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The UTAH CVX-RIPE™ is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.

The UTAH CVX-RIPE™ is a double balloon catheter. The tip is placed through the vagina and into the cervical canal. The distal balloon is positioned against the internal cervical os and inflated with saline. The proximal balloon is positioned against the external cervical os and inflated with saline, providing gradual mechanical cervical dilation by simultaneously applying pressure on the internal and external cervical os. The materials used to manufacture the device, and which have patient contact, are all medical grade silicone.

The UTAH CVX-RIPE™ consists of an 18 Fr., 42 cm silicone catheter with a silicone tip and two silicone balloons. Each balloon is independently inflated via a separate inflation lumen through color coded check valves located at the proximal end of the device. The check valves are marked accordingly, "U" for the distal uterine balloon and "V" for the proximal vaginal balloon. A malleable stainless steel stylet is included for ease of placement. The stylet is placed through a third separate lumen that is closed at the distal tip. The stylet is preloaded in the catheter.

This document is a 510(k) premarket notification for the UTAH CVX-RIPE™ cervical ripening balloon catheter. It asserts substantial equivalence to a predicate device, the Cook® Cervical Ripening Balloon (K131206).

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" with numerical or performance targets in a tabular format that is typically expected for, say, diagnostic accuracy or predictive power. Instead, it lists mechanical performance tests and states that the device successfully met the requirements of these tests.

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The performance tests mentioned are mechanical/bench tests. For these mechanical tests, the sample sizes are not explicitly stated. The document does not refer to any human-patient data collection (retrospective or prospective) for this 510(k) submission, as it relies on substantial equivalence to a predicate device based on similar intended use and technological characteristics, supported by bench testing. Therefore, there is no information on data provenance (e.g., country of origin).

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

This information is not applicable and not provided. The "test set" here refers to mechanical performance tests, not clinical data requiring expert human assessment for ground truth.

4. Adjudication Method for the Test Set:

This is not applicable as the "test set" refers to mechanical performance tests, not a clinical study involving human readers or adjudicators.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This type of study was not done. The submission is for a mechanical medical device (a balloon catheter), not an AI-powered diagnostic or assistive tool.

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

This is not applicable. The device is a physical medical device, not a software algorithm.

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

For the mechanical performance tests, the "ground truth" would be the engineering specifications and expected physical behavior validated through laboratory testing. For example, for "Balloon Deflation Reliability," the ground truth is simply whether the balloons did, in fact, deflate properly according to specified parameters. There is no biological or patient-related "ground truth" in this context.

8. The sample size for the training set:

This is not applicable. There is no machine learning or AI component to this device that would require a "training set." The training referenced in the document would be for healthcare professionals on how to use the device, not a dataset for an algorithm.

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

This is not applicable for the reasons stated in point 8.

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The FINESSE+ and FINESSE II+ are intended to deliver high frequency electrical current for surgical procedures that can be performed with monopolar cutting and/or coagulation of tissue. One intended use of the FINESSE+ and FINESSE II+ systems is Loop Excision of the Transformation Zone (LETZ®).

The Finesse 3rd Generation combines a high-quality, class I type BF electrosurgical generator and a smoke evacuation system into a single compact unit. This integrated system is designed to perform low-power excision and coagulation procedures of short duration. The Finesse 3rd Generation is comprised of two models: FINESSE+ and FINESSE II+. The FINESSE II+ is identical to the FINESSE+, but does not have as many user adjustable features.

The provided text is a 510(k) summary for the Utah Medical Products, Inc. Finesse 3rd Generation electrosurgical and suction unit. This document focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards.

Therefore, the supplied text does not contain information typically found in a clinical study report for AI/ML-enabled devices. Specifically, it does not include details on:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• A test set sample size, provenance, or how ground truth was established for AI/ML performance evaluation.
• The number or qualifications of experts used for ground truth.
• Adjudication methods.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm-only performance.
• Training set sample size or ground truth establishment for a training set.

