(191 days)
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.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.