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510(k) Data Aggregation
(30 days)
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.
The UroLift 2 ATC Advanced Tissue Control System is a modification of the UroLift 2 System (last cleared in K201837). The primary difference is the addition of a wing component on the distal tip of the UroLift 2 ATC Advanced Tissue Control System which provides a larger footprint. This design feature is intended to provide better mobilization of tissue when performing the UroLift System procedure.
The UroLift System (both the UroLift 2 and UroLift 2 ATC) is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift 2 System is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. Multiple implants are deployed in the UroLift 2 System procedure. The implants secure the retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms (LUTS). This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction. The UroLift 2 ATC Advanced Tissue Control System consists of two main components, the UL2 Delivery Handle and the UroLift 2 ATC Implant Cartridge (single use). Each UroLift 2 ATC Implant Cartridge comes pre-loaded with one UroLift Implant. The Delivery Handle with the Implant Cartridge installed is known as the Delivery Device.
This document is a 510(k) summary for a medical device called the UroLift 2 ATC Advanced Tissue Control System. It describes the device's design, intended use, and how it compares to a predicate device and a reference device. It also outlines the performance and biocompatibility testing conducted to demonstrate substantial equivalence.
However, the provided text does not contain information about acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML medical device submission. This document is for a mechanical medical device, specifically an "Implantable Transprostatic Tissue Retractor System," which treats benign prostatic hyperplasia (BPH). The information requested in your prompt (acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are all highly relevant to the evaluation of AI/ML-driven medical devices.
Since the provided text does not describe an AI/ML device or its performance study, I cannot extract the requested information. The document focuses on demonstrating substantial equivalence to a predicate mechanical device through mechanical performance testing, biocompatibility testing, sterilization, and shelf-life testing, not on AI/ML model performance.
Therefore, I cannot populate the table or answer the specific questions about AI/ML device approval from this document.
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(29 days)
The UroLift 2 System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.
The UroLift System is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift System is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. Multiple implants are deployed in the UroLift System procedure. The implants secure the retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms (LUTS). This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction. The UroLift 2 System (UL2), most recently cleared in K173087 under the marketing model number of UL500, is comprised of the UroLift Delivery Handle (single patient use), the UroLift Implant Cartridges (singleuse) and the UroLift Implants (one implant per cartridge). Each Implant Cartridge is preloaded with one UroLift Implant. The Implant Cartridges fit into the Delivery Handle. Each patient procedure will use one dedicated Delivery Handle and the number of Implant Cartridges/implants necessary to perform a typical procedure (estimated 2-6 implants). The UroLift 2 System is also provided with an optional Scope Seal which enables a clinician to examine the anatomy between implant deployments without removal of the telescope from the Delivery Handle.
This document, a 510(k) summary for the NeoTract UroLift 2 System (UL2), describes the device and claims substantial equivalence to predicate devices based on various performance and safety tests. However, it does not contain the level of detail requested regarding specific acceptance criteria, reported device performance metrics against those criteria, or clinical study information typically associated with such criteria (e.g., sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, or standalone algorithm performance).
The available information focuses on non-clinical testing to demonstrate that modifications to the UL2 system do not impact its safety and effectiveness compared to previously cleared versions.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Product Performance Testing | "All acceptance criteria were met." (Details of specific criteria and quantitative results not provided). |
| Compatibility Testing | "All acceptance criteria were met." (Details of specific criteria and quantitative results not provided). |
| Deployment Testing | "All acceptance criteria were met." (Details of specific criteria and quantitative results not provided). |
| Biocompatibility Testing (e.g., Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity) | "The UroLift 2 System has been tested for biocompatibility and passed the relevant tests according to ISO 10993-1: Biological evaluation of medical devices..." (Details of specific criteria and quantitative results not provided). |
| Sterilization Assurance Level (SAL) | "The UroLift System has been validated to determine the minimum gamma irradiation dose to ensure a 10⁻⁶ Sterility Assurance Level (SAL)." (Specific method and outcome for UL2 modifications mentioned as new sterilization performed). |
| Shelf-Life Testing (12 months) | "Device functional testing was performed in a manner equivalent to the predicate to ensure the device functioned as intended after the stated shelf life of 12 months." (Details of criteria and specific functional performance not provided). |
Note: The document explicitly states, "The test methods were equivalent to the previously cleared UroLift System, and all acceptance criteria were met." However, it does not detail what those specific acceptance criteria were or provide quantitative results for the UL2 system against them. The focus is on demonstrating that the modifications did not negatively impact safety and effectiveness, implying the new device meets the same standards as its predicates.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document describes non-clinical performance, biocompatibility, and sterilization testing. It does not mention any clinical test sets with data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This type of information is usually relevant for studies involving human interpretation or clinical outcomes, not for the non-clinical engineering and biological tests described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Similar to point 3, this is for clinical assessments, not the laboratory testing presented.
