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The HydroCision SpineSite System is intended to be used as a single-use endoscopic video camera in a variety of endoscopic diagnostic and surgical procedures for spine applications. The device is also intended to be used as an accessory for microscopic surgery.

The HydroCision SpineSite System is comprised of (i) sterile disposable endoscope and (ii) reusable Video Processing Unit (VPU). The HydroCision SpineSite System provides illumination, image processing and digital documentation for endoscopic procedures. The HydroCision SpineSite System is not suitable for use in the MR environment.

The SpineSite Endoscope provides distal LED illumination via LEDs surrounding a high-resolution video sensor. The SpineSite Endoscope contains a working channel for the passage of micro instrumentation to the surgical site. The SpineSite Endoscope is provided sterile, via ethylene oxide sterilization.

The SpineSite Endoscope is designed to be connected to the SpineSite VPU via a proprietary edge card connector which provides power to the endoscope and supports video processing capability. The SpineSite VPU is powered via connection to an external wall outlet via a 12V power adapter.

The provided text is a 510(k) clearance letter and a 510(k) summary for the HydroCision SpineSite System. It details the device's indications for use, its components, and various non-clinical performance tests conducted to meet regulatory requirements. However, this document does not contain any information about a study proving the device meets specific acceptance criteria related to its performance in a clinical or AI-assisted context.

The "Performance Testing" section lists only non-clinical tests:

• Biocompatibility per ISO 10993-1
• Design verification/validation to mechanical and optical specifications
• Electrical, Mechanical and Thermal (EMT) safety testing per IEC 60601-1, IEC 60601-2-18
• Human Factors/ Usability per IEC 60601-1-6
• Electromagnetic compatibility testing per IEC 60601-1-2
• Software validation

The "Substantial Equivalence Summary" focuses on comparing the HydroCision SpineSite System to its predicate device (Arthrex Nanoscope System) on aspects like intended use, technological design, sterilization, electrical safety, materials, and technical features (optical resolution, field of view, depth of field, etc.). It states: "The safety and effectiveness of the HydroCision SpineSite System are adequately supported by the non-clinical performance data, substantial equivalence information, and comparison of design characteristics provided within this premarket notification."

Therefore, based solely on the provided text, I cannot answer the specific questions related to acceptance criteria and a study proving the device meets those criteria, particularly those concerning:

1. A table of acceptance criteria and reported device performance (in a clinical/AI context).
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study (AI vs. human).
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The device described is an endoscopic video camera system, not an AI-powered diagnostic device, which is what the questions regarding "AI assistance," "effect size," "standalone algorithm performance," and "training set" typically refer to. The document suggests a traditional medical device clearance based on substantial equivalence and non-clinical performance testing for a physical device, not an AI/ML algorithm.

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The HydroCision Spinelet System is indicated for surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required. Specific functions include cutting, ablation and shaping of soft tissue, and decorticating and smoothing of bone, cartilage and other bone related tissue in open and minimally invasive in spinal surgeries.

The HydroCision SpineJet System comprises of (i) sterile disposable tubing assembly- SpineJet device and (ii) reusable console unit- HydroCision Console. The components of SpineJet device consists of a pump cartridge, handpiece and tubing assembly (also known as disposable hose). The SpineJet device is provided sterile, via ethylene oxide sterilization. The reusable HydroCision Console are packaged and sold separately. The SpineJet device is designed to be used in combination with the HydroCision console as a SpineJet system. The SpineJet system is connected with a foot pedal, a sterile bag of saline, and a waste container prior to operation.

