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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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Stryker's Precision Thin Reciprocating Blade, 0.010 inch (REF 5100-437-010) is a sterile, single use cutting accessory intended to cut bone in the posterior canal wall during an Otology procedure.

Stryker's Precision Thin Reciprocating Blade, 0.010in is a sterile, single use cutting accessory which is operated by a surgical drill (handpiece). This handpiece moves the Precision Thin Reciprocating Blade, 0.010in. in a reciprocating manner so that the blade removes bone material on the back stroke of its cut. The Precision Thin Reciprocating Blade, 0.010in. has a thickness of 0.010 inches and therefore can be used in surgical procedures where a narrow kerf width is required when cutting bone.

The document describes a 510(k) premarket notification for a medical device called "Precision Thin Reciprocating Blade, 0.010in." This device is a sterile, single-use cutting accessory intended to cut bone in the posterior canal wall during an Otology procedure. The submission argues for its substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" in the typical sense (e.g., a specific numerical threshold for performance metrics). Instead, it describes performance tests designed to demonstrate functionality, integrity, safety, and effectiveness. The "acceptance criteria" are implied to be satisfactory performance in these tests.

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

• Simulated Use (Cadaveric): 3 ENT surgeons used the device in fresh cadaveric Human temporal bone. The provenance is not explicitly stated (e.g., country of origin for the cadaveric specimens), but it is prospective (a new study conducted for this submission).
• Simulated Use (Model): 8 ENT surgeons used the device with PHACON's Temporal Bone Model. This is also prospective.
• Kerf Width Testing, Life Testing, Temperature Testing: The sample sizes for these specific engineering tests are not provided. The data provenance is implied to be from the manufacturer's internal testing as part of the design validation.

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

For the simulated use studies (both cadaveric and model), 3 ENT surgeons and 8 ENT surgeons, respectively, were involved. Their qualifications are stated as "ENT surgeons," indicating medical specialists in the Ear, Nose, and Throat field. The level of experience is not specified (e.g., "10 years of experience"). For these performance tests, the "ground truth" is not a diagnostic label but rather their expert assessment of the device's functionality and performance during the simulated surgical procedures.

4. Adjudication method for the test set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the simulated use studies. The role of the surgeons was to perform the simulated procedures and contribute to the validation, not necessarily to adjudicate findings. Their collective feedback and successful completion of the tasks would be considered the "acceptance."

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

There is no MRMC comparative effectiveness study mentioned in the document. This is a medical device, not an AI software. The study involves surgeons using the device, not interpreting images with or without AI assistance.

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

This question is not applicable. The device is a surgical instrument (a blade), not an algorithm or AI software. Its performance is always in a "human-in-the-loop" context as it is operated by a surgeon.

7. The type of ground truth used

For the performance section ("Section 5.8 Performance Data"):

• Functional/Performance Ground Truth: The "ground truth" for the Kerf Width, Life, and Temperature testing is based on engineering specifications and acceptable limits for those parameters.
• Clinical Performance Ground Truth: For the simulated use studies, the "ground truth" is the expert assessment and successful completion of the intended surgical task by qualified ENT surgeons in relevant models (cadaveric human temporal bone and PHACON model). This is a form of expert consensus/opinion on functionality and safety in a simulated environment, rather than pathology or outcomes data in a live patient, as no clinical studies were performed.

8. The sample size for the training set

This question is not applicable. The device is a physical surgical instrument, not an AI model requiring a training set.

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

This question is not applicable for the same reason as above.

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The DragonFly™ Surgical Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.

The DragonFly™ Surgical Drill System consists of a small surgical power tool (handpiece); a battery powered footswitch for control of speed and direction; various cutting instruments (burs); angled adaptors to adjust the angle between the handpiece and the bur; and a sterilization tray. Accessories include a battery charger and a battery replacement kit.

This document describes the DragonFly Surgical Drill System, a surgical power tool for light drilling of bones in procedures like stapedotomy or ossiculoplasty.

Here's an analysis of the acceptance criteria and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets for each performance metric, as might be seen for AI/Software-as-a-Medical-Device (SaMD) assessments. Instead, it describes performance verification and validation studies by comparing the device against predicate devices and demonstrating compliance with relevant standards. The "acceptance criteria" are implied by successful completion of these tests and comparable or superior performance to predicates.

