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The piezoelectric surgical system is indicated for: osteotomies, osteoplasties, drilling and shaping of hard tissue. Including:

• Otolaryngology,
• Maxillofacial surgery,
• hand- & foot-surgery and
• plastic & reconstructive surgery.

The new device, the "Piezomed Pro", is an ultrasonic surgical modular system which has to be connected to W&H's AMADEO device (K213221). The new device is an ultrasonic surgical system whose basic function is the conversion of electrical energy into mechanical vibration.

In addition, a physiological saline solution is pumped to the treatment site with a displacement pump, depending on the treatment.

Using a control unit with electronics, the user can change several operating parameters within predefined limits:

• oscillation amplitude, 5 to 100% in steps of 5 (100 % corresponds to max. power)
• coolant flow rate via pump speed control; 5 to 100% in steps of 5 (100% corresponds to max. water quantity)

The device is activated or deactivated via a foot control.

The provided FDA 510(k) clearance letter for the Piezomed Pro describes a surgical device (an ultrasonic surgical modular system), not a diagnostic AI device. Therefore, the information typically requested regarding acceptance criteria and performance studies for an AI/ML-enabled diagnostic device (such as accuracy, sensitivity, specificity, sample sizes, ground truth establishment, expert adjudication, MRMC studies) is not present in this document.

This document focuses on proving substantial equivalence for a physical medical device based on:

• Intended Use/Indications for Use: The Piezomed Pro is indicated for osteotomies, osteoplasties, drilling, and shaping of hard tissue in various surgical specialties. This is shown to be identical to the predicate device.
• Technological Characteristics: The device's operating principle (conversion of electrical energy into mechanical vibration), frequency, operating mode, electrical classification, and components are compared to predicate and reference devices, demonstrating similarity.
• Performance Data: This section details non-clinical testing for biocompatibility, electromagnetic compatibility, electrical safety, reprocessing validation, and general performance/functional testing (e.g., life-time, falling, vibration tests).
• Software and Cybersecurity: Compliance with relevant standards and guidance documents for software development and cybersecurity is stated.

Therefore, based on the provided text, it's not possible to extract the information required for an AI/ML diagnostic device performance study. The questions provided in the prompt are geared towards evaluating the performance of an AI algorithm against a ground truth, which is not the subject of this 510(k) submission for the Piezomed Pro.

If this were an AI/ML diagnostic device, the "Performance Data" section would describe clinical study results, including metrics like sensitivity, specificity, AUC, and details about the test set, ground truth, and reader studies. Since it's a surgical tool, the performance data relates to its physical and functional safety and effectiveness, rather than diagnostic accuracy.

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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, bone and biomaterials. The system is specifically intended for use in Neurosurgical (Cranial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Stemotomy, 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 hekaDrill device primarily consists of various components for surgical procedures involving cutting, drilling, and sawing of soft and hard tissues. The performance assessment focused on comparing the device's cutting performance, electrical safety, electromagnetic compatibility, and biocompatibility with predicate devices and relevant standards.

Here's a breakdown of the acceptance criteria and study 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 explicitly state the specific sample sizes for each performance test (e.g., number of cutting trials, number of biological samples). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective.

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the performance tests described. The assessment relied on objective measurements and comparisons against established standards and predicate device performance. For the biocompatibility tests, the "ground truth" is determined by the specific reaction observed (e.g., cytotoxicity, sensitization), not expert consensus on an image or diagnosis.

4. Adjudication Method for the Test Set:

Not applicable in this context. The performance tests involve objective measurements and comparisons to standards, not subjective interpretations requiring adjudication among experts.

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. The hekaDrill is a surgical drill system, not an AI-powered diagnostic or assistive device that would involve human readers or image interpretation.

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

Not applicable, as this is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used:

For the performance tests:

• General Performance: The "ground truth" was established by comparing direct measurements of performance characteristics (vibration, noise, control, cutting effectiveness) against those same characteristics of a predicate device.
• Electrical Performance: The "ground truth" was the adherence to established international safety standards (IEC 60601-1:2005 and IEC 60601-1-2:2014).
• Biocompatibility: The "ground truth" was dictated by the specific biological responses observed in standardized tests, such as the absence of biological reactivity in cytotoxicity assays or no significant reaction in sensitization tests.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device. The concept of a "training set" is typically associated with machine learning or artificial intelligence models.

