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The RetroX Transcutaneous System is intended for use in patients with Mild to Moderate high-frequency hearing loss.
The Transcutaneous Titanium Tube System: has the start of a hearing system for adults with Mild to Moderate high-frequency hearing loss.
Mild to moderate high frequency hearing loss.

The RetroX Transcutaneous System is intended for use in patients with Mild to Moderate high-The RetroX Transculatieous System is mended for asso is placed via a "functional piercing" frequency hearing foss. "The Triamum "Fase "System" is processor in the outer ear canal.

The provided text describes a medical device, the RetroX Titanium Tube System, and its 510(k) clearance application. However, it does not contain any information regarding acceptance criteria, device performance metrics, or study results that would allow for the completion of the requested table and detailed study description.

The document primarily focuses on the regulatory aspects of the device, including:

• Device Description: The RetroX Transcutaneous System is intended for use in patients with Mild to Moderate high-frequency hearing loss. It consists of a titanium tube placed via a "functional piercing" and a sound processor in the outer ear canal.
• Predicate Device: The RetroX TACHAS Titanium Tube System by Auric Hearing Systems (K013298).
• Intended Use: As a hearing system for adults with Mild to Moderate high-frequency hearing loss.
• Comparison Chart (Subject vs. Predicate Device): This chart details material, number of pieces, sizes, lengths, diameter, and how supplied, noting that the subject device (Gyrus ENT LLC) is sterilely supplied while the predicate device (Auric Hearing Systems, Inc.) is non-sterile. This comparison is for demonstrating substantial equivalence, not performance against specific criteria.
• FDA Clearance Letter: Confirms the 510(k) clearance (K040996) for the RetroX Titanium Tube System.
• Indications For Use: Mild to moderate high-frequency hearing loss.

Therefore, I cannot provide the requested table and study details because the necessary information is not present in the provided text.

To answer your request, I would need a document that includes sections on:

• Clinical study design and methodology
• Pre-specified acceptance criteria for device performance (e.g., audiometric thresholds, patient satisfaction scores, safety endpoints)
• Results from a study comparing the device's performance against these criteria
• Details about the ground truth, expert qualifications, sample sizes (training and test sets), and adjudication methods.

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The Diego RF Powered Dissector and Drill System's intended use is the cutting and removal of soft and hard tissue in general ENT, Head & Neck, and otoneurologic procedures.

Sinus applications would embody:

• applications in the most moidectorny, polypectorny, septoplasty and
• procedures such as endoscopic DCR antrostomy frontal sinus trephination and irrigation frontal sinus drill-out trans-spehnoidal procedures septal spurs removal

Nasõpharyngeal/laryngeal procedures would comprise:
adenoidectomy laryngeal polypectomy tonsillectomy
laryngeal lesion de-bulking tracheal procedures

Head & Neck procedures would encompass:
soft tissue shaving
rhinoplasty (narrowing of the bony vault & revision of the bony pyramid) removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular regions of the face acoustic neuroma removal

Otology procedures would include:
mastoidectomy
mastoidotomy.

The new Diego RF Powered Dissector and Drill System Console is identical to the console cleared in 510(k) # 020594 (3.08.02). However an additional panel was added to operate the current handpieces with new RF blades that can provide coagulation in addition to powered dissection. Other than coagulation during procedures, there are no new indications for use.

This document is a 510(k) summary for the Diego™ RF Powered Dissector and Drill System. It focuses on demonstrating the substantial equivalence of the new device to previously cleared predicate devices, particularly regarding the addition of RF coagulation capabilities. As such, the information typically requested for AI/ML device evaluations (such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies) is not applicable to this type of device submission.

The acceptance criteria for this device and the "study" that proves it meets them are established through a comparison to predicate devices in terms of intended use, functions, and power ratings, rather than a clinical study with performance metrics in the way an AI/ML device would be evaluated. The core of the acceptance is "substantial equivalence."

Here's an breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of medical device clearance:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (an electrical surgical drill/shaver with added RF coagulation), the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is compared in terms of features and power, not diagnostic accuracy or clinical outcomes in a quantified sense like an AI product.

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

• Sample Size: N/A. This is not a study involving patient data or a test set in the context of an AI/ML device. The "test" for the Diego RF System involves engineering and performance validation against internal specifications and comparison to predicate devices, not analysis of a clinical dataset.
• Data Provenance: N/A.

