Search Results
Found 4 results
510(k) Data Aggregation
(272 days)
EDAP Technomed, Inc.
The Focal One device is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue.
The Focal One® is an evolution from the previous generation device, designed by EDAP: Ablatherm Integrated Imaging (K153023) and Ablatherm Fusion (K172285). The Focal One® consists of the Focal One® module with a software control system, an endorectal dynamic focusing probe, a leg holder, a set of single use disposables and a coupling liquid pouch.
The Focal One® module consists of a motorized and manual endorectal dynamic focusing probe positioning unit, a RF amplifier to power the transducer, a computer to control device operation, a cooling system to cool Ablasonic (coupling liquid) and built-in safety features. It also allows the user to control the treatment while providing different user interfaces: two dual touch-screens, mouse, keyboard and printer. The Focal One® energy is delivered via an endorectal dynamic focusing probe, which includes an imaging system. The high-energy ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the focal area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The endorectal dynamic focusing probe is attached to a support, enabling movements in the longitudinal, transverse, vertical and angular directions, and in rotation. A coupling liquid pouch (Ablasonic®) included in the FocalPak disposable kit, attached to a stand, maintained at a controlled temperature flows continuously (via a peristaltic pump) into the balloon to preserve the rectal wall from heating associated with the treatment. The module is mounted on four multidirectional wheels allowing an easy positioning of the device in the treatment room.
The document describes the Focal One device, a high-intensity focused ultrasound (HIFU) system for prostate tissue ablation, and its substantial equivalence to predicate devices (Ablatherm Integrated Imaging and Sonablate) for 510(k) clearance. The provided text, however, does not contain a specific table detailing "acceptance criteria" for the device's performance followed by reported device performance against those criteria. Instead, it presents clinical data as evidence for the device's safety and effectiveness to support substantial equivalence.
Based on the information provided in the document, here's an attempt to answer your request, focusing on the evidence presented to demonstrate the device's performance, even without a formal "acceptance criteria table":
The study described is a clinical report summarizing data on subjects treated with the Focal One® HIFU device to provide evidence of the safety and effectiveness of the ablation of prostate tissue.
1. A table of acceptance criteria and the reported device performance
As mentioned, the document does not explicitly state predetermined "acceptance criteria" in a table format that the device had to meet. However, it presents clinical outcomes that serve as performance metrics to demonstrate efficacy and safety. These would implicitly be the "performance targets" or "evidence of effectiveness" that the FDA considered acceptable for substantial equivalence.
Here's an interpretation of the performance metrics and the reported device performance:
| Performance Metric (Implicit Acceptance Criteria) | Reported Device Performance (Clinical Study Results) |
|---|---|
| Prostate Volume Reduction | Demonstrate significant reduction in prostate volume post-HIFU. |
| Reported: Prostate volume reduced from 49.8 ± 23.1 mL (median 44.0 mL) to 38.6 ± 25.5 mL (median 31.5 mL) for paired cases (n=78). This represents a 22.7% reduction (95% CI 17.6%; 27.8%), with p |
Ask a specific question about this device
(67 days)
EDAP TECHNOMED, INC.
The Ablatherm® Fusion device is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue.
The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The system consists of the following main sub-assemblies: Therapy Control Module, Endorectal Probe, and consumable Ablapak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
The provided text is a 510(k) summary for the Ablatherm® Fusion device, which is an add-on feature, not a standalone AI device. Therefore, a direct response to all requested fields about standalone AI performance or MRMC studies is not fully applicable. However, I will extract the relevant information regarding the performance data provided to support the 510(k) submission for the AblaFusion feature, which allows for elastic fusion between MR images/biopsies locations and ultrasound.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices and does not explicitly list "acceptance criteria" in a quantitative performance metric format for the AblaFusion feature. Instead, it states that "Fusion accuracy assessment through bench testing" was provided. The key "performance" for the AI/fusion component is the ability to perform elastic fusion accurately.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fusion accuracy | Demonstrated through bench testing (Specific quantitative metrics are not detailed in this summary). The device "performs as intended." |
2. Sample size used for the test set and the data provenance:
The document mentions "bench testing" for fusion accuracy assessment. It does not specify:
- The sample size of cases/images used for this bench testing.
