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510(k) Data Aggregation
(90 days)
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."
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | "The performed biocompatibility tests show that the injeTAK needles are safe and perform as intended." "The materials of all components... have not changed and stay as exact the same as existing G1 needle that the device biocompatibility will be well maintained for injeTAK G2 versions." |
| Packaging Integrity | "All test results passed and met the acceptance criteria." "The device packaging performance and integrity will be maintained for injeTAK G2." |
| Sterilization Efficacy | "The testing performed confirms that sterilization output requirements were met." |
| Functional & Performance | "The test results passed the acceptance criteria." "Overall performance and results were positive and meet the related specifications." |
| Accelerated Aging/Shelf Life | "The essential functionality and performance of injeTAK G2 version (DIS199 & DIS201) passed all requirements after accelerated aging and are therefore acceptable for the three year shelf life." This implicitly covers flow rate and needle luer leak tests. |
| Critical Dimensions | "The test was intended to verify if the device critical dimensions... meet the design specifications... The test results passed 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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(125 days)
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:
- A table of acceptance criteria and reported device performance from a clinical study.
- Sample size used for the test set and data provenance from a clinical study.
- Number of experts used to establish ground truth or their qualifications from a clinical study.
- Adjudication method from a clinical study.
- MRMC study details or effect size from a clinical study.
- Standalone performance details from a clinical study.
- Type of ground truth used from a clinical study.
- Sample size for the training set from a clinical study.
- How the ground truth for the training set was established from a clinical study.
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(119 days)
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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