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

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

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

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

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

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

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

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The 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 Stryker® Consolidated Operating Room Equipment (CORE™) Maestro Air 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 and sternotomy surgeries.

The Stryker® Maestro Air™ Motor(s) is a pneumatic motor powered by a regulated gas source. When connected to a gas source via tubing, the pneumatic motor operates at a normal operating pressure up to 150-psi (per square inch). The motor speed is controlled by a handswitch or a footpedal that connects to the motor and to a regulated gas source.

This 510(k) summary describes a medical device, the Stryker® Maestro™ Air Motors, which is a pneumatic cranial drill motor. It does not involve any AI/ML components or describe a study related to AI/ML device performance. Therefore, the specific questions regarding AI/ML acceptance criteria, sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be answered from the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Stryker Maestro Pneumatic System, K041754) based on non-clinical performance testing.

Here's an analysis of the provided text, addressing what can be answered:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical targets for each performance metric in a pass/fail sense. Instead, it states that "The results of the performance testing demonstrate that the functionality, integrity and safety and effectiveness of the Stryker Maestro Air Motors are sufficient for their intended use and support a determination of substantial equivalence to the predicate device."

However, we can infer performance comparisons from Table 6-1, which compares the subject device to the predicate device. These comparisons implicitly serve as "performance criteria" for demonstrating substantial equivalence.

Study that proves the device meets the acceptance criteria:

The study performed was a set of non-clinical verification tests. These tests included:

• Reliability Testing (Motor body, Handswitch mounting, Router Retention, Pneumatic Hose assembly and automated washing)
• Packaging Testing
• Cleaning Testing
• Sterilization Testing

The results of these tests demonstrated that the functionality, integrity, and safety and effectiveness of the Stryker Maestro Air Motors are sufficient for their intended use and support a determination of substantial equivalence.

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

The document does not specify exact sample sizes for the non-clinical tests (e.g., how many motors were tested for reliability). It only lists the types of tests performed. It also does not provide information on data provenance in terms of country of origin or retrospective/prospective nature, as these are non-clinical engineering tests, not patient studies.

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

Not applicable. This is a submission for a mechanical device based on non-clinical engineering tests, not an AI/ML device requiring expert-established ground truth from medical images or clinical data.

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

Not applicable, as ground truth establishment by experts for a test set is not relevant to this type of device submission.

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

Not applicable. This is not an AI/ML device and no MRMC study was performed.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. For this mechanical device, the "ground truth" for performance is established through engineering specifications, validated test methods (e.g., measuring torque, speed, pressure resistance), and established industry standards for sterilization, packaging, and cleaning.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device.

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The LEGEND® Power Adapter is intended to be used with the MIDAS REX® LEGEND® System. When the LEGEND® Power Adapter is attached to the MIDAS REX® LEGEND® System, the MIDAS REX® LEGEND® System motors provide power to operate removable rotating surgical cutting tools and their accessories intended for neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, and sternotomy surgeries.

The LEGEND® Power Adapter is a stainless steel adapter that can be used with the MIDAS REX® LEGEND® System to provide power to MEDTRONIC rotating surgical cutting tools. The LEGEND® Power Adapter provides a 20:1 gear ratio reduction when used with the MIDAS REX® LEGEND® System.

The provided text describes the LEGEND® Power Adapter and mentions a study conducted to demonstrate its performance. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the sample size used for the dynamometer testing. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The study described is a performance test (dynamometer testing) of a mechanical adapter, not a study requiring expert interpretation or ground truth establishment in the traditional sense of clinical or image-based studies.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this was a performance test, not a study requiring adjudication of expert opinions.

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

No, an MRMC comparative effectiveness study was not done. The study focuses on the mechanical performance of the adapter.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. The "device" in question is a mechanical power adapter, not an algorithm, so the concept of standalone or human-in-the-loop performance for an algorithm does not apply. The dynamometer testing assesses the standalone mechanical performance of the adapter.

7. The Type of Ground Truth Used:

The "ground truth" for this device would be its ability to function appropriately and consistently deliver the specified gear ratio reduction (20:1) and power, as measured by dynamometer testing. It's essentially a direct measurement of mechanical performance against engineering specifications.

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a training set as this is not a machine learning or AI-based device.

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

Not applicable. There is no training set mentioned.

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The Synthes Air Pen Drive (APD) is indicated for screw insertion, pin and wire placement, cutting of bone and metal, drilling, reaming, decorticating, shaping and smoothing of bones and teeth in a wide variety of surgical procedures, including general orthopedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive and spine surgery

The Synthes Air Pen Drive (APD) System is a pneumatic powered system that consists of a Foot Pedal, Drive Unit, Hand Switch and Irrigation Control Unit that may be used with various commercially available attachments and cutting tools. The Drive Unit is pen-shaped and is connected to the Foot Pedal via a sterilizeable air hose. The rotation speed of the Drive Unit may be controlled from 0 to 60,000 rpm at 8 bar and from 0 to 80,000 at 12 bar via the Foot Pedal or the removable Hand Switch. Multiple attachments are available that have a quick-connect coupling to attach to the Drive Unit. The attachments accept various cutting tools including drill bits, burrs and saw blades.