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/Not provided. This device is an implantable medical device for treating BPH, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. The device does not involve an algorithm or AI in the sense of standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implicit ground truth from engineering and safety standards. For non-clinical tests:
- Product Performance/Compatibility/Deployment: Ground truth implicitly derived from established engineering specifications and functional requirements for the device's design and operation.
- Biocompatibility: Ground truth is established by the International Standard ISO 10993-1 and related sub-parts, which define acceptable biological responses.
- Sterilization: Ground truth is a 10⁻⁶ Sterility Assurance Level (SAL), an industry-standard for sterile medical devices.
- Shelf-life: Ground truth is the ability of the device to function as intended after a specified storage period (12 months).
8. The sample size for the training set
- Not applicable/Not provided. No training set for an algorithm is mentioned as this is a physical medical device.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No training set is mentioned.
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(102 days)
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.
The UroLift Advanced Tissue Control (ATC) System is a modification of the UroLift UL400 System (last cleared in K193269). The primary difference is the addition of a wing component on the distal tip of the UL400 which provides a larger footprint. This design feature is intended to provide better mobilization of tissue when performing the UroLift System procedure.
The UroLift System (both the UL400 and UroLift ATC) is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift System is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. Multiple implants are deployed in the UroLift System procedure. The implants secure the retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms (LUTS). This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction. The UroLift System consists of two main components, the UroLift Delivery Device (single use), and the UroLift Implants (one implant per delivery device). Each Delivery Device comes pre-loaded with one UroLift Implant.
The provided text is a 510(k) summary for the UroLift Advanced Tissue Control (ATC) System. It describes the device, its intended use, comparison to a predicate device, and performance testing. However, this document does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-driven medical device, nor does it discuss ground truth establishment, expert review, or multi-reader multi-case studies.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing (deployment, compatibility, implant/shaft/wing performance), biocompatibility, sterilization, and shelf-life testing. These are typical engineering and safety tests for a physical medical device, not a software algorithm with diagnostic or prognostic capabilities.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the context of AI/ML or diagnostic performance, nor can I answer the questions about sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.
The document explicitly states:
- "The design requirements for the UroLift System were reviewed and non-clinical design verification testing was required to assure that the modifications of the proposed device did not impact the safe and effective use of the device."
- "Non-clinical testing included deployment testing, compatibility with accessories, and implant, shaft, and wing performance testing."
- "The majority of the test methods were equivalent to the testing for the 510(k) cleared UroLift UL400 System (K193269), and all acceptance criteria were met."
This indicates that the "acceptance criteria" referred to are related to the physical performance and safety of the device, not its diagnostic accuracy or human-in-the-loop performance in an AI/ML context.
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(24 days)
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.
The UroLift System is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift System is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. Multiple implants are deployed in the UroLift System procedure. The implants secure the retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms (LUTS). This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction. The UL400 (most recently cleared in K173087), consists of two main components, the UroLift Delivery Device (single use), and the UroLift Implants (one implant per delivery device). Each Delivery Device comes pre-loaded with one UroLift Implant.
This document is a 510(k) summary for the UroLift System (UL400) by NeoTract, Inc. It describes a submission concerning a modification to a contraindication, specifically increasing the maximum prostate volume from >80 cc to >100 cc for patients indicated for treatment with the UroLift System.