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

• Functionality after repeated autoclave cycles: 13 handpieces.
• Biocompatibility: Representative burs were tested.
• Bench Testing and Surgical Evaluation of Performance:
  • Comparison of handling and bur runout: Not explicitly stated beyond "The DragonFly Surgical Drill system was tested in parallel with the predicate device".
  • Temporal bone labs evaluation: 15 Otologic surgeons.
  • Comparison by board-certified otolaryngologist: One board-certified otolaryngologist.
• Data Provenance: Not explicitly stated as retrospective or prospective or country of origin in the provided text. However, temporal bone labs and surgeon evaluations suggest a prospective, controlled testing environment, likely in the US where the submitter is located.

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

• Autoclave/Drill Speed/Simulated Use/Usability: While the tests involve "users" and "surgeons," the "ground truth" here is objective performance metrics (RPM, presence of issues) and user feedback on usability, rather than diagnostic "ground truth" like in imaging studies.
• Surgical Evaluation:
  • 15 Otologic surgeons: These surgeons were "familiar with and had used the predicate Xomed Skeeter drill." This implies clinical expertise in oto-laryngology. Their specific years of experience are not stated.
  • 1 board certified otolaryngologist: Performed surgical procedures on human temporal bone and provided comparative scores for 20 performance characteristics. This qualification establishes significant clinical expertise.

4. Adjudication Method for the Test Set

• For the surgical evaluations:
  • The 15 otologic surgeons provided individual feedback and generally "deemed" the DragonFly as "at least as good as" the predicate. This suggests consensus-based or individual assessments rather than a formal pre-defined adjudication method (like 2+1 or 3+1).
  • The single board-certified otolaryngologist provided comparative scores for 20 characteristics. This was a direct comparison by a single expert.
• For other performance tests (autoclave cycles, biocompatibility, electrical safety, etc.), the adjudication involves meeting predefined engineering specifications and regulatory standards, evaluated through testing rather than expert medical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

• No, an MRMC comparative effectiveness study involving AI assistance for human readers was not performed. This device is a surgical drill system, a hardware device, not an AI/SaMD diagnostic tool. The "readers" here are surgeons evaluating the physical device's performance, not interpreting medical images or data with AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• No, this question is not applicable. The device is a surgical drill system; it is not an algorithm or AI. It requires a human operator (surgeon).

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, clinical outcomes) doesn't directly apply in the same way to a surgical tool. Instead, the "truth" is established through:

• Objective Performance Metrics: RPM, autoclave cycle durability, force measurements (for magnetic latching/drive), biocompatibility test results, electrical safety certifications, shelf-life validation.
• Expert Clinical Opinion/Comparative Assessment: Direct subjective evaluation and comparison by qualified otologic surgeons and a board-certified otolaryngologist during bench testing and temporal bone labs, confirming the device's suitability and comparable performance to established predicates.

8. The Sample Size for the Training Set

• Not applicable. This is a hardware device; there is no "training set" in the context of machine learning or AI.

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

• Not applicable. This is a hardware device; there is no "training set" with associated "ground truth."

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The Diego Elite Drill is intended for cutting, drilling, and removal of bone, and soft and hard tissue in general ENT, and Otoneurologic procedures when used in conjunction with the Diego Elite console.

Specific procedures would include Mastoid Neurotology (Mastoidotomy) and Stapes procedures.

The Diego Elite Drill is similar to the drills associated with the predicate Diego® RF Powered Dissector and Drill System cleared under K034004. The Diego Elite Drill is the next generation drill and it is functionally equivalent to the predicate Gyrus ACMI product and other predicates.

The proposed Drill and accessories are to be used only in conjunction with the Diego Elite system (K123429) for Otologic procedures. The Diego Elite system original submission did not include an Otologic drill, and the predicate (K034004) is not compatible with the Diego Elite system.

Accessories include straight and angled attachments, an irrigation clip, various burrs, an irrigation tubeset, a cleaning kit, and a cleaning / sterilization tray. The drill base plugs into the existing Diego Elite console and is activated by the existing Diego Elite footswitch. The drill base and the straight and angled attachments, and irrigation clip are provided non-sterile and are reusable. The burrs and tubeset are provided sterile and are single-use. The cleaning kit is provided non-sterile and is single-use.

This document describes the premarket notification for the "Diego Elite Drill" (K152744), a surgical drill intended for ENT and Otoneurologic procedures. The submission claims substantial equivalence to existing predicate devices.

