Search Results

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

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.

Ask a specific question about this device

Ask a specific question about this device

The intended use of the HydroCision ArthroJet System with Cautery is to resect damaged tissue, remove extraneous matter, and control bleeding in surgical applications of articular body cavities.

The HydroCision ArthroJet System with Cautery is a surgical device which provides cutting, tissue removal, and electrocauterization in the same tool. The HydroCision ArthroJet System with Cautery uses the same system as the FDA approved HydroCision ArthroJet System (K982266) with the addition of a bipolar cauterization function at the distal tip of the handpiece. The ArthroJet System with Cautery is compatible with standard RF generators which provide bipolar energy output (with a voltage of less than or equal to 1.000 volts p-p). The ArthroJet System with Cautery operates in a saline or Ringer's Lactate environment. The bipolar cables used in the ArthroJet System with Cautery are available in two types, reusable and single use.

The HydroCision ArthroJet System with Cautery is a surgical device designed for cutting, tissue removal, and electrocauterization in articular body cavities. The 510(k) summary indicates that its substantial equivalence to predicate devices, rather than comprehensive performance studies with acceptance criteria, was the primary basis for its clearance.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a study. Instead, it relies on demonstrating substantial equivalence to existing legally marketed devices and compliance with voluntary standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not report any specific test set sample sizes or data provenance from a clinical study for the HydroCision ArthroJet System with Cautery. The clearance is based on substantial equivalence to predicate devices, which implies that the safety and effectiveness of the existing predicate devices provide the basis, rather than new clinical data from this specific device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable as the document does not describe a clinical study involving a test set and adjudication.

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

This information is not applicable. The device is a surgical tool, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study and AI assistance are irrelevant to its clearance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a surgical tool, not an algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic device studies (e.g., pathology, outcomes data) is not directly applicable in this 510(k) submission. The "ground truth" for demonstrating substantial equivalence is the established safety and effectiveness of the predicate devices. The device's performance is gauged against the functionalities and characteristics of these predicates.

8. The Sample Size for the Training Set

This information is not applicable as the document does not describe a training set for an algorithm.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as the document does not describe a training set.

In summary, the 510(k) clearance for the HydroCision ArthroJet System with Cautery was primarily based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than conducting new clinical trials with detailed performance data, acceptance criteria, or ground truth establishment as would be seen for new diagnostic or AI-driven systems. The focus was on comparing the new device's intended use, technological characteristics, and safety profiles to those of the predicates, along with compliance with relevant voluntary standards.

Ask a specific question about this device