finger controller is used to activate the flow of compressed air or nitrogen (gas) into the pneumatic motor and is connected to the pressure regulator of the gas supply system through the regulator hose. The Midas Rex MR7 Pneumatic High Speed System is intended to be used with all existing Midas Rex Legend attachments and dissecting tools previously cleared through K020069.

The provided text describes the Medtronic Midas Rex MR7 Pneumatic High Speed System, a pneumatically operated surgical instrument system. The submission (K090112) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way one might see for a diagnostic AI device.

Therefore, the requested information elements related to specific performance criteria, ground truth, sample sizes for training/testing, expert adjudication, and MRMC studies, which are typical for AI/diagnostic device evaluations, are not applicable in this context.

This document focuses on regulatory approval through substantial equivalence based on bench testing.

Here's the relevant information based on the provided text:

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

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 testing mentioned is "laboratory bench testing," which typically involves engineering-focused stress, durability, and functional tests rather than data-driven performance metrics on a "test set" of patient data.

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 as the evaluation is based on bench testing for substantial equivalence of a surgical instrument, not on expert-adjudicated performance for a diagnostic device.

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

This information is not applicable for the reasons stated above.

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

An MRMC study is not applicable as this is a surgical instrument, not an AI-powered diagnostic device.

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

This is not applicable as this is a surgical instrument, not an algorithm.

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

The "ground truth" in this context would be the functional specifications and performance characteristics of the predicate device. The MR7 system was tested to demonstrate that its performance characteristics were "substantially equivalent" to these established characteristics.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/algorithm that requires a training set.

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

This is not applicable for the reasons stated above.

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The Midas Rex Curved Burs are intended for use in surgical procedures for the following medical applications: Neurosurgical; Spine; Ear, Nose and Throat (ENT), Orthopedic Surgery, and General and Plastic Surgery including Maxillofacial, Craniofacial and Sternotomy. The Curved bur will be used to cut and/or remove bone and biomaterial.

Midas Rex Curved Bur is a sterile, single use, one piece device which includes the dissection tool (bur head, bur wire, bur tang) and the protective tube / cooling sleeve / hub. The hub connects and locks into the existing Legend telescoping attachment base. Legend telescoping attachment base connects to the Legend motor. The motor provides the power to rotate the dissecting tool / bur. The attachment / tube provide support and stability to the dissecting tool. The bur head which may be fluted or diamond coated, is the actual cutting tip on the device.

The provided document is a 510(k) summary for the Medtronic Midas Rex® Curved Burs. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for the curved burs themselves. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of regulatory submission.

However, I can extract the information that is available and highlight what is missing.

Here's the analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. A 510(k) submission for substantial equivalence generally doesn't include specific performance acceptance criteria for the new device in the same way a clinical trial or a test report would. The "performance" being evaluated here is the claim that the new device (Curved Bur) is as safe and effective as the predicate device, not against specific measurement thresholds.

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

This information is not provided in the document. There is no mention of a "test set" or data provenance as this 510(k) is based on a technological comparison, not a new performance evaluation study in the traditional sense.

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

This information is not provided in the document. As there's no "test set" or explicit ground truth establishment described, no experts for this purpose are mentioned.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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 and not provided in the document. This device (a surgical bur) is not an AI-assisted diagnostic or imaging device, so an MRMC study or AI-related effectiveness analysis is not relevant.

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

This information is not applicable and not provided in the document. This is a physical surgical tool, not an algorithm.

7. The Type of Ground Truth Used

This information is not explicitly stated as there is no mention of a formal ground truth used for performance validation. The "ground truth" in a 510(k) context for substantial equivalence is often implicitly the established performance and safety profiles of the predicate device.

8. The Sample Size for the Training Set

This information is not provided in the document. No "training set" is mentioned as this is not a machine learning or AI device.

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

This information is not provided in the document. No "training set" is mentioned.

Summary of Device and 510(k) Filing:

The document describes the Medtronic Midas Rex® Curved Burs, a sterile, single-use surgical dissecting tool. It's intended to cut and/or remove bone and biomaterials in various surgical procedures, including neurosurgical, spine, ENT, orthopedic, and general and plastic surgery.

The 510(k) filing (K072315) seeks to establish substantial equivalence to the predicate device, the Medtronic Midas Rex® Legend® Pneumatic High Speed System (K020069), specifically focusing on the Legend Telescoping System tools.

The core argument for substantial equivalence is that the device modification (Curved Bur) does not affect intended use, indication for use, device safety and effectiveness, and the fundamental scientific technology is the same as the previously cleared Legend Telescoping System. This implies that the safety and effectiveness are "proven" by virtue of being technologically equivalent to an already cleared and marketed product. The FDA's clearance letter confirms this determination of substantial equivalence.

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