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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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(81 days)
The UroLift System Rigid Retrieval Kit Sterilization Tray is intended to enclose and protect surgical instruments optionally used for the UroLift System procedure for storage and sterilization in a prevacuum steam sterilizer. The following instruments are intended to be loaded into the UroLift System Rigid Retrieval Kit Sterilization Tray: · UL-SCOPE4-0 / UL-SCOPE4-0-FE* - Cystoscope, 4.0 mm diameter x 302 mm length, 0° angle of view, wide angle - · UL-GRASP-R Optical Graspers, double action jaws - · UL-SCI-R Optical Scissors, double action jaws * Factory Exchange: Devices with a part number ending in "FE" have been repaired to meet product specifications. The tray by itself is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, 510(k) cleared sterilization wrap to maintain sterility of the enclosed instruments when sterilized using the following prevacuum steam sterilization cycles: Prevacuum Steam Temperature: 132°C (270°F) Sterilization time: 4 minutes Minimum dry time: 30 minutes Maximum weight: 5 lbs (2.7 kg)
The UroLift System Rigid Retrieval Kit Sterilization Tray is a rigid containment device consisting of a base with lid which enables reprocessing of surgical instruments that are optionally used in the UroLift System Procedure.
The document describes the acceptance criteria and the results of non-clinical studies for the UroLift® System Rigid Retrieval Kit Sterilization Tray.
1. Table of Acceptance Criteria and Reported Device Performance:
| Title of Test | Purpose of Test | Acceptance Criteria / Source of References | Reported Device Performance |
|---|---|---|---|
| Usability Testing | Assured that the user could perform the steps of the Instructions for Use (IFU) to meet the intended use of the sterilization tray and that the tray performed as intended to securely store and sterilize the instruments. | The user is able to load and unload the tray, perform the reprocessing workflow (Clean the tray, inspect the tray, clean and inspect the instruments, and load the tray and sterilize), and determine the end of the serviceable life of the tray. | |
| ANSI/AAMI ST77:2013 – Containment devices for reusable medical device sterilization | Pass | ||
| Cytotoxicity Testing | Evaluate the cytotoxicity of a test article extract using an in vitro mammalian cell culture test. | The test sample meets the requirements of the test if the biological response is less than or equal to grade 2 (mild). | |
| Cytotoxicity testing per ISO 10993-5:2009 – Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | Pass | ||
| Sensitization Testing | Evaluate the potential of the test article to cause delayed dermal contact sensitization in the guinea pig maximization test. | Grades of 1 or greater observed in the test group generally indicate sensitization, provided that grades of less than 1 are observed on the control animals. If grades of 1 or greater are noted on control animals, then the reactions of test animals that exceeded the most severe control reaction will be considered to be due to sensitization. | |
| Sensitization testing per ISO 10993-10:2010 – Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | Pass | ||
| Intracutaneous Reactivity Testing | Evaluate the local dermal irritation of a test article extract following intracutaneous injection in rabbits. | The difference of overall mean of the test group to the control group on erythema and edema score must be less than 1. | |
| Intracutaneous Reactivity testing per ISO 10993-10:2010 – Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | Pass | ||
| Useful Life Testing | Determine the serviceable life span of the tray after being subject to 100 cleaning and sterilization cycles per the IFU reprocessing directions. | The tray must pass the inspection criteria on the IFU after 100 reprocessing cycles. | |
| ANSI/AAMI ST77:2013 – Containment devices for reusable medical device sterilization | Pass | ||
| Cleaning Validation | Validate that the cleaning instructions listed in the IFU appropriately clean the tray to ensure the sterilization cycle will be effective. | Per the protocol, there were three acceptance criteria: protein residual analysis, hemoglobin residual analysis, and visual inspection. The protein residual benchmark level was 6.4µg/cm² and the hemoglobin benchmark level was 2.2µg/cm². The tray must pass the visual inspection in the IFU. | |
| AAMI TIR30: 2011/(R)2016, A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices revised 15 December 2016 | |||
| Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff issued 17 March 2015 | Pass | ||
| Sterilization Validation | Validate that the sterilization instructions listed in the IFU appropriately sterilize the tray and contents. | The minimum sterility assurance level (SAL) of 10-6 can be achieved if the sterilization instructions in the IFU were followed. | |
| ANSI/AAMI ST77:2013, Containment devices for reusable medical device sterilization | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each test in terms of the number of devices or data points beyond "100 cleaning and sterilization cycles" for Useful Life Testing. The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer (NeoTract, Inc.), so the data provenance would be from internal testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in a way that is applicable to typical "ground truth" establishment for AI/ML devices. The tests described are engineering/performance validations, not clinical studies requiring expert interpretation of results for ground truth. The "acceptance criteria" themselves serve as the standard by which the device's performance is judged.