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

Not applicable, as there is no training set for this type of device.

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The ORIGO system is a software-controlled motorized system that includes attachments and tools for cutting soft tissue and bone and provides irrigation fluid to the surgical site.

The ORIGO system is used in the following surgical fields:

· for cutting and shaping bones and resection of soft and hard tissues in the fields of head & neck/ENT (otology, rhinology, laryngology) and maxillofacial surgeries.

The ORIGO System is a software-controlled electrically-powered surgical system designed to be used in an operating room by a clinician for head & neck, ENT, and maxillofacial surgical procedures in a healthcare facility/hospital setting.

The ORIGO System consists of the ORIGO Control Unit, the ORIGO Foot Pedal, the ORIGO System-compatible micromotors and motorized handpieces with corresponding motor cables, handpieces, attachments, cutting tools, the ORIGO System Irrigation Line, and other accessories.

The ORIGO System transforms electrical energy through micromotors or motorized handpieces and converts it to rotational force to cut bones and resect soft and hard tissues through attached cutting tools.

Four motor subsystems of the ORIGO System include NANO, RAPIDO, OSSEOSTAP, and S120. The NANO and RAPIDO are micromotors. OSSEOSTAP is a motorized microdrill handpiece. S120 is a motorized shaver handpiece that is a microdebrider/microresector.

PM2 Handpieces are intended to be connected to the NANO Micromotor and RAPIDO Micromotor and used in conjunction with PM2 Burs. The PM2 80K Burs and PM2 50K Burs are used for cutting and shaping bones in ENT surgical procedures.

OSSEPSTAP is intended to be used for cutting and shaping bones in ENT surgical procedures, such as stapedotomy or ossiculoplasty. The OSSEOSTAP is used with OSSEOSTAP Burs and OSSEOSTAP Perforator.

S120 is intended to be used for resecting soft and hard tissues in ENT surgical procedures. The S120 is used with S120 Shaver Blades and S120 Shaver Burs.

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 the ORiGO System, a software-controlled motorized surgical system. However, it does not contain information regarding objective acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert qualifications, adjudication methods, or separate training/test set details for AI/algorithm-based performance evaluation.

The document outlines performance testing related to design validation, functional verification, usability, electromagnetic compatibility, electrical safety, software life cycle, and biocompatibility, all in conformance with relevant FDA recognized consensus standards and guidance documents. These tests are described as successfully demonstrating that the device performs as designed and is safe and effective when compared to predicate devices.

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance or provide the detailed study information requested.

The text generally states that the device's performance aligns with relevant standards and shows substantial equivalence to predicate devices, but specific numerical or objective performance criteria and their measured results are not presented in a traditional "acceptance criteria" format.

Here's an overview of what can be extracted and what is missing:

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

• Cannot be generated. The document mentions "functional verification, device performance, and usability" were carried out but does not provide specific acceptance thresholds or quantitative results for these tests. It only states that testing "demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device."

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. This device is a surgical motor system, not an AI or diagnostic device that typically uses test sets of data (e.g., medical images). The testing described is non-clinical bench testing, and no "test set" in the context of data analysis is 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. This information pertains to studies involving expert review for establishing ground truth, which is not described for this device.

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

• Not applicable. This pertains to expert review of data, which is not 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 device is a surgical motor system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

• Not applicable. The device is a surgical motor system, not a standalone AI algorithm. While it is "software-controlled," the performance evaluation described is for the physical device system.

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

• Not applicable generally. For non-clinical bench testing, "ground truth" typically refers to engineering specifications, physical measurements, and compliance with standards. The document states "conformance of the ORiGO System with applicable international and internal standards was verified" and "successfully demonstrated that the device correctly performs as designed."

8. The sample size for the training set

• Not applicable. This device is not an AI/ML system that undergoes a "training set" of data in the conventional sense.

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

• Not applicable. See point 8.

