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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 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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