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 iBur™ Hubs 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 iBur™ Hubs and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otorhinolaryngology; and Endoscopic applications.

Specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/ Anterior Skull Base/ Endoscopic/ Transnasal/ Transphenoidal, and Orthopedic Spine.

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

iBur™ Cutting Accessories 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 iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures including the following specialty areas: Neuro, Spine, ENT, Endoscopic. 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 iBur™ Cutting Accessories are designed to fit the corresponding iBur™ Hubs. The cutting accessories when used with a high speed drill and iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.

This document is a 510(k) premarket notification for a medical device, the Stryker iBur™ Hubs and Cutting Accessories. It outlines the modifications to an existing device, compares it to a legally marketed predicate device (K210377), and provides performance data to demonstrate substantial equivalence.

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

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

The document does not provide a specific table of acceptance criteria with corresponding numerical performance metrics for the iBur™ device. Instead, it makes a general statement about meeting acceptance criteria and demonstrating sufficiency for intended use.

However, it does indicate the types of performance tests conducted and their qualitative outcomes:

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 size used for the test set or the data provenance. It mentions "performance testing was conducted on the proposed devices" but does not specify the number of devices or units tested.

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 to this document. The device is a surgical cutting accessory, not an AI/diagnostic device that requires expert-established ground truth from a test set. The validation focuses on the device's physical performance characteristics.

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

This information is not applicable. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the nature of this 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

This information is not applicable. The device is a surgical tool, not an AI system.

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

This information is not applicable. The device is a surgical cutting accessory, not an AI algorithm.

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

This information is not explicitly stated in terms of "ground truth" as it would be for an AI or diagnostic device. For this type of device (surgical cutting accessory), the "ground truth" for performance is established through engineering and material science testing, ensuring the device meets predefined technical specifications for cutting efficacy, safety (e.g., temperature), and structural integrity. This is indicated by the mention of "all acceptance criteria were met for the performance testing."

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI model that requires a training set.

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

This information is not applicable. The device is a physical product, not an AI model.

In summary, the provided document is a 510(k) premarket notification for a modified medical device. It focuses on demonstrating that the device's modifications do not alter its fundamental scientific technology or intended use and that its performance remains substantially equivalent to a predicate device through non-clinical performance testing. The questions regarding AI, expert ground truth, and training data are not relevant to this type of device submission.

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The Surgical Drive System (Model: ES70, ES90, E8) 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 Surgical Drive System is an electrical drive unit, including a motor, power console, foot control, connection cables, and other accessories. It is intended for use in surgical procedures involving incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone. The basic function of the Surgical Drive System 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. 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 of the motor and changing parameters e.g. program, pump state, and motor direction. The motor's function is to provide power for handpieces with the gear ratio (1:1, 1:4.2, 1:5, 3.2:1, 3.4:1, 40:1), the Max. speed of the motor is 40000 min-1, and it is designed with an ISO 3964 Type 3 connector.

This FDA 510(k) summary (K240340) for the Surgical Drive System (Model: ES70, ES90, E8) describes a device that is not an AI/ML-driven medical device. The document focuses on establishing substantial equivalence to a predicate device based on technical design, intended use, and conventional performance and safety testing.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, cannot be extracted from this document because it does not involve AI/ML.

However, I can provide a summary of the non-clinical performance testing that was conducted to support the substantial equivalence claim for this medical device, which addresses the "study that proves the device meets the acceptance criteria" in a general sense, but not for AI/ML specific criteria.

Non-AI/ML Related Acceptance Criteria and Study Summary (Based on Provided Document):

The acceptance criteria for this non-AI/ML device are primarily related to safety, electromagnetic compatibility, and reprocessing effectiveness, demonstrated through adherence to recognized international standards.

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI/ML):

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

• Test Set Sample Size: Not explicitly stated in terms of number of devices / units. Testing would typically involve a statistically relevant sample of devices or components to demonstrate compliance with standards.
• Data Provenance: Not explicitly stated, but testing is implied to be conducted by the manufacturer (Guangdong Jinme Medical Technology Co., Ltd.) or a contracted testing facility. The nature of these tests (safety, EMC, reprocessing validation) implies prospective testing on manufactured devices to meet specific engineering and regulatory requirements.

