Search Results

The Precision™ Plus TUNA® Office System is indicated for use in the treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatic Hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

The Precision™ Plus TUNA® Office System consists of a RF Generator, a sterile single-use Cartridge attached to a reusable Handle, a reusable Telescope, a single-use Return Electrode, a sterile single-use Tubing set, and other accessories. The Precision™ Plus TUNA® Office System delivers low levels of 460 kHz RF energy up to 15 W from each of the 2 needles directly into prostatic tissue to produce a localized necrotic lesion to treat the symptoms associate with BPH. Each lesion takes 3.0 minutes.

The provided text is a 510(k) summary for the Precision™ Plus TUNA® Office System. This document is primarily focused on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study evaluating the device's performance against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, a specific study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text.

Here's an analysis of what can be gleaned and what is missing:

Inability to Fully Address Request

The provided 510(k) summary for the Precision™ Plus TUNA® Office System focuses on demonstrating substantial equivalence to a predicate device (PROVu™ TUNA® System) primarily through "lab bench testing" for "lesion equivalence." It does not contain the detailed clinical study design, performance metrics, acceptance criteria, or ground truth establishment typically found in a clinical trial report or a submission designed to prove device performance against predefined criteria.

Available Information (and what's missing)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not provided. The text refers to "lab bench testing," which implies physical tests rather than patient studies. If it involved simulated tissue or animal models, the sample size of those would not be explicitly stated here.
• Data Provenance: "Lab bench testing." This implies in-vitro or simulated environment testing, not human patient data. No country of origin is specified for this lab testing, nor is it identified as retrospective or prospective patient data.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• Not applicable / Not provided. Since the "test" mentioned is "lab bench testing" for "lesion equivalence," there's no indication of human experts establishing ground truth in the context of clinical outcomes. The equivalence would likely be determined by physical measurements or similar objective laboratory metrics.

4. Adjudication Method for Test Set

• Not applicable / Not provided. Given the nature of "lab bench testing" for "lesion equivalence," an adjudication method for a test set of patient cases is not relevant or described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. The document does not describe any MRMC study. The device is an electrosurgical generator and accessories, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a medical instrument (electrosurgical unit), not an algorithm or AI. Its performance is intrinsic to its physical and functional operation, not a computational output.

7. Type of Ground Truth Used

• For "lesion equivalence" in lab bench testing: The ground truth would likely be objective physical measurements of the created lesions (e.g., size, depth, necrosis characteristics) using standard laboratory methods, rather than expert consensus, pathology in a clinical setting, or patient outcomes data. The specific methods are not described.

8. Sample Size for Training Set

• Not applicable. This document describes a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of an algorithm.

9. How Ground Truth for Training Set was Established

• Not applicable. As above, no training set for an algorithm exists here.

Summary Limitations:

The provided 510(k) summary is a regulatory document focused on demonstrating that the new device is "substantially equivalent" to a previously cleared predicate device. This process often relies on comparisons of technical characteristics and performance data from internal testing (like the "lab bench testing" mentioned) rather than comprehensive clinical trials with detailed acceptance criteria and outcome measures, especially for devices like electrosurgical generators. Therefore, it does not contain the level of detail requested for a deep dive into clinical study design and performance metrics.

Ask a specific question about this device

The TUNA® System Product Family, including Precision™ TUNA® Office System and PROVu™ TUNA® System, is indicated for use in the treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatic Hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

Each System of the TUNA System Product Family consists of a RF Generator, a sterile single-use Cartridge attached to a reusable Handle, a reusable Telescope, a single-use Return Electrode, a sterile single-use Tubing set, and other accessories.

Here's a breakdown of the acceptance criteria and study information for the Precision™ TUNA® Office System and PROVU™ TUNA® System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device's intended use is to treat symptoms of Benign Prostatic Hyperplasia (BPH) and improve uroflow. The efficacy was evaluated by measuring AUA (American Urological Association) symptom scores, Quality of Life (QOL) scores, and Peak Flow Rate. Acceptance criteria are implicitly tied to a demonstrable improvement in these metrics, and the device's performance is compared against a predicate device (TURP) and baseline.

