(362 days)
Traus SSG30 Surgical System is an electrical appliance intended to cut, shave, bone & tissue resection, grinding, and drilling in the cranium and spine. Shaver handpiece is not intended for use in neurosurgical procedures.
Traus SSG30 Surgical System, is available to apply surgical operation by various handpieces incorporating a micro motor and a handpiece. The technological characteristics and operating parameters of OSSEODUO Shaver and Drill System is very similar to the predicate device. With respect to the functional aspects, Traus SSG30 Surgical System, Bone surgery Engine Unit, uses the same fundamental technology as the predicate device. Traus SSG30 Surgical System consists of a control box (main unit), foot controller, micro motor and handpieces. Traus SSG30 Surgical System is composed of a control box, micro motor and a foot controller as an electric bone surgery machine. A signal for operating a foot controller, a handpiece, etc... is transmitted when a power source is inputted to a control box (main body) to control functions such as rotational speed, torque and water injection amount. It is a mechanism for puncturing, and cutting bones and human tissues through rotation and reciprocating motion by connecting handpiece and attachments to a micro motor. Three modes (Drill, Saw, Shaver) can be set, and the handpiece and attachment for each mode can be used in many surgical areas.
The provided text describes the 510(k) premarket notification for the "Traus SSG30 Surgical System." This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria through clinical performance data, especially concerning AI/ML aspects.
The document explicitly states: "Clinical Data: No clinical performance testing was performed."
Therefore, I cannot fulfill all parts of your request as the information required for a study proving the device meets acceptance criteria, particularly for AI/ML performance, is not present in this regulatory submission. This submission primarily focuses on functional equivalence, electrical safety, software verification, and sterilization validation.
However, I can extract information related to the acceptance criteria that were tested (non-clinical) and the methods described:
Summary of Acceptance Criteria and Device Performance (Based on Non-Clinical Data Provided):
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance/Validation |
|---|---|---|
| Biocompatibility | Biological safety of materials | Materials tested in accordance with ISO 10993-1, -5, -10, -12 are used and confirmed to be biologically safe. |
| Electrical Safety & EMC | Basic safety and essential performance, electromagnetic compatibility | Testing conducted according to IEC 60601-1:2005/AMD2:2020 and IEC 60601-1:2015+A1:2021. Implicitly, the device met these standards for clearance. |
| Software Performance | Software verification and validation | Software verification and validation testing was conducted. Documentation provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005 (moderate level of concern). IEC 62304 including results of verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards. Implicitly, the software performed as intended. |
| Mechanical Performance | Operating safely within predefined design specifications (e.g., RPM) | Bench testing conducted to assure SSG 30 operates safely and within predefined design specifications. Performance report based on criteria such as RPM. Implicitly, the device met these specifications. |
| Sterilization | Sterilization validation | Validated in conformance to FDA recognized consensus standard ISO 17665-1:2006 for moist heat sterilization. |
| Operational Equivalence | Comparison to Predicate Device | Indications for Use: Substantially equivalent. Controller: Console with Foot pedal (Substantial Equivalent). Speed Indication: Digital (Substantial Equivalent). Function: Drill, Saw, Shaver (Substantial Equivalent to Drill and Microdebrider(Shaver)). Energy Source: Electrical (Substantial Equivalent). Motor Speed: Max. 80,000rpm (Substantial Equivalent). Irrigation: 1 peristaltic pump integrated into console (Substantial Equivalent). |
Information Not Available / Not Applicable for this Device's Clearance:
As stated previously, this submission is for a Traditional 510(k) of a physical surgical system, not an AI/ML-driven device that requires performance studies related to diagnostic accuracy or human-AI collaboration. Therefore, many of your specific questions are not applicable to the context of this FDA clearance.
- Sample sized used for the test set and the data provenance: Not applicable for a traditional surgical system's non-clinical performance tests like electrical safety or mechanical RPM. The "test set" here refers to physical bench tests and software V&V, not a clinical data set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and electrical systems is typically defined by engineering specifications and standards, not expert consensus on images or clinical outcomes.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable, as this is not an AI/ML device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For non-clinical tests, ground truth is based on engineering specifications, physical measurements, and industry standards (e.g., IEC, ISO).
- The sample size for the training set: Not applicable (not an AI/ML device).
- How the ground truth for the training set was established: Not applicable.
Conclusion from the Document:
The 510(k) summary concludes: "The non-clinical data support the safety of the device and software and software verification and validation demonstrate that the SSG30 device should perform as intended in the specified use conditions. The clinical data demonstrate that the SSG30 device performs comparably to the predicate device that is currently marketed for the same intended use Based on the available information, the subject device and the predicates are similar indication for use, operational principal, performance data. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification that we conclude that substantially equivalent with predicate device."
This explicitly indicates that substantial equivalence was primarily demonstrated through non-clinical performance and a comparison of technical specifications to a predicate device, without clinical performance testing.
§ 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).