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

Acceptance Criteria and Device Performance

The acceptance criteria for the "Diego Elite Drill" are primarily based on simulated use testing and preclinical evaluations to demonstrate substantial equivalence to predicate devices, focusing on functionality, usability, and safety. There are no explicit quantitative performance metrics like sensitivity, specificity, or AUC provided in the context of diagnostic accuracy, as this is a surgical device. Instead, performance is evaluated through surgeon feedback against predefined usability criteria.

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The OSSEOSTAP system has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty.

The OSSEOSTAP system has been designed for use by medical professionals for the light drilling of bone as part of surgical ENT otology procedures, such as stapedotomy or ossiculoplasty.

The OSSEOSTAP Microdrill System consists of a foot control unit and a handpiece, with an integrated micromotor, to drive various burs. The battery-operated foot control unit, connected via the drill cable, regulates the rotation speed.

The provided text describes a 510(k) premarket notification for the OSSEOSTAP Microdrill System, focusing on its substantial equivalence to a predicate device. This document does not describe an AI/ML powered device, nor does it contain information typically associated with studies proving acceptance criteria for such devices (e.g., performance metrics like sensitivity, specificity, F1-score, sample sizes for AI models, expert ground truth establishment, MRMC studies, or standalone performance).

The information provided pertains to a traditional surgical drill and its components comparing to an existing drill (the Skeeter Ultra-Lite Oto-Tool Drill). The "acceptance criteria" here are based on demonstrating that the new device is "at least as good" as the predicate device in terms of handling, cutting performance, and noise level, and that it meets established safety and performance standards for medical devices (e.g., sterilization, biocompatibility, electrical safety).

Therefore, I cannot fulfill your request as it's designed for an AI/ML medical device submission. However, I can extract the relevant non-clinical performance data and the general approach to demonstrating "acceptance" within the context of this 510(k) submission for a non-AI device.

Based on the provided text, the device is not an AI/ML powered device. As such, the standard acceptance criteria, study methodologies, and performance metrics typically associated with AI/ML device submissions (e.g., AUROC, sensitivity, specificity, expert readers, ground truth establishment for AI) are not applicable or present in this document.

However, I can describe the non-clinical performance and acceptance criteria for this traditional medical device based on the provided FDA 510(k) summary.

Description of Acceptance Criteria and Study for OSSEOSTAP Microdrill System

The OSSEOSTAP Microdrill System is a traditional surgical device and its acceptance criteria primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device (Skeeter Ultra-Lite Oto-Tool Drill) through non-clinical performance testing, material safety, and adherence to relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• This information is not applicable for the type of testing described. The "test set" here refers to specific units of the OSSEOSTAP device and its components (burs, handpiece) being subjected to bench and lab-based performance, durability, and safety assessments. No patient data or imagery is involved. The studies are non-clinical, likely conducted in a lab environment (as indicated by "external lab" for validation).
• Data Provenance: The studies were conducted by the manufacturer (Bien-Air Surgery SA, Switzerland) and external labs. The nature of these tests (e.g., material stress tests, cleaning validation) doesn't typically involve "country of origin of the data" in the same sense as clinical or imaging data; it refers to the location of the test facilities.
• Retrospective/Prospective: These are non-clinical, prospective tests specifically designed to evaluate the manufactured device against pre-defined performance and safety standards.

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

• This is not applicable as the studies are non-clinical performance tests for a traditional surgical device. There is no "ground truth" to be established by clinical experts in the context of diagnostic interpretation or clinical outcomes. Performance criteria are based on engineering specifications, material standards, and comparative testing against a predicate device.

4. Adjudication Method for the Test Set:

• Not applicable for these non-clinical, objective performance tests. The results are typically quantitative measurements or pass/fail assessments against established standards and predicate device performance.

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

• No, an MRMC comparative effectiveness study was not done. These studies are typically conducted for AI-powered diagnostic or screening devices involving human readers interpreting clinical cases.

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

• Not applicable, as this is not an algorithm-only or AI-powered device.

7. The Type of Ground Truth Used:

• Not applicable in the context of AI/ML. For this device, the "ground truth" or reference for performance is established by:
  • Predicate Device Performance: The primary reference is the performance of the Medtronic Xomed Inc. Skeeter Ultra-Lite Oto-Tool Drill (K041523).
  • Industry Standards: Compliance with international standards such as ISO 10993-1 (biocompatibility), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (EMC).
  • Engineering Specifications: Internal design specifications for bur resistance, handpiece functionality, rotation speed, etc.
  • Laboratory Validation Results: Objective measurements from external lab validations for cleaning and sterilization.

8. The Sample Size for the Training Set:

• Not applicable as this is not an AI/ML device that requires a training set.