The SpineJet device pump cartridge plugs into the front of the HydroCision Console. This connection provides power to the SpineJet device and pressurizes the saline to deliver to the tip of the SpineJet handpiece through high pressure saline tube. The SpineJet handpiece consists of a plastic handle and a two-lumen needle: high pressure tube lumen and evacuation tube lumen, which are welded together in the handle. As the high-pressure saline passes from one lumen nozzle to another lumen nozzle, the targeted tissues are cut, debrided and removed into the evacuation tube lumen, passing into the waste container. The SpineJet tubing assembly (also known as disposable hose) consists of three tubes: (i) Clear saline supply tube (fluid supply hose) - which delivers saline from saline bag to pump cartridge (ii) High pressure saline tube- which delivers pressurized saline from the pump cartridge to the tip of Spinelet handpiece and (iii) Evacuation tube (waste hose) - which removes debrided tissue, along with saline from tip of the handpiece and delivers it to waste container, which is provided by the facility.

The Hydrocision Console (K190804) is an electrically powered device. It provides the power to pressurize sterile saline fluid, which is delivered to the distal tip of the SpineJet handpiece. The HydroCision console includes the software functionality to provide touch-screen LCD display and graphical user interface.

To perform an open or minimally invasive spinal procedure, the SpineJet handpiece needle is inserted into the spine through cannula access set and guided toward the targeted diseased tissue under fluoroscopic guidance. Once the Spinelet handpiece needle is in position, the surgeon activates the high-pressure saline of Spinelet device using the Hydrocision console and foot pedal. Using fluoroscopic guidance, the surgeon uses the Spinelet handpiece to cut and remove the targeted diseased tissue. When the procedure is complete, the handpiece is withdrawn, and the incision is closed using steri-strips for a closed, minimally invasive procedure.

The Spinelet device is provided sterile, via ethylene oxide sterilization.

This is a medical device 510(k) summary for the HydroCision SpineJet System. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study of the device's clinical performance against acceptance criteria in the way a novel AI/software medical device might.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, type of ground truth) are not applicable or not provided in this type of submission.

Here's a breakdown of the information provided, tailored to your request where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria and corresponding performance metrics for the HydroCision SpineJet System in the context of a clinical study. Instead, the submission focuses on validating that the modified device maintains the safety, functionality, and performance characteristics substantially equivalent to its predicate device.

The "acceptance criteria" are implied to be adherence to various engineering standards and confirmation that the design changes do not negatively impact the device's function or safety.

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

This is not applicable as there was no clinical test set in the sense of patient data for evaluating a diagnostic or predictive algorithm. The testing described is primarily engineering bench testing and compliance with standards.

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

Not applicable. Ground truth, in the context of diagnostic performance, is not established for this type of submission.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. This device is a surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithm-only device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this device's evaluation is primarily its adherence to engineering specifications, safety standards, and functional equivalence to its predicate device through bench testing rather than clinical outcomes or diagnostic accuracy.

8. The Sample Size for the Training Set

Not applicable. No training set is mentioned as this is not an AI/ML device.

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

Not applicable.

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HydroCision TenJet Device is indicated for orthopedic surgical procedures where the cutting, debridement and removal of soft and hard tissue is required in a variety of open, arthroscopic, and minimally invasive surgical procedures.

The TenJet device is a single use disposable device intended for use in orthopedic surgical procedures where the cutting, debridement and removal of soft and hard tissue is required in a variety of open, arthroscopic, and minimally invasive surgical procedures. The TenJet device is constructed from various biocompatible materials. The TenJet device is designed to be used in combination with HydroCision Console and Foot Pedal, which are sold and package separately. The Accessory Kit, also known as supply kit is packaged along with each HydroCision TenJet Device. The supply kit contains sterile packaged, single use, OEM surgical supply items for use in the surgical site preparation and closure. The itemized contents of the kit with their manufacturer and regulatory information are provided in section 11.7.3 of this 510(k).