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The drive unit for surgical transmission instruments is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery

The AMADEO is an electrical drive unit, including motor, attachments and accessories, for surgical transmission attachments which is indicated for: drilling, cutting, sawing, screwing (for placement) of osteosynthesis screws, implants and plates, in soft and hard tissue. The foreseen areas of application will be: ENT (ear, nose, throat) surgery and Maxillofacial surgery. The basic function is the conversion of electrical energy into a mechanical rotary motion. The control unit is used to control the connected motor and the integrated pump. Depending on the treatment, a physiological saline solution is pumped to the treatment site by a displacement pump. A single-use sterile disposable irrigation tubing set is supplied within the scope of delivery and offered as an accessory. The integrated touch display is used to monitor the actual settings and to change, within predetermined limits, the operating parameters. The foot control is used for activation/deactivation of the motor and for changing parameters e.g. program, pump state and motor direction.

This document is a 510(k) Premarket Notification from the FDA for the medical device AMADEO, an electrical drive unit for surgical transmission instruments. It primarily focuses on demonstrating substantial equivalence to a predicate device, the NSK Primado2.

The document does not contain an acceptance criteria table or a study proving the device meets specific performance acceptance criteria in the manner one might expect for a new AI/software device submission. This is because the device, AMADEO, is an electro-mechanical surgical drill system, not an AI or software-only diagnostic device. The evaluation focuses on demonstrating its safety and effectiveness are substantially equivalent to a previously cleared device.

Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or not explicitly detailed in the provided text as they would be for an AI diagnostic device.

However, based on the principle of the 510(k) submission, we can infer the "acceptance criteria" is that the device performs as intended and is as safe and effective as the predicate device. The "study that proves the device meets the acceptance criteria" is the entirety of the non-clinical testing performed to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" in the form of performance metrics (like sensitivity, specificity, accuracy) are not provided, as this is an electro-mechanical device, not an AI diagnostic. The "acceptance" is substantial equivalence to the predicate. The performance data and technological characteristics are compared against the predicate device.

2. Sample Size for the Test Set and Data Provenance

Not applicable in the typical sense for an AI/software diagnostic. The "test set" here refers to the physical device and components undergoing bench testing, biocompatibility, electrical safety, and reprocessing validation. The provenance of this would be internal laboratory testing by the manufacturer. No patient data is involved in these types of tests for this device.

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

Not applicable for this type of electro-mechanical device submission. Ground truth, in this context, would be established by engineering standards, validated test methods, and industry-accepted protocols for safety and performance (e.g., precise measurements, material analyses).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical image interpretation or similar diagnostic tasks, which is not relevant here.

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

No. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks. The AMADEO is a surgical drill and does not involve AI assistance for human readers/interpreters in a diagnostic context.

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

No. This is relevant for AI diagnostic algorithms. The AMADEO is a physical surgical device. Its software controls the device's functions, but it's not a standalone diagnostic algorithm.

7. Type of Ground Truth Used

The "ground truth" for the AMADEO's performance comes from:

• Engineering Specifications and Standards: The device's design, operational parameters (e.g., motor speed, torque), electrical safety, and electromagnetic compatibility are validated against established engineering specifications and international standards (e.g., IEC 60601-1, IEC 60601-1-2).
• Biocompatibility Standards: Materials in contact with the patient are tested against ISO 10993 standards.
• Reprocessing Protocols: The ability to clean and sterilize/disinfect reusable components is validated against FDA guidance and established cleaning protocols.
• Functional Bench Testing: Verification that the device performs its intended functions (e.g., touchscreen responsiveness, motor control) according to its own design specifications.

8. Sample Size for the Training Set

Not applicable. There is no AI model being trained with a training set for this device.

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

Not applicable, as there is no training set for an AI model.

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The Celeris System (reusable power pack and Disposable Sinus Debrider) is intended for cutting, debriding, and removal of thin bone and soft tissue in general ENT and Sinus/Rhinology procedures and applications would include:

· FESS (Functional Endoscopic Sinus Surgery) – Including Endoscopic approaches for: Polypectomy, Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy

· Turbinate Reduction / Turbinoplasty, including sub-mucosal resection.

The Celeris DSD handpiece is a single-use disposable debrider handle and blade permanently combined with a built-in motor that plugs into a reusable power pack that contains a power supply for motor control. The power pack is also part of the subject system. The power supply is able to auto-adapt to any voltage via the universal power cord connection. Motor control requires software on a controller board inside the power pack.

