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The injeTAK Adjustable Tip Needles are intended to be used to deliver a variety of legally marketed drugs into tissues or structures during cystoscopic procedures. They are provided sterile for single use only.

The injeTAK Adjustable Tip Needles (injeTAK Needles) are intended to be used to deliver a variety of legally marketed drugs into tissues of structures during cystoscopic procedures. They are provided sterile for single use only.
The needles will contact the bladder tissue and urine fluid in the patient. The typical injection procedure lasts 10-20 minutes; each injection spot contact lasts approximately 5 seconds but may vary slightly depending on the skill of surgeon.
The models of the injeTAK needles are used with a rigid or flexible cystoscope during cystoscopic procedures and differ in length of the needle dependent upon the type of procedure. The intended use does not vary based on the model number or difference in measurement specifications.
The injeTAK Needle comprises of a needle cannula, contrast mark, needle sheath, handle, needle length dial, hub/luer connector, lock-pin, and a seal ring located inside the handle.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

This document is a 510(k) summary for a medical device called "injeTAK Adjustable Tip Needle (DIS199; DIS201)". The FDA's substantial equivalence determination process for 510(k) clearances typically involves demonstrating that a new device is as safe and effective as a legally marketed predicate device. This often involves non-clinical testing to compare the new device's performance against its design specifications and, by extension, against the predicate.

Given this context, the document primarily focuses on non-clinical testing and comparisons to a predicate device, rather than a clinical study evaluating an AI algorithm or human-in-the-loop performance.

Here's the information extracted and organized based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes various non-clinical tests performed to ensure the device meets its design specifications and performs as intended. Specific, quantifiable acceptance criteria are not explicitly listed in a table format within the provided text, but the general outcome for each test is stated. The "acceptance criteria" are implied by the statement "passed all requirements" or "met the acceptance criteria."

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

The document does not specify exact sample sizes for the non-clinical tests conducted (e.g., how many needles were tested for biocompatibility, packaging, or functional performance). It mentions "the product's packaging testing" and "the testing performed," implying a set of samples were used for each test.

Data Provenance: The tests are described as non-clinical and in-house/manufacturer-conducted tests to verify product design specifications. The data is internal to Laborie Medical Technologies Corp.

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

Not applicable. This device is an invasive medical instrument (needle) and the evaluation presented is a non-clinical device verification and validation summary, not an AI/software product requiring expert ground truth for interpretation of images or other data. The "ground truth" here is the device's adherence to its engineering specifications and relevant ISO standards.

4. Adjudication method for the test set

Not applicable. This is not a study involving human assessment of data that would require an adjudication method. The "adjudication" in this context would be the internal quality and regulatory review process of the manufacturer.

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

No. This is not an AI-assisted diagnostic or predictive device, and no MRMC study was conducted or is relevant to this submission.

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

No. This is a hardware device (needle), not an algorithm.

7. The type of ground truth used

The "ground truth" for this medical device's performance evaluation is based on:

• Engineering Design Specifications: The device must meet its predefined critical dimensions, functional parameters (e.g., flow rate, luer leak), and material properties.
• International Standards: Adherence to relevant ISO standards for biocompatibility (e.g., ISO 10993 series), sterilization (e.g., ISO 11135, ISO 11137), and packaging (e.g., ISO 11607).
• Predicate Device Performance: Demonstrating that the new device performs at least as well as the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is a hardware medical device, not a machine learning model, so there is no "training set."

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

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

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The Solar Compact is intended to record, store, view, and analyze pressure, impedance, and EMG data, gathered from anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, and anorectal area, including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area of the gastrointestinal tract.

An optional perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump.

The Solar Compact is indicated for use in adult to infants with common gastrointestinal conditions, for the monitoring and diagnosis of motility disorders of the GI tract.

The Solar Compact is a medical device for measuring gastrointestinal motility characteristics. The system consists of an electromechanical hardware device which connects to pressure catheters (air-charged or solid-state), and a PC software. Catheters provide measurements of pressure and impedance to the device from various sites along the gastrointestinal tract, which are then displayed and analyzed by the Laborie PC software. This provides the clinician with data that may aid in the diagnosis or management of various gastrointestinal disorders. Additionally, the system connects to provide EMG measurements of the muscles along the pelvic floor. Devices such as pressure catheters and surface electrodes are required to complete a gastrointestinal motility investigation, but they are not considered part of the Solar Compact device and not included standard with the system.