This document describes a 510(k) summary for the Synthes Air Pen Drive (APD) System, a pneumatic powered surgical drill system. The entire document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing, rather than presenting a study to prove a device meets specific performance acceptance criteria for an AI/ML powered device.

Therefore, many of the requested categories about acceptance criteria and AI/ML study design cannot be extracted from the provided text.

Here is the information that can be extracted or explicitly stated as not present:

1. 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):
Not applicable. This is a medical device (surgical drill) and the testing involved non-clinical performance and engineering evaluations, not studies on a test set with 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):
Not applicable. Ground truth for a diagnostic AI/ML device is not relevant here as this is a surgical drill. The evaluation was based on engineering performance and adherence to standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI/ML powered device for diagnostic or analytical purposes.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device's evaluation was based on established engineering principles, industry standards for medical devices, and performance characteristics of predicate devices.

8. The sample size for the training set:
Not applicable. This is not an AI/ML powered device.

9. How the ground truth for the training set was established:
Not applicable.

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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 Anspach iMRI Surgical Drill System (including pneumatic drill motor, foot control, nosepiece attachments and cutters), is indicated for intra-operative (non-imaging) use within a Magnetic Resonance Imaging (MRI) environment rated at 1.5 Tesla or less, for surgical cutting, shaping and removal of bone, including bones of the skull and spine.

The iMRI Surgical Drill System is a Class II medical device which includes a pneumatic drill motor and foot control; a variety of nosepiece attachments; and various bone dissection tools (cutters). To make the drill system "MRI useable", ferrous metals comprising each system component have been replaced with materials known to have significantly lower or no discernable magnetic susceptibility. The iMRI Drill System foot control was tested with the Drill System within Zone IV. The iMRI motor does not require continuous oiling and therefore runs at slower speeds (60 - 65k RPM) than noniMRI Anspach motors (80 - 85k RPM). Nosepiece attachments (bearing tubes) support the cutter to minimize vibration , wobble and whipping. iMRI cutters are identical to other Anspach non-iMRI cutters with exception of materials and indications for use.

The provided text is a 510(k) summary for the Anspach iMRI Surgical Drill System. It describes the device, its indications for use, and its substantial equivalence to predicate devices, focusing on material changes to ensure MRI compatibility. However, the document does not contain specific acceptance criteria or details of a study with performance metrics in the format requested.

It primarily outlines:

• Device Description: A pneumatic drill system modified for use in an MRI environment by replacing ferrous metals with low or non-magnetic susceptibility materials.
• Indications for Use: Intra-operative (non-imaging) use within a 1.5 Tesla or less MRI environment for cutting, shaping, and removal of bone (skull and spine).
• Contraindications: Presence in Zone IV of an iMRI system during actual imaging due to potential image distortion.
• Performance Standards: Lists various ASTM, ISO, and AAMI standards related to materials, biological evaluation, sterilization, and risk management. It explicitly states, "Full conformance to these standards is not intended to be implied or declared, as implementation of various specific aspects of the standards are not yet fully established."
• Substantial Equivalence: Claims equivalence to other Anspach pneumatic drill systems (MicroMax, original 65K) with primary differences in materials, indications for use, and a modified locking mechanism to prevent interchangeability.

Based on the provided text, I cannot complete the requested tables and information because the document does not include:

1. A table of acceptance criteria and reported device performance. The document lists standards applicable to materials and processes but does not detail specific performance metrics, pass/fail criteria, or how the device explicitly met those criteria through a study. The relevant ASTM standards mentioned (F2213-04 for magnetically induced torque and F2052-02 for magnetically induced displacement force) imply acceptance criteria related to MRI compatibility, but the actual performance results against these criteria are not reported.
2. Details of a specific study proving device meets acceptance criteria. There is no mention of a formal clinical or technical study designed to generate performance data for the iMRI Surgical Drill System. The closest references are to standards that should be met (e.g., ASTM standards for MRI safety), but not to data demonstrating compliance.
3. Sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or details of training sets. These types of details are typically found in studies evaluating performance (e.g., accuracy, sensitivity, specificity for diagnostic devices, or specific functional performance criteria for surgical devices) against a defined ground truth, which this document does not present. The document focuses on regulatory compliance through substantial equivalence, primarily based on material science and safety considerations for MRI compatibility, rather than a performance study as might be conducted for an AI/diagnostic device.

Therefore, many parts of your request cannot be answered from the given text. The 510(k) summary focuses on demonstrating substantial equivalence primarily through material changes and adherence to general safety standards, rather than providing a detailed performance study with quantitative results as a diagnostic or AI-driven device might.

