(88 days)
The ArthroJet system is intended to resect damaged tissue and remove extraneous matter found in articular body cavities. The system may be used open or arthroscopically to resect tears and other defects, remove loose fragments, shave away debris and perform appropriate synovectomy procedures.
The HydroCision ArthroJet system consists of an electric motor used to power a drive train inside a console. The drive train converts the rotational motion of a cam to a transverse motion of a plunger which in turn drives a piston contained in a disposable cartridge. The repeated motion of the piston pressurizes saline in the cartridge which is then carried through tubing to a handpiece. The handpiece delivers the high pressure saline to the joint, resulting in the cutting action of the waterjet. The result is a thin waterjet stream capable of cutting and ablating tissue which is then removed from the surgical site.
The provided text details a 510(k) submission for the HydroCision ArthroJet system, focusing on its substantial equivalence to a predicate device. It describes the device, its intended use, and performance data. However, the document does not present "acceptance criteria" and "reported device performance" in the structured format typically seen for medical device evaluations against specific performance metrics with quantitative results.
Based on the provided text, here's an analysis of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria or detailed reported device performance in a tabular format. Instead, it describes performance in qualitative terms aimed at demonstrating equivalence to the predicate device and functionality for intended use.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tissue Resection and Ablation Capability | Demonstrated in porcine knee evaluation. (Qualitative assessment based on observation) |
| Efficacy in Resecting Menisci | Demonstrated in in-vivo rabbit testing, comparable to the predicate device. Confirmed adequate function for intended use. (Qualitative assessment and comparative observation) |
| Handpiece Bending Strength | Evaluated for ability to withstand arthroscopic applications. (Implies a successful evaluation, but without specific metrics or thresholds) |
| Substantial Equivalence to Predicate Device (Dyonics Articular Shaver System) | Indications for use are identical. Performance data supports the claim of substantial equivalence. |
| Meeting Intended Use | The device functions adequately to meet its intended use of resecting damaged tissue and removing extraneous matter in articular body cavities. |
2. Sample Size for the Test Set and Data Provenance
- Porcine Evaluation: Implies use of porcine knee tissue. The exact number of porcine knees or tissue samples is not specified.
- In-Vivo Testing: Used rabbits. The exact number of rabbits used is not specified.
- Bending Strength: Refers to evaluation of "the handpiece." The number of handpieces tested is not specified.
- Data Provenance:
- In-Vivo Testing: "resecting rabbit menisci" suggests a pre-clinical animal model.
- The evaluations appear to be prospective studies conducted by the manufacturer for the 510(k) submission.
- The country of origin is not explicitly stated but can be inferred to be the United States, given the submitter's location (Wilmington, MA) and the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish "ground truth" in the context of diagnostic accuracy, as this is a surgical device. The "performance data" focuses on tissue interaction and mechanical integrity. Therefore, the concept of "experts" for ground truth as typically understood for diagnostic AI/imaging devices is not directly applicable here. The evaluations were likely performed by the manufacturer's engineers and/or animal study researchers.
4. Adjudication Method for the Test Set
Not applicable. The described tests are not diagnostic in nature, nor do they involve subjective interpretations by multiple observers requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or reported. This type of study is typically relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The ArthroJet is a surgical cutting system, not a diagnostic device.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. The ArthroJet is a human-operated surgical device; it does not operate autonomously as an algorithm or AI system. Its "performance" inherently involves interaction with a human surgeon.
7. Type of Ground Truth Used
The "ground truth" in this context refers to the observable effects and outcomes of the device's action, rather than an independent diagnostic confirmation.
- Porcine Evaluation: The ability to "resect and ablate various types of tissue" implies direct visual assessment and potentially histological examination of the resected tissue. The ground truth is the physical evidence of tissue removal and alteration.
- In-Vivo Testing (Rabbit Menisci): Demonstrated "efficacy... in resecting rabbit menisci" and confirmed "device functions adequately." The ground truth would be the observed state of the menisci post-procedure, possibly confirmed by histology or gross observation, and comparison to the predicate device's effects.
- Bending Strength: The "ability to withstand arthroscopic applications" suggests engineering tests against defined forces or conditions, where "ground truth" is the structural integrity or failure point of the handpiece.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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.