The handpiece incorporates a rotatable blade and attached RF cable for bipolar models. The blades are either standard, bipolar, or malleable. The bipolar function requires a separate electrosurgical generator (not part of this system), connected via a cable. The cutting performance is equivalent to the current Gyrus ACMI predicate models.

A trigger style button on the DSD handle, or analog footswitch (sold separately) connected to the power pack, activates the blade oscillation and a standard electrosurgical unit footswitch (sold separately) powers the binolar effect for bipolar blades. The electrosurgical generator and footswitch alone will control the RF energy delivery.

A nosecone on the DSD handpiece allows the blade cutting window to rotate left or right. The blades are offered in 2mm and 4mm variants, either straight or malleable, and standard or bipolar. The malleable blade angle is flexible, and the design allows the blade to be bent with the provided bending fixture up to 60° at the user's discretion.

A standard suction tube (sold separately) is attached to the DSD handpiece proximal suction port and a clip attaches the tubing to the power cable. The handpiece power cable plugs directly into the power pack. The non-sterile power pack plugs into a standard power outlet and only provides power to the connected DSD handpiece. When the handpiece is activated power is sent to the motor which oscillates a gear which in turn oscillates the inner blade. For bipolar models, the energy lead from the cable is connected directly to the blade and energy is provided by the separate electrosurgical generator footswitch. For bipolar models, insulation around the cutting window limits energy delivery to the surgical site.

The provided document is an FDA 510(k) summary for the Gyrus ACMI Celeris Disposable Sinus Debrider. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.

However, the document does not describe a study involving an AI/algorithm model that processes data (like images) to provide diagnostic or prognostic information. Instead, it describes a physical medical device used for surgical procedures. Therefore, many of the requested criteria related to AI/algorithm performance, ground truth, expert review, sample size for test/training sets, and MRMC studies are not applicable to this submission.

Based on the information provided for this physical surgical device, here's an attempt to address the applicable parts of your request:

Acceptance Criteria and Device Performance (Based on the provided document for a physical surgical device):

The document details various non-clinical and preclinical tests to demonstrate the device's safety, effectiveness, and substantial equivalence to existing predicate devices. The "acceptance criteria" for a physical device like this are typically derived from recognized standards, performance requirements, and comparisons to predicate devices. The "reported device performance" indicates that the device met these criteria.

While not presented in a formal table with specific quantitative thresholds as one might expect for an AI model, the document implies the following acceptance criteria were met:

Table 1: Acceptance Criteria and Reported Device Performance (Adapted for a Physical Surgical Device)

Here's an assessment of the other points, noting their applicability to a physical device rather than an AI/algorithm:

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

   • Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical or preclinical test (e.g., how many units were tested for electrical safety, or how many tissue samples were used for performance evaluation). It mentions "representative samples" for stability testing.
   • Data Provenance: The tests are described as "non-clinical" and "preclinical," involving bench testing and ex vivo bovine tissue. There is no mention of human clinical data or patient data being used for these performance tests. Therefore, concepts like "country of origin" or "retrospective/prospective" studies for patient data are not applicable to the described performance testing.

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

   • This question is highly relevant for AI/algorithm performance where "ground truth" often comes from expert adjudication of medical images or data.
   • For this physical surgical device, "ground truth" for performance is typically established by physical measurements, adherence to engineering specifications, and established biological responses in ex vivo models. There is no mention of expert consensus establishing a "ground truth" as would be done for an AI diagnostic tool. Qualifications would be standard engineering and biological testing expertise.

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

   • Not applicable in the context of testing a physical device's mechanical, electrical, or tissue interaction properties. Adjudication methods are typically for evaluating subjective interpretations, such as expert consensus on medical image findings.

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 designed for AI assistance in diagnostic tasks. The Celeris system is a surgical tool, not a diagnostic aid for human readers. No MRMC study was performed or needed for this type of device.

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

   • Not applicable. The device itself is a tool that requires human operation; it doesn't have a standalone algorithm that performs a task without human interaction in the way an AI diagnostic algorithm would. The "software" mentioned is for motor control within the power pack, not a standalone diagnostic algorithm.