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The Medicon VIPAIR high speed system is specially designed for cutting and drilling of cranial and spinal bones in the Neurology. Thanks to a wide variety of working attachments and tools, the Medicon pneumatic high speed system "VIP AIR" can be also used in the ENT and Orthopaedics.

The Medicon VIPAIR pneumatic high speed system is specially designed for cutting and drilling of cranial and spinal bones. This system combines security and precision in an ergonomic design. The latest technology allows a reduction of the noise level to a minimum. The System consists of a small handpiece motor, a motor air tube, a foot control, a wall air tube, various hand pieces, craniotoms , burs, drills and cutters. The system components connect to each other via a safety coupling mechanism.

The provided document is a 510(k) Summary for the Medicon VIPAIR Pneumatic High Speed System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving performance against those specific criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study details, human reader studies, and training data is not present.

However, I can extract information related to the comparison with predicate devices, which serves as a form of "acceptance criteria" in the context of 510(k) submissions, as the device must be shown to be substantially equivalent.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission, "acceptance criteria" are typically defined by demonstrating substantial equivalence to existing legally marketed predicate devices. The performance is assessed by comparing key characteristics.

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

• Not applicable (N/A): This document describes a 510(k) submission focused on substantial equivalence to predicate devices, not a clinical study with a "test set" in the traditional sense of evaluating a novel algorithm or diagnostic performance. Instead, it relies on comparative analysis of technical specifications and intended use against existing devices. There is no mention of a "test set" or data provenance (country of origin, retrospective/prospective).

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

• Not applicable (N/A): As explained above, there is no "test set" or "ground truth" to be established by experts in the context of this 510(k) submission. The evaluation is based on comparing device specifications and regulatory compliance.

4. Adjudication method for the test set:

• Not applicable (N/A): No test set or expert adjudication is 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, not done: This is a pneumatic surgical drill system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and not described.

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

• No, not done: This is medical hardware (a pneumatic drill system), not a standalone algorithm.

7. The type of ground truth used:

• Not applicable (N/A): No "ground truth" as typically defined in diagnostic studies (e.g., pathology, outcomes data, expert consensus) is used here. The "truth" for this 510(k) submission is the existence and regulatory status of predicate devices with similar characteristics and the device's conformance to established industry standards and its own specifications.

8. The sample size for the training set:

• Not applicable (N/A): This document does not describe the development or evaluation of an algorithm or AI model, so there is no training set.

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

• Not applicable (N/A): As there is no training set, this information is not relevant or provided.

In summary: The provided document is a regulatory submission for a pneumatic surgical drill, demonstrating substantial equivalence to existing devices. It is not a study evaluating acceptance criteria for a novel diagnostic or AI-powered medical device. Therefore, many of the requested details about studies, sample sizes, ground truth establishment, and expert involvement are not pertinent to this specific document or type of device.

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The Stryker Maestro Pneumatic 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.

The Stryker Maestro Pneumatic System is a pneumatic, high-speed instrument system consisting of a motor (handpiece), hoses, and a variety of attachments and cutting accessories.

This document is a 510(k) summary for the Stryker Maestro Pneumatic System, a surgical drill motor. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria for device performance.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, as typically found in clinical performance studies of diagnostic or AI-driven devices.

Here's a breakdown of why the requested information is absent and what the document does provide:

Why the requested information is not present:

• Device Type: The Stryker Maestro Pneumatic System is a surgical instrument (a drill motor). For such mechanical devices, the regulatory pathway (510(k)) primarily requires demonstrating that its technological characteristics and performance are substantially equivalent to a predicate device already on the market. This typically involves engineering benches tests, material compatibility tests, and comparison of performance specifications rather than clinical trials with human subjects and statistical performance metrics like sensitivity, specificity, or AUC against a ground truth.
• 510(k) Process: A 510(k) summary focuses on comparing the new device to a predicate based on intended use, technological characteristics, and performance data to show that it is as safe and effective. It does not usually require a clinical study with acceptance criteria in the way an AI/diagnostic device would.
• Timeframe: The document is dated 2004. Diagnostic device regulations, especially for AI/ML, have evolved significantly since then, often requiring more rigorous clinical validation.

What the document does state regarding "performance":

The document states:

• "The Stryker Maestro Pneumatic System... has the same intended use as the Medtronic Legend®. This device and the predicate device have the same technological characteristics, the same operating principles, use the same patient contacting materials, and have similar performance characteristics."
• "Based upon the comparison to the predicate devices, the Stryker Maestro Pneumatic System is substantially equivalent to legally marketed devices."

This "similar performance characteristics" is the closest the document comes to discussing performance. However, it does not quantify these characteristics, define acceptance criteria, or describe a study designed to statistically prove performance against specified targets.

Therefore, I cannot fill out the requested table and answer the study-related questions from the provided text. The information simply isn't there for this type of device and regulatory submission.

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