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

• N/A. Ground truth in the context of diagnostic accuracy studies is not relevant here. The ground for this device would be its engineering specifications and safe operation relative to its intended use and predicate devices. Regulatory experts within the FDA review the submission.

4. Adjudication method for the test set

• N/A. This concept is typically applied to clinical studies involving human interpretation or assessment, not for the clearance of a surgical instrument.

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

• N/A. MRMC studies are specific to evaluating AI/ML devices that assist human readers in diagnostic tasks. This device is a surgical tool.

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

• N/A. This device is a surgical instrument operated by a human surgeon. It is not an algorithm.

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

• N/A for the definition usually applied to AI/ML devices. For a surgical device, the "ground truth" would relate to its engineering performance as designed (e.g., power output, coagulation effectiveness in a lab setting, safety features) and its stated intended use, all compared against established predicate devices and recognized standards.

8. The sample size for the training set

• N/A. This device is not an AI/ML algorithm that requires training data.

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

• N/A. This device is not an AI/ML algorithm that requires training data.

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The Hemostatix Model 2400Z Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.

The Hemostatix Model 2400Z Thermal Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.

This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance. This document primarily focuses on establishing substantial equivalence to a predicate device and outlining basic device characteristics and regulatory compliance.

Here's an breakdown of the available information:

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

The document states that "The Hemostatix Model 2400Z Thermal Scalpel System is designed to meet UL 2601-1 including Australian deviations, CSA 22.2 No. 601, IEC 601-1-1 (EN 60601-1), IEC 601-1-2 (EN 60601-1-2), IEC 601-1-4 (EN 60601-1-2), IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 529, ISO 10993-1, EN 55011, Class B."

This lists a set of international and national standards that the device is designed to meet. However, it does not provide specific performance metrics or acceptance criteria tables as they would typically be presented (e.g., minimum cutting efficiency, maximum tissue damage, etc.). It also does not report detailed performance results against these standards, only a general statement of compliance.

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

This information is not provided in the given text. There is no mention of any specific test sets, sample sizes, or data provenance from a device performance study.

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 provided. The document does not describe any studies involving experts establishing ground truth.

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

This information is not provided. As there's no mention of a test set or ground truth establishment, there's no adjudication method 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:

This is not applicable. The device is a "Thermal Scalpel System," not an AI-assisted diagnostic or imaging system that would typically involve human readers or MRMC studies.

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

This is not applicable. The device is a surgical instrument. There is no mention of an algorithm in the context of performance studies.

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

This information is not provided. No specific performance study with ground truth is described. The approval is based on "substantial equivalence" to a predicate device and compliance with general safety and performance standards.

8. The sample size for the training set:

This information is not provided. No training set for an algorithm is mentioned or relevant to this type of device and submission.

9. How the ground truth for the training set was established:
This information is not provided. No training set for an algorithm is mentioned or relevant to this type of device and submission.

Summary based on available information:

The provided document, a 510(k) summary, focuses on establishing the substantial equivalence of the "Hemostatix Model 2400Z Thermal Scalpel System" to a predicate device (Oximetrix Shaw Hemostatic Surgical System) and its intended compliance with various technical and safety standards. It does not present a detailed study with specific acceptance criteria, performance metrics, or clinical data in the format you requested. The regulatory approval is based on demonstrating that the new device has "the same technological characteristics, power modality and mode of operation as the predicate device" and meets a list of recognized safety and performance standards, rather than a specific comparative effectiveness study with ground truth and expert evaluation.

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SMart Offset Stapes Piston Prosthesis: Bridging the stapes in cases of otosclerosis: specifically for surgical revision in patients with a shortened incudal process, and also in primary surgery with this anatomical condition.
SMart ISJ Prosthesis: Bridging defects at the long incudal process with otherwise intact mobile chain.

SMart Offset Stapes Piston: Middle Ear Piston, Partial Ossicular Replacement Prosthesis. Utilizes nitinol wire embedded in a fluoroplastic shaft. Offered in lengths of 3.0 mm through 6.0 mm (functional length) and shaft diameters of .4, .6, .8 mm. Offset lengths between 1mm and 2mm. Supplied sterile.
SMart ISJ Prosthesis: Partial Ossicular Replacement Prosthesis. Utilizes nitinol shaft and loops welded to a titanium bell. Offered in lengths of offset of 2.25 mm, 3.25 mm. Supplied sterile.