The components of TenJet device consists of a pump cartridge, handpiece and tubing assembly, which is used in combination with HydroCision Console. The TenJet device pump cartridge plugs into the front of the HydroCision Console. This connection provides power to the TenJet device and pressurizes the saline to deliver to the tip of the TenJet handpiece through high pressure saline tube. The TenJet handpiece consists of a plastic handle and a two-lumen needle: high pressure tube lumen and evacuation tube lumen, which are welded together in the handle. As the high-pressure saline passes from one lumen nozzle to another lumen nozzle, the targeted tissues are cut, debrided and removed into the evacuation tube lumen, passing into the waste container. The TenJet tubing assembly (also known as disposable hose) consists of three tubes: (i) Clear saline supply tube (fluid supply hose) - which delivers saline bag to pump cartridge (ii) High pressure saline tube- which delivers pressurized saline from the pump cartridge to the tip of TenJet handpiece and (iii) Evacuation tube (waste hose) - which removes debrided tissue, along with saline from tip of the handpiece and delivers it to waste container, which is provided by the facility.

The Hydrocision Console is an electrically powered device. It provides the power to pressurize sterile saline fluid, which is delivered to the distal tip of the TenJet handpiece. The HydroCision console includes the software functionality to provide touch-screen LCD display and graphical user interface. The detailed software description and associated documentation is included in Section 16 of the TenJet 510(k).

To perform an open, arthroscopic or minimally invasive surgical procedure, the TenJet handpiece needle is inserted into the body through a small incision and guided toward the targeted diseased tissue under ultrasound visualization. Once the Tenlet handpiece needle is in position, the surgeon activates the high-pressure saline of TenJet device using the Hydrocision console and foot pedal. Using ultrasound visual guidance, the surgeon uses the TenJet handpiece to cut, debride and remove the targeted diseased tissue. When the procedure is complete, the handpiece is withdrawn and the incision is closed using steri-strips for a closed, minimally invasive, ultrasound guided procedure.

The TenJet device is provided sterile, via ethylene oxide sterilization.

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets those criteria.

Based on the provided text, the device in question (HydroCision TenJet Device) is a medical device and not an AI/ML enabled device. Therefore, a significant portion of the requested information, specifically regarding AI/ML related studies (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone performance, etc.), is not applicable and cannot be extracted from this document.

The document details a 510(k) premarket notification for a medical device that uses high-pressure saline for tissue debridement. The "acceptance criteria" and "proof" in this context are related to demonstrating substantial equivalence to a previously cleared predicate device, rather than performance metrics of an AI model.

The "studies" are primarily non-clinical bench testing, biocompatibility testing, human factors/usability studies, and electrical/EMC testing, all aimed at confirming the device's safety and effectiveness compared to the predicate and applicable standards.

Breakdown of Applicable Information from the Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a single, concise table of acceptance criteria with corresponding performance for each. Instead, it describes general conformance to standards and internal test protocols to prove substantial equivalence. The "acceptance criteria" can be inferred from the types of tests conducted and their successful completion.

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

• Sample Size:
  • For TenJet Tissue Differentiation- Safety and Efficacy, the text mentions "Bovine and Cadaver" tissue. It does not specify the number of bovine or cadaver samples used.
  • For other bench tests, biocompatibility, human factors, and electrical testing, specific sample sizes are not provided.
• Data Provenance:
  • The studies appear to be non-clinical, laboratory-based tests. The country of origin for the data is implied to be the US, as the company (HydroCision, Inc.) and consultants are based in the US, and it's a submission to the US FDA.
  • The data is inherently prospective in nature, as it was generated specifically for this 510(k) submission to demonstrate compliance and substantial equivalence before market clearance.

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

• Not Applicable / Not Provided. This type of information is relevant for AI/ML performance studies, not for the types of non-clinical device performance studies described here for a mechanical/fluidic device. The "ground truth" for these tests are objective measurements, pass/fail criteria based on standards, or comparison to the predicate device's established performance.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or expert review processes, especially for image analysis or diagnostic tasks, which are not described here.

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:

• No. This is not an AI-enabled device. Therefore, no MRMC comparative effectiveness study involving AI assistance would have been conducted or is mentioned.

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

• No. This is not an AI-enabled device. Software is mentioned for the console's functionality (touch-screen LCD display, graphical user interface), and it states "The HydroCision console software has been developed, verified, tested and validated to the company's documented development and test procedures." This refers to standard medical device software validation, not standalone AI algorithm performance.