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

   • For this physical device, the "ground truth" for its described performance tests are:
     • Electrical/Safety: Adherence to established international electrical safety standards.
     • Mechanical/Functional: Engineering specifications, comparative performance to predicate devices' known characteristics, and objective measurements of mechanical output (e.g., cutting performance).
     • Biocompatibility: Results of standardized biological tests (cytotoxicity, sensitization, etc.) as per ISO 10993 series.
     • Sterility: Validation of sterilization protocols to achieve specific sterility assurance levels.
     • Preclinical (Tissue): Objective measurements on ex vivo bovine tissue and visual comparisons (e.g., thermal impact, coagulation).

8. The sample size for the training set:

   • Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

   • Not applicable. As there is no training set for an AI model.

In summary, the provided document describes the regulatory submission for a traditional surgical device. Therefore, the questions related to AI/algorithm performance, training data, ground truth establishment by experts, and MRMC studies are not relevant to this specific device submission. The device's substantial equivalence and safety/effectiveness were demonstrated through engineering bench tests, preclinical ex vivo studies, and adherence to recognized performance and safety standards.

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The Pi Drive 2 and Pi Drive 2 Plus Motors are intended for use with the Stryker Consolidated Operating Room Equipment (CORE) System. When used with a variety of attachments and cutting accessories, the drill is intended for use in cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to Dental, ENT (Ear, Nose and Endoscopic Applications. They are also usable in the placement or cutting of screws, metals, wires, pins, and other fixation devices.

The Pi Drive 2 and Pi Drive 2 Plus Motors are non-patient contact, reusable, electric powered (40 VDC) motors that are supplied non-sterile and intended to be to be sterilized by the user prior to each use. The devices are driven by a three-phase, four-pole, brushless DC motor that is housed in a black anodized aluminum body and directly rotates cutting accessories up to speeds of 75,000 RPM. A 4.6 m long cord is integrated into the proximal end of each motor which is used to connect directly to the CORE 2 Console. The CORE 2 Console is used to supply power to the motors and in conjunction with a foot switch (connected to the console) is used for motor activation and speed control. The Pi Drive 2 Plus contains circuitry that also allows it to be operated using a Stryker handswitch for activation and speed control. Both motors are identical in technology, functionality, indications for use, and are compatible with the same attachments and cutting accessories. The Pi Drive 2 Plus motor is approximately 10.3 mm longer and weighs 85 grams more than the Pi Drive 2 motor, this additional length accommodates use of the Stryker handswitch.

Here's a breakdown of the acceptance criteria and study information for the Stryker Pi Drive 2 Motor and Pi Drive 2 Plus Motor, based on the provided FDA 510(k) submission:

The submission is for a medical device that does not involve AI; it's an electric surgical drill. Therefore, many of the questions related to AI device performance (effect size of human readers with AI vs. without AI, standalone AI performance, ground truth for training set, etc.) are not applicable to this document. The document describes a "Special 510(k)" submission for a line extension of an existing predicate device, focusing on demonstrating substantial equivalence through non-clinical testing.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes non-clinical testing, which typically refers to laboratory or bench testing rather than studies involving human subjects or real-world data like clinical trials. Therefore, concepts like "test set sample size" and "data provenance" (country of origin, retrospective/prospective) in the context of patient data are not applicable. The testing would have involved a sufficient number of device units to demonstrate statistical confidence in the stated performance characteristics, but specific numbers are not provided in this summary.

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

This question is not applicable as the device is not an AI diagnostic device requiring expert interpretation for ground truth establishment. The performance is assessed through engineering and functional testing.

4. Adjudication Method for the Test Set:

This question is not applicable for the same reason as above. Adjudication methods are typically for resolving discrepancies in expert interpretations in diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is not an AI-powered diagnostic device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

No. This is not an AI algorithm. Its performance is inherent to its mechanical and electrical design, and its operation is always human-in-the-loop (a surgeon using the drill).

7. The Type of Ground Truth Used:

For the non-clinical testing of this surgical drill, the "ground truth" would be established by:

• Engineering specifications and design requirements: The device is expected to meet predefined performance metrics (e.g., maximum RPM, torque, electrical safety limits).
• Established industry standards: Adherence to standards like ISO 14971 (risk management), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (EMC/EMI) serves as the "ground truth" for compliance.
• Predicate device performance: The performance of the predicate device (Stryker® Pi Drive Plus Motor K152641) acts as a benchmark, with the new device demonstrating "substantial equivalence" in safety and effectiveness.