Based on the information provided in the document, here's a description of the acceptance criteria and the study that proves the device meets them, specifically regarding the change in contraindication:
Acceptance Criteria and Study for Modified Contraindication (Increased Prostate Volume)
The core of this submission is not about proving a new device's performance from scratch, but rather demonstrating that a modification to a contraindication (increasing the prostate volume limit) does not negatively impact the device's established safety and effectiveness. Therefore, the "acceptance criteria" and "study" described herein are focused on demonstrating non-inferiority or equivalence of outcomes in the expanded patient population.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for expanded prostate volume) | Reported Device Performance (as demonstrated by clinical literature review) |
|---|---|
| Device Performance Equivalence (Safety & Effectiveness): | Outcomes (from sponsored and independent clinical studies): |
| - Symptom response in patients with prostate volumes >80cc is equivalent to those with prostate volumes 80cc is equivalent to those with prostate volumes 80cc are equivalent to those with prostate volumes 80cc are equivalent to those with prostate volumes 80cc are equivalent to those with prostate volumes 80cc is established by the aggregate findings and conclusions of the respective clinical studies included in that review. |
- The document does not specify the number of experts, their qualifications, or their role in reviewing the literature for this specific submission. The "review" itself would have been conducted by the sponsor's clinical/regulatory team, and ultimately evaluated by the FDA.
4. Adjudication Method for the Test Set
- Given that the evidence is based on a "clinical literature review" rather than a de novo test set with expert reads, there is no explicit adjudication method described for this submission. The "adjudication" effectively comes from the scientific rigor and peer review (if published) of the underlying studies themselves, and the FDA's assessment of the presented literature review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done for this specific 510(k) submission. This submission is focused on a change to a contraindication based on existing clinical evidence, not on evaluating the performance of an AI model or the improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The UroLift System is a medical device (implantable system), not an AI algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for the claim that outcomes (symptom response, quality of life, uroflowmetry, adverse events, catheterization rates) are equivalent for patients with prostate volumes >80cc compared to those
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(30 days)
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.
The UroLift System is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift System is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. Multiple implants are deployed in the UroLift System procedure. The implants secure the retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms (LUTS). This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction. The UL400 (most recently cleared in K173087), consists of two main components, the UroLift Delivery Device (single use), and the UroLift Implants (one implant per delivery device). Each Delivery Device comes pre-loaded with one UroLift Implant.
The provided document describes a 510(k) submission for the UroLift System (UL400) by NeoTract, Inc. This submission focuses on minor device modifications and asserts substantial equivalence to a previously cleared predicate device (K173087).
Crucially, this document focuses on non-clinical performance testing and does not describe a study involving patient data, ground truth establishment, or clinical outcomes that would typically be associated with AI/ML device performance. The acceptance criteria and "device performance" discussed here pertain to engineering and material testing, not diagnostic or predictive accuracy.
Therefore, many of the requested sections (sample size for test/training sets, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, type of ground truth) are not applicable to the information provided in this regulatory submission.
Here is the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Deployment Testing | Not explicitly stated, but implied to ensure safe and effective deployment. | "All acceptance criteria were met." |
| Needle Depth Testing | Not explicitly stated, but implied to ensure correct tissue penetration. | "All acceptance criteria were met." | |
| Urethral End-piece to Suture Joint Strength | Not explicitly stated, but implied to ensure structural integrity. | "All acceptance criteria were met." | |
| Needle Spool to Right Case wall gap testing | Not explicitly stated, but implied to ensure proper assembly and function. | "All acceptance criteria were met." | |
| Biocompatibility | General Biocompatibility Testing | Compliance with ISO 10993-1: Biological evaluation of medical devices. | "Passed the relevant tests according to ISO 10993-1." |
| Sterility | Sterilization Validation | Minimum gamma irradiation dose to ensure a 10⁻⁶ Sterility Assurance Level (SAL). | "Confirmed that the modification did not impact product sterility." |
| Aging/Transit | Impact of sterilization, accelerated aging, and transit | Not explicitly stated, but implied that all mechanical tests were performed on devices subjected to these conditions, and acceptance criteria were met after these conditions. | "All acceptance criteria were met" even after worst case sterilization, accelerated aging, and transit testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The described tests are non-clinical engineering and material tests, not clinical studies with patient data. Therefore, there is no "test set" in the context of diagnostic performance or patient data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth in the context of expert consensus for diagnostic performance is not relevant to this type of device modification submission. The "ground truth" here would be the physical properties and performance metrics defined in engineering standards and specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used in clinical studies for resolving discrepancies in expert interpretations, which is not relevant 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
- Not Applicable. This document pertains to a medical device (UroLift System) for treating BPH, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The UroLift System is a physical medical device, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the tests performed would be defined by engineering specifications, international standards (e.g., ISO 10993-1 for biocompatibility), and established test methods (e.g., for mechanical strength, sterility assurance). This is not related to clinical "ground truth" derived from patient data.