Safety Data: The clinical trials demonstrated that the TUNA® procedure can be performed without the need for general anesthesia (only regional/spinal), and is associated with few side effects and adverse events. Specific adverse event rates are provided in Table 1-1, showing rates for obstruction, catheterization, bleeding, pain/discomfort, urinary tract infection, and dysuria. The acceptance criteria here would be that these adverse event rates are within acceptable clinical limits and comparable or better than alternative treatments. The trials concluded that no increased risks were associated with the shortened needle length across the median lobe.

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

• Original TUNA® vs. TURP Study (Test Set):

  • Total Patients Enrolled: 167 men over 50 years of age with symptomatic BPH.
  • Randomized Group: 121 patients (65 treated with TUNA®, 56 underwent TURP).
  • Additional Non-randomized TUNA Patients: 46
  • Total TUNA® Treated Population: 111 (in this specific study for efficacy comparison against TURP).
  • Data Provenance: Multi-center clinical trials conducted across the United States. Prospective.

• Additional Studies (PMT and PO1 - for lateral and median lobe enlargement):

  • Total Patients Enrolled: 50, with 2 additional studies.
  • Number with 6-month follow-up: 40
  • Number with 1-year follow-up: 24
  • Data Provenance: Multi-center clinical studies performed in the United States. Prospective.

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" in the traditional sense of image analysis or diagnostic studies. Instead, the "ground truth" for this device appears to be the clinical outcomes and patient-reported symptoms, as measured by standardized clinical tools (AUA symptom score, QOL score, uroflowmetry) and physician assessment of adverse events. These are inherent clinical measures conducted by healthcare professionals involved in the study sites, though their specific qualifications are not detailed beyond "medical institutions."

4. Adjudication Method for the Test Set

The document describes a "multicenter, single blind, randomized study comparing transurethral needle ablation (TUNA) of the prostate with transurethral resection of the prostate (TURP)." It does not explicitly mention an adjudication method (like 2+1 or 3+1 decision rules) for the clinical outcomes data. In clinical trials, the primary outcome measures (AUA score, QOL, uroflow) are typically collected directly from patients or objective measurements, and adverse events are reported by investigators based on defined study protocols. Data review and monitoring would have occurred, but a formal "adjudication" committee for ground truth agreement in the way it's described for, say, imaging studies, is not detailed.

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

An MRMC study was not applicable as this is a medical device for treatment of BPH, not a diagnostic or AI-assisted diagnostic tool involving "human readers" or "AI assistance" in interpretation. The study compares a device-based treatment (TUNA) to another treatment (TURP) or baseline, focusing on patient outcomes.

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

This is not applicable as the device (TUNA system) is a treatment device, not a standalone algorithm. Its performance is directly measured by its clinical effect on patients.

7. The Type of Ground Truth Used

The ground truth used is primarily clinical outcomes data and patient-reported symptoms, including:

• AUA Symptom Score (patient-reported severity of BPH symptoms)
• Quality of Life (QOL) Score (patient-reported impact on daily life)
• Peak Flow Rate (objective measurement of urinary flow)
• Post Void Residual Volume (objective measurement of urine retention)
• Adverse Events (clinician-reported and objective complications)

8. The Sample Size for the Training Set

The document describes pre-market clinical trials for efficacy and safety. There is no separate "training set" as would be applicable for machine learning models. The clinical studies involving 167 patients (original TUNA vs TURP) and 50 patients (additional median lobe studies) served as the primary data for demonstrating safety and efficacy for the device.

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

As there is no separate "training set" in the context of an algorithm, this question is not applicable. The "ground truth" or evidence for the device's performance was established through the collection of clinical outcome measures and adverse event data in the aforementioned prospective, multi-center clinical trials.