8. The Sample Size for the Training Set:

This question is not applicable as there is no training set for an AI algorithm here.

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

This question is not applicable as there is no training set for an AI algorithm here.

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The UNIDRIVE® S III ENT system consists of an active control unit used in conjunction with the High-Speed Micro Motor and DrillCut-X® II Shaver handpieces. The system is intended for use by qualified surgeons to provide controlled cutting, drilling, debriding, sawing, and shaving for the ablation, excision, removal, or transection of tissue or bone during head, neck, ENT, or otoneurological surgical procedures.

The UNIDRIVE S III ENT is a motorized surgical device system used for the excision, ablation, removal or transection of bones/tissues during head, neck, ENT, or otoneurological surgical procedures. The system components include a control unit used in conjunction with the High-Speed Micro Motor that houses the high-speed handpieces and DrillCut-X® II Shaver handpieces. The modifications made to the UNIDRIVE® S III ENT system is the addition of the DrillCut-X® II-35 and DrillCut-X® II-35 N Shaver handpieces. Additional accessories used with the UNIDRIVE S III ENT system include the shaver blades, sinus burrs and the sinus burr 35k.

The provided text describes a 510(k) premarket notification for the UNIDRIVE S III ENT system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study for a new AI/CAD device. Therefore, many of the requested criteria related to AI/CAD system performance, such as human reader improvement with AI assistance, sample sizes for AI training/test sets, expert qualifications for ground truth, and adjudication methods, are not applicable or findable in this document.

However, I can extract the information relevant to the device's technical performance and the non-clinical testing performed to demonstrate its acceptance criteria.

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

The document doesn't present acceptance criteria in a quantitative table with specific performance metrics for the device itself (like accuracy, sensitivity, specificity for an AI system). Instead, its acceptance appears to be based on adherence to recognized consensus standards and successful completion of specific non-clinical tests to demonstrate safety and effectiveness, and substantial equivalence to a predicate device.

Here's a summary of the non-clinical performance data provided, which serves as the "acceptance criteria" through compliance:

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. This device is a surgical drill system, not an AI/CAD system evaluated on patient data. The "test set" here refers to the device itself undergoing various engineering and biological safety tests. No patient data or associated provenance is 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. Ground truth in the context of AI/CAD systems usually refers to verified diagnoses or findings from medical images. For this surgical device, "ground truth" would be established by engineering standards, material science, and biological safety standards, which are inherent to the testing methodologies used. The document does not specify the number or qualifications of experts involved in the direct testing of the device, beyond implying qualified personnel conducting the tests and regulatory bodies reviewing the submissions.

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

Not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations for establishing ground truth in AI/CAD image analysis studies. This document discusses mechanical, electrical, and biological testing of a surgical device.

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. An MRMC study is relevant for AI/CAD systems that assist human interpretation of medical images. This document describes a surgical drill system.

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

Not applicable. This device is a surgical hardware system, not an AI algorithm. Its performance is inherent to its mechanical and electrical function.

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

The "ground truth" for this device's acceptance is established by engineering standards, material science, and biological safety standards, as demonstrated through the various non-clinical tests (electrical safety, EMC, cleaning/sterilization validity, rotation speed/torque inspection, biological evaluation) and compliance with national and international standards (IEC, ISO, ANSI/AAMI).

8. The sample size for the training set

Not applicable. This document describes a hardware device, not an AI algorithm that requires a training set.

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

Not applicable. As noted above, this is not an AI/CAD algorithm.

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The EndoRotor® System is intended for use in airway procedures including removal of granulation tissue and endobronchial lesions.

The EndoRotor® Airway Microdebridement System is a powered resection tool consisting of a power Console with Foot Control, Specimen Trap with pre-loaded filter, and a singleuse Catheter with a cutting tool mounted on the distal end. The EndoRotor's flexible design allows it to be used within the working channel of flexible bronchoscopes in tortuous paths. The Console houses the control panel, drive motor, vacuum control valve, and peristaltic irrigation pump drive. The Catheter includes a debriding cutter and allows for aspiration from the resection site through the bronchoscope working channel to the Specimen Trap.

