(32 days)
The HydroCision ArthroJet System with Cautery, TurboBurr and Curette 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 minimally invasive spinal surgeries and small and large joint arthroscopic procedures.
The HydroCision ArthroJet System with Cautery, TurboBurr, and Curette consists of the reusable power control unit; a sterile, disposable pump cartridge and tubing assembly; and sterile, disposable handpieces with curette. 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.
This 510(k) summary describes a modification to an existing medical device, the HydroCision ArthroJet System. The primary focus of the document is to demonstrate substantial equivalence to a predicate device, rather than to establish new acceptance criteria through a comprehensive clinical study.
Therefore, many of the typical elements of an acceptance criteria and study report for a novel medical device are not applicable or explicitly stated in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functionality with Added Curette: The modified device must perform its intended functions (cutting, ablation, removal of tissue/bone, control of bleeding) effectively and safely with the addition of the curette. | Bench and cadaver testing were conducted to determine device functionality and conformance to design input requirements. The FDA determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use, implying that its performance with the curette is acceptable and meets the expected safety and efficacy profile of similar devices. The document does not provide specific quantitative performance metrics (e.g., cutting rates, tissue removal efficiency, precision). |
| Substantial Equivalence: The modified device must be substantially equivalent to the predicate device (HydroCision ArthroJet System with Cautery and TurboBurr, K020688) in terms of intended use, technological characteristics, and performance. | Both the current and modified devices: |
- Have the same intended use (resection of tissue and bone in orthopedic procedures).
- Use the same fundamental scientific technology (reusable power console, fluid jet technology, mechanical cutting, bipolar electrocautery, sterile disposable components).
The primary difference is the addition of a Curette tool to the distal end of direct fluidjet handpieces. The FDA's 510(k) clearance confirms the determination of substantial equivalence. |
| Conformance to Design Input Requirements: All aspects of the device, including the new curette, must meet pre-defined design specifications. | Bench and cadaver testing were conducted to determine conformance to design input requirements. No specific failures or deviations are reported, implying successful conformance. |
| Safety: The device, including the modified components, must be safe for its intended use. | The FDA clearance letter implies that based on the provided information, the device meets the general controls provisions of the Act related to safety. No specific safety risks or mitigations are detailed in the provided text. Bench and cadaver testing would implicitly include safety assessments. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states "Bench and cadaver testing were conducted." It does not specify the sample size for either the bench or cadaver tests (e.g., number of cadavers, number of tests performed on bench).
- Data Provenance: The testing was conducted by HydroCision, Inc. (device sponsor). The location of the cadaver testing is not specified, nor is the country of origin. The study is retrospective in the sense that the data was generated specifically for this 510(k) submission, not from ongoing clinical use. It's not a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not specify the number or qualifications of experts used to establish ground truth. For bench and cadaver testing of a surgical instrument, "ground truth" would likely be established through objective measurements (e.g., precise cuts, complete tissue removal, lack of damage to adjacent structures) assessed by engineers and potentially observed by or conducted under the guidance of orthopedic surgeons. However, this is not explicitly stated.
4. Adjudication Method for the Test Set
- Given the nature of bench and cadaver testing for a surgical instrument, a formal "adjudication method" in the sense of multiple independent reviewers of diagnostic images is unlikely. Performance would typically be objectively measured against engineering specifications and clinical requirements. The document does not describe any formal adjudication method for the test results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices where human readers interpret medical images. This document describes a surgical tool, and the testing outlined (bench and cadaver) is focused on device functionality and safety, not on human interpretation of data.
6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)
- Yes, in essence. The "Performance Testing" section states "Bench and cadaver testing were conducted to determine device functionality and conformance to design input requirements." This testing assesses the device's performance directly, independent of the human-in-the-loop performance in a clinical scenario (though a surgeon would operate it). It evaluates the inherent capabilities of the device itself. This is a standalone performance assessment in the context of a surgical instrument.
7. Type of Ground Truth Used
- The ground truth for the bench and cadaver testing would be based on objective performance metrics and observations as defined by engineering specifications and surgical requirements. This would include:
- Successful completion of specified tasks: e.g., removal of tissue, drilling of bone to a certain depth/shape.
- Absence of mechanical failure: e.g., burr breaking, curette bending.
- Controlled application of energy: e.g., effective cautery without excessive thermal damage.
- Achieving desired surgical effects: e.g., smooth bone surfaces, clean tissue resection.
- These are akin to "functional ground truth" and "safety ground truth." It is not based on pathology, expert consensus on diagnostic interpretation, or long-term clinical outcomes data in the way a diagnostic device might be.
8. Sample Size for the Training Set
- The document does not refer to a "training set." This terminology is common in machine learning and AI device development. This device is a mechanical surgical tool, not an AI/ML-driven device. Therefore, the concept of a training set as used in AI development is not applicable here.
9. How the Ground Truth for the Training Set Was Established
- As there is no "training set" for this mechanical device, this question is 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.