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The Uroplasty Rigid Endoscopic Needles are accessories to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needles may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.

The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 4 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The Rigid Endoscopic Needle is comprised of a stainless steel cannula 300 - 500 mm in length with an 18-23 gauge tip (10 - 15 mm in length) and a copolyester Luer lock hub.

This document is a 510(k) summary for the Uroplasty Rigid Endoscopic Needles. It describes the device, its intended use, and compares it to a predicate device. The document also mentions functional and biocompatibility testing conducted to support substantial equivalence.

Here's an analysis of the provided text in relation to your questions, noting that this is for a medical device cleared via 510(k) for substantial equivalence, not a standalone AI/software as a medical device (SaMD) study, so many of your detailed questions regarding AI performance and ground truth establishment are not directly applicable.

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

   The document does not explicitly state "acceptance criteria" in the format typically used for performance studies of AI/SaMD. Instead, it refers to "functional tests to demonstrate forces experienced by the needle during use and to demonstrate mechanical strength" and "biocompatibility." The reported performance is a general statement that these tests were conducted to support substantial equivalence.

   Acceptance Criteria (Implied)	Reported Device Performance
   Demonstrate forces experienced by the needle during use	Functional testing conducted (specific results not detailed)
   Demonstrate mechanical strength	Functional testing conducted (specific results not detailed)
   Meet biocompatibility standards	Biocompatibility testing conducted (specific results not detailed)
   Substantial equivalence to predicate device (K091391)	Determined to be substantially equivalent by FDA, based on conducted tests

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   The document primarily describes physical device testing. It does not refer to "test sets" or "data provenance" in the context of clinical data or AI model evaluation. The tests are functional and biocompatibility tests on the physical needles. The sample sizes for these types of engineering tests are typically determined by standards and internal protocols, but are not specified here. The location of testing is Uroplasty, Inc. (Minnetonka, MN, USA), which implies the data provenance is also within the US. The tests would be prospective in nature, conducted on new or prototype devices.

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)

   This question is not applicable to the type of device and study described. This is not a study requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" for functional and biocompatibility tests is based on established engineering and biological standards.

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

   This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations where there can be disagreement among experts. Here, the tests are objective, physical, and chemical evaluations.

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 question is not applicable. The Uroplasty Rigid Endoscopic Needles are a physical accessory, not an AI or imaging device, and therefore, an MRMC study related to AI assistance for human readers was not performed.

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

   This question is not applicable. The device is a physical endoscopic needle, not an algorithm or standalone software.

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

   The "ground truth" for this device's evaluation is based on engineering standards for mechanical strength and functionality, and biocompatibility standards (e.g., ISO 10993 series) for biological safety. There is no clinical or diagnostic "ground truth" as would be found in an imaging or diagnostic device study.

8. The sample size for the training set

   This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

   This question is not applicable. There is no "training set."

Summary of Findings:

The provided 510(k) summary focuses on demonstrating "substantial equivalence" of a physical medical device (endoscopic needles) to a previously cleared predicate device. The evaluation involved functional and biocompatibility testing of the physical product, rather than clinical studies with human subjects or performance evaluations of AI algorithms. Therefore, many of your questions regarding AI-specific criteria (sample size for test/training sets, data provenance for AI, number/qualifications of experts for AI ground truth, adjudication methods, MRMC studies, standalone AI performance) are not applicable to this particular 510(k) submission.

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The Urgent PC Neuromodulation System is intended to treat patients with Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

The Urgent® PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.

The provided text does not contain a study that proves the device meets specific acceptance criteria in the manner requested. The document is a 510(k) premarket notification for the Urgent® PC Neuromodulation System. It highlights that the "new device" is substantially equivalent to a previously cleared predicate device (K071822). The primary difference noted is a change in the wording of the indications statement to incorporate "Overactive Bladder (OAB)" terminology, which is described as an "update in wording rather than a change in the device patient population."

Therefore, the submission relies on the established performance and safety of the predicate device, rather than presenting new clinical study data with specific acceptance criteria and detailed performance metrics for the updated device itself.

Based on the provided information, I cannot complete the requested tables and details as the document does not include a new study with explicit acceptance criteria and corresponding performance data for the device.

