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510(k) Data Aggregation
(61 days)
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(71 days)
UROlogic is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to urologic and endoscopic applications The system may be used for other imaging applications at physician's discretion.
UROlogic is a universal fluoroscopic x-ray diagnostic system intended for use in providing x-ray imaging of patient with an undertable image intensifier. The system consists of a floor mounted tilting patient support table, x-ray generator, xsystem or a sembly, image intensifer and the tv system. The system is operated via tableside control panel, foot/handswitches and x-ray control panel. The system comes with a tripple mode image intensifier, a CCD camera with one frame memory, x-ray tube with housing and an image monitor. The tabletop can be moved motorized in longitudinal and lateral directions. The table can be tilted -15 to +87 degrees. Cranial movement of connected x-ray tube and image intensifer assembly gives the operator the advantage of scanning without moving patient. System has a stationary grid and casette holder for wallow mo films. Patient positioning and other accessories are also provided.
This 510(k) submission pertains to the UROlogic Urological Table, an image-intensified fluoroscopic x-ray system. The document provided does not contain specific acceptance criteria, device performance data, details of a clinical study, or information about AI integration.
The submission focuses entirely on demonstrating substantial equivalence to predicate devices (OEC Uroview 2600 and Liebel-Flarsheim Hydradjust IV) based on technological characteristics and intended use. The FDA letter confirms this substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or AI-related metrics as these are not present in the provided text.
Based on the provided text, here's what can be stated:
1. A table of acceptance criteria and the reported device performance:
- This information is not provided in the given 510(k) summary. The submission focuses on substantial equivalence based on the device's technical specifications and intended use, rather than specific performance metrics against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance:
- This information is not provided. No clinical study data is presented in the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. No clinical study data is presented, and therefore no ground truth establishment for a test set is discussed.
4. Adjudication method for the test set:
- This information is not provided. No clinical study data is 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:
- This information is not provided. The device described is an X-ray table, and the submission makes no mention of AI or software for image interpretation, or human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not provided. No AI algorithm is mentioned or evaluated.
7. The type of ground truth used:
- This information is not provided. No clinical study data is presented requiring ground truth.
8. The sample size for the training set:
- This information is not provided. No AI training is mentioned.
9. How the ground truth for the training set was established:
- This information is not provided. No AI training is mentioned.
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(71 days)
The Apogee Medical,Inc. Urinary Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder
Urinary Catheter
The provided text is a U.S. FDA 510(k) clearance letter for the Apogee Medical, Inc. Urological Catheter. This document does not contain information about acceptance criteria, device performance studies, or details about AI algorithms. It is a regulatory clearance document.
Therefore, I cannot fulfill your request as the necessary information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a device performance study is not present in the provided text.
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(51 days)
BD-3 Catheters are intended for urological dilatation; ureteral and urethral.
Urological Balloon Dilatation Catheter
The provided document is a 510(k) premarket notification for a medical device, specifically the BD-3 Urological Balloon Dilatation Catheters. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical trial data that would establish novel safety and effectiveness.
Therefore, the document does NOT contain the detailed information typically found in studies designed to prove a device meets specific acceptance criteria in the way a clinical trial might. It explicitly states: "The proposed modified device is Substantially Equivalent to the predicate devices in terms of performance characteristics tested." This implies that the device's performance is being benchmarked against existing devices rather than a new set of predefined acceptance criteria for novel claims.
However, I can extract the information available from the document that is relevant to your request, indicating where information is missing for a full answer to your questions.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the document, the "acceptance criteria" for the BD-3 Catheters are implicitly tied to demonstrating Substantial Equivalence to legally marketed predicate devices. The performance reported is that it meets this equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices for indications of use (urological dilatation; ureteral and urethral). | "The proposed modified devices are Substantially Equivalent to devices previously cleared by the FDA via the 510(k) Notification process and indicated for dilatation of the urinary tract." |
| Substantial Equivalence to predicate devices in terms of performance characteristics tested. | "The proposed modified device is Substantially Equivalent to the predicate devices in terms of performance characteristics tested." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a prospective clinical study with human subjects or a defined dataset for algorithm evaluation. The "performance characteristics tested" would typically refer to bench testing or animal studies demonstrating the physical and functional properties of the catheter (e.g., burst pressure, durability, guidewire compatibility), but the specific details (sample sizes, results, and provenance) are not included in this summary.
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document. Given the nature of a 510(k) for a well-established device type, it's likely to involve internal bench testing or possibly data from previous 510(k) clearances for similar predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the document. A 510(k) notification for a physical device like a catheter typically relies on engineering specifications, bench testing, and potentially animal studies to demonstrate safety and performance equivalent to existing devices, not expert human assessment of a "test set" to establish ground truth in the way it would for an AI diagnostic device.
4. Adjudication Method for the Test Set
Not applicable and not provided. See explanation for point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention any MRMC study. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of a 510(k) for a physical medical catheter.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a physical medical device, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. Type of Ground Truth Used
The concept of "ground truth" as it applies to diagnostic algorithms is not directly applicable here. For this device, "truth" would involve demonstrating that the catheter can withstand intended pressures, navigate the urinary tract, and perform its dilatation function as expected and without causing undue harm, similar to predicate devices. This is typically established through:
- Engineering specifications and design verification.
- Bench testing (e.g., burst pressure, tensile strength, fatigue testing).
- Biocompatibility testing.
- Potentially animal studies for in-vivo performance.
- Comparison to the known performance and safety profiles of the predicate devices.
The document states the device is "Substantially Equivalent to the predicate devices in terms of performance characteristics tested," implying that the "truth" is established by matching the performance of already-approved devices, rather than establishing a completely new medical "ground truth."
8. Sample Size for the Training Set
Not applicable and not provided. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable and not provided. This is a physical device, not an AI model.
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