- The data provenance (e.g., country of origin of data).
- Whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the use of experts to establish ground truth for the fusion accuracy assessment. Bench testing typically involves comparison against known physical phantoms or simulated data with precise, known transformations, rather than expert-derived ground truth.
4. Adjudication method for the test set:
Not applicable, as expert-driven ground truth establishment is not mentioned.
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 MRMC comparative effectiveness study is mentioned for the AblaFusion feature. The submission focuses on device safety and effectiveness in the context of substantial equivalence, not on quantifying human reader improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The "Fusion accuracy assessment through bench testing" could be considered a standalone assessment of the algorithmic component's performance, as it likely evaluates the accuracy of the fusion process itself. However, specific standalone metrics like sensitivity, specificity, or AUC are not provided in this summary.
7. The type of ground truth used:
For the fusion accuracy assessment (bench testing), the ground truth was likely established using physical phantoms or simulated data with known, precise transformations that the fusion algorithm was expected to replicate. The document does not explicitly state "pathology" or "outcomes data" for this specific feature's ground truth.
8. The sample size for the training set:
The document does not provide information on the sample size used for training the AblaFusion software for elastic fusion.
9. How the ground truth for the training set was established:
The document does not provide information on how the ground truth for the training set was established.
Ask a specific question about this device
(22 days)
EDAP TECHNOMED, INC.
The Ablatherm® Integrated Imaging device is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue.
The Ablatherm Integrated Imaging is a computer controlled medical device intended to provide High Intensity Focused Ultrasound (also referred as HIFU) to ablate prostate tissue. The system consists of the following main sub-assemblies: Treatment Module, Control Module, Endorectal Probe, and Ablapak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures.
The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.
Acceptance Criteria and Device Performance Study for Ablatherm Integrated Imaging
The provided document describes the Ablatherm Integrated Imaging device, indicated for transrectal high-intensity focused ultrasound (HIFU) ablation of prostate tissue. The study presented is a clinical study designed to demonstrate the device's effectiveness through measures of prostate tissue ablation and patient outcomes.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for a 510(k) premarket notification, formal "acceptance criteria" for performance are not explicitly stated in the same way they might be for a PMA. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Sonablate 450) and providing clinical evidence of the device's ability to achieve its intended purpose (prostate tissue ablation) and its safety profile.
Therefore, the table below consolidates the performance metrics presented as evidence of the device meeting its intended use for prostate tissue ablation and the associated clinical outcomes.
