(239 days)
The drive unit for surgical transmission instruments is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery
The AMADEO is an electrical drive unit, including motor, attachments and accessories, for surgical transmission attachments which is indicated for: drilling, cutting, sawing, screwing (for placement) of osteosynthesis screws, implants and plates, in soft and hard tissue. The foreseen areas of application will be: ENT (ear, nose, throat) surgery and Maxillofacial surgery. The basic function is the conversion of electrical energy into a mechanical rotary motion. The control unit is used to control the connected motor and the integrated pump. Depending on the treatment, a physiological saline solution is pumped to the treatment site by a displacement pump. A single-use sterile disposable irrigation tubing set is supplied within the scope of delivery and offered as an accessory. The integrated touch display is used to monitor the actual settings and to change, within predetermined limits, the operating parameters. The foot control is used for activation/deactivation of the motor and for changing parameters e.g. program, pump state and motor direction.
This document is a 510(k) Premarket Notification from the FDA for the medical device AMADEO, an electrical drive unit for surgical transmission instruments. It primarily focuses on demonstrating substantial equivalence to a predicate device, the NSK Primado2.
The document does not contain an acceptance criteria table or a study proving the device meets specific performance acceptance criteria in the manner one might expect for a new AI/software device submission. This is because the device, AMADEO, is an electro-mechanical surgical drill system, not an AI or software-only diagnostic device. The evaluation focuses on demonstrating its safety and effectiveness are substantially equivalent to a previously cleared device.
Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or not explicitly detailed in the provided text as they would be for an AI diagnostic device.
However, based on the principle of the 510(k) submission, we can infer the "acceptance criteria" is that the device performs as intended and is as safe and effective as the predicate device. The "study that proves the device meets the acceptance criteria" is the entirety of the non-clinical testing performed to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit "acceptance criteria" in the form of performance metrics (like sensitivity, specificity, accuracy) are not provided, as this is an electro-mechanical device, not an AI diagnostic. The "acceptance" is substantial equivalence to the predicate. The performance data and technological characteristics are compared against the predicate device.
| Characteristic | Acceptance Criteria (Equivalent to Predicate) | Reported Device Performance (AMADEO) |
|---|---|---|
| Indications for Use | Equivalent to Primado2 | Drive unit for surgical transmission instruments indicated for drilling, milling, cutting, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery. (Note: Excludes neurological indications, which is noted as not impacting substantial equivalence). |
| Regulation Number | Identical to Primado2 (874.4850) | 874.4850 |
| Secondary Reg. Number | Identical to Primado2 (872.4120) | 872.4120 |
| Class | Identical to Primado2 (Class II) | II |
| Product Code | Equivalent to Primado2 | ERL, DZI (Predicate also includes GEY, HWE, HBC, DZJ, HBE, GFF, EQJ, but the core ERL, DZI are shared for the applicable uses). |
| Regulation Generic Name | Identical to Primado2 | Drill, Surgical, Ent (Electric or Pneumatic) Including Handpiece |
| Sterility | Equivalent to Primado2 (Provided non-sterile) | Provided non-sterile |
| Use | Equivalent to Primado2 (Rx only) | Rx only |
| Basic Functions | Equivalent to Primado2 | Conversion of electrical energy into mechanical rotary motion. Physiological saline solution pumped to treatment site via displacement pump. Control unit with electronics allows user to change motor speed, torque, and coolant flow rate. |
| Mains Voltage/Frequency | Identical to Primado2 (120V, 50-60 Hz) | 120 V, 50-60 Hz |
| Operating Mode | Equivalent to Primado2 | Intermittent duty S3 (load time max. 3min / rest time min. 5min). (Predicate is "intermittent duty (load/rest depending on motors used)"). |
| Foot Control | Equivalent to Primado2 | Wireless and wired options. (Predicate is wired only, but adding wireless is generally acceptable as an enhancement, not a fundamental difference in safety/effectiveness if properly validated). |
| Biocompatibility | Compliance with ISO 10993 standards | Evaluation performed according to ISO 10993-1, -10, -11, -12, -17, -18, and -23. |
| Electrical Safety/EMC | Compliance with IEC 60601 standards | In compliance with IEC 60601-1 and IEC 60601-1-2. |
| Reprocessing Validation | Per FDA Guidance Document | Validation provided per FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." Cleaning/disinfection for control unit/foot controller, cleaning/sterilization for motor cable/handpieces. |
| Bench Testing | Meets device specifications | Functional testing performed to test application, settings, features, and touchscreen per device specifications requirements. |
| Software Verification | Compliance with IEC 62304 and FDA Guidance | Verification according to IEC 62304 and FDA Guidance Document for Software Contained in Medical Device; necessary software documentation for moderate level of concern provided. |
2. Sample Size for the Test Set and Data Provenance
Not applicable in the typical sense for an AI/software diagnostic. The "test set" here refers to the physical device and components undergoing bench testing, biocompatibility, electrical safety, and reprocessing validation. The provenance of this would be internal laboratory testing by the manufacturer. No patient data is involved in these types of tests for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of electro-mechanical device submission. Ground truth, in this context, would be established by engineering standards, validated test methods, and industry-accepted protocols for safety and performance (e.g., precise measurements, material analyses).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical image interpretation or similar diagnostic tasks, which is not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks. The AMADEO is a surgical drill and does not involve AI assistance for human readers/interpreters in a diagnostic context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is relevant for AI diagnostic algorithms. The AMADEO is a physical surgical device. Its software controls the device's functions, but it's not a standalone diagnostic algorithm.
7. Type of Ground Truth Used
The "ground truth" for the AMADEO's performance comes from:
- Engineering Specifications and Standards: The device's design, operational parameters (e.g., motor speed, torque), electrical safety, and electromagnetic compatibility are validated against established engineering specifications and international standards (e.g., IEC 60601-1, IEC 60601-1-2).
- Biocompatibility Standards: Materials in contact with the patient are tested against ISO 10993 standards.
- Reprocessing Protocols: The ability to clean and sterilize/disinfect reusable components is validated against FDA guidance and established cleaning protocols.
- Functional Bench Testing: Verification that the device performs its intended functions (e.g., touchscreen responsiveness, motor control) according to its own design specifications.
8. Sample Size for the Training Set
Not applicable. There is no AI model being trained with a training set for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model.
§ 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.