8. The sample size for the training set
- Not Applicable. This submission does not involve an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This submission does not involve an AI/ML device.
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(90 days)
The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.
The UroLift System is designed to access the prostatic urethra and deliver one UroLift Implant through a lobe of the prostate. The UroLift System is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. Multiple implants are deployed in the UroLift System procedure. The implants secure the retracted position of the urethra, thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving lower urinary tract symptoms (LUTS). This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant. The procedure typically requires 2-6 implants to retract the obstruction.
The UroLift System includes two generations of the device, the UL400 and the UL500. Both generations use the same UroLift Implant. The only differences are in the delivery device.
The UL400 (cleared in K133281), consists of two main components, the UroLift® Delivery Device (single use), and the UroLift Implants (one implant per delivery device). Each Delivery Device comes pre-loaded with one UroLift Implant.
The UL500 (UroLift 2 System, cleared in K172359) is comprised of the UroLift® Delivery Handle (single patient reusable), the UroLift Implant Cartridges (single-use) and the UroLift Implants (one implant per cartridge). Each cartridge is pre-loaded with one UroLift Implant. The cartridges fit into the delivery handle. Each patient procedure will use one dedicated handle and the number of cartridges/implants necessary to perform a typical procedure (estimated 2-6 implants). For the UL500, users are also provided with an optional Scope Seal which enables them to examine the anatomy between implant deployments without removal of the telescope from the Delivery Handle.
The provided text describes a 510(k) submission for the UroLift System (UL400 and UL500) and includes information about a clinical study conducted to support its safety and effectiveness, specifically for patients with an enlarged median lobe.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effectiveness Endpoint (at 6 months): The 95% lower confidence limit of the mean percent improvement in subject's International Prostatic Symptom Score (IPSS) over baseline for the UroLift System must be $\geq$ 25%. | Results: At 6 months, the 95% lower confidence limit of the mean percent improvement in subject's International Prostatic Symptom Score (IPSS) over baseline for the UroLift System was 50.8%, which is substantially above the goal of $\geq$ 25%. The mean percent change at 6 months was 57.7%. |
| Safety Endpoint (at 3 months): The composite observed rate of post-procedure device-related serious complications ≤ 15%. Composite device-related serious complications include: de Novo (new) severe urinary retention lasting more than 21 consecutive days post procedure, device-related formation of fistula between the rectum and urethra, perforation of the rectum or GI tract, damage to ureter or ureteral orifices, damage to the trigone requiring surgical repair, or de novo, sustained erectile dysfunction. | Results: The safety endpoint was achieved with 0% (5.7% CI upper limit) meeting criteria within the composite. From 3 to 6 months, there were no reported events that would meet the endpoint criteria. |
2. Sample size used for the test set and the data provenance
- Sample Size: 45 subjects were enrolled in the study.
- Data Provenance: The study was a prospective, multicenter, non-blinded, single-arm study conducted at 9 investigational sites located in the US. It gathered data through 1, 3, 6, and 12 months of follow-up.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The information provided does not specify the number of experts or their qualifications used to establish ground truth for the test set in the conventional sense of image or diagnosis review. Instead, a Clinical Events Committee (CEC) was used for adjudication related to the safety endpoint.
4. Adjudication method for the test set
- Adjudication Method: A Clinical Events Committee (CEC) was responsible for adjudicating adverse events and relevant subject questionnaires to evaluate against the safety endpoint. The specific composition or method (e.g., 2+1, 3+1) of the CEC 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
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focused on the performance of the UroLift System directly on patients, not on human reader performance with or without AI assistance. This device is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The UroLift System is a medical device (implantable system) that is used in a procedure performed by a clinician. Its "performance" is measured by its impact on patient symptoms and safety, not as a standalone algorithm.
7. The type of ground truth used
- Ground Truth: The ground truth for the effectiveness endpoint was based on patient-reported outcomes, specifically the International Prostatic Symptom Score (IPSS).
- The ground truth for the safety endpoint was based on clinical events adjudicated by a Clinical Events Committee against predefined criteria for serious complications.