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

• Not applicable as this is not an AI/ML device.

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Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are designed for use in limited sinus applications involving soft tissue and thin bone such as lamina papyracea.

Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are sterile single use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. The Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are originally manufactured by OLYMPUS/Gyrus ACMI.

This document is a 510(k) premarket notification for Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that defines and proves acceptance criteria for a novel device or AI algorithm.

Therefore, most of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment is not present in this document. This document primarily describes the regulatory process for reprocessed medical devices.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results. Instead, it states that "The functional characteristics of the proposed devices have been evaluated and found to be equivalent to the predicate devices after the specified number of reprocessing cycles." The "acceptance criteria" appear to be that the reprocessed blades perform equivalently to the new predicate devices.

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

The document does not specify the sample sizes used for the various tests (biocompatibility, cleaning validation, product stability, product performance). The data provenance is not mentioned, but given it's a 510(k) submission to the US FDA, the testing would typically be conducted to US regulatory standards. It would be considered prospective for the reprocessed device, as tests are conducted on the reprocessed products.

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 in the document. The testing described (biocompatibility, cleaning validation, bench tests for device function) does not typically involve "experts establishing ground truth" in the same way an AI algorithm for medical imaging would. It involves laboratory testing and comparison to manufacturing specifications or predicate device performance.

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

This is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data where consensus among multiple reviewers is needed to establish ground truth or evaluate performance. The tests described are laboratory-based and objective performance measurements.

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 and not provided. This device is a reprocessed surgical blade, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

This is not applicable. This device is a physical surgical tool and does not involve any algorithms.

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

The "ground truth" in this context is the performance specifications of a new, original equipment manufacturer (OEM) device (the predicate device) and accepted industry standards (e.g., ISO 10993-1 for biocompatibility). The reprocessed device's performance is compared against these established benchmarks.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable. There is no "training set."

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The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are intended for cutting and shaping bone including spine and cranium.

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

The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are surgical drills that handle a complete range of surgical procedures ranging from power demanding applications to the most delicate dissection.

The ANSPACH® Otologic Curved Micro (OCM) Attachment consists of the attachment which connects directly to the ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems handpieces with the standard twist lock mechanism, and the OCM Burr Support Sleeves. The OCM is provided non-sterile and is reusable. Cleaning and sterilization instructions are provided in the ANSPACH® OCM Attachment package insert.

The ANSPACH® OCM Burr Support Sleeves with integral cutting burrs mount to the OCM Attachment with a simple snap-in connection. The 20° curve and small diameter of the OCM Burr Support Sleeves provides excellent visibility. The non-rotating support sleeve protects soft tissue from the rotating cutting burr shaft. The OCM Burr Support Sleeves can be used at speeds from 10,000 to 80,000 rpm. They are available in two lengths (5.6 and 7.3 cm), each with a wide variety of different cutting burr styles and diameters to accommodate varying surgeon preferences. The OCM Burr Support Sleeves are provided sterile and for single use only.

The provided text describes a 510(k) premarket notification for a surgical device, not an AI or imaging diagnostic device. Therefore, the information typically required for describing the acceptance criteria and study proving device performance for AI/diagnostic devices (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, effect size, standalone performance, ground truth types) is not present in this document.

This submission focuses on demonstrating substantial equivalence to predicate devices for a mechanical surgical instrument based on its physical characteristics, materials, and functional testing.

Here's an analysis of what is available regarding acceptance criteria and performance:

1. Acceptance Criteria and Reported Device Performance (based on mechanical and biocompatibility testing)

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

• Sample Size: Not explicitly stated as numerical sample sizes for "test sets" in the context of an AI/diagnostic device. For this surgical instrument, testing would involve a certain number of units for various mechanical, thermal, and biocompatibility tests. For example, "a series of biocompatibility tests" and "several performance tests" imply multiple tests on one or more samples, but specific quantities are not provided.
• Data Provenance: The tests were likely conducted internally by The Anspach Effort, Inc. or by contract labs on their behalf, in accordance with regulatory standards (e.g., GLP for biocompatibility). The country of origin and retrospective/prospective nature are not specified, but typically this would be a prospective testing program for a new medical device.

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

This is not applicable to a mechanical surgical device as there's no "ground truth" to be established by clinical experts in the same way as an AI diagnostic algorithm for image interpretation. The performance is assessed through objective physical and biological tests. A "simulated use study" implies assessment by skilled personnel, possibly surgeons or engineers, but their qualifications and numbers are not detailed.

