(123 days)
The IPC System with the TRITON Electric High-Torque Handpiece is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The purpose of this submission is to add a new handpiece and an accompanying software module as a line extension to the current Integrated Power Console IPC® System. The handpiece is powered by the previously cleared integrated Powered Console. In order to operate the TRITON Electric Handpiece, the IPC will be equipped with the appropriate software module to drive the handpiece. The handpiece is used for sawing, drilling, driving and placing screws, wires and pins when used in conjunction with various attachments previously cleared for use during spinal surgery.
The provided text describes a 510(k) premarket notification for the TRITON Electric High Torque Handpiece and Software Module, a device used in various surgical procedures. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices based on laboratory bench testing.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria (from predicate device/general safety) | Reported Device Performance (TRITON Handpiece) |
|---|---|---|
| Maximum Applied Torque | 7 Nm (Predicate Device) | With Attachment: 3.1 Nm |
| Range of Speed | 0 - 250 rpm (Predicate Device) | With Attachment: 0 - 250 rpm |
| Free Run: 0 to max free run speed of 1250 - 1800 rpm | ||
| Range of Safe Working Temperatures | 48°C max (Predicate Device) | Max temperature through the entire operating |
| range at any external surface location on | ||
| handpiece shall be less than 51 °C for less than | ||
| 1 minute and shall not exceed 48 °C for less | ||
| than 10 minutes | ||
| Duty Cycle | Continuous Operation (Predicate Device) | Cycle Time: 20 seconds on maximum / 20 |
| seconds off minimum | ||
| Maximum number of cycles before resting | ||
| handpiece: 6 | ||
| Maximum number of cycles before resting | ||
| attachment: 3 | ||
| Minimum rest period: 25 minutes | ||
| Performance Characteristics | Substantially equivalent to predicate devices | Laboratory bench testing demonstrates substantially equivalent performance characteristics to the predicate devices currently on the market. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical data or patient samples. The testing described is laboratory bench testing. Therefore, the concept of sample size for clinical test data or data provenance (country of origin, retrospective/prospective) is not applicable here as the study is not a clinical trial involving human subjects or patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As the study is based on laboratory bench testing, there is no "ground truth" derived from expert consensus on clinical cases. The performance metrics are objectively measured physical properties of the device.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication for laboratory bench testing of device performance characteristics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document makes no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human readers or AI assistance. This submission pertains to a surgical handpiece, not an imaging or diagnostic device typically evaluated with MRMC studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical surgical tool with an accompanying software module to control its operation. It is not an AI algorithm or a standalone diagnostic tool that would operate without human intervention. The "standalone" performance here refers to the device's functional characteristics as measured in a lab.
7. Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on objective physical measurements obtained during laboratory bench testing. These measurements are compared against the performance characteristics of predicate devices, which serve as the reference for establishing substantial equivalence.
8. Sample Size for the Training Set
Not applicable. The document describes a physical medical device (surgical handpiece) and its controlling software. There is no "training set" in the context of machine learning. The software module is designed to drive the handpiece and recognize its control parameters, not to learn from a data set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no machine learning "training set," there is no ground truth established for it. The software's functionality is pre-programmed based on engineering design and specifications.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).