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Traus SSG10 Surgical System is an electrical appliance intended to cut, shave, bone & tissue resection, grinding, and drilling in the cranium and spine. Shaver handpiece is not intended for use in neurosurgical procedures.

Traus SSG10 Surgical System is composed of a control box, micro motor and a foot controller as an electric bone surgery machine. A signal for operating a foot controller, a handpiece, etc.., is transmitted when a power source is inputted to a control box (main body) to control functions such as rotational speed, torque and water injection amount.

It is a mechanism for puncturing, and cutting bones and human tissues through rotation and reciprocating motion by connecting handpieces and attachments to a micro motor. Three modes (Drill, Saw, Shaver) can be set, and the handpiece and attachment for each mode can be used in many surgical areas.

The provided text is a Premarket Notification (510(k)) from the FDA for the Traus SSG10 Surgical System. This type of document is for demonstrating substantial equivalence to a predicate device, not typically a detailed study proving acceptance criteria for new or innovative device features.

Therefore, the document does not contain the detailed information requested for acceptance criteria or a study proving those criteria, particularly in the context of an AI/ML medical device. The device in question is an "Electric Cranial Drill Motor," which is a traditional hardware device, not an AI/ML powered one.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on demonstrating substantial equivalence to a predicate device based on general features and safety/EMC standards, not specific performance metrics against defined acceptance criteria.
2. Sample size used for the test set and the data provenance: Not provided. Performance testing mentioned is "bench testing" to assure operation within predefined design specifications, but no details on sample size, data origin, or retrospective/prospective nature are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons 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: 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 device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as this is not an AI/ML device. Performance is assessed against engineering specifications.
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.

Information that can be extracted or inferred from the document regarding "acceptance" in a general sense:

The "acceptance criteria" for devices seeking 510(k) clearance are primarily about demonstrating substantial equivalence to a legally marketed predicate device regarding safety and effectiveness. This is achieved by showing conformance to recognized standards and comparable performance.

Implicit Acceptance Criteria (based on 510(k) process):

Study Proving Device Meets Acceptance Criteria (as described in the document):

The "study" or evidence provided is a collection of non-clinical tests and conformance to standards, rather than a single, formal "study" with specific statistical endpoints to prove new performance claims.

• Non-clinical Performance Data:
  • (1) Electrical Safety and Electromagnetic Compatibility (EMC): Conducted according to IEC 60601-1:2005/AMD2:2020 and IEC 60601-1:2015+A1:2021. This demonstrates adherence to recognized safety standards.
  • (2) Software Verification and Validation Testing: Conducted in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) and IEC 62304, for a "moderate level of concern." This ensures the software operates as intended and mitigates risks.
  • (3) Performance Testing (Bench Test): This testing was performed to "assure that the SSG10 operates safely and within the predefined design specifications." The report references "performance criteria such as RPM." Although the maximum RPM (40,000rpm) is lower than the predicate (80,000rpm), the testing results reportedly showed this difference "does not raise any problems in the safety and effectiveness."
  • (4) Sterilization: Validated in conformance to ISO 17665-1:2006.
  • Biocompatibility: Materials tested and confirmed safe per ISO 10993 series (1, 5, 10, 12).

Key Takeaway: The document outlines the evidence used to support a substantial equivalence determination, focusing on compliance with established safety and performance standards for a medical device that is not an AI/ML technology. It does not contain the specific AI/ML-related study details requested.

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Traus SSG30 Surgical System is an electrical appliance intended to cut, shave, bone & tissue resection, grinding, and drilling in the cranium and spine. Shaver handpiece is not intended for use in neurosurgical procedures.