The performance data mentioned in the document states:

"Laboratory testing was conducted to certify the Finesse 3rd Generation's compliance with the requirements of ANSI / AAMI ES 60601-1:2005, AAMI / ANSI / IEC 60601-1-2:2007, and ANSI / AAMI / IEC 60601-2-2:2009. The operating principle of the Finesse 3rd Generation is identical to the predicate device."

This indicates that the acceptance criteria and study proving device performance are based on compliance with electrical safety and electromagnetic compatibility standards for electrosurgical devices, rather than performance metrics for an AI/ML algorithm.

Given the information provided, it is not possible to fill out the requested table or answer the specific questions about AI/ML device performance or clinical study details. The device described is an electrosurgical unit, not an AI/ML-enabled medical device requiring a study of AI performance.

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BT-Cath (BTC-100) is intended to provide temporary control or reduction of uterine bleeding during postpartum hemorrhage that is unresponsive to standard therapy including massage and oxytocin administration.

The BT-Cath consists of an extruded silicone dual lumen catheter with an inflatable molded silicone tamponade balloon attached on the distal end. One lumen of the catheter serves as the conduit through which saline is infused into the balloon after insertion into the bleeding uterus. When inflated properly to press against the uterine wall, the balloon provides compression against multiple sites of torn arteries, ruptured sinuses, lacerations and other tissue evoking hemorrhage. The second lumen, which is open at the distal end of the catheter, provides a drainage port for blood and other bodily fluids. At the proximal end of the catheter, a stopcock retains the saline in the balloon until a clinician gradually drains it allowing the uterus to contract. For ease of filling the balloon with multiple syringes, a check valve is also provided at the proximal end. The device is latex-free and provided sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BT-Cath device:

1. Table of Acceptance Criteria and Reported Device Performance

• Relationship of volume of saline infused into the balloon and resulting balloon diameter.
• Burst volume of the balloon.
• Ability of the balloon to hold its shape and not leak during repeated and prolonged inflations. | "Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor." (This statement confirms that the BT-Cath met the mechanical integrity requirements for the balloon, matching the predicate.) |
  | Mechanical Integrity - Catheter | Structural integrity of the catheter using leak tests. | "Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor." (This statement confirms that the BT-Cath met the mechanical integrity requirements for the catheter, matching the predicate.) |
  | Tensile Strength | Tensile strength in each joint in the devices. | "Both the BT-Cath and the Bakri device were tested and found to achieve structural integrity with a reasonable safety factor." (This statement confirms that the BT-Cath met the tensile strength requirements for joints, matching the predicate.) |
  | Clinical Performance/Safety | Device consistently achieving its intended purpose without reported likelihood of patient injury. | "Clinical feedback was obtained after about 840 uses of BT-Cath by U.S. clinicians that indicates the device consistently achieved its intended purpose without any reported likelihood of patient injury." (This is presented as evidence of field performance meeting the safety and efficacy expectations.) |

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

• Sample Size: "about 840 uses"
• Data Provenance: "U.S. clinicians" (prospective, real-world clinical feedback after deployment, rather than a controlled test set from a formal clinical trial for pre-market submission directly).

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

• The document mentions "U.S. clinicians" providing feedback. It does not specify a number of experts or their qualifications for establishing a ground truth in the context of a controlled test set with expert consensus. The feedback provided is general clinical observation rather than a structured expert review of specific cases.

4. Adjudication Method for the Test Set

• No formal adjudication method is described. The "clinical feedback" appears to be an aggregation of observations from multiple clinicians.

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 MRMC comparative effectiveness study was done, nor is AI involved with this device. This is a medical device, specifically a balloon tamponade catheter, not an AI/software-as-a-medical-device (SaMD).

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

• Not applicable as this is a physical medical device and does not involve an algorithm.

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

• The "ground truth" for the clinical performance assessment seems to be real-world clinical outcomes and observations as reported by clinicians using the device. This is more akin to post-market surveillance data contributing to a pre-market submission, rather than a pre-defined ground truth for a structured clinical trial.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.