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

• This concept is not applicable as this is a non-AI/ML device. "Ground truth" established by expert consensus is typically relevant for evaluating the diagnostic or classification performance of AI/ML algorithms. For this device, compliance is measured against engineering specifications, industry standards, and regulatory requirements, which do not rely on expert "ground truth" in the same way.

4. Adjudication method for the test set:

• Not applicable for a non-AI/ML device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or performance evaluations for diagnostic devices to resolve discrepancies in expert interpretations, particularly for establishing ground truth for AI model training or testing.

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

• Not applicable as this is a surgical drive system, not an AI-driven diagnostic or assistive imaging device involving human readers.

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

• Not applicable as this is a hardware-based surgical drive system, not an AI algorithm.

7. The type of ground truth used:

• For this device, "ground truth" is established by:
  • Engineering Specifications: The device is designed to meet specific performance parameters (e.g., motor speed, power output, operating mode).
  • International Standards: Compliance with established safety (e.g., IEC 60601-1), EMC (e.g., IEC 60601-1-2), and reprocessing (e.g., ISO 17665-1) standards, where the standard itself defines the acceptable criteria and test methods.
  • Software Design Requirements: For the device's control software, compliance is against its own validated design requirements and IEC 62304.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of AI/ML.

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

• Not applicable.

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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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TruDi® Shaver Blades are intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. Their use is indicated for any medical condition in which the use of navigated surgery may be appropriate, and where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.

TruDi® Shaver Blades may be used in, but is not limited to, the following procedures:

• · Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
• · Drainage of mucoceles or abscesses that have extended from the paranasal sinuses and up to the dura mater
• · Orbital decompression
• · Any other of a number of tumors involving the lateral nasal wall, paranasal sinuses and orbit
• · Access to the sphenoid sinus

The subject device, TruDi® Shaver Blade, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended to be used with the Bien-Air S120 Shaver Handpiece (reference device, K083720) and the TruDi® Navigation System (K192397) to aid in the incision and removal of soft and hard tissue or bone in ENT, Maxillofacial surgery, Head and Neck and ENT skull base surgery. The device is tracked by the navigation system within the low energy magnetic field volume generated by the TruDi® Navigation System. The TruDi® Navigation System software displays the position of the shaver blade distal tip on preoperative scans (e.g. CT, MRI). The TruDi® Shaver Blade consists of several configurations ranging from straight to curved blades of different diameters.

The TruDi® Shaver Blade underwent various performance tests to demonstrate its substantial equivalence to its predicate device. This device is an electromagnetically (EM) navigated instrument intended for use with the Bien-Air S120 Shaver Handpiece and the TruDi® Navigation System to aid in incision and removal of soft and hard tissue or bone in various ENT and maxillofacial surgeries.

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

The eG1 Wireless Hand Control System consists of two articles:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8. The sample size for the training set

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

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

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

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

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The 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 P300 Attachment is intended to be used with electric and pneumatic surgical instruments and cutting accessories for cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, and General Surgery.

NSK Sterile Cutting Accessory(ies) is for single use only. This device is intended for use, in conjunction with P300 Attachment, in cutting, drilling, removal, and shaping of bone in the procedures of: Neuro, Spine, Orthopedic, ENT, Maxillofacial, and General Surgery.