| Performance Metric (Indicative of Acceptance) | Reported Device Performance (Ablatherm Integrated Imaging) | Notes/Context |
|---|---|---|
| Prostate Tissue Ablation | ||
| Mean Prostate Volume Reduction (post-HIFU vs. baseline) | 13.6 cc (95% CI: 10.9, 16.3) | Measured at first post-HIFU ablation biopsy. Mean post-HIFU volume: 9.0 cc; Baseline mean volume: 22.7 cc. |
| Mean PSA Nadir (first 6 months post-HIFU) | 0.53 ng/mL (95% CI: 0.37, 0.69) | |
| Mean % PSA Reduction from Baseline to Nadir | 87.97% (95% CI: 84.80, 91.15) | |
| PSA Reduction from Baseline (1-month post-HIFU) | 78.14% (95% CI: 72.95, 83.34%) | Mean PSA: 0.89 ng/mL |
| PSA Reduction from Baseline (1-year post-HIFU) | 80.34% (95% CI: 75.77, 84.91) | Mean PSA: 0.91 ng/mL |
| PSA Reduction from Baseline (2-year post-HIFU) | 82.25% (95% CI: 77.61, 86.89%) | Mean PSA: 0.72 ng/mL |
| Phoenix Biochemical Survival Rate | 90.5% (95% CI: 85.2, 95.8%) (116 evaluable subjects) | Defined as: No PSA between 6 and 24 months post-HIFU procedure ≥ PSA Nadir + 2 ng/ml. |
| Negative Post-Ablation Biopsy Rate | 59% (95% CI: 50, 68) (Total cohort of 135 patients) | For ITT analysis, 17 patients without biopsy were considered "positive". |
| Safety Profile (Adverse Events) | (All adverse events collected regardless of relationship to device/procedure, n=135) | |
| Any Adverse Event | 97.0% | |
| Erectile Dysfunction | 67.4% (61/135 unresolved at 2 years) | 12/61 subjects had pre-HIFU ED; 9/61 unresolved ED were mild. Expected due to targeting lateral margins. |
| Urinary Incontinence | 38.5% (21/135 unresolved at 2 years) | 16/21 unresolved UI were mild. |
| Urinary Obstruction (unresolved at 2 years) | 0.7% (1 subject) | |
| Stricture (unresolved at 2 years) | 2.2% (3 subjects) | |
| Bladder Neck Contracture (unresolved at 2 years) | 1.5% (2 subjects) | |
| Sepsis (unresolved at 2 years) | 0.7% (1 subject) | Two cases of sepsis reported, both not considered related to device/procedure. |
| Urinary Tract Infections (resolved within 2 years) | 34.1% (46 subjects) | All resolved within 2 years. |
| Bowel Injury (resolved within 2 years) | 3.0% (4 subjects) | All resolved within 2 years. Includes "anal tears". |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 136 subjects were enrolled, of which 135 subjects underwent the HIFU procedure. One subject was excluded due to calcifications.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be a prospective clinical study (IDE study) where subjects were enrolled and followed over time. The first subject was enrolled on May 4, 2006, and the last on June 30, 2010.
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 of experts used to establish the ground truth or their qualifications. The clinical outcomes (prostate volume reduction, PSA levels, biopsy results, adverse events) were likely assessed by the treating physicians and clinical staff involved in the study, consistent with standard medical practice.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method (e.g., 2+1, 3+1). Clinical data such as PSA levels, prostate volume, and biopsy results are generally based on objective measurements and established clinical diagnostic criteria, rather than subjective expert interpretation requiring adjudication in this context. Adverse events were collected and summarized.
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 MRMC comparative effectiveness study was done. This device is a treatment device (HIFU for prostate ablation), not an AI-assisted diagnostic or imaging interpretation device. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm performance study was reported. This device is a medical instrument used by trained physicians, not an autonomous AI system.
7. The Type of Ground Truth Used
The ground truth used in the clinical study is a combination of:
- Objective Medical Measurements:
- Prostate Volume Reduction: Measured clinically.
- PSA Levels: Standard laboratory test results.
- Biopsy Results: Histopathological analysis (determines presence/absence of cancer cells post-ablation or tissue characteristics).
- Clinical Outcomes/Patient Reported Outcomes:
- Adverse Events: Clinically observed and reported events during follow-up.
These are considered relevant clinical endpoints for evaluating the effectiveness and safety of a prostate ablation device.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of an AI/machine learning model. The clinical study described involved 135 subjects who underwent the HIFU procedure, which served as the primary clinical evidence for the device's performance in this 510(k) submission. Therefore, it's not applicable to the concept of a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an AI/machine learning algorithm, this question is not applicable. The clinical data used to support the device's effectiveness and safety were gathered prospectively from the 135 subjects undergoing the procedure and evaluated against established clinical benchmarks and adverse event reporting.
Ask a specific question about this device
(88 days)
EDAP TECHNOMED, INC.
Ask a specific question about this device
Page 1 of 1