The device hardware consists of an external housing, pneumatics to inflate and deflate rectal balloons, and electronics to readout data from the pressure catheters and to control all other functions of the system. The device connects to a PC via Bluetooth to display measurements within the Laborie software. The Laborie software contains a patient database module, and an analysis module. The software displays measurements from the system as time-tracing based plots, Clouse Countour Plots (High Resolution Manometry), and as 3D plots. Clinicians can analyze the data provided by placing markers and using calculations within the software. The device does not provide an independent diagnosis.

The Solar Compact device is compatible with a number of of catheters for these aforementioned parameter measurements. For a full list of these compatible catheters please consult the instructions for use.

The provided text is an FDA 510(k) clearance letter and summary for a medical device called "Solar Compact (G4-1)". It contains information about the device's indications for use, technological characteristics, and comparison to predicate devices, but it explicitly states that "Clinical testing was not conducted and is not applicable for demonstrating substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria, as no such clinical study was performed or needed for this specific 510(k) clearance based on the provided document.

To clarify, the document focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through non-clinical testing and comparison of technological characteristics. This pathway to market typically does not require a full clinical study with acceptance criteria like those outlined in the request, especially for devices that are considered well-understood or incremental improvements.

The document does mention "System verifications were conducted, including functional, electrical, lifetime verification testing, calibration and volume measurement, to ensure that the Solar Compact demonstrates by meeting requirements defined for the device." These "requirements defined for the device" are internal engineering and design specifications, not clinical acceptance criteria derived from a human study.

Therefore, since the document explicitly states "Clinical testing was not conducted and is not applicable," it's impossible to extract:

1. A table of acceptance criteria and reported device performance from a clinical study.
2. Sample size used for the test set and data provenance from a clinical study.
3. Number of experts used to establish ground truth or their qualifications from a clinical study.
4. Adjudication method from a clinical study.
5. MRMC study details or effect size from a clinical study.
6. Standalone performance details from a clinical study.
7. Type of ground truth used from a clinical study.
8. Sample size for the training set from a clinical study.
9. How the ground truth for the training set was established from a clinical study.

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The Solar anorectal manometry catheter is a non-sterile, single patient use catheter for use on patient requiring anorectal manometry testing.

The Solar™ Anorectal Manometry Catheter is a high-resolution anorectal manometry (HRAM) catheter. It is a diagnostic device used to assess the function of anal and rectum muscles. The device consists of 10 air-charged sensing balloons which can sense pressures during anorectal manometry, along with a distal balloon used for the assessment of recto anal inhibitory reflex (RAIR). The catheter is disposable and non-sterile. Through manual insertion in the device assesses pressures within the anorectal anatomy as well as assessing sensation and reflexes. This product is non-sterile, single patient use catheter intended for use with a reusable Solar™ Anometry Charger on patients requiring lower gastrointestinal pressure measurements.

The provided text does not contain information about acceptance criteria for an AI/ML device or a study proving that such a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a Solar™ Anorectal Manometry Catheter, which is a medical device for measuring gastrointestinal motility, not an AI/ML product.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device from this document.

The document focuses on:

• The regulatory clearance of the catheter.
• Comparisons of the new catheter’s design and technology to a predicate device.
• Non-clinical bench performance testing (visual, dimensional, functional, destructive, biocompatibility, bioburden, transit simulation) for the catheter and its charger. These tests aim to demonstrate substantial equivalence to the predicate device, not the performance of an AI/ML algorithm.
• Usability assessment according to EN IEC 62366-1 for the device.

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The NuWav Ultrasound Probe System is intended to used to perform diagnostic general ultrasound studies including Fetal, Abdominal (Solid Organs, Aneurysms, bladder), Pediatric, Small organ (breast, thyroid, bladder, testes, prostate), Neonatal Cephalic, Cardiac, Trans-vaginal, Trans-rectal, Peripheral Vascular, and Musculoskeletal (Conventional and Superficial). The system provides imaging for guidance of biopsy and imaging to assist in the placement of needles or other anatomical structures as well as performing Urodynamic Studies.