The provided text does not contain information about acceptance criteria or a study proving device performance in the context of a diagnostic or AI-powered medical device. The documents are 510(k) notifications for two medical devices: the SMart™ Offset Stapes Piston Prosthesis and the SMart™ ISJ Prosthesis.

These notifications focus on demonstrating substantial equivalence to predicate devices rather than proving a specific performance against acceptance criteria through a clinical study or AI performance evaluation. The substantial equivalence argument is based on similar intended use, comparable materials (with acknowledged differences whose biocompatibility is asserted), and similar design features.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and a study that proves the device meets them, as this kind of information is not present in the provided FDA 510(k) summary. The document does not describe:

1. Acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy).
2. A study (clinical or otherwise) designed to measure the device's performance against such criteria.
3. Sample sizes for test or training sets, as it's not an AI/diagnostic device.
4. Expert ground truth establishment, adjudications, or MRMC studies, as these relate to performance evaluation of diagnostic tools, which these prostheses are not.
5. Standalone algorithm performance as there is no algorithm.
6. Type of ground truth (pathology, outcomes data) as this relates to diagnostic accuracy.
7. Training set sample size or how its ground truth was established, as this is irrelevant for a physical medical implant.

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The intended use of the Diego Powered Dissector and Drill System equipped with an image guided surgery system is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.

Sinus applications would embody:

• ethmoidectomy/sphenoethmoidectomy .
• polypectomy .
• septoplasty and .
• procedures such as .
  • antrostomy .
  • endoscopic DCR .
  • frontal sinus drill-out .
  • frontal sinus trephination and irrigation .
  • septal spurs removal .
  • trans-spehnoidal procedures .

Nasopharyngeal/laryngeal procedures would comprise:

• adenoidectomy ●
• laryngeal lesion de-bulking ●
• laryngeal polypectomy .
• tracheal procedures ●
• . tonsillectomy

Head & Neck procedures would encompass:

• . soft tissue shaving
• rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) .
• removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face
• acoustic neuroma removal .

Otology procedures would include:

• mastoidectomy .
• mastoidotomy .

The Diego Powered Dissector and Drill System Handpiece, cleared under 510(k) K020594, has been modified to accept the BrainLAB VectorVision (K003589) and Kolibri (K014256) Image-Guided Surgery System Instrument Adapter that will allow the Dissector blades and burs to be tracked in real time in the surgical field.

The provided text is a 510(k) summary for the Gyrus ENT Image-Guided Diego™ Powered Dissector & Drill System Modified Handpiece. This document is related to a medical device's regulatory review and does not contain information about acceptance criteria or a study proving device performance in the context of typical AI/software device evaluation.

The 510(k) is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the way an AI/software device would. The modifications described are about allowing the existing "Diego Powered Dissector and Drill System Handpiece" to integrate with BrainLAB Image-Guided Surgery Systems (VectorVision and Kolibri) through an adapter. This likely involves mechanical integration and compatibility, rather than a clinical performance study with statistical endpoints.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/software device is not present in this document.

Here's an attempt to answer based on the spirit of the request, highlighting what's missing in the context of your questions, and what can be inferred.

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not present acceptance criteria for device performance in terms of clinical accuracy or outcome metrics as would be seen for an AI/software device. Instead, the "acceptance criteria" for a 510(k) submission are largely based on demonstrating substantial equivalence to a predicate device, which implies that the modified device will perform as safely and effectively as the predicate.

The document implicitly "reports device performance" by stating its intended use and showing equivalence to predicate devices for navigation. The performance here is in terms of compatibility and retaining the function of the original dissector and drill system while integrating with image guidance.

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

• Sample Size: Not applicable/Not provided. This 510(k) submission does not describe a clinical performance study that would use a "test set" in the context of an AI/software device evaluation. The assessment is likely based on engineering verification and validation of the mechanical and functional integration with the IGS systems, rather than a statistical sample of patient data.
• Data Provenance: Not applicable/Not provided for a clinical "test set."