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

Not applicable. This concept belongs to studies where human experts are making subjective judgments (e.g., reading medical images) that need to be reconciled. For mechanical device testing, outcomes are typically measured quantitatively against defined specifications.

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 specific to AI/diagnostic imaging devices.

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

Not applicable. This is specific to AI/diagnostic algorithms. The device is a physical surgical instrument that always requires a human operator.

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

The "ground truth" for this device's performance is established through objective test methods and specifications. For instance:

• Biocompatibility: Adherence to ISO standards for biocompatibility (e.g., cytotoxicity, irritation, sensitization), with results compared against pass/fail criteria.
• Functionality: Measurements of power, speed, temperature, durability (after repeated cycles), efficacy of cleaning/sterilization methods, and successful cutting/shaping of target material (e.g., bone surrogate) as intended.
• Simulated Use: Demonstration that the device "perform[s] as intended in cutting and shaping bone properly." This would likely involve visual inspection and perhaps quantitative assessment of the cutting performance on a model.

8. The sample size for the training set

Not applicable. This refers to AI model development.

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

Not applicable. This refers to AI model development.

In summary: This 510(k) submission relies on demonstrating substantial equivalence through a combination of:

• Comparison of technological characteristics with predicate devices.
• Biocompatibility testing to assure material safety.
• Performance testing to demonstrate proper functionality, thermal safety, durability, and effectiveness in simulated use, aligning with the intended purpose and implicitly meeting industry standards for such devices.

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The Primado 2 is an AC-electrically powered 10tal surgical system that is intended for cutting, drilling, sawing, and otherwise manipulating soft tissue, bone, bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures, including but not limited to Cranial (Craniofacial), ENT, Endoscopic / Arthroscopic / Arthroscopic, Neuro, Orthopedic, Spinal, and General surgical procedures.

The Primado2 consists of the Control Unit, the Foot Control (optional) and various handpieces for use with specific motors. Available Motors include Slim, High Torque, Micro Bone Saw, and Wire Pin Driver. Each motor series has handpieces or attachments specific to that series. Burs, drills, blades (saws), and rasps are available for use with specific handpieces / attachments. Handpieces and attachments are available for cranial surgery, trephination, oral surgery, and craniotomy. Sagittal, reciprocating, and oscillation saw blades are available, including for intra oral use.

The control unit drives the motors during procedures and is used to control the functions related to that motor such as speed and rotational direction. Two motors can be connected to the control unit at one time for asynchronous use. The control unit also incorporates the irrigation pump and controls the irrigation functions.

The foot control is an optional additional user interface. The foot control is available as a single or multi control. The single foot control has one button that can be programmed. The multi foot control has three buttons that can be programmed. The features available for allocation to the buttons include Foot Control ON/OFF, A/B Control Switching, Speed Control, Reverse Rotation, Irrigation ON/OFF, Flush, and Disable.

The provided text describes a surgical system, the "Primado2 Total Surgical System," and its performance testing. However, the document does not contain specific acceptance criteria or a study that rigorously proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or other quantitative measures. The document is a 510(k) summary for a medical device submission to the FDA, focusing on substantial equivalence to predicate devices and compliance with safety and electrical standards.

Here's an analysis based on the information provided and what is missing:

The device is the Primado2 Total Surgical System. Its intended use is "for cutting, drilling, sawing, and otherwise manipulating soft tissue, hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue in a variety of surgical procedures."

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

   Acceptance Criteria (Stated/Implied)	Reported Device Performance
   Compliance to internal functional specifications (including software)	Demonstrated that the device is safe and effective.
   Compliance to FDA Guidance for Software Contained in Medical Devices (verification/validation, traceability to software requirements and risk hazards)	Documentation provided; testing confirmed compliance.
   Compliance to relevant voluntary safety standards (IEC 60601-1, IEC 60601-1-2) for Electrical safety and Electromagnetic Compatibility	Testing confirmed compliance.
   Compliance to applicable standards for biocompatibility and sterilization	Evaluations and validations performed to demonstrate compliance.
   Substantial equivalence to predicate devices (K083112, K040369, K040300, K081475, K053526)	Stated that the device is substantially equivalent based on similarities in primary intended use, principles of operation, functional design, and established medical use.

   Note: The document does not report specific quantitative performance metrics for the device's surgical capabilities beyond general statements of "safe and effective" and compliance with standards. There are no sensitivity, specificity, or accuracy figures typical of diagnostic or AI-driven devices.