Ask a specific question about this device

The TUNA Office System is intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to Benign Prostatic Hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

Precision™ TUNA® Office System with Model 6800 Cartridge, Model 6198 Handle, Model 7800 RF Generator (with no rectal temperature monitoring tape)

This document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device. It does not contain information about acceptance criteria, study details, or device performance metrics typically found in a clinical study report or a detailed pre-market submission.

Therefore, I cannot provide the requested information from the provided text. The document primarily focuses on regulatory approval and classification for the "Precision™ TUNA® Office System."

Ask a specific question about this device

Ask a specific question about this device

The Cobra Hand Piece presented in this submission is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hvperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

The Cobra Hand Piece delivers the energy from the VidaMed TUNA System RF Generator. The Cobra Hand Piece contains two needle electrodes which are deployed at an angle of 90°. The needles can be deployed at 4 preset lengths which vary between 10-22mm. The needles are insulated at the base to protect the urethra during ablation of the prostatic tissue. The disposable Cobra Cartridge is attached to a reusable handle, containing the mechanism for the needle deployment and retraction. The Cobra Hand Piece only works with the VidaMed TUNA System RF Generator.

The provided text describes a 510(k) submission for the VidaMed Cobra Hand Piece, which is a modification to an existing electrosurgical device for treating benign prostatic hyperplasia (BPH).

Based on the provided text, a formal study proving the device meets specific acceptance criteria is not explicitly detailed. The submission focuses on demonstrating "Substantial Equivalence" to previously cleared devices. This means that instead of new clinical trials with acceptance criteria, the regulatory approval is based on the new device (Cobra Hand Piece) being similar enough in intended use, technological characteristics, safety, and effectiveness to a predicate device (VidaMed's TUNA System and RF Generator) that has already been approved.

Therefore, the information you requested about acceptance criteria, study details, sample sizes, ground truth, and expert adjudication for a prospective study is largely not applicable (N/A) in this specific context, as the approval route is substantial equivalence rather than a new clinical efficacy study.

However, I can extract the relevant information regarding the device's intended use, which would implicitly define its performance domain.

Here's a breakdown of the requested information based only on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission based on substantial equivalence, explicit quantitative acceptance criteria for this new device and reported performance for this specific device from a standalone clinical trial are not presented. The "performance" is implicitly tied to the predicate device's established performance, assuming the modifications do not negatively impact it.

2. Sample size used for the test set and the data provenance

• Sample size for test set: N/A (No specific test set for efficacy or performance described in this 510(k) summary for the Cobra Hand Piece itself; relies on substantial equivalence to predicate device's prior approvals).
• Data provenance: N/A (Not specified for a new clinical study. The existing TUNA System would have had data from its prior approvals, but not detailed here for the Cobra Hand Piece).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: N/A
• Qualifications of experts: N/A

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication method: N/A

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

• MRMC study done: No. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device, so MRMC studies involving human readers and AI assistance are not relevant to its approval.
• Effect size: N/A

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

• Standalone study done: N/A. This is a medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of ground truth: N/A (Relies on the established safety and effectiveness of the predicate device).

8. The sample size for the training set

• Sample size for training set: N/A (No algorithm or machine learning training set mentioned).

9. How the ground truth for the training set was established

• Ground truth for training set established: N/A (No algorithm or machine learning training set mentioned).

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The provided document describes a 510(k) submission based on "Substantial Equivalence." This regulatory pathway does not typically involve a new clinical study with explicit acceptance criteria for the new device itself. Instead, the submission argues that the Cobra Hand Piece is a modification to an already legally marketed device (VidaMed's TUNA System and RF Generator) and shares similar features and functions.

The "proof" that the Cobra Hand Piece meets acceptance criteria stems from the fact that its predicate device, the TUNA System, has already been cleared for the treatment of symptomatic BPH in several prior 510(k)s. The current submission for the Cobra Hand Piece asserts that the modifications do not raise different questions of safety and effectiveness compared to the predicate device. Therefore, the device meets its intended use and is deemed substantially equivalent, implying it will perform similarly to the previously approved predicate. No new clinical trials, expert consensus, or specific dataset analyses (as would be typical for AI/diagnostic devices) are detailed in this summary for the Cobra Hand Piece itself.