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

Not applicable. There is no mention of a "test set" with expert ground truth in this submission, as it's not an AI/software device undergoing such a performance evaluation. The review for 510(k) is about substantial equivalence based on engineering, bench, and potentially pre-clinical (e.g., cadaveric) testing, and comparison to existing predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. As no clinical "test set" requiring expert ground truth or adjudication is described.

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

Not applicable. This is not an AI-assisted diagnostic or therapeutic guidance system that would typically undergo an MRMC study to show human reader improvement. The device itself is a surgical tool, and the modification enhances its guidance capabilities, but the submission doesn't include an MRMC study comparing surgeon performance with/without the image-guided assistance provided by this specific adapter.

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

Not applicable. This device is a manual surgical tool that is guided by an image-guided surgery system. Its function inherently involves a human operator (the surgeon) and the image navigation system. There is no "algorithm only" component that would perform a task independently. The performance is the combined system's ability to track the instrument accurately.

7. Type of Ground Truth Used:

Not applicable in the context of an AI/software device's performance study. For a mechanical device, "ground truth" would relate to engineering specifications, e.g., the true position of the instrument as measured by highly accurate systems, or the physical dimensions and tolerances of the adapter. However, the submission does not detail these engineering verification methods beyond stating the intent to integrate with image-guided systems.

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical surgical instrument; it does not utilize a "training set" for machine learning.

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

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

Summary of what the document DOES provide:

• Device Description: A modified handpiece for the Diego™ Powered Dissector and Drill System, designed to accept adapters for BrainLAB Image-Guided Surgery Systems (VectorVision and Kolibri).
• Intended Use: Cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures, with specific examples listed.
• Predicate Devices: BrainLAB Kolibri IGS System (K014256) and BrainLAB Vectorvision2 IGS System (K003589). The modification makes the Gyrus ENT device "compatible" with these predicate image-guided systems.
• Regulatory Classification: Class II, Stereotaxic instrument (HAW).
• 510(k) Clearance: The document is the FDA's clearance letter, stating substantial equivalence to predicate devices, thus permitting marketing.

This 510(k) focuses on the mechanical and functional compatibility of a modified surgical instrument with existing image-guided navigation systems, rather than a new AI/software diagnostic or therapeutic device whose performance would be assessed with detailed statistical studies against clinical ground truth.

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The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures.

The Gyrus ENT Nerve Stimulator that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate device.

This 510(k) summary describes a traditional medical device, the Gyrus ENT Nerve Stimulator, not an AI/ML-powered device. Therefore, the specific questions regarding AI/ML study design, such as acceptance criteria based on AI performance metrics, sample sizes for AI training/test sets, expert adjudication for ground truth, MRMC studies, or standalone algorithm performance, are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (Neurosign Model 100) based on intended use and technological characteristics, as well as adherence to established safety standards.

Here's a breakdown of the requested information based on the provided text, adapted for a non-AI/ML device:

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

The acceptance criteria for the Gyrus ENT Nerve Stimulator appear to be compliance with specific electrical safety and electromagnetic compatibility (EMC) standards. The "reported device performance" is its successful testing against these standards.

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 to this type of device submission. This is a traditional electrical medical device, and its performance is evaluated against engineering and safety standards, not through a clinical test set of patient data.

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

Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert-labeled data) is not relevant here. The "ground truth" for this device's performance would be verifiable compliance with the specified safety and EMC standards, likely assessed by expert engineers and testing laboratories.

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

Not applicable. There is no "test set" in the context of patient data requiring adjudication for this type of 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. This is not an AI-assisted device.

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

Not applicable. This is not an algorithm-only device.

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

The "ground truth" for this device's regulatory acceptance is its adherence to universally recognized and specified electrical safety (UL2601/IEC 601) and electromagnetic compatibility (IEC 601-1-2) standards. This is not a biological or clinical ground truth, but an engineering and regulatory one, confirmed through compliance testing.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes a training phase.

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

Not applicable.

Summary of the Study/Evidence Provided:

The provided documents describe a 510(k) submission for the Gyrus ENT Nerve Stimulator. The "study" mentioned is not a clinical trial in the typical sense for AI/ML devices, but rather a demonstration of substantial equivalence to an existing predicate device (Neurosign Model 100) and adherence to established safety and EMC standards.

