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Advanced UroScience InnerSheath is indicated for use to help position an injection needle within the center of an endoscope.

Advanced UroScience InnerSheath consists of a cannula and a cap. The cannula is designed to fit easily within an endoscope and to permit easy alignment of an injection needle within to in easily within an endosope and to provide adequate gripping of the cannula and endoscope, and an adequate seal with the injection needle. Advanced UroScience InnerSheath is provided sterile and is intended for single use only.

Here's an analysis based on the provided document, addressing the various points about acceptance criteria and device study.

It's important to note that this document is a 510(k) summary for a medical device (Advanced UroScience InnerSheath) submitted to the FDA for market clearance. 510(k) submissions typically rely on demonstrating "substantial equivalence" to a predicate device rather than presenting full-blown clinical trials with detailed acceptance criteria and statistical performance metrics in the same way a PMA (Pre-Market Approval) study would. Therefore, some of the requested information (especially around specific performance metrics, sample sizes for specific tests, and AI-related details) is unlikely to be found in this type of document because it wasn't required for this device's regulatory pathway.

Device Name: Advanced UroScience InnerSheath

Intended Use: To help position an injection needle within the center of an endoscope.

1. A table of acceptance criteria and the reported device performance

Based on the provided document, specific quantitative acceptance criteria and detailed performance metrics are not explicitly stated as they would be in a full clinical study report. The submission relies on "technological characteristics and performance" being "similar to or equivalent to the predicate device" and demonstrating safety and effectiveness through "Biocompatibility and bench testing."

Note: The acceptance criteria listed above are inferred from the device description and the claim of "safety and effectiveness" and "substantial equivalence." The document does not provide pass/fail thresholds or specific quantitative results from these tests.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in this 510(k) summary. The document mentions "bench testing" but does not provide details on the number of devices or iterations tested.
• Data Provenance: The document does not specify the country of origin of the data. Given it's an FDA submission, the testing would typically be conducted according to US or international standards accepted by the FDA. It would generally be prospective for bench testing and biocompatibility, but the exact study design details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable / Not specified. For a device like an endoscope accessory, "ground truth" (in the sense of expert radiological or pathological labels) is not typically established. The testing would focus on engineering and functional performance, and possibly biocompatibility by qualified lab personnel.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable / Not specified. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints. For bench testing of a device's physical and functional properties, a formal adjudication process as described (e.g., 2+1 reader consensus) is not typically used.

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 device (Advanced UroScience InnerSheath) is a physical medical device (an endoscope accessory) and does not involve AI or human "readers" in the context of interpretation. Therefore, an MRMC study or AI assistance effect size is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a physical, non-AI medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable in the conventional sense. For this device, "ground truth" would relate to the successful and safe mechanical/functional performance (e.g., proper fit, seal, alignment) as evaluated by engineering standards, and biological compatibility as evaluated by established lab tests. It's not about diagnosing or classifying medical conditions, so expert consensus, pathology, or outcomes data in a diagnostic context are not relevant.

8. The sample size for the training set

• Not applicable / Not specified. This device does not use machine learning, so there is no "training set." The engineering and biocompatibility testing would not be described in terms of training data.

9. How the ground truth for the training set was established

• Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

Summary of Limitations due to 510(k) Regulatory Pathway:

This document is a 510(k) summary, which aims to demonstrate "substantial equivalence" to a predicate device rather than proving de novo safety and effectiveness through extensive, detailed clinical trials with explicit acceptance criteria and statistical endpoints in the way a PMA submission or an AI/software as a medical device (SaMD) study would. The focus is on showing that the new device is as safe and effective as a legally marketed predicate device through similar technological characteristics and performance. Therefore, many of the detailed quantitative and methodological questions provided in the prompt are not addressed in this type of regulatory filing.

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For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

[Trade name] is a sterile, processed and treated porcine skin, which is intended for use in the reconstruction of soft tissue deficiencies.

This document is a 510(k) summary for a surgical mesh. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The information provided describes the device, its intended use, and states that its technological characteristics and performance are "the same as or equivalent to the predicate device." It also mentions that "Biocompatibility and bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to the predicate device." However, no specific details about these tests, the acceptance criteria used, or the results are provided.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance study results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document is a high-level summary for regulatory submission, not a detailed study report.

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The Advanced UroScience Injection needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.

The Advanced UroScience Injection Needle consists of a stainless steel needle attached to a plastic luer lock hub. Needle length ranges up to 200 cm to accommodate the length of the endoscope channel and gauge ranges from 14 to 25. The needle length and gauge will be identified on the label. The luer lock hub, which is molded onto the needle, is designed to accommodate a standard syringe. The Advanced UroScience Injection Needle is intended for use as an accessory for currently marketed endoscopes and provides delivery of injectable materials during an endoscopic procedure. The type of material to be injected is dependent on the nature of the procedure, but may include delivery of collagen during cystoscopic procedures, sclerosing agents during esophagoscopic and gastroscopic procedures, local anesthetics during cystoscopic or laryngoscopic procedures, or saline or contrast media during colonoscopic procedures. The Advanced UroScience Injection Needle is provided sterile and is intended for single use only.

The provided text details a 510(k) summary for the Advanced UroScience Injection Needle. This type of submission is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This process does not typically involve studies that define and meet specific acceptance criteria in the same way a new device with novel technology would.

Therefore, many of the requested elements for acceptance criteria and study design are not applicable to this type of regulatory submission. The primary "study" involved is a comparison to a predicate device to establish substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: For a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness. The specific criteria are thus a qualitative comparison rather than quantitative performance metrics.
• Reported Device Performance: The document does not report specific quantitative performance data for the Advanced UroScience Injection Needle. Instead, it describes its design and intended use, asserting its similarity to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Not applicable. This document is a 510(k) summary, not a report of a performance study with a test set of data. The "test" for a 510(k) is the comparison to the predicate device based on design, materials, manufacturing methods, and indications for use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. No such "test set" or ground truth establishment by experts for performance evaluation is described in this 510(k) summary. The "ground truth" here is the regulatory acceptance of the predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. There is no described "test set" and thus no adjudication method mentioned. The decision on substantial equivalence is made by the FDA reviewer.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is not relevant to a 510(k) submission for this device. An MRMC study would typically be for diagnostic imaging devices or algorithms where human reader performance is being evaluated.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No. This device is a physical medical instrument (an injection needle), not an algorithm or software. Therefore, the concept of "standalone performance" in this context is not applicable.

7. The Type of Ground Truth Used

• The "ground truth" in a 510(k) submission like this is primarily regulatory precedent and engineering principles. The device is deemed safe and effective because it is substantially equivalent to devices already on the market (the predicate devices K843719 and K960519) that have a history of safe and effective use. There's no specific clinical outcomes or pathology data for this device within this submission that establishes a "ground truth" of its performance.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" for this type of device.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set, this question is not relevant.

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