Ask a specific question about this device

The TUNA 5 Catheter is indicated for use as part of the VIDAMED TUNA System. The VIDAMED TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

The VIDAMED TUNA System includes an RF generator and an accessory catheter for delivery of energy to the patient. The TUNA 5 Catheter contains two electrodes which can be deployed through a cystoscopic sheath at various angles between 0° and various lengths between 14 and 22 mm. The needles are insulated at the base to protect the urethra during ablation of tissue.

This 510(k) summary describes a medical device, the TUNA 5 Catheter, but it does not contain the information requested regarding acceptance criteria and a study proving device performance.

The provided text focuses on:

• Indication: What the device is used for (treatment of BPH).
• Device Description: A brief technical overview of the catheter.
• Substantial Equivalence: How it relates to previously cleared devices.
• Standards/Classifications: Its regulatory class.

To answer your request, information regarding a specific study (e.g., clinical trial, bench test, animal study) conducted for the TUNA 5 Catheter to demonstrate its performance against predefined acceptance criteria would be necessary. This summary does not provide details about:

1. Acceptance Criteria and Reported Device Performance: There is no table of specific performance metrics (e.g., efficacy rates, safety outcomes, technical success rates) or corresponding acceptance thresholds.
2. Sample Sizes and Data Provenance: No mention of any study participants, test sets, or data sources.
3. Experts for Ground Truth: No studies are described that would require expert adjudication.
4. Adjudication Method: Not applicable as no adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned; this device is a physical catheter, not an AI diagnostic tool.
6. Standalone Performance: Not applicable for this type of device.
7. Type of Ground Truth: Not applicable as no diagnostic or predictive study is described.
8. Training Set Sample Size: Not applicable as this is not an AI/ML device requiring training.
9. Ground Truth for Training Set: Not applicable.

Therefore,Based on the provided 510(k) summary for the TUNA® 5 Catheter, none of the requested information regarding acceptance criteria and a study proving device performance is available.

The summary describes the device's indications, physical characteristics, and its substantial equivalence to previously cleared devices. It does not include details about specific performance metrics, clinical study designs, sample sizes, ground truth establishment, or expert involvement, which are typically found in sections discussing clinical data or performance testing.

To fulfill your request, you would need to consult other sections of the 510(k) submission, such as the "Performance Data" or "Clinical Data" sections, if they exist for this device, which would detail any studies conducted to support its safety and effectiveness.

Ask a specific question about this device

The VIDAMED Model 7600 RF Generator is indicated for use as part of the VIDAMED TUNA System to deliver RF energy and record patient treatment data. The VIDAMED TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

The VIDAMED Model 7600 RF Generator is capable of delivering up to 30W (15W/channel) of RF energy and is designed for use with VIDAMED accessory electrodes including the TUNA Catheter. When used with VIDAMED accessory electrodes, the VIDAMED Model 7600 RF Generator is capable of reading, recording, and storing data obtained from thermocouple sensors within the electrode. Software within the RF generator and controls the RF energy output to the tissue.

This 510(k) summary describes a medical device, the VIDAMED Model 7600 RF Generator, which is indicated for use in treating benign prostatic hyperplasia (BPH). However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria related to its clinical efficacy or performance in terms of diagnostic accuracy, sensitivity, specificity, or similar metrics.

This document is focused on demonstrating substantial equivalence to previously cleared devices (VIDAMED Model 7205 RF Generator and VIDAMED Model 7312 RF Generator Data Recorder) and compliance with electrical safety standards (ANSI, AAMI, UL). This is a common approach for 510(k) submissions where the new device is substantially similar to an existing one, and thus, extensive new clinical performance studies are often not required to demonstrate safety and effectiveness for predicate devices.

