(87 days)
The Riwo Drive System is used for arthroscopic procedures in human joints. It is also used for sinus procedures in the nasal cavity. The Riwo Drive generator with motor handle serves to drive WOLF blades or abraders. Depending on the indication, different styles of blades are attached to the motor handle. Two basic styles are most common: 1. Blades are for removal of soft tissue and cartilage 2. Abraders for bones and bony structures
The RIWO Drive Generator is build to efficiently drive and control different motor handles. The handle functions are controlled by a footswitch. The Motor Handle is a tubular system with a motor and clamping chuck for driving rotary blades and abraders. A suction pump is connected to the built-in suction tube and the suction stream can be controlled by a valve. The rotary blades consist of a hollow, fenestrated tube, containing a rotating two-edged cylindrical blade or an abrader that spins within the hollow tube.
This 510(k) submission describes the Riwo Drive Generator and Accessories, a surgical instrument used for arthroscopic and sinus procedures. The submission outlines the device's description, intended use, technological characteristics, and claims substantial equivalence to existing devices.
However, the document does not contain the kind of detailed information typically found in acceptance criteria and study reports for software as a medical device (SaMD) or AI/ML-based devices. Instead, it focuses on hardware performance and safety testing.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance (for AI/ML performance)
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth
- Adjudication method
- MRMC comparative effectiveness study
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
Based on the provided text, here is the information that can be extracted:
1. Acceptance Criteria and Device Performance (for hardware/electrical safety):
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| IEC601-1 | Tested according to this specified standard. |
| IEC601-1-2 | Tested according to this specified standard. |
| UL2601-1 | Tested according to this specified standard. |
| Longevity/Durability | A life-cycle test shows that the function of the motor handle can be guaranteed for more than 200 steam sterilization cycles when using the fractional method. |
| Safety and Effectiveness | Devices are designed and tested to guarantee safety and effectiveness when used according to the instruction manual. (This is a general statement rather than specific performance metrics, but it represents the overall conclusion regarding meeting safety and effectiveness requirements, implying adherence to relevant standards and design specifications outlined elsewhere in the submission). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of AI/ML or diagnostic performance. The document refers to "a life-cycle test" for durability, but a specific sample size (e.g., number of units tested) is not provided.
- Data Provenance: Not applicable for AI/ML or diagnostic performance. The testing described relates to hardware performance and electrical safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not a study involving expert-derived ground truth for AI/ML or diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 MRMC study was performed. The device is a surgical power tool, not an AI-assisted diagnostic or decision-support system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a surgical power tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in terms of diagnostic ground truth. The "ground truth" for the performance described would be defined by the specifications of the standards (IEC601-1, IEC601-1-2, UL2601-1) and the functional requirements for mechanical operation and sterilization cycles.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.