4. Adjudication Method for the Test Set:
Not applicable to these non-clinical performance and biocompatibility tests. The "Pass" results are based on meeting predefined quantitative and qualitative acceptance criteria specified by relevant standards (e.g., ISO, AAMI).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a non-clinical device (sterilization tray) and does not involve AI or human readers for diagnostic purposes.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a non-AI medical device.
7. Type of Ground Truth Used:
The "ground truth" for these non-clinical tests is based on:
- Predefined performance specifications and acceptance criteria derived from established industry standards (e.g., ANSI/AAMI ST77:2013, ISO 10993 series, AAMI TIR30: 2011/(R)2016).
- Laboratory measurements (e.g., protein and hemoglobin residuals, biological responses in cell cultures/animals).
- Visual inspection criteria.
8. Sample Size for the Training Set:
Not applicable. This is a non-AI medical device and does not involve machine learning models with training sets.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As noted above, this is a non-AI device.
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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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(197 days)
The UroLift System Procedure Kit Sterilization Tray is intended to enclose and protect surgical instruments used for the UroLift System Procedure for storage and sterilization in a pre-vacuum steam sterilizer.
The following instruments are intended to be loaded into the UroLift System Procedure Kit Sterilization Tray:
- UL-SCOPE / UL-SCOPE-FE Cystoscope, 2.9 mm diameter x 365 mm length, 0° angle of view, 85° field of view
- UL-SHEATH / UL-SHEATH-FE Sheath, 20 Fr., with 2 tube connectors (Luer lock and Luer lock with stopcock)
- UL-VO / UL-VO-FE Visual obturator, 20 Fr.
The tray by itself is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed. validated, 510(k) cleared sterilization wrap to maintain sterility of the enclosed instruments when sterilized using the following pre-vacuum steam sterilization cycles:
132 °C Pre-vacuum Steam Cycle Exposure temperature: 270 °F (132 °C) Exposure time: 4 minutes Vacuum dry time: 30 minutes
134 ℃ Pre-vacuum Steam Cycle Exposure temperature: 273 °F (134 °C) Exposure time: 3 minutes Vacuum dry time: 20 minutes
The maximum weight of the tray is 1.8kg / 4lbs.
The UroLift System Procedure Kit Sterilization Tray is a rigid containment device consisting of a base with lid which enables reprocessing of the surgical instruments used in the UroLift System Procedure.