Therefore, I cannot provide the requested information for the following items based solely on the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not define numerical acceptance criteria for clinical performance (e.g., success rates of BPH treatment, or specific device output parameters that define success). It primarily describes the capabilities of the device (delivering RF energy, recording data) and its indication for use.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical performance study with a test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. The device is an RF generator, not a diagnostic imaging device typically associated with MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an RF generator used by a clinician, not a standalone algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What can be inferred from the document regarding "acceptance criteria" and "study" in a broader sense:

The "acceptance criteria" for the submission itself are primarily related to demonstrating:

• Substantial Equivalence: The primary "study" or justification provided is the comparison of the Model 7600 RF Generator to the predicate devices (Model 7205 and Model 7312). The "acceptance criterion" here is that the new device does not raise new questions of safety or effectiveness and performs as intended, similar to the cleared predicate devices. The document explicitly states it "is substantially equivalent" to the two previously cleared devices.
• Compliance with Electrical Safety Standards: The document states the device "is designed to be in compliance with ANSI, AAMI and UL electrical safety standards." This implies that testing (a form of "study") was performed or design specifications were met to ensure electrical safety. The "acceptance criterion" would be meeting the specifications outlined in those standards.

In summary, the provided text is a summary for a 510(k) submission focused on substantial equivalence and regulatory compliance for a device that delivers RF energy. It does not include the type of performance metrics, study designs, or ground truth information typically associated with evaluating a diagnostic or AI-driven device's clinical performance against specific acceptance criteria.

Ask a specific question about this device

The VIDAMED RF Generator Data Recorder is indicated for use in recording patient treatment data when used in conjunction with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator. The data recorder software does not control or effect the output of power from the RF Generator, nor is it intended to be used in the treatment or diagnosis of any disease.

The VIDAMED RF Generator Data Recorder is designed for use with VIDAMED RF Generators such as the VIDAMED Model 7205 RF Generator. When used with VIDAMED RF Generators, the VIDAMED RF Generator Data Recorder Software is capable of recording the lesion temperature, proximal shield (urethral) temperature, needle impedance, power delivered, and total energy delivered.

The provided text describes a medical device, the "VIDAMED RF Generator Data Recorder," and its intended use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth, or expert involvement for the purpose of validating performance.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study report. The key points from the provided text are:

• Indication: Records patient treatment data when used with VIDAMED RF Generators.
• Function: Records lesion temperature, proximal shield (urethral) temperature, needle impedance, power delivered, and total energy delivered.
• Limitation: The software does not control or affect the output of power from the RF Generator and is not intended for treatment or diagnosis.
• Substantial Equivalence: It is an accessory to the VIDAMED Model 7205 RF Generator (K955035).

Therefore, I cannot provide the requested information based on the input text. The text explicitly states: "No performance standard(s) or special controls applicable to this device have been promulgated under Section 514 of the Act," which further implies that a specific performance study with acceptance criteria, as one might find for a diagnostic or therapeutic device, is not detailed here.

To answer your questions, I would need a different type of document, such as a clinical study report, a validation study report, or a detailed performance specification document for the device.

Ask a specific question about this device

The TUNA System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cc.

The TUNA® System consists of the TUNA® 3 Catheter, the VIDAMED Model 7205 RF Generator, the VIDAMED Return Electrode, the VIDAMED Rectal Monitoring Tape, and the TUNA® Optics.

The electrosurgical generator is capable of delivering up to 30W (15W / channel) of power and is designed for use with VIDAMED accessory electrodes including the TUNA® 3 Catheter. When used with VIDAMED accessory electrodes, the electrosurgical generator is capable of reading temperature from thermocouple sensors within the electrode and controlling power output to the tissue.

The provided text is a 510(k) summary for the VIDAMED TUNA® (Trans Urethral Needle Ablation) System, which is a medical device for treating benign prostatic hyperplasia (BPH). This document describes the device, its indication, and its substantial equivalence to other devices.

However, it does not contain any information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies related to device performance.

The summary states: "Confirmatory clinical data is also provided to support the safety and effectiveness of the device for use in the treatment of symptoms due to urinary outflow obstruction secondary to BPH." However, it does not detail the specifics of this clinical data or how it relates to acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information as the input text does not contain it.

Ask a specific question about this device