Traus SSG30 Surgical System, is available to apply surgical operation by various handpieces incorporating a micro motor and a handpiece. The technological characteristics and operating parameters of OSSEODUO Shaver and Drill System is very similar to the predicate device. With respect to the functional aspects, Traus SSG30 Surgical System, Bone surgery Engine Unit, uses the same fundamental technology as the predicate device. Traus SSG30 Surgical System consists of a control box (main unit), foot controller, micro motor and handpieces. Traus SSG30 Surgical System is composed of a control box, micro motor and a foot controller as an electric bone surgery machine. A signal for operating a foot controller, a handpiece, etc... is transmitted when a power source is inputted to a control box (main body) to control functions such as rotational speed, torque and water injection amount. It is a mechanism for puncturing, and cutting bones and human tissues through rotation and reciprocating motion by connecting handpiece and attachments to a micro motor. Three modes (Drill, Saw, Shaver) can be set, and the handpiece and attachment for each mode can be used in many surgical areas.

The provided text describes the 510(k) premarket notification for the "Traus SSG30 Surgical System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria through clinical performance data, especially concerning AI/ML aspects.

The document explicitly states: "Clinical Data: No clinical performance testing was performed."

Therefore, I cannot fulfill all parts of your request as the information required for a study proving the device meets acceptance criteria, particularly for AI/ML performance, is not present in this regulatory submission. This submission primarily focuses on functional equivalence, electrical safety, software verification, and sterilization validation.

However, I can extract information related to the acceptance criteria that were tested (non-clinical) and the methods described:

Summary of Acceptance Criteria and Device Performance (Based on Non-Clinical Data Provided):

Information Not Available / Not Applicable for this Device's Clearance:

As stated previously, this submission is for a Traditional 510(k) of a physical surgical system, not an AI/ML-driven device that requires performance studies related to diagnostic accuracy or human-AI collaboration. Therefore, many of your specific questions are not applicable to the context of this FDA clearance.

• Sample sized used for the test set and the data provenance: Not applicable for a traditional surgical system's non-clinical performance tests like electrical safety or mechanical RPM. The "test set" here refers to physical bench tests and software V&V, not a clinical data set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and electrical systems is typically defined by engineering specifications and standards, not expert consensus on images or clinical outcomes.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For non-clinical tests, ground truth is based on engineering specifications, physical measurements, and industry standards (e.g., IEC, ISO).
• The sample size for the training set: Not applicable (not an AI/ML device).
• How the ground truth for the training set was established: Not applicable.

Conclusion from the Document:

The 510(k) summary concludes: "The non-clinical data support the safety of the device and software and software verification and validation demonstrate that the SSG30 device should perform as intended in the specified use conditions. The clinical data demonstrate that the SSG30 device performs comparably to the predicate device that is currently marketed for the same intended use Based on the available information, the subject device and the predicates are similar indication for use, operational principal, performance data. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification that we conclude that substantially equivalent with predicate device."

This explicitly indicates that substantial equivalence was primarily demonstrated through non-clinical performance and a comparison of technical specifications to a predicate device, without clinical performance testing.

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The ORiGO System is a software-controlled motorized system that includes attachments and tools for cutting bone, and provides irrigation fluid to the surgical site. The ORiGO System is used in the following surgical fields: -For cutting bones in neuro (cranial) and spinal surgeries.

The ORIGO System is a software-controlled electrical surgery system intended to be used in an operating room by a clinician in a healthcare facility/hospital setting for cranial and spinal surgical procedures. The ORIGO System consists of the ORIGO Control Unit, the ORIGO Foot Pedal, the ORIGO System-compatible two micromotors and one motorized handpiece with corresponding motor cables, handpieces, attachments, cutting tools, the ORIGO System Irrigation Line, and other accessories. The ORIGO System transforms electrical energy through motors and converts it to rotational force to shape and cut bones through attached cutting tools. Three micromotor subsystems of the ORIGO System include NANO, RAPIDO, and PM PERFO. The NANO and RAPIDO are micromotors. The PM PERFO is a motorized cranial perforator handpiece. PM2 Handpieces are intended to be connected to the NANO Micromotor and RAPIDO Micromotor. Cranio-Guards are attached to the PM2 Handpieces, and craniotomy is performed using PM2 Craniotomy Burs. Other PM2 80K Burs are attached to the PM2 Handpieces without attachment. The PM2 80K Burs are used for cutting bones in cranial and spinal surgical procedures. PM PERFO is intended to be used for a cranial perforation. The ORiGO System is equipped with a peristaltic pump, which delivers saline irrigation solution to surgical sites through a 5m ORiGO System Irrigation Line. The ORiGO System is a prescription-only device.