7. The Type of Ground Truth Used:

• The "ground truth" for the various tests were:
  • Bench Testing: Objective physical measurements, comparison to predicate device characteristics, and observed performance on specific tissue types (bovine and cadaver).
  • Biocompatibility: Established ISO standards (ISO 10993-1:2009) and FDA guidance for toxicology and material safety.
  • Sterilization: Industry standards for ethylene oxide sterilization validation.
  • Human Factors/Usability: Conformance to IEC 62366-1:2015.
  • EMC/Electrical Safety: Conformance to IEC 60601-1 and IEC 60601-1-2.
  • Software: Conformance to the company's documented development and test procedures.
  • The document explicitly states: "Clinical evidence was not necessary to show substantial equivalence." This means that ground truth from patient outcomes or extensive clinical trials was not used for this submission.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device. No training set for an algorithm is mentioned.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. As there is no AI/ML training set, this question is not relevant.

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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 employs two basic system components to achieve its mechanism of action:

• the reusable power console unit
• the sterile, disposable pump cartridge, handpiece and tubing assembly.

The handpiece component of the sterile, disposable assembly is comprised of two principal components:

• a high pressure fluid conduit with integral fluidjet nozzle.
• a low pressure collection tube.

The high pressure conduit consists of a hollow stainless steel tube with a nozzle at the distal end. The collection tube incorporates an opening at its distal end such that the fluidjet is directed into the opening when in use. Because of the hydrodynamic design of the fluidjet/collection tube combination, the orifice serves to pull excised tissue fragments and other debris into the collection tube. Controls on the front panel allows the user to adjust the pressure, from zero to a factory pre-set limit of 15,000 psi.

The provided 510(k) summary for the HydroCision ArthroJet System with Cautery, TurboBurr, and Curette (K041233) describes an electrosurgical cutting and coagulation device. However, it does not contain the specific information requested about acceptance criteria and a study proving device performance against those criteria in the context of AI/ML or diagnostic accuracy studies.

The document discusses substantial equivalence to a predicate device based on:

1. Design similarities: between the proposed system and the currently marketed HydroCision ArthroJet with Cautery, TurboBurr and Curette.
2. Performance testing: Stated as "Bench testing was conducted to determine device functionality and conformance to design input requirements."

This summary is typical for a traditional medical device (like a surgical tool) 510(k) submission, where the focus is on physical characteristics, mechanical function, and comparison to a predicate device, rather than the kind of diagnostic accuracy or AI/ML performance study metrics outlined in your request.

Therefore, I cannot provide the requested information for the acceptance criteria and study details as they pertain to AI/ML or diagnostic performance based on the input document.

The document does not mention:

• Specific acceptance criteria with numerical targets.
• Reported device performance against such criteria.
• Sample sizes for test sets or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness study or human reader improvement with AI.
• Standalone algorithm performance.
• Types or establishment of ground truth in the context of diagnostic accuracy.

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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 General Surgery FluidJet System is for the tangential cutting, resection and removal of soft tissue or fluid from the body. HydroCision General Surgery FluidJet System is not intended for use in suction lipoplasty procedures.

The HydroCision General Surgery FluidJet System uses a pressurized stream of sterile saline to lavage and clean wounds. The stream of saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from the wound. The system employs two basic system components to achieve this purpose: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.

This 510(k) premarket notification for the HydroCision General Surgery FluidJet System does not contain the level of detail required to answer your questions about acceptance criteria and study design for Artificial Intelligence (AI) / Machine Learning (ML) enabled devices.

Here's why and what information is missing:

The document describes a medical device called the "HydroCision General Surgery FluidJet System" which is a surgical instrument using a pressurized stream of sterile saline. This is a mechanical device, not an AI/ML powered device. The "performance testing" mentioned refers to traditional engineering and biological tests, not AI model evaluation.