8. The sample size for the training set
- Training Set Sample Size: The document does not mention a "training set" as this is a clinical trial for a medical device and not an AI/machine learning model that would typically have a training set. The 45 enrolled subjects constitute the study population for evaluating the device's safety and effectiveness.
9. How the ground truth for the training set was established
- This question is not applicable as there was no explicit "training set" in the context of an AI/ML model for this medical device study. The ground truth for evaluating the device's performance was established through the objective measurement of IPSS scores and the adjudication of adverse events by a CEC.
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(14 days)
The UroLift 2 System (UL500) is intended for treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.
The UroLift 2 System (UL500) is comprised of the UroLift® Delivery Handle (single patient reusable), the UroLift Implant Cartridges (single-use) and the UroLift Implants (one implant per cartridge). Each patient procedure will use one dedicated sterile handle and the number of cartridges/implants necessary to perform a successful procedure (estimated 2-6 implants). The cartridges fit into the delivery handle.
The UroLift 2 System (UL500) is designed to access the prostatic urethra and deliver one UroLift Implant through a lateral lobe of the prostate. The UroLift 2 System (UL500) is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. The implants secure the retracted position of the urethra thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving LUTS. This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant.
Minor modifications have been made to the UroLift 2 System (UL500) to improve the device. The overall design, as well as the patient contacting materials, is substantially equivalent to the predicate device.
Users are now provided with an optional Scope Seal which enables them to examine the anatomy between implant deployments without removal of the telescope from the device handle. In addition, a Suture Support Tube has been incorporated into the device to provide additional support to the suture during Implant Cartridge assembly at NeoTract's manufacturing facility.
The provided document describes a 510(k) premarket notification for the UroLift 2 System (UL500), which is a medical device and not an AI/ML powered device. Therefore, the information requested in your prompt about an AI device's acceptance criteria, study details, and related metrics (such as sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance) cannot be found in this document.
The document primarily focuses on establishing substantial equivalence to a predicate device based on:
- Intended Use: Treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.
- Technological Characteristics: Minor modifications (optional Scope Seal, Suture Support Tube) to improve the device, but the overall design and patient-contacting materials are substantially equivalent to the predicate. The UroLift Implant is identical.
- Performance Testing: Testing demonstrated the modified device meets the same performance requirements as the predicate, plus additional requirements for the Scope Seal. The changes do not affect the implant deployment procedure.
Without additional information about an AI/ML component or a separate study describing such, I cannot fulfill your request as it pertains to an AI device.
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(30 days)
UroLift System is intended for treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.
The UroLift System UL500 is comprised of the UroLift® Delivery Handle (single patient resusable), the UroLift Implant Cartridges (single-use) and the UroLift Implants (one implant per cartridge). Each patient procedure will use one dedicated sterile handle and the number of cartridges/implants necessary to perform a successful procedure (estimated 2-6 implants). The cartridges fit into the delivery handle.
The UroLift System UL500 is designed to access the prostatic urethra and deliver one UroLift Implant through a lateral lobe of the prostate. The UroLift System UL500 is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. The implants secure the retracted position of the urethra thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving LUTS. This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant.
I am sorry, but the provided text does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) summary for the UroLift® System UL500, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a comprehensive study for initial device efficacy.
While it mentions "Performance Testing" was conducted, it only states that "the device meets the same performance requirements of the predicate device" and that "the changes made to the device do not affect the implant deployment procedure." It does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details about the test set.
- Information about experts, ground truth establishment, or adjudication methods.
- Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Sample size or ground truth details for a training set.
The document primarily focuses on establishing that modifications to the UroLift System UL500 do not introduce new questions of safety or effectiveness compared to its predicate device, rather than providing a detailed study of its primary efficacy or safety from scratch.
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(91 days)
The UroLift® System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.