The provided text describes a 510(k) premarket notification for the ORiGO System, an electrical surgical system. It details the device's indications for use, technological characteristics, and performance testing to demonstrate substantial equivalence to a predicate device. However, it does not contain the specific information required to complete the detailed table and answer all the questions regarding acceptance criteria and the study proving the device meets those criteria.

The document focuses on demonstrating that the ORiGO System is substantially equivalent to a legally marketed predicate device (OSSEODUO Shaver and Drill System K173066) based on similarities in intended use, technological characteristics, and performance. The performance testing section primarily lists compliance with various international standards, FDA guidance documents, and biocompatibility tests. It does not provide specific acceptance criteria values with corresponding device performance metrics for the device itself or the study that definitively proves the device meets those criteria in a quantitative sense as might be expected for an AI/software-based device performance study.

Here's what can be extracted and what is missing based on your request:

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

The document does not specify quantitative acceptance criteria or detailed device performance metrics in a table format. Instead, it states:

• "The conformance of the ORiGO System with applicable international and internal standards was verified during non-clinical bench testing and evaluation."
• "Tests were performed on the subject device, which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device."
• "Together, these verification/validation activities successfully demonstrated that the device correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate devices."

This broadly states that the device met the required standards for safety and effectiveness and is comparable to the predicate. Specific numerical criteria and results are not provided.

Missing Information/Answers to Specific Questions:

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

• Not provided. The document describes non-clinical bench testing, but does not specify sample sizes for test units or any 'data sets' in the context of an AI/software performance study. This is a hardware device; thus, the concept of a "test set" as understood for AI performance is not applicable here in the same way. The provenance of any test data (country of origin, retrospective/prospective) is also not mentioned.

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

• Not applicable/Not provided. This is a hardware surgical device. The document does not describe any human expert review or ground truth establishment relevant to an AI model's performance.

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

• Not applicable/Not provided. No mentions of adjudication are present as it's not relevant to the type of device and testing described.

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. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the ORiGO System." Therefore, no MRMC study involving human readers or AI assistance was performed.

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

• Not applicable/Not provided. While the device is "software-controlled," the evaluation focuses on the mechanical and electrical safety/performance of the surgical system, not on the standalone performance of an independent algorithm in the context of diagnostic or interpretive tasks.

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

• Not applicable/Not provided in the context of AI ground truth. The "ground truth" for this device's performance is compliance with established engineering standards (e.g., electrical safety, software lifecycle, usability, biocompatibility) and its functional performance in cutting bone as designed through bench testing, not through a diagnostic or interpretive ground truth.

8. The sample size for the training set

• Not applicable/Not provided. The device is a hardware surgical system. The concept of a "training set" as used for AI/machine learning models does not apply here.

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

• Not applicable/Not provided. As there is no training set mentioned, there is no discussion of establishing ground truth for it.

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The eG1 High Speed System is indicated for cutting and shaping bone including spine and cranium.

The eG1 Wireless Hand Control System is intended to be used as an optional accessory to the eG1 High Speed System (K133604) to provide an alternative method for controlling the eG1 Handpiece motor speed instead of using the existing wired foot control pedal.

The eG1 Wireless Hand Control System consists of two articles:

1. The Wireless Hand Control, EG1A (article # WIRELESS-HC) is a sterile, single-use device that snaps on the eG1 Handpiece.

2. The Receiver for Wireless Hand Control, EG1A (article # RECEIVER-HC) is a non-sterile reusable device that plugs into the eG1 Control Console.

The WIRELESS-HC sends information about the amount of pressure applied by the user on its button to the RECEIVER-HC wirelessly. The RECEIVER-HC uses this information to modulate the speed of the eG1 Handpiece motor.