The UroLift® System Procedure Kit Sterilization Tray is a rigid containment device for surgical instruments, intended for storage and sterilization in a pre-vacuum steam sterilizer. The device was evaluated through non-clinical testing including usability, biocompatibility, cleaning, and sterilization testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Title of test | Purpose of test | Acceptance Criteria / Source of references | Results |
|---|---|---|---|
| Usability Testing | Assured that the user could perform the steps of the Instructions for Use to meet the intended use of the sterilization tray and that the tray performed as intended to securely store and sterilize the instruments. | The user is able to load and unload the tray, perform the reprocessing workflow (clean the tray, inspect the tray, clean and inspect the instruments, and load the tray and sterilize), and determine the end of the serviceable life of the tray. ANSI/AAMI ST77:2013 - Containment devices for reusable medical device sterilization. | Pass |
| Cytotoxicity Testing | Evaluated the cytotoxicity of a test article extract using an in vitro mammalian cell culture test. | The test sample meets the requirements of the test if the biological response is less than or equal to grade 2 (mild). Cytotoxicity testing per ISO 10993-5:2009 – Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. | Pass |
| Sensitization Testing | Evaluated the potential of the test article to cause delayed dermal contact sensitization in the guinea pig maximization test. | Grades of 1 or greater observed in the test group generally indicate sensitization, provided that grades of less than 1 are observed on the control animals. If grades of 1 or greater are noted on control animals, then the reactions of test animals that exceeded the most severe control reaction will be considered to be due to sensitization. Sensitization testing per ISO 10993-10:2010 – Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. | Pass |
| Intracutaneous Reactivity Testing | Evaluated the local dermal irritation of a test article extract following intracutaneous injection in rabbits. | The difference of overall mean of the test group to the control group on erythema and edema score must be less than 1. Intracutaneous Reactivity testing per ISO 10993-10:2010 – Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. | Pass |
| Useful Life Testing | Determined the serviceable lifespan of the tray by subjecting it to 100 cleaning and sterilization cycles. | The tray must pass the inspection criteria on the IFU after 100 reprocessing cycles. ANSI/AAMI ST77:2013 - Containment devices for reusable medical device sterilization. | Pass |
| Cleaning Validation | Validated that the cleaning instructions in the Instructions for Use appropriately clean the tray to ensure the sterilization cycle will be effective. | Per the protocol, there were three acceptance criteria: protein residual analysis, hemoglobin residual analysis, and visual inspection. The protein residual benchmark level was 6.4µg/cm², and the hemoglobin benchmark level was 2.2µg/cm². The tray must pass the visual inspection in the IFU. AAMI TIR30: 2011/(R)2016 and Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff issued 17 March 2015. | Pass |
| Sterilization Validation | Validated that the sterilization instructions in the Instructions for Use appropriately sterilize the tray and contents. | The minimum sterility assurance level (SAL) of 10-6 can be achieved if the sterilization instructions in the IFU were followed. ANSI/AAMI ST77:2013, Containment devices for reusable medical device sterilization. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify the exact sample sizes for each test in the test set (e.g., number of units tested for usability, number of samples for biocompatibility). The testing is described as non-clinical in nature. The provenance of the data is manufacturer-generated (NeoTract, Inc.) through non-clinical design verification testing. It is retrospective in the sense that the testing was conducted on the device to demonstrate conformance to pre-defined criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not explicitly provided. Non-clinical studies like these generally rely on established scientific protocols and standards (e.g., ISO, AAMI) rather than expert consensus on interpretation for ground truth. For "Usability Testing," the evaluation would typically involve trained users or human factors engineers, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
The document does not detail specific adjudication methods as would be typical for clinical studies involving multiple reviewers or subjective assessments. The results are reported as "Pass" or "Fail" based on whether the acceptance criteria were met according to established laboratory methods and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This device is a sterilization tray, not a diagnostic or therapeutic device evaluated for human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is a physical medical device (sterilization tray), not an algorithm or AI system.
7. The Type of Ground Truth Used:
The ground truth for the non-clinical tests was based on:
- Established scientific and regulatory standards: e.g., ISO 10993 for biocompatibility, AAMI ST77 and TIR30 for sterilization and cleaning.
- Predefined acceptance criteria: Specific quantitative (e.g., protein residual levels, SAL) and qualitative (e.g., visual inspection, user performance steps) benchmarks derived from these standards and industry best practices.
- Performance of the device itself through repeated cycles (for useful life testing).
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical device, not an AI or 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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(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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