Here's an explanation of why the requested information cannot be extracted:

• No explicit acceptance criteria or measured performance: The document states that the "Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use," but it does not provide any specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, or clinical efficacy rates) or reported performance values against those criteria.
• No new study details: The submission is a 510(k) for substantial equivalence, not a new clinical trial reporting primary endpoints and statistical analysis. It does not describe a study involving test sets, ground truth establishment, expert adjudication, or MRMC studies.

In summary, the provided document is a regulatory submission asserting substantial equivalence to a predicate device, and thus does not contain the detailed study information (acceptance criteria, sample sizes, ground truth methodology, etc.) that would typically be found in a clinical study report.

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The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.

The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 4 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The stainless steel cannula is 300 to 500 mm long with an 18-23 gauge tip (10 - 15 mm in length) and a metal luer lock connector; the needle also has a protective polyethylene sheath.

The provided text describes a 510(k) premarket notification for the Uroplasty Rigid Endoscopic Needle, asserting its substantial equivalence to a previously cleared predicate device. However, it does not contain information about specific acceptance criteria or a dedicated study that proves the device meets such criteria in terms of quantitative performance metrics.

The submission focuses on demonstrating technological equivalence to the predicate device, not on presenting novel performance data from human or animal studies.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

A table of acceptance criteria and reported device performance is not available in the provided text. The submission states: "The new and predicate devices are technologically the same; they are both rigid endoscopic needles intended to be accessories for standard endoscopes for the use of administering injectable materials. Both devices have similar intended uses and principles of action; they are both supplied sterile and are for single use only. In the few instances where the devices differ, no concerns about safety or effectiveness are raised."

The "Performance" section merely states: "The Uroplasty Rigid Endoscopic Needle allows delivery of injectable materials into tissues during an endoscopic procedure, thereby achieving its intended use." This is a description of its intended function, not a quantification of its performance against specific criteria.

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

Not applicable. No test set or clinical study data is presented. The submission relies on demonstrating substantial equivalence to a predicate device.

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

Not applicable. No test set or ground truth establishment by experts is mentioned.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No. An MRMC comparative effectiveness study was not conducted or reported in this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical medical instrument, not an algorithm, so standalone performance in this context is irrelevant.

7. The Type of Ground Truth Used:

Not applicable. No ground truth data is presented. The basis for clearance is substantial equivalence to a predicate device, meaning the new device is considered as safe and effective as the legally marketed predicate.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware device submission, not an AI/ML algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of the Study (Implied by the 510(k) process):

The "study" in this context is essentially the comparison to the predicate device (K051905). The submission is a regulatory filing arguing that the new device is sufficiently similar to an already cleared device that it does not raise new questions of safety or effectiveness.

• Acceptance Criteria (Implied): The implied acceptance criteria for this 510(k) would be that the new device's technological characteristics, intended use, and principles of operation are substantially equivalent to the predicate device, and any differences do not negatively impact safety or effectiveness.
• Proof: The "proof" is the written argument provided in the "Technological Characteristics" section, stating that the new and predicate devices are "technologically the same" and that "In the few instances where the devices differ, no concerns about safety or effectiveness are raised." This is a qualitative assessment presented to the FDA. The FDA's letter confirms their agreement with this assessment by stating the device is "substantially equivalent."

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The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.

The Urgent® PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).

The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.

The provided document is a 510(k) Pre-market Notification for the Urgent® PC Neuromodulation System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with specific acceptance criteria and detailed performance metrics as would be found in a PMA (Premarket Approval) application.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, specifically:

1. A table of acceptance criteria and the reported device performance: This information is not present. The submission states that the new device and the predicate device are "technologically the same" and that the new device "allows for the successful performance of the product's intended use," implying that its performance is equivalent to the predicate, but no specific performance metrics or acceptance criteria are given.
2. Sample size used for the test set and the data provenance: Not applicable, as no new clinical study data is presented for this 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary from the document:

The Urgent® PC Neuromodulation System (K071822) is being cleared as substantially equivalent to a previously cleared device (Urgent® PC Neuromodulation System, K061333). The basis for this equivalence is that:

• Both devices have the same intended use: to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.
• They are technologically the same: percutaneous tibial nerve stimulator devices with lead sets, intended to deliver retrograde access to the sacral nerve.
• Both have the same principles of action.
• The only difference is in the Instructions for Use.

