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The SMARTO is intended for use in drilling in conjunction with craniofacial (does not include oromaxillofacial applications), craniotomnies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and single use only.

The SMARTO is an DC-powered device that includes a hand-held motor, switch and hold for the rotation attachment for surgery. It is supplied radiation-sterile and disposable use.

The provided text describes the SMARTO device, a surgical motor unit, and outlines its technical specifications and comparison with a predicate device for 510(k) clearance. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of AI-driven performance metrics (e.g., sensitivity, specificity, AUC).

The document is a 510(k) summary for a surgical motor unit. The "acceptance criteria" discussed are related to electrical safety, electromagnetic compatibility, and performance tests for torque and speed, using existing standards (IEC 60601-1, IEC 60601-1-2) and internal standards. These are typical for hardware medical devices.

Therefore, I cannot fulfill parts of your request that pertain to performance metrics like sensitivity, specificity, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies, as these types of studies and criteria are generally associated with AI/software medical devices that interpret images or data for diagnostic or prognostic purposes.

Here is what can be extracted from the document regarding the acceptance criteria and study, based on the provided text's focus on a physical medical device:

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

Notes:

• The document states, "The test was conducted to verify that the proposed device met all design specifications." and "The test results demonstrated that the proposed device complies with the following standards and worst case criteria report." This implies that the device did meet these criteria.
• The specific magnitude of the acceptance criteria for the internal standards is not explicitly stated as a pass/fail threshold, but the reported performance values are given. The inference is that the reported performance meets the internal standard.

Regarding the other requested information:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device (physical surgical motor). The "tests" are engineering performance tests, not clinical studies 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" in this context refers to the measured physical properties of the device against engineering specifications.
• 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-assisted diagnostic device.
• 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 concensus, pathology, outcomes data, etc): For physical characteristics like torque and speed, the "ground truth" would be the measured physical properties against designed specifications. For electrical safety and EMC, it's compliance with established international standards.
• 8. The sample size for the training set: Not applicable. This device is not an AI algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

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Insurgical™ Single Use Power Equipment is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.

The Insurgical™ Single Use Power Equipment System includes surgical power tools and rechargeable batteries. The battery powered DC Motor products include the Insurgical Drill, and the Insurgical Orthopedic Reamer. Insurgical handpieces and attachments are provided pre-sterilized and ready to use. The powered DC Motor products and attachments are single-use and intended to be disposed of after use. The batteries can be recharged and are re-usable. The Insurgical Drill is designed for drilling holes and placing bone screws in a variety of reconstructive and trauma procedures. The Insurgical Orthopedic Reamer can be used for boring, drilling, and reaming during orthopedic procedures.

The provided text is a 510(k) Summary for the Insurgical™ Single Use Power Equipment. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI/software medical device.

Therefore, the requested information elements related to AI/software performance studies (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this submission. The "acceptance criteria" here refer to the successful completion of various engineering and safety tests to show the device is safe and effective and similar to a predicate.

Here's an attempt to answer the questions based on the provided text, acknowledging the differences in scope:

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

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

The document does not specify sample sizes for any of these tests. For most of the engineering and safety standards (IEC, CISPR, UL, ISO), the "sample size" is typically determined by the standard itself (e.g., testing a certain number of units or cycles to demonstrate compliance). For the cadaveric simulated use test, a specific number of cadavers or test runs is not mentioned. Data provenance is not explicitly stated, but it would typically be from internal laboratory testing conducted by the manufacturer or a certified testing facility.

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

Not applicable. This is a hardware device submission focused on safety and equivalence, not a diagnostic or AI device requiring expert-established ground truth for a test set.

4. Adjudication method for the test set

Not applicable. This is a hardware 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 a hardware device submission, not an AI or software-assisted diagnostic.

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

Not applicable. This is a hardware device submission.

7. The type of ground truth used

For the engineering and safety tests, the "ground truth" is compliance with the specific requirements and limits defined by each standard (e.g., passing electromagnetic immunity tests, showing no cytotoxicity). For the cadaveric simulated use test, the "ground truth" would be the successful and safe performance of the intended surgical actions without mechanical failure or other safety concerns.

8. The sample size for the training set

Not applicable. This is a hardware device submission, not an AI/machine learning device that uses a training set.

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

Not applicable. This is a hardware device submission.

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The SMARTO is used to drive screws, and drilling in conjunction with craniofacial (does not include maxillofacial applications), craniotomies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and is for single use only.

The SMARTO is a sterile battery powered screwdriver. The device includes a DC motor, battery, switch and holder for the rotation attachment. It is disposable.

The provided document describes a 510(k) submission for the SMARTO surgical motor unit. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria based on a defined performance standard.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance, an AI algorithm, or detailed statistical analysis, is not applicable to this type of regulatory submission. This document describes a traditional medical device (a surgical motor unit), not an AI-powered device or one that requires extensive clinical performance studies to achieve marketing clearance via the 510(k) pathway.