The UroLift® System UL500 is comprised of the UroLift® Delivery Handle (single patient reusable), the UroLift® Implant Cartridges (single-use) and the UroLift® Implants (one implant per cartridge). Each patient procedure will use one dedicated sterile handle and the number of cartridges/implants necessary to perform a successful procedure (estimated 2-6 implants). The cartridges fit into the delivery handle. The UroLift Delivery Handles (UL500-H) and UroLift Implant Cartridges (UL500-C) will be sold separately. The UroLift System UL500 Delivery Handles will be sold two per carton and the UroLift System UL500 Implant Cartridges will be sold eight per carton. Both cartons will contain the same UroLift System UL500 Instructions for Use (IFU). The UroLift System UL500 is designed to access the prostatic urethra and deliver one UroLiff Implant through a lateral lobe of the prostate. The UroLift System is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. The UroLift Implant is then deployed transversely through the prostatic tissue. The implants secure the retracted position of the urethra thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving LUTS. This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant.
The provided text does not contain information about specific acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case (MRMC) comparative effectiveness studies, standalone performance, type of ground truth used, or details about the training set for the NeoTract UroLift System UL500.
The document discusses performance testing which included:
- Bench testing (design verification and transit testing) which demonstrated the device meets the same performance requirements as the predicate device.
- Verification of packaging and labeling integrity.
- Bench verification testing of the devices.
- Joint strength testing.
- Design validation performed in a cadaveric model which demonstrated the UroLift System UL500 met customer requirements.
- Biocompatibility testing in accordance with ISO 10993.
- Sterilization and shelf-life testing.
It states that "All acceptance criteria were met" for these tests, but it does not specify what those criteria are or the exact reported performance against those criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed information requested in the prompt based on the provided text. The document is primarily a 510(k) summary demonstrating substantial equivalence to a predicate device based on general performance testing categories.
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(56 days)
The UroLift System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older.
The NeoTract UroLift System comprises two main components, the UroLift Delivery Device and UroLift Implant. Each delivery device comes pre-loaded with one UroLift Implant. The insertion of the UroLift Delivery Device into the male urethra is performed under direct visualization using standard surgical technique, using a standard cystoscopy sheath and telescope. The UroLift Delivery Device is designed to access the prostatic urethra and deliver one UroLift Implant through a lateral lobe of the prostate. The UroLift Delivery Device is inserted into the urethra through the penile orifice and used to displace the urethra toward the prostatic capsule. A UroLift Implant is then deployed transversely through the prostatic tissue. The implants secure the retracted position of the urethra thereby maintaining an expanded urethral lumen, reducing fluid obstruction and improving LUTS. This is accomplished by holding the approximated position of the inner (urethral) tissue and the outer (capsular) tissue of the prostate with the UroLift Implant.
The provided text describes a Special 510(k) submission for minor modifications to the NeoTract UroLift System and does not include a study demonstrating the device meets specific acceptance criteria in terms of clinical performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device (K130651) based on performance testing related to usability and reliability after minor modifications to the delivery device.
Therefore, most of the details requested in your prompt (e.g., specific acceptance criteria for clinical performance, sample size for test sets, number of experts for ground truth, MRMC study results, standalone performance, training set size) cannot be extracted from this document as these types of clinical performance evaluations are typically not conducted for Special 510(k) submissions focusing on minor modifications that do not raise new questions of safety or effectiveness.
However, based on the information provided, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria for clinical performance (e.g., AUA symptom score improvement, Qmax improvement) or reported device performance against such criteria. The "Performance Testing" section states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets same performance requirements as predicate device | Transit and functionality testing demonstrate this requirement is met. |
| Modified device does not affect usability | Usability test results confirm this requirement is met. |
| Modified device can be utilized in the same manner as predicate device | Usability test results confirm this requirement is met. |
2. Sample sized used for the test set and the data provenance
The document mentions "Transit and functionality testing" and "Usability test results" but does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These tests would typically involve a smaller number of devices or simulated use cases to verify engineering specifications rather than a large clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This type of information is typically related to clinical studies or evaluations where expert consensus defines a "ground truth" for diagnostic or prognostic outcomes. The testing described here is focused on the device's mechanical performance and usability, not clinical efficacy or diagnostic accuracy.
4. Adjudication method for the test set
Not applicable, as no clinical test set for ground truth establishment is described.
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. The NeoTract UroLift System is a medical device (implantable transprostatic tissue retractor system) used for treating BPH, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical implant and delivery system, not an algorithm.
7. The type of ground truth used
For the "Transit and functionality testing" and "Usability test results," the "ground truth" would be established by engineering specifications, proper functional operation, and user feedback/observational analysis against defined tasks. It would not be expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
Not applicable. The device is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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