(294 days)
The Power Control 2303 in connection with Power Stick M4 (8564.121) or alternatively Power Stick M3 (8563.111/311) serves to drive Wolf rotary blades/ abraders and morcellators (tissue punches) for removal of tissue in endoscopic operations. At the same time aspiration allows continuous removal of ablated tissue.
Indication and Field of Use:
For use with endoscopic accessories:
- · In arthroscopy, e.g. for meniscus resection, removal of soft tissue as well as intraarticular severing or abrasion of osseous tissue (e.g. in ACL or shoulder operations)
- · In thorax surgery, e.g. for removing hematomas
- In sinus surgery, e.g. for removing of polyps
- In spinal surgery (arthroscopic microdiskectomy (AMD)), e.g. for the removal of degenerated tissue
The POWER CONTROL 2303 controls the motor in the POWER STICKS M3 and M4 that drives rotary blades and abraders, operated by a footswitch.
The POWER CONTROL 2303 is controlled by software.
The modes clockwise, counter-clockwise or oscillation can be selected in four speed ranges from 100 rpm up to 6000 rpm. The stop position of the rotary blade can be set and stored, so that the blade will always stop in this position until it is removed.
Values, functions and components are monitored at the graphically LCD display in various languages, accompanied by optical and acoustic signals.
Via the integrated CAN-BUS interface, the POWER CONTROL 2303 can be integrated into the R.Wolf RIWO NET SYSTEM with remote control, speech control and touchscreen monitor.
Due to the nature of the provided document, which is a 510(k) summary for a medical device submitted to the FDA, it primarily focuses on establishing "substantial equivalence" to predicate devices rather than providing detailed performance studies with acceptance criteria in the way a clinical trial or algorithm validation study would.
Here's an analysis based on the provided text, addressing your points where possible, and noting where information is not present:
Device: Power Control 2303 with Power Stick M4
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical or diagnostic outcome, nor does it report device performance in those terms. Instead, the "performance data" section states adherence to electrical safety standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformity to electrical safety standards IEC601-1 | Designed to meet IEC601-1 |
| Conformity to electrical safety standards IEC601-1-2 | Designed to meet IEC601-1-2 |
| Conformity to electrical safety standards UL2601-1 | Designed to meet UL2601-1 |
| Safety and effectiveness when used according to instructions | Designed and tested to guarantee safety and effectiveness |
2. Sample size used for the test set and the data provenance
No clinical or performance test set (as would be understood for an AI or diagnostic device) is described. The document explicitly states: "No clinical tests performed."
The "test set" in this context refers to the device itself being tested for compliance with electrical safety standards, not a set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts for a test set of clinical data is mentioned as "No clinical tests performed."
The device operates under direct human control, and its safety/effectiveness is assumed based on compliance with manufacturing and electrical standards and equivalence to predicate devices, not on a ground truth derived from expert consensus on patient cases.
4. Adjudication method for the test set
Not applicable, as no test set requiring adjudication (e.g., of diagnoses or outcomes) is 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
Not applicable. This device is an electromechanical surgical tool (motor control, motor handle), not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm; it's a piece of hardware that requires human operation. Performance is intrinsically human-in-the-loop.
7. The type of ground truth used
For this type of device, the "ground truth" for its safety and effectiveness is primarily established through:
- Compliance with recognized electrical and medical device safety standards (e.g., IEC601-1, IEC601-1-2, UL2601-1).
- Engineering design and testing to ensure the device functions as intended (e.g., speed ranges, control modes, monitoring features).
- Substantial equivalence to previously cleared devices which have an established record of safety and effectiveness.
There is no "clinical ground truth" in the sense of pathology, outcomes data, or expert consensus on patient cases, as no clinical studies were performed.
8. The sample size for the training set
Not applicable. This document is for a traditional hardware medical device, not an AI or machine learning system. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI or machine learning model.
Summary of Approach in the Document:
The provided document is a 510(k) submission, whose primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove de novo safety and effectiveness through extensive clinical trials or performance metrics against a defined ground truth. For certain Class II devices, particularly electromechanical ones like this, demonstrating conformity to recognized standards (like electrical safety standards) and showing similar technological characteristics and intended use to existing devices is often sufficient for clearance without requiring new clinical performance data. The explicit statement "No clinical tests performed" underscores this approach.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.