The P300 Attachment is a powered bone cutting and drilling instruments designed to be used with the Primado2 Total Surgical System (K132264), which provides mechanical power to the attachment. The P300 Attachment is comprised of two families: Standard Attachment 300 and Slim Attachment 300. The Standard Attachment 300 and Slim Attachment 300 consist of angled and straight types of attachments with varying lengths. The Standard Attachment 300 is an attachment to the Primado2 Total Surgical System that can be in either a straight or angled configuration and comes in 5 different tube lengths, ranging from 12 mm to 79 mm. Accessories compatible with the Standard Attachment 300 include 52 NSK Sterile Cutting Accessories, a STD Attachment Beak, and 4 Irrigation Nozzles. The Slim Attachment 300 consists of 2 parts, a Slim Attachment Hub that comes in 2 configurations (straight or angled) and a Slim Tube that comes in 8 configurations and varies in tube lengths from 110 mm to 240 mm, and can be straight, curved, or angled. Accessories compatible with the Slim Attachment 300 include 49 NSK Sterile Cutting Accessories, a Slim Tube Beak and a Slim Tube Hood, and 2 Irrigation Nozzles. The Standard Attachment 300 and Slim Attachment 300 share the same Cleaning Tools for automated cleaning, manual cleaning, and purging. For both the Standard Attachment 300 and the Slim Attachment 300, the length of the bur can be adjusted in six levels. Both the Standard and Slim attachments include a non-slip surface etching on the grip. The attachments consist of stainless steel, polytetrafluoroethylene, Copper-Beryllium Alloy, fluorocarbon rubber, and PEEK.

Here's an analysis of the acceptance criteria and study information for the P300 Attachment and NSK Sterile Cutting Accessories, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, but a surgical attachment. Therefore, most of the requested AI/ML specific criteria (sample size for test set, data provenance, number of experts, adjudication, MRMC study, standalone performance, training set size and ground truth establishment for training set) are not applicable.

Acceptance Criteria and Reported Device Performance

The device appears to be a traditional medical device (Powered Simple Cranial Drills, Burrs, Trephines, and Their Accessories), and the FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, rather than a clinical study with traditional acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC).

The acceptance criteria are implied by the successful completion of specific non-clinical tests and demonstrations of compliance with relevant standards. The "performance" section describes the results of these tests, which effectively serve as the reported device performance meeting the implicit acceptance criteria of the standards and internal specifications.

Study Information

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

   • Sample Size: Not applicable. The "test set" in this context refers to samples used for non-clinical bench testing (e.g., cell cultures, animal models for biocompatibility, physical device units for functional testing). Specific numbers for these types of samples are not provided in the summary. For example, for the "Acute Systemic Toxicity Test," it mentions "mice" but not the count. The biocompatibility testing selected "worst-case representative models" (Slim Attachment 300, specific bur/nozzle models) for evaluation.
   • Data Provenance: The manufacturing site for NAKANISHI INC. is listed as Kanuma, Tochigi 322-8666 Japan. The tests would likely have been conducted by or for the manufacturer. The FDA 510(k) summary does not specify the country of origin for the testing facilities, but it typically aligns with the manufacturer's region or accredited labs. All testing is prospective in nature, as it's conducted specifically for demonstrating the safety and effectiveness of the device being submitted.

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. This is a non-clinical submission for a surgical instrument. "Ground truth" in the context of expert consensus, as might be used for AI diagnostic devices, is not a concept applied here. The "truth" is established by adherence to recognized international and national standards (e.g., ISO, ASTM, ANSI/AAMI) for material safety, reprocessing, and sterilization, verified through laboratory testing.

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

   • Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation of data where consensus is needed to establish ground truth for a diagnostic outcome. This submission relies on objective physical, chemical, and biological testing results.

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 non-clinical submission for a mechanical surgical instrument. MRMC studies are used for evaluating the performance of AI/CADe diagnostic devices in conjunction with human readers.

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

   • No. This device does not have an algorithm or AI component.

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

   • For this device, the "ground truth" is defined by established scientific and engineering principles, as articulated in national and international standards (e.g., ISO 10993 for biocompatibility, ISO 17664/17665/ANSI/AAMI ST79 for reprocessing, ISO 11137-2 for sterilization). Compliance with these standards, demonstrated through specific laboratory tests (e.g., cytotoxicity assays, sensitization tests, pyrogenicity tests, material characterization), serves as the evidence that the device is safe and performs as intended.

7. The sample size for the training set:

   • Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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