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

• Not applicable as this is a physical medical device.

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TVUS/HSG-Cath™ is intended for intracervical injection of saline into the uterus for enhanced transvaginal ultrasonography (TVUS), also known as saline infusion sonography (SIS). TVUS/HSG-Cath may also be used for the delivery of contrast media into the female reproductive tract for diagnostic examination of the uterus and fallopian tubes.

TVUS (SIS) with saline infusion:

• persistent abnormal or dysfunctional uterine bleeding .
• suspected myometrial or intraluminal abnormalities (e.g., . fibroids or polyps)
• . thickened or irregular endometrium
• recurrent pregnancy loss t
• pre- and post-operative assessment of uterine pathology . HSG with contrast media:
  • unexplained infertility .
  • recurrent pregnancy loss

Not Found

The provided document is a 510(k) summary for the TVUS/HSG-Cath™ Saline/Contrast Media Infusion Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific performance criteria through a standalone study with acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria studies, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance studies.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the 510(k) summary (specifically Section 9 from the first page) indicates that the device's substantial equivalence is based on its similarity in intended use, indications for use, and technological characteristics to a predicate device, the "H/S Elliptosphere Catheter, (K013972) ACKRAD Laboratories, Inc."

The document details the intended use and indications for use of the TVUS/HSG-Cath™, which are consistent with the predicate device. For devices seeking 510(k) clearance, the primary "proof" that the device is safe and effective is its substantial equivalence to a legally marketed predicate device, not typically a de novo clinical study against specific performance acceptance criteria like those outlined in the request.

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The Irrigation/Aspiration/Coagulation Electrodes, ICE-311 and ICE-511, are indicated for electrosurgical fulguration (coagulation) of the uterine cervix as part of the procedure called Loop Excision of the Transformation Zone (LETZ®), or other loop electrosurgery procedures where simultaneous electrosurgical fulguration and small-volume fluid irrigation and/or aspiration is needed.

The device consists of a stainless steel spherical ball electrode attached to an ULTEM® irrigation and aspiration head that has PVC irrigation and aspiration tubes. The posterior end of the electrode shaft fits snugly into a standard electrosurgical pen which is connected to an electrosurgical generator that has been cleared for marketing by the FDA. The irrigation tube has a PVC female Luer fitting for connection to a fluid source and the aspiration tube has an ABS suction adapter for connection to a standard vacuum suction system.

The provided document is a 510(k) summary for a medical device called the "TBD Irrigation Aspiration Coagulation Electrode" (ICE). This summary describes the device and its substantial equivalence to previously cleared devices. However, it does not include a detailed study proving the device meets specific acceptance criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and functional comparisons with predicate devices, rather than presenting a performance study with defined acceptance criteria.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and what is missing:

Information that can be extracted/inferred:

• Device Performance Reported: The document reports that:
  • "Laboratory tests of the UMP ICE and the MMP #0055 have demonstrated that the irrigation fluid flow differs by less than 4% and that the aspiration capability differs by less than 8%."
  • "The coagulation capabilities of the UMP ICE and the UMP ACE are equivalent since they are based on the same UMP DBL electrodes."

Information that is missing or not explicitly detailed in the provided text:

• A table of acceptance criteria: Specific, quantifiable acceptance criteria are not explicitly defined in the document as "acceptance criteria." Instead, the performance metrics mentioned above (e.g.,

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This device is intended as therapeutic aid in the conservative treatment of stress incontinence, urge incontinence or mixed stress and urge incontinence in women. Patients appropriate for this therapy should be selected using the following criteria:

Indications:

• Good general health, both mentally and physically. .
• Urge incontinence due to detrusor instability or of idiopathic origin. .
• Stress incontinence not associated with intrinsic sphincter deficiency. ●
• Mixed incontinence. .
• Ability of patient to understand and demonstrate understanding of the use of the Liberty Plus . System.
• . Willingness to comply with the therapy plan.

