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The DuraPro™ Oscillating System is indicated for drilling, burring, removing, and otherwise manipulating hard and soft tissue, bone, and other bone related tissue during spinal and orthopedic procedures.

ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

DuraPro™ Oscillating System consists of electrical The drill handpieces/attachments powered by an oscillating motor with a foot switch, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided non-sterile and are reusable. Attachments are provided sterile and are single-use.

The provided text does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML medical device. The document is a 510(k) clearance letter for a device called "DuraPro™ Oscillating System," which is a surgical tool.

The document discusses:

• Device Name: DuraPro™ Oscillating System
• Regulation Number: 21 CFR 882.4560 (Stereotaxic Instrument)
• Indications for Use: Drilling, burring, manipulating hard and soft tissue, bone during spinal and orthopedic procedures. It also mentions its use with ExcelsiusGPS® and ExcelsiusHub™ for navigation and guiding surgical instruments for screw and interbody fusion device placement.
• Technological Characteristics: States it has similar characteristics to predicate instruments in design, intended use, material composition, function, and range of sizes.
• Performance Testing: "The navigation and guidance accuracy of the DuraPro™ Oscillating System was evaluated using intra-operative imaging and accuracy verification testing. Testing confirmed that accuracy values meet the product requirement specification."
• Electrical Safety/EMC: Confirmed to meet all standards.

However, none of this information outlines specific acceptance criteria for performance metrics usually associated with AI/ML devices (e.g., sensitivity, specificity, AUC), nor does it describe a study using human readers, ground truth establishment by experts, or training/test set details that would be relevant to an AI/ML performance evaluation. The "Performance Testing" section is very high-level and does not provide the granular details requested in your prompt regarding AI/ML device evaluation.

Therefore, I cannot provide the requested table and details because the source document does not pertain to the evaluation of an AI/ML medical device's performance in the way your prompt describes.

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The Footed Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the Footed Attachments and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, shaping, dissecting, shaving and smoothing for the following medical applications: Neuro: Spine: Ear, Nose, and Throat (ENT) / Otology /Neurotology/Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and Sternotomy.

Specific applications include Craniectomy, Pterional Craniotomy, Sub Occipital/Retro Sigmoid/Posterior Fossa Craniotomy, Sphenoid Wing Dissection, Laminotomy/Laminectomy, and Orthopedic Spine.

These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.

Footed Attachments are prescription medical devices that are designed to provide an interface between a cutting accessory and a high speed motor. When used with a motor and a cutting accessory, the Footed Attachments are intended cut, drill, ream, dissect and shape bone in a variety of surgical procedures including the following specialty areas: Neuro, Spine, ENT, Sternotomy and Orthopedics.

The Stryker Footed Attachments are available in footed and non-footed configurations. The primary difference is the addition of the foot feature at the end of the nose tube.

The footed attachment is offered in two configurations: Fixed Footed Attachments and Rotating Footed Attachments. The primary difference between the Fixed and the Rotating Footed Attachment is the ability to rotate the foot portion of the device independently from the motor.

Cutting accessories are single use, sterile devices which have a mount or notch machined at their proximal end and a head with a sharp cutting edge at their distal end. The cutting accessories when used with a high speed drill and Footed Attachments are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.

The document provided is a 510(k) Premarket Notification for Stryker Footed Attachments and Cutting Accessories. It outlines the device's indications for use, describes the device, and discusses performance and biocompatibility testing. However, it does not include an acceptance criteria table with reported device performance in the manner typically seen for diagnostic or AI-driven devices (e.g., sensitivity, specificity, AUC).

Instead, the document details a comparative study against predicate and reference devices, focusing on demonstrating substantial equivalence for a medical device that cuts bone. The "acceptance criteria" here are met through various non-clinical performance tests and biocompatibility assessments, and by showing similarity to legally marketed devices.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method for ground truth, MRMC study, standalone performance, training set sample size and ground truth establishment) are not applicable in the context of this device and the type of information presented in a 510(k) for a surgical tool like this one. This document focuses on demonstrating physical, functional, and material equivalence rather than diagnostic performance metrics.

Here's an attempt to answer the questions based on the provided document, noting where information is not present or not applicable:

Acceptance Criteria and Device Performance Study

The acceptance criteria for the Stryker Footed Attachments and Cutting Accessories are demonstrated through a series of non-clinical performance tests and biocompatibility evaluations, aimed at showing that the device meets its performance requirements and is substantially equivalent to legally marketed predicate devices. The study detailed is primarily a bench-testing and comparative analysis rather than a clinical trial or diagnostic performance study.

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 sample sizes for the individual non-clinical performance and biocompatibility tests. It indicates these were "verification tests" performed to demonstrate performance. The data provenance is internal to Stryker Instruments, as these are non-clinical bench tests. There is no mention of country of origin for data as it's not a clinical study involving patients. The tests are prospective in nature, as they are part of the device development and verification process.

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

Not Applicable (N/A). For this type of device (a surgical cutting tool), "ground truth" as it pertains to diagnostic accuracy (e.g., for an AI algorithm) is not relevant. The "ground truth" for performance is established by engineering specifications, safety standards, and functional requirements for cutting bone, which are verified through the described non-clinical tests.

4. Adjudication Method for the Test Set

Not Applicable (N/A). There is no "adjudication method" in the context of diagnostic agreement, as this is not a diagnostic device or a study involving subjective assessment of output by multiple readers.