• Substantial Equivalence: The submission asserts that the Gyrus ENT Nerve Stimulator has the same intended use and similar technological characteristics (e.g., power supply, current range, probe support) as the predicate device, the Neurosign Model 100. Differences in frequency settings and current display are noted but considered not to raise new issues of safety or effectiveness.
• Safety and Performance Testing (Implicit): The device is stated to be "designed to meet" UL2601/IEC 601 for various AC voltages and IEC 601-1-2 for EMC. This implies that testing was conducted or design validated to ensure compliance with these international electrical safety and electromagnetic compatibility standards. The compliance with these standards serves as the performance demonstration for the safety aspects of the device.

In conclusion, for this traditional nerve stimulator, the "acceptance criteria" revolve around established regulatory pathways for medical devices: demonstrating substantial equivalence to a predicate and compliance with recognized safety and performance standards, rather than clinical performance metrics in a study with patient data.

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The PlasmaKinetic Generator section of the GII RF Workstation is indicated for ablation of coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (Head and Neck) surgery including: Adenoidectomy, Cysts, Head, Neck, Oral, and Sinus Surgery, Mastoidectomy, Myringotomy with effective Hemorrhage Control, Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates, Nasopharyngeal / Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking, Neck Mass, Papilloma Keloids, Submucosal Palatal Shrinkage, Tonsillectomy, Traditional Uvulopalatoplasty (RAUP), Tumors, Tissue in the Uvula/Soft Palate for the Treatment of Snoring.

The Gyrus ENT Somnoplasty TCRF Generator section of the GII RF Workstation with the Temperature Controlled Radio-frequency (Somnoplasty®) Electrodes is indicated for coagulation of soft tissue including: The coagulation of enlarged tonsils in patients 13 years of age and older; the reduction of the incidence of airway obstructions, e.g., base of tongue, soft palate, etc., in patients suffering from UARS or OSAS; tissue coagulation in the inferior turbinates; and tissue coagulation in the uvula/soft palate which may reduce the severity of snoring in some individuals.

The Gyrus ENT G II RF Workstation is a combination of two previously cleared radio-frequency generators: 1. The Gyrus ENT Somnoplasty Temperature-Controlled Radio-frequency Generator -K020067, and 2. The Gyrus Medical Inc. (formerly Everest Medical Corporation) PlasmaKinetic™ Generator - K003060.

The Gyrus ENT G II Radio-frequency Workstation has two modes of operation: The monopolar mode has controls for maximum temperature and energy delivered. The unit has readouts for total energy delivered, impedance, temperature for two thermocouples and time of energy delivery. The bipolar mode has controls for output waveform type and power. The unit has readouts for set power and waveform. Connectors on the front panel include the monopolar connector for active electrode and dispersive electrode and separate dual bipolar connectors for PlasmaCision electrodes and bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the G II Radiofrequency Workstation include the PlasmaCision electrodes, bipolar instruments, connector cable, footswitch and a power cable.

This document is a 510(k) Summary of Safety and Effectiveness for the Gyrus ENT G II Radio-frequency Workstation & Accessories, submitted in 2002. It describes the device, its intended uses, and its substantial equivalence to predicate devices. It does not contain information about pre-defined acceptance criteria or a specific study proving the device meets acceptance criteria in the manner applicable to AI/ML devices.

The information provided relates to a medical device from 2002, which is an electrosurgical generator, not an AI/ML device as implied by the detailed questions about ground truth, sample sizes for training/test sets, expert consensus, and MRMC studies. These types of studies and acceptance criteria are standard for AI/ML-driven diagnostics or assistive technologies, but not for a radio-frequency workstation as described.

Therefore, many of the requested fields cannot be directly answered from the provided text, as the underlying technology and regulatory requirements are different.

However, based on the context of a 510(k) submission, the "acceptance criteria" and "study" are interpreted as the demonstration of substantial equivalence to predicate devices through comparison and performance testing.

Here's an attempt to answer the questions based on the provided text, noting where the information is not applicable or not present for this type of device:

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

For a 510(k) submission of this type (electrosurgical generator), the "acceptance criteria" is typically demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety/effectiveness. The "reported device performance" is the claim that this equivalence has been met through comparison and testing.