The submission concludes that the new device allows for the successful performance of its intended use based on its substantial equivalence to the predicate, implying that the predicate's performance history and regulatory clearance serve as the "proof" for the new device.

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The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.

The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).

The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.

The provided text is a 510(k) summary for the Uroplasty, Inc. Urgent® PC Neuromodulation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance metrics. Therefore, many of the requested details about a study proving device performance against acceptance criteria are not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or provide a table of performance metrics for the Urgent® PC Neuromodulation System itself. The submission is a Special 510(k), which typically relies on comparisons to changes made in a previously cleared device. The key acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device.

The "Performance" section explicitly states: "The Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use." This is a qualitative statement, not a quantified performance metric.

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

No test set or associated sample size is mentioned. This submission is a Special 510(k) for a modification to an already cleared device, not a new clinical study. The submission focuses on technological equivalence.

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

Not applicable. No test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set:

Not applicable. No test set 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. This device is a neuromodulation system, not an AI-powered diagnostic device, and no MRMC study is mentioned.

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

Not applicable. This device is a neuromodulation system, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No ground truth is established as there is no new clinical trial described. The "ground truth" for the 510(k) revolves around demonstrating the device's technological and safety equivalence to its predicate.

8. The Sample Size for the Training Set:

Not applicable. This device is a neuromodulation system, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set is described.

Summary of what the document does communicate:

• Device: Urgent® PC Neuromodulation System, used for percutaneous tibial nerve stimulation (PTNS) to treat urinary urgency, frequency, and urge incontinence.
• Regulatory Pathway: Special 510(k) (K061333).
• Predicate Device: Urgent® PC Neuromodulation System (K052025).
• Key Argument for Equivalence: The new and predicate devices are "technologically the same" with similar intended uses and principles of action. Any differences are stated not to raise concerns about safety or effectiveness.
• Conclusion: The device is substantially equivalent to the previously cleared predicate.

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The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The I-STOP Device is comprised of a non-resorbable polypropylene material woven into a mesh with each end attached to a polyethylene clip, two technique-dependant stainless steel implantation needles and two polycarbonate needle handles. The device is EtO sterilized and intended for single-use only.

This document describes a 510(k) premarket notification for the I-STOP™ Mid-Urethral Sling, asserting its substantial equivalence to a predicate device, the Tension Free Vaginal Tape (TVT) System.

Based on the provided text, the device's acceptance criteria and the study proving it meets these criteria are not explicitly defined in a quantitative manner typical for AI/ML device evaluations. This is a traditional medical device submission, not an AI/ML device submission, and therefore, the information requested for AI/ML performance metrics (such as sample sizes for test/training sets, ground truth methodology, expert qualifications, adjudication methods, or MRMC studies) is largely not applicable and not present in the given text.

The document focuses on demonstrating substantial equivalence to an existing predicate device based on technological characteristics and intended use, rather than presenting a performance study with acceptance criteria often seen for novel AI/ML diagnostics.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) submission, the "acceptance criteria" are implied by the regulatory standard of "substantial equivalence" to the predicate device. This means the new device must be as safe and effective as the predicate. The "reported device performance" is qualitative and based on clinical experience and biocompatibility testing rather than specific quantitative metrics.

Study Details (as inferable from the text, primarily noting absence of AI/ML specific details)

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not specified. The document mentions "Clinical experience with the I-STOP device" but does not provide details on the sample size, study design (retrospective/prospective), or data provenance for any specific clinical test set. This type of detail is not typically required for a 510(k) submission based on substantial equivalence when performance is demonstrated qualitatively and through biocompatibility.

2. 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 specified. This is not an AI/ML diagnostic device where a ground truth for a test set would be established by experts in this manner. The performance is based on clinical outcomes and engineering principles.

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

   • Not applicable/Not specified. As above, this concept pertains to AI/ML evaluations for diagnostic accuracy.

4. 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:

   • No. This is a surgical implant device, not an AI-assisted diagnostic tool. MRMC studies are not relevant here.

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

   • Not applicable. This is a physical device, not an algorithm.

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

   • The "truth" for this medical device's performance would be considered clinical outcomes data (success/failure in treating SUI, safety profile, absence of significant complications) and biocompatibility testing results. Specific details on how this "truth" was collected or adjudicated are not provided in this summary.

