(30 days)
The HydroCision ArthroJet System with Cautery and TurboBurr is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation and shaping of soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and arthroscopic spinal surgeries and small and large joint arthroscopic procedures.
The HydroCision ArthroJet System with Cautery and TurboBurr consists of the reusable power control unit; a sterile, disposable pump cartridge and tubing assembly; and sterile, disposable handpieces. It provides the same functions as the predicate upon which it is based. The handpiece includes the rotating burr, which is driven by a fluidjet driven rotor.
The provided text describes a 510(k) submission for a medical device modification, the HydroCision ArthroJet System with Cautery and TurboBurr. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria against quantitative performance metrics for a novel efficacy claim.
Therefore, many of the specific questions about acceptance criteria, detailed study design, sample sizes, expert ground truth, and comparative effectiveness studies cannot be fully answered from the given document as they are not explicitly reported in this type of submission.
However, based on the information provided, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria or detailed results of device performance against such criteria. The "Performance Testing" section states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functionality as per design input requirements | Bench and cadaver testing confirmed "device functionality" |
| Conformance to design input requirements | Bench and cadaver testing confirmed "conformance to design input requirements" |
| Substantial equivalence to predicate device (K002764 and K011444) | FDA determined the device is "substantially equivalent" |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Bench and cadaver testing," but no numbers are provided for how many tests were performed or how many cadavers were used.
- Data Provenance: The document does not specify the country of origin. The testing appears to be prospective bench and cadaver testing conducted by the manufacturer, HydroCision, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not stated. The document doesn't describe the establishment of a "ground truth" by experts in the context of clinical outcomes or diagnostic accuracy. The testing performed was for device functionality and design conformance.
4. Adjudication Method for the Test Set
Not applicable/Not stated. No adjudication method is described as the testing performed was focused on engineering and functional validation rather than clinical assessment requiring expert consensus.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated. This type of study is more common for diagnostic imaging devices where human reader performance is a key metric. The submission focuses on device function and substantial equivalence for a surgical tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical tool, not an algorithm. The testing described would inherently involve human operators, even in a bench setting.
7. The Type of Ground Truth Used
The "ground truth" in this context appears to be engineering specifications and functional requirements for the device. The testing aimed to confirm that the device performs its intended functions (cutting, ablation, drilling, etc.) and meets its design inputs. There's no mention of pathology, expert consensus on clinical findings, or long-term outcomes data for establishing ground truth in this submission.
8. The Sample Size for the Training Set
Not applicable/Not stated. There is no mention of a "training set" in the context of this device. Training sets are typically associated with machine learning algorithms, which are not described here.
9. How the Ground Truth for the Training Set was Established
Not applicable. As no training set is mentioned, the method for establishing its ground truth is also not applicable.
§ 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.