• Somnoplasty TCRF Generator section: Indications are coagulation of enlarged tonsils, reduction of airway obstructions (base of tongue, soft palate), tissue coagulation in inferior turbinates, and uvula/soft palate for snoring. These align with predicate device K020778, K982717, K971450, K973618.
• PlasmaKinetic Generator section: Indications include ablation, resection, coagulation, and hemostasis for various ENT surgeries (Adenoidectomy, Cysts, Head/Neck/Oral/Sinus Surgery, Mastoidectomy, Myringotomy, Nasal Airway Obstruction, Nasopharyngeal/Laryngeal indications, Neck Mass, Papilloma Keloids, Submucosal Palatal Shrinkage, Tonsillectomy, RAUP, Tumors, Uvula/Soft Palate for Snoring). These align with predicate device K014290. |
  | Technological Characteristics similar to predicate devices. | The G II RF Workstation combines two previously cleared RF generators: The Gyrus ENT Somnoplasty Temperature-Controlled Radio-frequency Generator (K020067) and The Gyrus Medical Inc. PlasmaKinetic™ Generator (K003060). The submission states "The Gyrus ENT G II Radio-frequency Workstation has been carefully compared to legally marketed devices with respect to intended use and technological characteristics." (Page 2, "Comparison to Predicate Devices") |
  | Performance Testing demonstrating similar function to predicate devices where applicable. | For the PlasmaKinetic Generator section: "Testing was presented in our July 19, 2002, supplement to K021777 that demonstrated the The PlasmaKinetic Generator section of the GII RF Workstation performed similarly to the ArthroCare ENTec Plasma Wand." (Page 1) No specific test results or metrics are provided in the summary. |

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

This information is not provided in the 510(k) Summary. For a device of this nature, performance testing would typically involve bench testing and possibly animal or cadaveric studies, rather than a "test set" of clinical data in the AI/ML sense. Clinical data (if any was used for specific performance claims beyond basic safety) details are not included in this summary document.

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/not provided. "Ground truth" in the context of expert consensus on diagnostic images is specific to AI/ML diagnostic tools. For an electrosurgical device, performance would be assessed through objective measurements of its physical output (e.g., power, temperature control, tissue effects) rather than human interpretation.

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

This information is not applicable/not provided. Adjudication methods are relevant for human interpretation tasks, not for the performance assessment of an electrosurgical generator.

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 is not applicable. This device is an electrosurgical generator, not an AI-assisted diagnostic or decision-support tool for human readers. Therefore, an MRMC study is outside the scope of its evaluation.

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

This is not applicable. The device is a physical electrosurgical workstation, not an algorithm. Its operation requires a human operator ("qualified medical personnel trained in the use of electrosurgery").

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

This is not applicable in the context of AI/ML ground truth. For an electrosurgical device, the "ground truth" equivalent for performance testing would be objective physical measurements and observations of tissue effects (e.g., coagulation depth, ablation rates) against predetermined specifications or compared to the predicate devices' known performance. The summary does not detail these specific "ground truths" but rather refers to "performance testing."

8. The sample size for the training set

This information is not applicable/not provided. Training sets are relevant for machine learning algorithms. The development of this electrosurgical generator would involve engineering design, prototyping, and testing, not algorithmic training on data.

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

This information is not applicable/not provided for the same reasons as #8.

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The Gyrus ENT Somnoplasty® Model 2420 Tissue Coagulating Electrode is intended for use in the coagulation of tissues in the head and neck by qualified medical personnel trained in the use of electrosurgery. Indications for use for the Gyrus ENT Model 2420 Tissue Coagulating Electrode include the coagulation and reduction of enlarged tonsils for patients 13 years of age and older.

The Model 2420 Tissue Coagulating Electrode is used to deliver RF energy for selective thermal coagulation of tissue. The electrode is provided as a dual needle that is deployed from a guide sleeve. The angle of deployment is fixed at approximately 45°. The needle is covered proximally by insulation to protect the mucosa during coagulation. A beveled penetrator plate is located at the tip of the guide sleeve and serves to penetrate the tonsil mucosal surface prior to electrode deployment. Temperature sensors located at the tip of the needle and the tip of the insulation monitor lesion temperature.

Like the previously cleared Model 1420 electrode, the Model 2420 provides a slide actuator on the handle used to extend or retract the needle electrodes through attached dual guide lumens. The proximal end of the handle accepts the detachable and reusable power cable. The distal end of the handle is attached to the guide lumens containing the needle electrodes. The entire device is disposable.