Here's a breakdown of the available information and why other points are not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: For a 510(k) submission like this, "acceptance criteria" are primarily established by demonstrating substantial equivalence to a legally marketed predicate device. The performance criteria are therefore implied to be met if the new device performs comparably to the predicate for its intended use. Bench testing of mechanical properties (motor speed, torque) is mentioned as evidence of safety and effectiveness, which are the fundamental requirements.

Information NOT available or NOT applicable based on the provided document:

• 2. Sample size used for the test set and data provenance: Not applicable. The document refers to "bench testing" on mechanical properties, but details such as sample size, specific test configurations, or data provenance (country, retrospective/prospective) are not provided. This is not a clinical study with a "test set" in the sense of patient data.
• 3. Number of experts used to establish ground truth and qualifications: Not applicable. There is no mention of "ground truth" established by experts in this context as this is a mechanical device, not an AI or diagnostic tool.
• 4. Adjudication method: Not applicable. No expert review or adjudication process is described.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study and effect size: Not applicable. This type of study is for diagnostic devices where human readers interpret data, often with AI assistance. The SMARTO is a surgical motor.
• 6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. The SMARTO is a physical surgical tool, not an algorithm.
• 7. Type of ground truth used: Not applicable. Ground truth typically refers to a definitive diagnosis or outcome for a diagnostic or AI study. For a surgical motor, the "truth" is its mechanical performance and functional safety.
• 8. Sample size for the training set: Not applicable. There is no AI model or algorithm being trained.
• 9. How the ground truth for the training set was established: Not applicable. No AI model or training set.

In summary, the provided document is a 510(k) summary for a surgical motor. Its primary goal is to establish substantial equivalence through bench testing of mechanical properties and comparison of intended use, technology, energy source, claims, and material composition with a predicate device. It does not contain the detailed study information typically associated with AI/ML devices or complex clinical performance studies.

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The Stryker System 4000 Battery Powered Heavy Duty System is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.

The Stryker System 4000 is comprised of drills, a reamer, a rotary driver, saws, rechargeable batteries, battery chargers, a battery protector kit, sterilization cases and racks, and cutting accessories. The system is designed to meet the IEC 601.1 safety standards.

The provided document is a 510(k) premarket notification for the Stryker System 4000. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting detailed performance data from a specific study with acceptance criteria.

Therefore, many of the requested fields cannot be directly populated from the given text. The document primarily makes claims of equivalency in intended use, safety, and effectiveness.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria or detailed performance metrics. Instead, it asserts substantial equivalence to existing devices. The key "acceptance criteria" for a 510(k) submission is typically that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness.

Study Information (Based on 510(k) Nature)

1. 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. This document is a 510(k) premarket notification. It does not describe a clinical study with a test set of data in the manner of an AI/ML device. The claim is based on substantial equivalence to predicate devices, potentially through design comparison, bench testing, and compliance with standards rather than clinical performance data from a "test set."

2. 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. No "ground truth" for a test set is described or established in this document.

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

   • Not Applicable / Not Provided. No test set requiring adjudication is described.

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

   • No. This is a mechanical surgical instrument, not an AI/ML diagnostic device. An MRMC study is not relevant to this type of device and was not performed.

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

   • Not Applicable / Not Provided. This is a physical surgical device, not an algorithm.

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

   • Not Applicable / Not Provided. The concept of "ground truth" as typically used for AI/ML or diagnostic studies does not apply here. The "truth" for this submission revolves around demonstrating that the device's design, materials, and intended use are comparable to legally marketed devices already established as safe and effective.

7. The sample size for the training set:

   • Not Applicable / Not Provided. This is not an AI/ML device; therefore, there is no "training set."

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

   • Not Applicable / Not Provided. As there is no training set, this question is not relevant.

In summary: The provided text is a regulatory submission focused on establishing substantial equivalence for a physical surgical device. It explicitly states that the device does not raise new safety or effectiveness concerns compared to existing, legally marketed predicate devices (Stryker's own pre-1976 products, and products from 3M, Zimmer, and Sodem). The "study" here is essentially the comparison and justification provided within the 510(k) submission itself, supported by design specifications and compliance with standards like IEC 601.1. It does not involve a clinical study with acceptance criteria and performance metrics in the way a diagnostic AI device would.

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The Acumed Bone Grafting System is a set of various size drills, a Hudson adaptor fitting, a starting punch, a bone plug extractor, and a removal key. A manual drill handle will be added to the system eventually so that the drills may be operated manually. The Hudson adaptor fitting attaches to a standard DC-powered surgical drill. The drill size is selected and attached to the adaptor. The starting punch dimples the bone so a reference point for the drill tip is made. After drilling and harvesting the bone, the drill assembly is removed. The drill piece is detached with the removal key and the bone material is extracted or pushed out by the plug extractor.

I apologize, but the provided text is a 510(k) summary for a medical device called the "Acumed Bone Grafting System." This document describes the device, its components, materials, sterilization information, and a comparison to a similar device on the market.

It does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth, expert opinions, or any of the other specific details regarding the evaluation of a device's performance that you have requested.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria based on the provided input. The information you are asking for typically comes from clinical trial reports, validation studies, or performance evaluation documents, which are not present in this 510(k) summary.

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