This looks like an FDA 510(k) summary for a medical device called the "eG1 Wireless Hand Control System." The document aims to demonstrate that this new device is substantially equivalent to a previously cleared predicate device ("Foot control pedals used with eG1 High Speed System K133604").

However, the provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way you've outlined for diagnostic aids or AI products (e.g., sensitivity, specificity, clinical endpoints).

Instead, this document focuses on demonstrating substantial equivalence based on:

• Identical intended use and indications for use.
• Similar technological characteristics where applicable, and where there are differences (e.g., wireless technology, power source, sterilization), verifying that these differences do not raise new questions of safety or effectiveness through specific engineering and regulatory testing.

The "studies" and "acceptance criteria" discussed here are primarily engineering verification and validation tests and compliance with recognized standards.

Let's break down what is available in the provided text in relation to your request, and explicitly state what is not present:

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

• What's available: The document lists several tests performed to assess the device's safety, effectiveness, and compliance with standards. It generally states that "All acceptance criteria are met." However, it does not provide a specific table with quantitative acceptance criteria (e.g., a specific speed range, latency, signal reliability percentage) paired with reported performance metrics from a clinical study or a performance study with human subjects operating the device for diagnostic or therapeutic outcomes.
• Example of what is present as "performance" in this context:
  • Test Category: Design verification analysis
  • Purpose: Verify physical characteristics meet design inputs related to interfaces.
  • Reported Performance/Conclusion: Met acceptance criteria; differences do not raise new questions of safety/effectiveness.
  • Test Category: Design verification testing
  • Purpose: Verify functional aspects of the proposed device.
  • Reported Performance/Conclusion: Met acceptance criteria; differences do not raise new questions of safety/effectiveness.
  • Test Category: Software Validation
  • Purpose: Developed applying IEC 62304:2015.
  • Reported Performance/Conclusion: Met acceptance criteria; differences do not raise new questions of safety/effectiveness.
  • Test Category: Electrical Safety (IEC 60601-1:2012 / ANSI/AAMI ES60601-1:2012)
  • Purpose: Basic Safety and Essential Performance.
  • Reported Performance/Conclusion: Certified compliant.
  • Test Category: Electromagnetic Compatibility (IEC 60601-1-2:2014)
  • Purpose: Electromagnetic disturbances.
  • Reported Performance/Conclusion: Certified compliant.
  • Test Category: Radio Emissions (IEC 62311:2007)
  • Purpose: Human exposure restrictions for electromagnetic fields.
  • Reported Performance/Conclusion: Tested according to standard. (Implies compliance, though "compliant" isn't explicitly stated here).
  • Test Category: Sterilization Validation (ISO 11135:2014)
  • Purpose: Ethylene Oxide sterilization for WIRELESS-HC.
  • Reported Performance/Conclusion: Validated according to standard.

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

• Not applicable/Not provided in this document. This device is a surgical tool control, not a diagnostic device relying on patient data. The "test set" here refers to the physical devices and software being tested. There's no mention of patient data, retrospective/prospective studies, or country of origin for such 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)

• Not applicable/Not provided. This type of information is relevant for studies involving expert interpretation of medical images or other clinical data to establish a "ground truth." This document describes engineering and regulatory compliance testing for a physical device. Ground truth, in this context, would be defined by engineering standards and specifications.

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

• Not applicable/Not provided. Similar to point 3, this refers to methods for resolving discrepancies among expert interpretations, which is not relevant for the type of testing described 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

• Not applicable/Not provided. This is explicitly for AI-enabled diagnostic aids. The eG1 Wireless Hand Control System is a physical surgical control device, not an AI system or diagnostic aid.

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

• Not applicable/Not provided. Again, this is for AI algorithms. The device performs its function as designed; there's no "algorithm only" performance separate from the device's operation.

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

• N/A in the context of your question. For this device, "ground truth" equates to adherence to engineering specifications, performance standards (e.g., motor speed control accuracy, signal latency, electromagnetic compatibility limits), and recognized regulatory standards (IEC, ISO, FCC). It's not a clinical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/machine learning device that requires a training set.