2. Sample sized 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 document. The testing described is verification/validation to internal specifications, software requirements, and safety standards, rather than a clinical trial with a "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)

   This information is not provided. The device is a surgical system, and the reported testing is about its functional, electrical, and safety performance, not about assessing clinical outcomes against expert-established ground truth in a diagnostic context.

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

   This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed 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

   This information is not provided. An MRMC study is not relevant for this type of device (a surgical tool) and the type of performance testing described. The device is not an AI-driven assistive tool for readers.

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

   This information is not provided and is not applicable. This device is a surgical system, requiring human operation, not a standalone algorithm.

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

   This information is not provided and largely not applicable in the context of the reported performance testing. The "ground truth" for the device's performance appears to be its ability to meet engineering specifications, safety standards, and functional requirements. For example, for "electrical safety," the ground truth would be conformance to IEC 60601-1.

8. The sample size for the training set

   This information is not provided. The device is not described as involving machine learning or AI that would require a "training set."

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

   This information is not provided and is not applicable, as there is no mention of a "training set" or AI/machine learning components in the device description.

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The system, including Image Guided Surgery compatibility, and optional Suction console, is intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus / Rhinology, Nasopharyngeal / Laryngology, and Head & Neck procedures.

Specific procedures and applications would include: Sinus / Rhinology:

• FESS (Functional Endoscopic Sinus Surgery) .
• Including Endoscopic approaches to: Polypectomy, Ethmoidectomy, o
• Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy
• Septal Spur removal ●
• Endoscopic DCR .
• Trans-sphenoidal procedures specifically to create access through the sinuses to the . Pituitary, Skull base, and CSF leak repair
• . Turbinate Reduction / Turbinoplasty
• o Including sub mucosal resection

Nasopharyngeal / Laryngeal:

• Adenoidectomy / Tonsillectomy .
• Laryngeal procedures for Recurrent respiratory papilloma, Lesion de-bulking, . Polypectomy

Head & Neck:

• Soft tissue shaving .

The DIEGO ELITE system is the second generation of the RF Diego® system cleared under K034004. The second generation system offers many improvements over the previous system. The DIEGO ELITE includes a power console with touchscreen, footswitch, reusable handpiece, image guided surgery compatibility, an optional powered suction pump, single use disposable accessories and interchangeable burrs / blades and electrosurgical blades. This second generation device adds monopolar capability, disposable sensing technology, improved blades. improved fluid pathway, a more durable reusable handpiece, a premium tubeset with a declog feature and IGS connector, and a powered suction pump that is an optional accessory that can be used to replace the standard facility suction.

The provided 510(k) summary for the DIEGO ELITE device (K123429) lists performance testing, but it does not express these in terms of specific, quantifiable acceptance criteria or provide a detailed study that measures the device's performance against such criteria. Instead, it describes various types of tests performed to ensure the device functions as intended and meets design specifications, relying on comparative performance to predicate devices for substantial equivalence.

Here's an attempt to extract and infer the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for a surgical device like an electrosurgical drill/shaver, formal acceptance criteria with specific numerical targets and measured performance values are typically not explicitly stated in the public summary. The performance is primarily demonstrated through compliance with recognized standards and comparison to predicate devices.

However, based on the "Summary of Performance Testing," we can infer the intent of the acceptance criteria as substantial equivalence to predicate devices and meeting design specifications.

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

• Sample Sizes: The document does not specify exact sample sizes for any of the non-clinical or preclinical tests (e.g., number of bench tissue samples, number of cadavers, number of animals). It only refers to "Representative samples" for stability testing.
• Data Provenance:
  • Bench Tissue: Ex vivo using bovine tissue.
  • Cadaver: In vivo (though cadaver tissue is technically ex vivo in a surgical context, it implies human anatomy simulation). The country of origin is not specified.
  • Animal: In vivo using porcine models. The country of origin is not specified.
  • Non-Clinical (electrical, mechanical, functional): Performed in a lab setting; provenance not specified.
  • Retrospective or Prospective: These appear to be prospective tests specifically conducted for the 510(k) submission to demonstrate device performance.