This document is a 510(k) Summary for a medical device (Gyrus ENT Somnoplasty® Model 2420 Tissue Coagulating Electrode) seeking market clearance. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in terms of performance metrics.

Therefore, much of the requested information regarding acceptance criteria and performance evaluation through a study is not available in the provided text. The document is an FDA submission for market clearance, which relies on demonstrating equivalence to existing products rather than a novel clinical effectiveness study with defined acceptance criteria and performance outcomes.

Here is an attempt to address your request based only on the provided text, highlighting what is missing or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided 510(k) summary. Acceptance criteria for device performance (e.g., success rates, percentage reduction in tonsil size, complication rates) and corresponding reported performance metrics from a study are not included. The document emphasizes substantial equivalence to a predicate device, not a new performance evaluation against predefined criteria.

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

This information is not available. The document does not describe a new clinical study with a defined test set for performance evaluation. It references previously cleared devices and states the current device "is substantially the same."

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

This information is not available, as no new clinical study with a test set requiring expert ground truth establishment is described.

4. Adjudication Method

This information is not available, as no new clinical study with a test set requiring adjudication is described.

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

This information is not available. No MRMC comparative effectiveness study is mentioned, nor is any human-in-the-loop performance evaluation or an effect size for human readers improving with/without AI assistance. The device is a surgical electrode, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

This information is not available. The device is a physical electrosurgical electrode and does not involve an algorithm for standalone performance evaluation.

7. Type of Ground Truth Used

This information is not available, as no new clinical study requiring ground truth establishment is described.

8. Sample Size for the Training Set

This information is not available. The device is an electrosurgical electrode, not an AI model, and therefore does not have a "training set" in the context of machine learning. The submission relies on the established safety and effectiveness of predicate devices.

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

This information is not available (see point 8).

Summary of Device and its Basis for Clearance (Extracted Information):

• Intended Use/Indications: Coagulation and reduction of enlarged tonsils for patients 13 years and older in the head and neck by qualified medical personnel trained in electrosurgery.
• Device Description: The Somnoplasty® Model 2420 Tissue Coagulating Electrode is part of the Somnoplasty® System. It's a dual-needle electrode that deploys at approximately 45°, with insulation to protect mucosa and temperature sensors to monitor lesion temperature. It has a slide actuator on the handle and is disposable.
• Basis for Clearance: Substantial Equivalence to previously cleared devices:
  • Previous Somnoplasty® Systems cleared for uvula/soft palate coagulation (K971450), chronic turbinate hypertrophy (K973618), and UARS/OSAS airway obstruction reduction (K982717).
  • Current Model S2 Generator cleared in K001438.
  • RC-20 Cable cleared in K000720.
  • Model 2420 Tissue Coagulating Electrode is "substantially the same" as the Model 1420 Electrode cleared in K000720.
• Conclusion of FDA: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

The 510(k) process is primarily a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not to prove clinical efficacy and safety through new, extensive clinical trials with defined acceptance criteria for performance (unless the device is significantly different or intended for a new use not covered by predicates).

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The Gyrus ENT Somnoplasty Generator, in combination with Gyrus ENT Somnoplasty Electrodes, is intended for use in the coagulation of soft tissue. This device is intended for use by qualified medical personnel trained in the use of electrosurgery.

The Gyrus ENT Somnoplasty Generator with the Gyrus ENT Soft Tissue Coagulating Electrodes is indicated for the coagulation of soft tissue. The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The Gyrus ENT Somnoplasty Generator has controls for maximum temperature, energy delivered and time of energy delivery. The unit readouts for total energy delivered, has temperature for two impedance. and thermocouples. Connectors on the front panel include connector for active electrode and dispersive electrode. The foot pedal is connected on the back panel. Accessories included with the generator are a power cable and a footswitch.

The provided documents are a 510(k) summary for the Gyrus ENT Somnoplasty Generator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical trial to prove safety and efficacy against pre-defined acceptance criteria. Therefore, the documents do not contain information regarding detailed acceptance criteria, a specific study proving the device meets those criteria, or the other specific details requested (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).

The 510(k) process relies on performance validation testing to show substantial equivalence. The summary states:

"Performance validation testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use."

