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

The ORIGO system is used in the following surgical fields:

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

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

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

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

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

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

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

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

The ORIGO System is equipped with a peristaltic pump, which delivers saline irrigation solution to surgical sites through a 5m ORIGO System Irrigation Line.

The ORIGO System is a prescription-only device.

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

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

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

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

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

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

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

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

• Not applicable/Not provided. This device is a surgical motor system, not an AI or diagnostic device that typically uses test sets of data (e.g., medical images). The testing described is non-clinical bench testing, and no "test set" in the context of data analysis is mentioned.

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

• Not applicable. This information pertains to studies involving expert review for establishing ground truth, which is not described for this device.

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

• Not applicable. This pertains to expert review of data, which is not described.

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

• No. The device is a surgical motor system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

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

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

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

8. The sample size for the training set

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

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

• Not applicable. See point 8.

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The ORiGO System is a software-controlled motorized system that includes attachments and tools for cutting bone, and provides irrigation fluid to the surgical site. The ORiGO System is used in the following surgical fields: -For cutting bones in neuro (cranial) and spinal surgeries.

The ORIGO System is a software-controlled electrical surgery system intended to be used in an operating room by a clinician in a healthcare facility/hospital setting for cranial and spinal surgical procedures. The ORIGO System consists of the ORIGO Control Unit, the ORIGO Foot Pedal, the ORIGO System-compatible two micromotors and one motorized handpiece with corresponding motor cables, handpieces, attachments, cutting tools, the ORIGO System Irrigation Line, and other accessories. The ORIGO System transforms electrical energy through motors and converts it to rotational force to shape and cut bones through attached cutting tools. Three micromotor subsystems of the ORIGO System include NANO, RAPIDO, and PM PERFO. The NANO and RAPIDO are micromotors. The PM PERFO is a motorized cranial perforator handpiece. PM2 Handpieces are intended to be connected to the NANO Micromotor and RAPIDO Micromotor. Cranio-Guards are attached to the PM2 Handpieces, and craniotomy is performed using PM2 Craniotomy Burs. Other PM2 80K Burs are attached to the PM2 Handpieces without attachment. The PM2 80K Burs are used for cutting bones in cranial and spinal surgical procedures. PM PERFO is intended to be used for a cranial perforation. The ORiGO System is equipped with a peristaltic pump, which delivers saline irrigation solution to surgical sites through a 5m ORiGO System Irrigation Line. The ORiGO System is a prescription-only device.

The provided text describes a 510(k) premarket notification for the ORiGO System, an electrical surgical system. It details the device's indications for use, technological characteristics, and performance testing to demonstrate substantial equivalence to a predicate device. However, it does not contain the specific information required to complete the detailed table and answer all the questions regarding acceptance criteria and the study proving the device meets those criteria.

The document focuses on demonstrating that the ORiGO System is substantially equivalent to a legally marketed predicate device (OSSEODUO Shaver and Drill System K173066) based on similarities in intended use, technological characteristics, and performance. The performance testing section primarily lists compliance with various international standards, FDA guidance documents, and biocompatibility tests. It does not provide specific acceptance criteria values with corresponding device performance metrics for the device itself or the study that definitively proves the device meets those criteria in a quantitative sense as might be expected for an AI/software-based device performance study.

Here's what can be extracted and what is missing based on your request:

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

The document does not specify quantitative acceptance criteria or detailed device performance metrics in a table format. Instead, it states:

• "The conformance of the ORiGO System with applicable international and internal standards was verified during non-clinical bench testing and evaluation."
• "Tests were performed on the subject device, which demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate device."
• "Together, these verification/validation activities successfully demonstrated that the device correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate devices."

This broadly states that the device met the required standards for safety and effectiveness and is comparable to the predicate. Specific numerical criteria and results are not provided.

Missing Information/Answers to Specific Questions:

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

• Not provided. The document describes non-clinical bench testing, but does not specify sample sizes for test units or any 'data sets' in the context of an AI/software performance study. This is a hardware device; thus, the concept of a "test set" as understood for AI performance is not applicable here in the same way. The provenance of any test data (country of origin, retrospective/prospective) is also not mentioned.

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

• Not applicable/Not provided. This is a hardware surgical device. The document does not describe any human expert review or ground truth establishment relevant to an AI model's performance.

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

• Not applicable/Not provided. No mentions of adjudication are present as it's not relevant to the type of device and testing described.

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

• No. The document explicitly states: "Clinical testing was not required for a determination of substantial equivalence of the ORiGO System." Therefore, no MRMC study involving human readers or AI assistance was performed.

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

• Not applicable/Not provided. While the device is "software-controlled," the evaluation focuses on the mechanical and electrical safety/performance of the surgical system, not on the standalone performance of an independent algorithm in the context of diagnostic or interpretive tasks.

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

• Not applicable/Not provided in the context of AI ground truth. The "ground truth" for this device's performance is compliance with established engineering standards (e.g., electrical safety, software lifecycle, usability, biocompatibility) and its functional performance in cutting bone as designed through bench testing, not through a diagnostic or interpretive ground truth.

8. The sample size for the training set

• Not applicable/Not provided. The device is a hardware surgical system. The concept of a "training set" as used for AI/machine learning models does not apply here.

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

• Not applicable/Not provided. As there is no training set mentioned, there is no discussion of establishing ground truth for it.

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The OSSEODUO system is intended for shaping bones in spine and cranium surgical operation. Shaver handpiece is not intended for use in neurosurgical procedures.

The OSSEODUO Shaver and Drill System is already cleared for other indications. This submission adds the PM2 Family of handpieces and accessories to the system with indications for shaping bones in spine and cranium surgical operations. These additional motors, NANO, RAPIDO, and PM PERFO incorporate previously cleared technology with a proprietary coupling. The available handpieces include 4 straight and five angled models, plus three fixed and two rotary craniotomies. Various burs are available that are sold sterile and for single use. The motors and handpieces are to be sterilized prior to first use and after each subsequent use. Validated processes for both cleaning and sterilization are included in the instructions.

The acceptance criteria and study proving the device meets them can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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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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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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