Not Found

The provided text is a 510(k) premarket notification for the "NuWay Ultrasound Probe System." It primarily details the regulatory clearance for the device and its various transducers, listing the intended uses. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for studying the device's diagnostic performance.

The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning that its performance does not need to be independently proven against new acceptance criteria. Instead, it relies on the established safety and effectiveness of its predicate.

Therefore, I cannot provide the requested information from the given text.

Summary of what cannot be provided from the text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory clearance by substantial equivalence, not performance metrics against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not present. No performance study details are included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No performance study details are included.
4. Adjudication method for the test set: Not present. No performance study details are included.
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 present. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not present. This is a hardware device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. No performance study details are included.
8. The sample size for the training set: Not present. This is a hardware device; no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not present. This is a hardware device; no training set for an algorithm is mentioned.

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Laborie Urodynamic systems are intended for Urodynamics testing. The traditional equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra, uses near infrared spectroscopy, for non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms - that is patients who suffer from Urinary Incontinence.

All Urodynamic equipment including the Laborie Urodynamic System with Tetra Accessory are for use under the direction of a licensed physical or health care professional in an office or hospital setting.

The complete device includes traditional Urodynamic system and the Tetra accessory. That is all the standard components, for uroflowmetry and pressure measurement, and the new non-invasive component the Tetra accessory to detect bladder activity.

The provided 510(k) summary for the Laborie Medical Technologies Urodynamic System with Tetra Accessory is for a Class II medical device that measures urodynamic parameters. It's important to note that this submission is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through rigorous clinical trials with specific acceptance criteria in the same way a new drug or a high-risk AI device might.

Therefore, the study information requested regarding acceptance criteria and performance metrics (e.g., sensitivity, specificity, reader improvement with AI) is not applicable in the context of this 510(k) summary. The summary focuses on bench testing and a clinical study to confirm the efficacy of the system and its accessory, as well as safety testing, but these are not described with specific acceptance criteria in terms of diagnostic performance.

Here's an breakdown of the available information:

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

This information is not provided in the 510(k) summary in the traditional sense of diagnostic performance metrics with defined acceptance criteria. The summary lists technical specifications for the UDS-94 and Tetra Accessory, which are inherent design parameters rather than performance outcomes against a gold standard in a diagnostic context.

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

The 510(k) summary states "Bench and clinical studies have confirmed the efficacy of the Laborie Urodynamic System with Tetra Accessory," but does not provide details on the sample size, data provenance, or study design (retrospective/prospective) for these studies.

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 in the 510(k) summary. Since the submission focuses on substantial equivalence for a device measuring physiological parameters, the method of "establishing ground truth" for diagnostic accuracy involving expert consensus would not typically be a primary focus for this type of device.

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

This information is not provided.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not performed. The Tetra Accessory uses near-infrared spectroscopy for non-invasive bladder activity detection; it is a measurement device, not an AI diagnostic tool designed to assist human readers in interpreting complex images or data in a way that would require an MRMC study.

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

A standalone algorithm performance study is not applicable as the device is not an AI algorithm. The Tetra accessory is a physical component that uses near-infrared spectroscopy to detect bladder activity. It's a measurement device intended for use by a healthcare professional, not a standalone diagnostic algorithm.

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

The 510(k) summary does not specify the "ground truth" used for the efficacy confirmation. For a urodynamic system, "efficacy" would likely relate to the accuracy and reliability of its physiological measurements compared to established standards or clinical observations, rather than a diagnostic 'ground truth' like pathology.

8. The sample size for the training set:

As this is not an AI/ML device, there is no training set in the conventional sense.

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

As mentioned above, there is no training set and therefore no ground truth establishment for a training set.

In summary:

The provided document describes a 510(k) submission for a medical device that measures physiological parameters. The primary goal of this submission is to demonstrate substantial equivalence to a predicate device, focusing on technical specifications and safety rather than a detailed performance study with diagnostic acceptance criteria. As such, many of the requested details regarding AI/ML device performance validation metrics are not applicable to this submission.

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