(342 days)
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.
| Acceptance Criteria (Not explicitly stated with values in the document) | Reported Device Performance (General statements from document) |
|---|---|
| Conformity with applicable technical standards (IEC 60601-1, 60601-1-2, 60601-1-6, IEC 62304, IEC 62366-1) | Demonstrated conformity |
| Compliance with FDA guidance documents (e.g., Reprocessing Medical Devices, Sterility Information, ISO 10993-1, Software Content, EMC, Cybersecurity) | Demonstrated compliance |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Indirect Hemolysis) | Testing conducted and devices selected in accordance with ISO 10993-1, implying successful completion. |
| Safety and Effectiveness comparable to predicate device | Tests demonstrated device is safe and effective, performs comparably, and is substantially equivalent. |
| Device performs as designed and validated for intended use | Verification/validation activities demonstrated correct performance. |
| Raises no new questions regarding safety or effectiveness | Verification/validation testing supports this. |
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.
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).