The provided text describes regulatory information for a medical device (EndoRotor Airway Microdebridement System) and its substantial equivalence determination by the FDA. It does not contain information about acceptance criteria and a study that proves a device meets acceptance criteria in the context of an AI/algorithm-based diagnostic or assistive device.

Instead, the document details:

• Device Identification: EndoRotor Console, Catheter, Specimen Trap, Filter Set, Roll Stand (K190715).
• Intended Use: Airway procedures including removal of granulation tissue and endobronchial lesions.
• Regulatory Classification: Class II, product code ERL (Ear, nose, and throat electric or pneumatic surgical drill).
• Comparison to Predicate Device: XPS 3000 System (Medtronic XOMED, K041413). It highlights similarities in principle of operation (mechanical resection using rotational movement) and differences such as access (flexible bronchoscope vs. rigid), and components (specimen trap).
• Non-Clinical Testing: Biocompatibility, sterilization validation, pyrogenicity, shelf-life, packaging, transport, and functional testing for the catheter; design verification, power-up/set-up, functional, electrical safety, and electromagnetic compatibility testing for the console; procedural testing for the specimen trap. These tests "Met established acceptance criteria." However, specific numerical acceptance criteria and reported performance values are not detailed.
• Clinical Testing: No new clinical study was conducted. Substantial equivalence was based on prior clearance for gastrointestinal use (K181127) where the device demonstrated safety and performance in regions with thin tissue walls, implying its suitability for airway applications.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI/algorithmic device based on the provided text, as this document pertains to a mechanical surgical device. The questions about sample size of test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training sets, and how ground truth was established are all relevant to AI/algorithmic device validation, which is not what this document describes.

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When used with the ANSPACH Systems, the OCM-G1 Attachment and Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cocleostomies.

The OCM-G1 (Otologic Curved Micro) Attachment is an accessory to the G1 electric drill system. It is a one-piece straight attachment that is manufactured from 17-4PH and 303 stainless steels (ASTM A564 and ASTM A582). The OCM-G1 Attachment can be connected and disconnected to the distal end of the handpiece via a locking mechanism by the user. After the OCM-G1 Attachment is secured to the handpiece, it will accept and hold an OCM curved burr support sleeve assembly (previously cleared). The OCM curved burr support sleeve assembly will rotate at a speed selected by the user for cutting and shaping bone, primarily in otology procedures such as cochleostomies. The OCM-G1 Attachment is provided non-sterile and is reusable.

This document describes the OCM-G1 Attachment, an accessory for surgical drills used in otology procedures. The submission is a 510(k) premarket notification, indicating a comparison to a predicate device demonstrating substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

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

• Locking feature compatibility: Tested and demonstrated.
• Temperature: Tested and demonstrated safe external temperatures.
• Disconnect without tools: Tested and demonstrated.
• System functionality: Tested and demonstrated proper functionality.
• Simulated use study: Demonstrated the OCM-G1 Attachment and curved cutting burrs perform as intended in cutting and shaping bone, similarly to the predicate. |
  | Cleaning and Reprocessing | Criterion: Ability to be cleaned and sterilized effectively to achieve a Sterility Assurance Level (SAL) of 10^-6 without adverse effects. |
  | | Performance: The OCM-G1 Attachment's characteristics are considered equal to or less challenging to sterilize than the currently validated "worst case" predicate device. This implies that existing validated cleaning and sterilization processes are capable of achieving the required SAL. |

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

The document does not explicitly state the sample sizes for the test sets in the performance data section. The performance data seems to be based on bench testing and simulated use studies rather than clinical data from human subjects.

• Provenance: All testing appears to be internal verification and validation conducted by the manufacturer, The Anspach Effort, Inc., or its affiliates. No information is provided about the country of origin for the data or whether it was retrospective or prospective in a clinical context, as clinical testing was not performed or deemed necessary.

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. Given that the testing included bench tests and a simulated use study, the "ground truth" would likely be defined by engineering specifications, performance standards, and the intended use of the device, rather than expert clinician consensus on patient data.

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

Not applicable. This type of adjudication method is typically used in clinical studies involving multiple readers evaluating medical images or diagnoses against a predefined ground truth. The studies described are engineering verification tests and a simulated use study, which would not involve such a method.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices. The OCM-G1 Attachment is a mechanical surgical handpiece accessory, not an AI device.