However, the specific details of this "performance validation testing" are not included in the provided summary. This validation would typically involve bench testing to ensure the device performs as intended and comparably to the predicate device, but not a clinical study with detailed acceptance criteria as one might find for a novel device or a PMA submission.

Therefore, I cannot provide the requested table and information based on the given text.

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The Diego Powered Dissector and Drill System's intended use is the cutting and removal of bone and tissue in general ENT, Head & Neck, and otoneurologic procedures.
Sinus applications would embody:

• ethmoidectory/sphenoethmoidectomy .
• polypectomy .
• septoplasty and .
• procedures such as .
  • antrostomy ●
  • endoscopic DCR .
  • frontal sinus drill-out .
  • frontal sinus trephination and irrigation ●
  • septal spurs removal .
  • trans-spehnoidal procedures .

Nasopharyngeal/laryngeal procedures would comprise:

• adenoidectomy .
• laryngeal lesion de-bulking .
• laryngeal polypectomy .
• tracheal procedures ●
• tonsillectomy .

Head & Neck procedures would encompass:

• soft tissue shaving .
• rhinoplasty (narrowing of the bony vault and revision of the bony pyramid) .
• minopial of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular . regions of the face
• acoustic neuroma removal .

Otology procedures would include:

• mastoidectomy ●
• mastoidotomy. .

The Diego Powered Dissector and Drill System is an Electrical Surgical Drill/Shaver. It consists of a console with a separate footswitch and integrated irrigation pump. It supports 4 handpieces (Diego, Stapes, and Viper Straight and Angled). The console is controlled by an 8-bit Microprocessor. The handpieces have suction capability for the Shaver Handpiece and no suction for the Drill Handpiece. Irrigation capability is present with the exception of the Stapes Drill Handpiece. The chucking mechanism varies by handpiece type. The system is sterilizable by Autoclave or EO.

The provided text is a 510(k) premarket notification for the Diego™ Powered Dissector and Drill System. It focuses on demonstrating substantial equivalence to a predicate device (Turbo 7000 System) rather than presenting a study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria and performance studies for an AI/algorithm-based device is not applicable to this document.

However, I can extract the relevant information where available and explicitly state when information is not provided.

Acceptance Criteria and Device Performance

The "acceptance criteria" for this type of device (a powered surgical instrument) are typically met by demonstrating substantial equivalence to a legally marketed predicate device and compliance with recognized safety standards. The document primarily focuses on the latter.

The primary "study" that proves the device meets the acceptance criteria is the demonstration of substantial equivalence to the predicate device (Turbo 7000 System) and compliance with the listed safety standards. The document asserts that the "Diego Powered Dissector and Drill system has the same technological characteristics, power modality and mode of operation as the predicate device" and that the "difference of the processors that control the units should not affect the safety or effectiveness of the device."

Additional Information (Not Applicable or Not Provided for this Device Type)

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

   • Not applicable/Not provided. This is a traditional mechanical/electrical medical device, not an AI/algorithm-based one that would typically require a test set of data for performance evaluation in the context of this question. The assessment is based on design specifications, compliance with standards, and comparison to a predicate device.

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

   • Not applicable/Not provided. Ground truth in the context of AI/algorithm performance is not relevant here.

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

   • Not applicable/Not provided.

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:

   • Not applicable/Not provided. This is not an AI-assisted diagnostic or interpretative device.

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

   • Not applicable/Not provided. This is not an algorithm.

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

   • Not applicable/Not provided. The "ground truth" for this device's safety and effectiveness implicitly relies on established engineering principles, material science, and the safety track record of the predicate device.

7. The sample size for the training set:

   • Not applicable/Not provided. This is not an AI/machine learning device.

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

   • Not applicable/Not provided.

Summary of what the document does provide:

• Intended Use & Indications for Use: Clearly defined and found substantially equivalent to the predicate.
• Technological Characteristics Comparison: A detailed table comparing the Diego system to the Turbo 7000 system, showing similarities and minor differences (e.g., processor type, specific handpieces supported, operating speeds for sinus surgery). The submitter argues these differences do not affect safety or effectiveness.
• Compliance with Standards: A list of international and national safety and performance standards the device is designed to meet.
• Regulatory Conclusion: The FDA's finding of substantial equivalence based on the provided information, classifying it as a Class II device.

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