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

• The document does not specify the number of experts or their qualifications for establishing ground truth for the test sets.
• It mentions "surgeon input" was used to confirm appropriate tissue medium for simulated use and bench testing. This suggests expert involvement, but details are absent.
• For preclinical studies, outcomes like "Overall design confidence" were evaluated, implying expert assessment, but again, no specifics on the experts.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for evaluating the test set results. The tests are primarily functional and comparative, with "ground truth" established by the design specifications, recognized standards, and direct observation of performance against predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. The device being a surgical tool (drill/shaver/electrosurgical unit) means its performance is assessed directly on tissue/cadavers/animals, not through human reader interpretation of images or data.
• Therefore, there is no effect size reported for how human readers improve with or without AI assistance, as AI assistance in this context is not applicable in the way it is for diagnostic imaging devices.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• This question is framed for AI/software devices. In the context of this electrosurgical and drill system, the "standalone" performance refers to the device's intrinsic functional capabilities.
• Yes, standalone performance (without a human-in-the-loop in an interpretive sense) was extensively tested. All the non-clinical/preclinical tests described (electrical, mechanical, functional, biocompatibility, stability, cutting, coagulation, tissue removal, suction, thermal impact) represent the device's standalone performance characteristics. The human operator is integral to using the device, but the device's performance itself is evaluated directly.

7. The Type of Ground Truth Used

The ground truth for this device's performance testing appears to be based on:

• Compliance with Recognized Standards: Meeting the requirements outlined in standards such as IEC 60601-1, IEC 60601-2-2, ISO 10993-1, ISO 14971, etc.
• Design Specifications: The device's ability to "function as intended and met design specifications."
• Comparative Performance to Predicate Devices: "performs substantially equivalent to the predicate devices" and "exhibited comparable performance characteristics to the predicates."
• Direct Observation/Measurement: For aspects like cutting efficiency, coagulation effect, tissue removal, suction efficacy, thermal margins, and mechanical properties.
• Surgeon Input: Used to confirm appropriateness of tissue models and likely for evaluation of usability aspects.

8. The Sample Size for the Training Set

• Not applicable. This device is a surgical instrument, not an AI or machine learning model that requires a "training set." The concept of a training set is relevant for data-driven algorithms.

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

• Not applicable. As there is no "training set" for this type of medical device, the establishment of ground truth for a training set is not relevant. The device's design and functionality are based on engineering principles, material science, and established medical knowledge, not on learning from a data set.

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The OSSEODUO is a drill and shaver system that has been designed for drilling and shaping bone and for the resection of soft and hard tissues as part of surgical operations in the areas of otorhinolaryngology, otoneurology, maxillofacial surgery, and head and neck surgery.

The shaver handpiece S80 or S120 is designed for cutting and removal of soft and hard tissue in the fields of:

• Endoscopic sinus surgery (such as ethmoidectomy, polypectomy, septoplasty)
• Endoscopic dacryocystorhinostomy (DCR)
• Nasopharyngeal and laryngeal prodedures (such as adenoidectomy, polypectomy, tonsillectomy)
• Head and neck surgery( such as acoustic-neuroma removal, tumor removal, rhinoplasty, adipose tissue removal, plastic, reconstructive and aesthetic surgery)

The micromotor 80K combines with different drill and micro saw handpieces and is intended for cutting, drilling, shaping and sawing bone as part of various surgical procedures in the areas of ENT and head and neck surgery such as otoneurology, otorhinolaryngology and maxillofacial surgery (facial plastic, reconstructive and aesthetic surgery).

The OSSEODUO Shaver and Drill System consists of a control unit, a footswitch, connection cables, a shaver handpiece (also named microdebrider or microresector) to drive various shaver blades, a drill motor and assorted handpieces to drive various burs, drills, rasps and micro saw.

The control unit consists of a closed box with, on its main side, an LCD display screen and various function keys allowing the device to be adjusted according to the planned operation. On the right-hand side of the control unit are the connectors for the shaver handpiece S80 and for the micromotor 80K, while the pedal is connected on the rear panel. A peristaltic pump for irrigation and cooling is mounted on the rear panel which also contains the main power-up switch and the fuse holder.

The shaver handpiece includes a micromotor, a gear set, a coupling system for shaver blades and connections for irrigation. Through the control unit it can operate in oscillating modus (reversing after a user-defined number of turns in each direction) or in continuous CW and CCW rotation. Its made of stainless steel and autoclavable. The shaver handpiece is available in two version: the S80 being the basic model and the 5120 with higher rotation speed (up to 12'000 rpm in continuous rotation) and the ability to orient the shaver blade during operation without releasing the chucking mechanism.

The micromotor 80K has an ISO 3964 type E standard coupling which connects to a broad range of different handpieces, such as drill, contra-angle, saw, etc. Through the control unit it can achieve speeds of up to 80'000 rpm. All outer surfaces are made of stainless steel and the motor is autoclavable.

