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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

• 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.

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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.

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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.

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.

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