Therefore, for this specific document, I cannot provide the requested information about acceptance criteria and study details for an AI-powered device.

To answer your questions for an AI/ML device, the input document would need to include information such as:

• Quantitative performance metrics: Specific thresholds for sensitivity, specificity, AUC, F1-score, accuracy, etc.
• A "study" section detailing the evaluation of an AI algorithm. This would typically involve:
  • Descriptions of training and test datasets.
  • Ground truth establishment methods.
  • Expert involvement in ground truth and/or reading studies.
  • Details of any comparative effectiveness studies (e.g., MRMC).
  • Reporting of standalone performance.

Without an AI component in the described device, the concept of "acceptance criteria" as you've framed it (referring to AI performance) and an AI-specific study is not applicable to this document.

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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:

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.

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The HydroCision. Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.

The HydroCision Debridement System uses a pressurized stream of sterile saline to lavage and clean wounds. The stream of saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from the wound. The svstem employs two basic system components to achieve this purpose: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.

The provided document is a 510(k) summary for a modification to the HydroCision, Inc. Debridement System. It describes the device, its intended use, and a comparison to a legally marketed predicate device. However, it does not contain the detailed information requested regarding specific acceptance criteria, study results with numerical performance data, sample sizes for test and training sets, expert ground truth establishment, or multi-reader multi-case studies.

The document states: "Bench testing was conducted to determine device functionality and conformance to design input requirements." but does not provide any results or specific criteria.

Therefore,Based on the provided text, I cannot complete the request. The document is a 510(k) summary that states "Bench testing was conducted to determine device functionality and conformance to design input requirements" but does not provide any specific acceptance criteria, reported device performance data, study details (like sample sizes, ground truth, expert qualifications, or MRMC studies).

This document describes the device and its intended use but does not contain the performance study details required to answer your questions.

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The HydroCision, Inc. Debridement System is intended for wound debridement, soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgement, would require the use of a pulse lavage device with sharp debridement. This device is not intended to be used on burns.

The HydroCision Debridement System uses pressurized streams of sterile saline to lavage and clean wounds. The streams of saline simultaneously wash the tissue surface and vacuum away foreign material, including contamination and infected and necrotic tissue from the wound. The system employs two basic system components to achieve this purpose: the reusable power console unit and the sterile, disposable pump cartridge, handpiece and tubing assembly.

The HydroCision, Inc. Debridement System, a pulse lavage device with sharp debridement, was reviewed for K991383. The study relied on bench testing and a comparative animal study against a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Porcine Study (Test Set): While a specific number for the porcine subjects is not explicitly stated in the provided text, the study involved a comparison between the HydroCision device and the Zimmer Puls-A-Vac II device.
• Data Provenance: The porcine study was conducted as a prospective, in-vivo animal study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA.

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

This information is not provided in the given text. For the porcine study, it's possible that veterinary pathologists or microbiologists were involved in assessing bacterial and particulate contamination, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the given text. For the porcine study, it's unknown if multiple assessors were used and how discrepancies were resolved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance

This section is not applicable as the device is not an AI-powered diagnostic tool, but rather a surgical debridement system. The study was a comparison of device effectiveness, not human reader performance with or without AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable as the device is not an algorithm. The "standalone" performance refers to the device's functional and cleaning capabilities demonstrated through bench and animal testing.

7. The Type of Ground Truth Used

• Bench Testing: The ground truth for functionality would have been engineering specifications and predetermined performance parameters for flow rates, power, etc.
• Porcine Study: The ground truth for wound cleaning effectiveness was established through:
  • Quantitative Bacteriology: Direct measurement of bacterial load.
  • Radiographic Analysis: Assessment of particulate contamination removal using imaging.

8. The Sample Size for the Training Set

This section is not applicable as there is no "training set" in the context of this device. The device is not a machine learning algorithm that requires training data. The development and validation relied on engineering design and performance testing.

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

This section is not applicable as there is no training set.

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