The footswitch allow a smooth progressive and continuous command of the shaver or drill speed. It is IPX8 waterproof.

The provided 510(k) summary for the OSSEODUO Shaver and Drill System describes non-clinical performance assessments rather than a typical study comparing a device's performance against defined acceptance criteria using a test set and ground truth in the way one might evaluate AI/ML systems.

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of technical features and informal non-clinical trials. The "acceptance criteria" here are implicitly achieving similar performance to the predicate devices in the specific tests conducted.

Here is an analysis based on the provided text, structured to address your points as much as possible within the context of this medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not explicitly stated in numerical terms for the non-clinical trials. However, the description implies multiple trials were conducted for each test (oyster-flesh/eggshell, scallops flesh, water aspiration). For post-market surveillance, feedback was gathered from "different ENT Surgeons from Italy, Switzerland and China."
• Data Provenance:
  • Non-Clinical Trials: Performed by the manufacturer (Bien-Air Surgery SA). The location of these trials is not specified but is presumably Switzerland, where the device was made.
  • Post-Market Surveillance: Retrospective collection of feedback (qualitative) from "different ENT Surgeons from Italy, Switzerland and China" after the device had been CE-marked and marketed in Europe since October 2007.

3. Number of Experts and Qualifications for Ground Truth

• Non-Clinical Trials: No mention of external experts establishing ground truth for these trials. The "ground truth" was based on direct observation and measurement of physical parameters (weight removed, aspiration frequency) by the testing personnel, comparing directly to the predicate devices.
• Post-Market Surveillance: "Different ENT Surgeons" provided feedback. Their number is not specified beyond "different," nor are their specific qualifications (e.g., years of experience), though their role as "ENT Surgeons" implies clinical expertise relevant to the device's use. They served as the "experts" providing real-world feedback.

4. Adjudication Method for Test Set

• No formal adjudication method (like 2+1 or 3+1 consensus) is described for either the non-clinical trials or the post-market surveillance.
  • In the non-clinical trials, direct measurements were taken and compared.
  • For post-market feedback, it appears to be a collection of individual surgeon opinions/experiences, rather than a consensus-driven adjudication.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed in the context of this 510(k) submission. This type of study is more common for diagnostic devices (e.g., imaging AI) where human readers interpret results. This submission pertains to a surgical tool, and the "effectiveness" is assessed by physical performance metrics and qualitative surgeon feedback.

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

• Yes, the non-clinical trials can be considered a form of "standalone" performance assessment in that they evaluated the device's functional capabilities (tissue removal, aspiration) directly, independent of a specific surgeon's technique or interaction in a clinical setting. The device's operation was tested in a controlled environment to simulate its intended function.

7. Type of Ground Truth Used

• Non-Clinical Trials: The ground truth was essentially physical measurements and direct comparison of performance metrics (tissue removal rate, aspiration rate) against the performance of physically existing predicate devices.
• Post-Market Surveillance: The ground truth was based on expert clinical opinion/feedback from ENT surgeons regarding the device's real-world performance (cutting, suction, drilling effectiveness and safety).

8. Sample Size for the Training Set

• Not applicable. This device is a mechanical surgical tool, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense. The device's design and engineering would be refined through traditional R&D processes, prototypes, and testing rather than machine learning training.

9. How Ground Truth for the Training Set was Established

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

Summary of the Study:

The "study" described in the 510(k) submission is a two-pronged approach to demonstrate substantial equivalence:

1. Non-Clinical Performance Assessment: This involved performing laboratory-based trials using simulated tissues (oyster-flesh/eggshell, scallops flesh) and water aspiration tests. The goal was to compare physical performance metrics (tissue removal rate, aspiration results) of the OSSEODUO system directly against two legally marketed predicate devices (Medtronic XPS 3000 and Gyrus Diego). The conclusion was that the OSSEODUO system has a "similar rate of tissue removal" and "equivalent results" for aspiration, with clogging frequency being too variable for meaningful comparison.
2. Post-Market Surveillance Feedback: This involved collecting qualitative feedback from "different ENT Surgeons from Italy, Switzerland and China" who had used the OSSEODUO system after its CE-marking in Europe (October 2007). This feedback addressed aspects like cutting performance, suction/aspiration capabilities, and bone drilling, with surgeons reporting confirmation of the system's effectiveness and safety.

Together, these assessments aimed to confirm that the OSSEODUO system is "substantially as safe and effective as the predicate devices," which is the core requirement for 510(k) clearance.

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