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

• Not applicable/Not provided. As above, no training set for this device.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence of a new surgical control device to an existing one by confirming adherence to engineering specifications, recognized safety and performance standards (like IEC and ISO), and regulatory compliance (FCC). It does not present clinical study data with acceptance criteria for diagnostic performance or AI model evaluation as implied by your detailed questions.

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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 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 OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures.

The OSSEODUO Shaver and Drill System is already cleared for other indications. This submission adds the PM2 Family of handpieces and accessories to the system with indications for shaping bones in spine and cranium surgical operations. These additional motors, NANO, RAPIDO, and PM PERFO incorporate previously cleared technology with a proprietary coupling. The available handpieces include 4 straight and five angled models, plus three fixed and two rotary craniotomies. Various burs are available that are sold sterile and for single use. The motors and handpieces are to be sterilized prior to first use and after each subsequent use. Validated processes for both cleaning and sterilization are included in the instructions.

The acceptance criteria and study proving the device meets them can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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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 ELAN 4 Electro 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 Electro motor system is an electrical motor system consisting of a control unit with different sizes and types of handpieces, each containing its own integrated motor, and attachments such as burrs, saw blades, drills, etc. 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. System settings are controlled with the touch screen panel of the control unit, while all functions of the handpieces can be controlled from the sterile field by the foot control.

The provided document details the acceptance criteria and study results for the ELAN 4 Electro Motor System.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents several tables detailing acceptance criteria and results for different handpieces of the ELAN 4 Electro Motor System. Below is a consolidated representation of these, focusing on the general themes rather than repeating every specific test if the acceptance criteria and results are similar across different components.

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

• Sample Size:
  • For the "ELAN 4 Bench Testing Handpieces Summary Table" and "ELAN 4 Bench Testing Craniotome Handpiece Summary Table," the sample size for most tests was 120-123 cycles.
  • For the "ELAN 4 Bench Testing Perforator Summary Table," "ELAN 4 Bench Testing Reciprocating Saw Handpiece Summary Table," and "Elan 4 Bench Testing Sagittal Saw Handpiece Summary Table," the sample size for most tests was 100 cycles.
• Data Provenance: The studies described are bench tests, meaning they were conducted in a controlled laboratory environment rather than on human or animal subjects. The document does not specify the country of origin of the data, but the context implies it was conducted by Aesculap, Inc., whose address is in Center Valley, PA, USA. These are prospective tests designed to demonstrate device performance against predefined criteria.

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

• This information is not provided in the document. The studies are bench tests, and the "ground truth" implicitly refers to engineering specifications and performance criteria that the device is expected to meet. It's not a clinical study requiring human experts to establish diagnostic ground truth.

4. Adjudication Method for the Test Set:

• This information is not applicable as the studies are bench tests with clearly defined pass/fail criteria based on engineering specifications. There is no mention of human adjudication for these technical performance tests.

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

• No, an MRMC comparative effectiveness study was not done. The document describes bench testing comparing the ELAN 4 Electro Motor System to its predicate device based on technological characteristics and performance in a controlled environment. It does not involve human readers or AI assistance.

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

• Yes, the studies described are analogous to standalone performance studies for mechanical devices. The ELAN 4 Electro Motor System was tested in a standalone capacity (i.e., the device itself, without human intervention in the evaluation of the test results beyond operating the equipment and recording data) against predefined performance criteria. There is no "algorithm" in the sense of AI; it's the mechanical/electrical device's performance that is being evaluated.

7. Type of Ground Truth Used:

• The ground truth used is primarily engineering specifications and predefined performance criteria. For example, a burr should not release during use, labels should remain readable after a certain number of cycles, and temperature should remain within an acceptable range. These are objective, measurable parameters.

8. Sample Size for the Training Set:

• This concept is not applicable to the described studies. The document describes verification and validation bench testing for a physical medical device, not a machine learning or AI model that requires a training set.

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

• This information is not applicable as it is not a study involving a training set for an AI/machine learning model. The ground truth for the verification and validation (bench testing) was established through engineering specifications and safety requirements relevant to the device's function.

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