7. The sample size for the training set:

   • Not applicable/Not specified. This device does not involve a "training set" in the AI/ML sense.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified. As above, no training set for AI/ML.

In summary, the provided document is a 510(k) submission for a non-AI surgical implant, focusing on regulatory substantial equivalence. It does not contain the detailed quantitative performance study information, expert qualifications, or ground truth methodologies typically associated with AI/ML diagnostic or assistive devices. The regulatory approval is based on the device's similarity to an already approved predicate device and general safety/effectiveness demonstrated through clinical experience and biocompatibility.

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The Urgent PC Neuromodulation System is intended to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.

The Urgent® PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).

The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.

The provided text is a 510(k) premarket notification summary and the FDA's clearance letter for the Uroplasty, Inc. Urgent® PC Neuromodulation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a new product.

Therefore, the document does NOT contain information on:

• A table of acceptance criteria and reported device performance based on a new study.
• Sample sizes used for a test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, etc.).
• Sample size for a training set.
• How ground truth for a training set was established.

Explanation Based on Provided Text:

The core of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (UroSurge® Percutaneous SANS™ Device, K992069). This means the focus is on showing that the new device has the same intended use, technological characteristics, and principles of operation, and that any differences do not raise new questions of safety or effectiveness.

The "Performance" section within the 510(k) summary states: "The Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use." This is a declarative statement of perceived performance, not a report of a specific study with defined acceptance criteria and quantitative results.

The FDA's decision letter confirms this approach, stating "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

In summary, there is no detailed study described in this document that would provide the requested information regarding acceptance criteria, sample sizes, ground truth establishment, or expert involvement for a performance study. The device's "performance" is implicitly accepted because it is deemed substantially equivalent to a device already cleared by the FDA.

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The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.

The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 5 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The 5 French stainless steel cannula is 380 to 500 mm long with an 18-gauge tip (10 mm in length) and a metal luer lock connector; the needle also has a protective polyethylene sheath.

Here's a breakdown of the acceptance criteria and study information for the Uroplasty Rigid Endoscopic Needle, based on the provided document:

This document is a marketing submission (510(k)) for a medical device. These submissions generally aim to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies like those for novel high-risk devices.

Based on the provided information, the "study" described is a declaration of substantial equivalence to a predicate device rather than a performance study with acceptance criteria in the typical sense of a diagnostic or therapeutic accuracy study.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This submission relies on substantial equivalence to a predicate device, not on a new performance study with a test set.

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

Not applicable.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a comparative effectiveness study involving human readers and AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. The device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used

Not applicable. The "ground truth" here is the established performance and safety profile of the predicate device, K982890, as determined by its prior clearance. The submission argues that the new device shares those characteristics.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/algorithm-based device.

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

Not applicable.

Summary of the Device's "Acceptance Criteria" Met by the "Study":

The acceptance criteria for the Uroplasty Rigid Endoscopic Needle, within the context of this 510(k) submission, is to demonstrate Substantial Equivalence to a legally marketed predicate device (Advanced UroScience Injection Needle, K982890).

The "study" that proves the device meets this acceptance criteria is the comparison provided in Section 8: 510(k) Summary under "Technological Characteristics" and "Performance."

• Technological Characteristics: The submission explicitly states, "The new and predicate devices are technologically the same; they are both rigid endoscopic needles intended to be accessories for standard endoscopes for the use of administering injectable materials. Both devices have similar intended uses and principles of action; they are both supplied sterile and are for single use only." It further notes, "In the few instances where the devices differ, no concerns about safety or effectiveness are raised."
• Performance: The document states, "The Uroplasty Rigid Endoscopic Needle allows delivery of injectable materials into tissues during an endoscopic procedure, thereby achieving its intended use." This implies its performance is aligned with its intended use, which is consistent with the predicate device.
• Conclusion: The submission explicitly concludes, "The subject device, the Uroplasty Rigid Endoscopic Needle, is substantially equivalent to the previously cleared endoscopic needle by Advance UroScience (K982890)."

The FDA's decision letter (K051905) confirms that the FDA reviewed the submission and "determined the device is substantially equivalent...". This FDA determination is the ultimate "proof" in the regulatory sense that the "acceptance criteria" of substantial equivalence were met.

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