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

Not applicable. The OCM-G1 Attachment is a mechanical device, not an algorithm, so a standalone algorithm performance study is not relevant. Its performance is always in conjunction with a human operator and other surgical system components.

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

The "ground truth" for the performance data appears to be based on:

• Engineering Specifications and Standards: For tests like locking feature compatibility, temperature, disconnect without tools, and system functionality. These are likely evaluated against predefined design requirements and industry standards.
• Intended Use Performance: For the simulated use study, the ground truth is the successful cutting and shaping of bone as intended for otology procedures, evaluated by direct observation and measurement against expected outcomes.
• Predicate Device Equivalence: A significant part of the submission relies on demonstrating that the device performs "the same as the predicate (K131053)" in various aspects, implying the predicate's established safety and effectiveness serve as a practical ground truth.

8. The sample size for the training set

Not applicable. The OCM-G1 Attachment is a mechanical device, not an AI or machine learning algorithm, and therefore does not have a "training set."

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

Not applicable, as there is no training set for this mechanical device.

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The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.

The Stryker CORE 2 Console is a modernization of the currently marketed CORE Console. The CORE 2 Console supplies power to a variety of devices, which include small and large bone handpieces, footswitches, and a bone mill. The CORE 2 Console contains a touch screen graphical user interface (GUI), which allows the user to program a number of customized settings related to the connected devices and irrigation.

This FDA 510(k) summary is for the Stryker Consolidated Operating Room Equipment (CORE) 2 Console. It asserts substantial equivalence to a predicate device (Stryker Consolidated Operating Room Equipment (CORE) System, K112593) rather than defining specific acceptance criteria for a novel device and then proving it meets them. Therefore, many of the requested categories related to algorithmic performance and ground truth establishment are "Not Applicable" or "Not Provided" in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission, explicit quantitative acceptance criteria for novel performance metrics are not specified in the document. Instead, the focus is on demonstrating that the device meets established regulatory standards and performs comparably to its predicate.

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

• Sample Size: Not specified for any of the performance tests. The document broadly states "Reliability and Use Life Testing," "Compatibility Testing," and "Performance testing for torque mapping capability and capacitive touchscreen" were conducted but does not provide numbers of units tested or duration of tests.
• Data Provenance: Not explicitly stated, but given it's a device manufacturer submitting to the FDA, it is presumed to be internal testing data from the company's facilities. The document does not indicate country of origin of data or whether it was retrospective or prospective.

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

• Not Applicable/Not Provided. For a device of this nature (surgical console), "ground truth" usually refers to the accuracy or correctness of an AI algorithm's output relative to established medical fact. As this is not an AI-driven diagnostic or prescriptive device, and the submission is focused on substantial equivalence of hardware/software functionality, this concept of "ground truth" in the context of expert review does not apply directly. The performance tests would be validated against engineering specifications and industry standards by qualified engineers and testers.

4. Adjudication Method for the Test Set

• Not Applicable/Not Provided. Adjudication methods (like 2+1, 3+1 for consensus) are typically used in clinical studies or for evaluating AI diagnostic performance where human expert discrepancy needs resolution. This submission focuses on engineering and regulatory compliance, not clinical diagnostic accuracy requiring expert consensus adjudication.

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 conducted as this is not an AI-assisted diagnostic or interpretation device that would involve human "readers" or image interpretation. The device is a surgical console that powers other instruments.

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

• Not Applicable. This is not an AI-driven algorithm with a "standalone" diagnostic or predictive function. The software mentioned "accommodate internal circuitry redesigns" and manages "illumination rings," "GUI workflow," and "transfer saved use-preference profiles." The "software verification and validation testing" would assess the standalone functionality of the software's control over the console's operations, but not in the sense of an "AI algorithm."

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Engineering Specifications and Regulatory Standards. For this device, the "ground truth" for its performance tests would be adherence to documented engineering specifications and compliance with relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2) and the stated indications for use.

8. The Sample Size for the Training Set

• Not Applicable/Not Provided. This device does not use machine learning or AI that requires a "training set" of data in the conventional sense. The "software was rewritten" and verified/validated, but this refers to traditional software development, not AI model training.

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

• Not Applicable/Not Provided. As there is no "training set" for an AI model, this question is not relevant to this submission.

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