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

No. A MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this submission for a surgical instrument.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable (N/A). This device is a mechanical surgical tool, not an algorithm or AI system. Therefore, a standalone performance study in that context is not relevant. The device implicitly performs "stand-alone" in its function as a tool, but its performance is measured against engineering and safety criteria, not AI metrics.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the engineering specifications, functional requirements, and safety standards for a device intended to cut bone. For biocompatibility, the ground truth is established by international standards (e.g., AAMI/ANSI/ISO 10993-1) for biological evaluation of medical devices. The assessment of "substantial equivalence" is based on comparing the subject device's features and performance to those of legally marketed predicate devices.

8. Sample Size for the Training Set

Not Applicable (N/A). This device is not an AI/ML algorithm that requires a training set.

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

Not Applicable (N/A). As there is no training set, this question is not applicable.

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The eSPIN System is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).

The eSPIN System consists of access and positioning instruments to access the disc space and to position the hand-piece for discectomy, a handpiece, disposable cutting tips, a suction tube & alignments guide and electrical motor unit.

The provided text describes the 510(k) summary for NLT SPINE's eSPIN System, a device intended for cutting and grinding intervertebral disc material during discectomy.

Based on the provided text, 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 the data provenance

The document only states "Performance testing in bench (e.g. system mechanism durability & functionality)". There is no information provided about the specific sample size, country of origin, or whether the data was retrospective or prospective.

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 is "bench testing" focusing on mechanical performance rather than clinical data requiring expert review for ground truth.

4. Adjudication method for the test set

This information is not provided in the document. As the testing was bench-based, no human adjudication of diagnostic or clinical outcomes is mentioned.

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

There is no mention of an MRMC comparative effectiveness study involving human readers or AI assistance. The device is a surgical instrument, not an AI diagnostic tool.

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

This is not applicable as the eSPIN System is a surgical instrument, not a diagnostic algorithm.

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

For the performance data reported, the "ground truth" seems to be based on engineering benchmarks and predicate device performance standards as assessed through "bench testing" for "system mechanism durability & functionality." It's about how well the device mechanically performs its intended function, not a diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

This information is not provided. The device is a physical instrument, and while it might have undergone extensive internal development and testing (which could be considered analogous to a "training set" for an algorithm development, though not typically referred to as such for hardware), the document doesn't detail this.

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

This information is not provided and is largely not applicable in the context of a physical surgical device's 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices through engineering and functional testing rather than algorithmic training against a defined ground truth.

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The IPC® System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC® POWEREASE™ System is indicated for drilling, tapping, and driving screws and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in the placement of screws, or cutting of screws, posts, and rods.

The purpose of this submission is to add a new driver and an accompanying software module to the IPC® . The new system is the IPC® POWEREASE™System. The IPC® POWEREASE™ System provides a powered driver that performs multiple functions and also has nerve stimulation capabilities. The IPC® POWEREASE™ System consists of the Integrated Powered Console (K081475, 10/17/2008), a driver handpiece, and cables to connect the driver, IPC® and NIM-ECLIPSE® System together. The driver is powered by the previously cleared Integrated Powered Console equipped with the appropriate software to operate the driver. The driver is used for drilling, tapping and driving screws in the pedicle, placing screws, and driving working end attachments capable of breaking set screw heads, cutting posts, and cutting rods during spinal surgery. The POWEREASE™ Driver also has nerve stimulation capabilities when connected to the Medtronic NIM -ECLIPSE® System (K061113 - 05/23/2006; K061639 -11/01/2006). An external POWEREASE™NIM Cable that connects the NIM-ECLIPSE® System to the driver enables the driver to have nerve stimulating capability. It should be noted that the IPC® does not provide the stimulation. The stimulation used with the IPC® POWEREASE™ is provided by the Medtronic NIM-ECLIPSE® System.

The driver is equipped with a quick connect feature which allows for easy and secure attachment of different working end attachments compatible with the IPC® POWEREASE™ Driver to perform the various functions mentioned above.

The provided document describes the Medtronic IPC® POWEREASE™ System, a medical device for surgical procedures, and its substantial equivalence to predicate devices. It does not contain information typically found in studies evaluating acceptance criteria and device performance for AI/ML-based medical devices.

Therefore, I cannot extract the requested information such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document focuses on:

• Device Description: The IPC® POWEREASE™ System, a powered driver with nerve stimulation capabilities for spinal surgery.
• Indications for Use: Detailed uses in various surgical procedures, including drilling, tapping, driving screws, and cutting screws/posts/rods in spinal surgery.
• Predicate Device Identification: A list of previously cleared devices to which the IPC® POWEREASE™ System is deemed substantially equivalent.
• Comparison to Predicate Devices: A table comparing features like indications, handpiece compatibility, and nerve monitoring capability.
• Testing: Stating that "Laboratory bench testing conducted on the POWEREASE™ System demonstrates substantially equivalent performance characteristics to the predicate devices currently on the market. Testing was performed according to IEC 60601 Medical Electrical Equipment."
• Conclusion: The device is substantially equivalent based on bench tests, intended use, and design control activities.

This document describes a traditional medical device clearance, not an AI/ML diagnostic or prognostic device that would typically involve the types of performance metrics and ground truth establishment you are asking about.

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