Contraindications:

• Use of a cardiac pacemaker, or a history of rate or conductive disturbances. .
• Neurological deficiency that would not permit proper sensory perception or stimulation. .
• . Currently pregnant or attempting to get pregnant.
• Anatomical vaginal structure that does not permit proper and complete placement of the . vaginal probe.
• . Irregular menstrual bleeding cycles.
• Any urinary or vaginal infections, localized lesions or other undiagnosed symptoms. .
• . History of urinary retention or current symptoms.

The device consists of a hand held electrostimulation unit and an injection molded thermoplastic applicator that supports two stainless steel electrode rings that apply electrical stimulation to a patient in order to help train neuromuscular tissue in the pelvic floor for improvement or restoration of urinary continence for women. The applicator includes a pressure transducer that provides biofeedback relations of the pelvic floor muscles. The electrical stimulation energy and the power for the transducer are conducted to the electrodes via a six conductor cable and connector that plugs into the PFS-300. The transducer output signal is conducted back to an LCD graphical display by the same cable.

The PFS-300 is indicated for use to help train the pelvic floor muscles using electrical stimulation and biofeedback. The PFS-044 is a vaginal applicator that is used with the PFS-300. The PFS-300 is a battery powered electrostimulation device that applies electrical stimulation through electrodes on the PFS-044 applicator.

The provided text is a 510(k) summary for the Liberty Plus System (PFS-300), a non-implanted electrical continence device. The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices and does not describe acceptance criteria, a specific study proving device performance against those criteria, or the detailed aspects of a clinical trial.

Therefore, I cannot extract the requested information based on the provided text. The document states that "Laboratory tests of the PFS-300 and the PFS-200 have demonstrated that they provide equivalent electrical stimulation of the pelvic floor muscles" and that "The PFS-300 and the Cardio Design Pty Ltd. PFX both display readings of the pressures generated by contractions of the pelvic floor muscles." However, it does not provide details about these laboratory tests, including acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

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The ABC ("Arterial Blood Collection") In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.

The ABC ("Arterial Blood Collection") In-Line Blood Sampling Kit is a closed blood sampling system used in conjunction with continuous blood pressure monitoring in a critical care setting. The ABC Kit is designed for use with all disposable and reusable pressure transducers and for connection to central line catheters and arterial catheters. The ABC Kit is used for the drawing and retention within the line of heparinized blood from the catheter/cannula, allowing undiluted blood samples to be drawn from an in-line sampling site. At the completion of sample drawing, the mixed heparin/blood solution is reinfused into the patient to reduce fluid loss.

The provided text is a 510(k) summary for a medical device called the "ABC In-Line Blood Sampling Kit." This document is a regulatory submission for premarket notification to the FDA, not a study report detailing performance acceptance criteria and validation studies in the way you've requested.

Therefore, I cannot extract the information you've asked for (acceptance criteria, study details, sample sizes, expert qualifications, etc.) for the following reasons:

• Clinical Performance Study Not Described: The document focuses on demonstrating substantial equivalence to a predicate device (Baxter VAMP™ blood sampling system cleared under 510(k) K/885281) for regulatory clearance. It does not describe an independent clinical performance study with acceptance criteria and results.
• Focus on Substantial Equivalence: The primary points made are about the device's function, materials, and substantial equivalence to the predicate, with a brief mention of pressure monitoring frequency response being "essentially equivalent." This is a regulatory comparison, not a detailed performance study with defined metrics.
• No Mention of AI or Algorithm Performance: The device is an "In-Line Blood Sampling Kit," a physical medical device. There is no mention of an algorithm, AI, or software component that would require the kind of performance metrics you've outlined (e.g., standalone performance, MRMC studies, ground truth establishment methods for a machine learning model).

To summarize, the document does not contain the information required to answer your prompt because it is a regulatory submission demonstrating substantial equivalence of a physical medical device, not a report on a clinical or AI performance study.

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The PFS-043 is indicated for use to help train the pelvic floor muscles using electrical stimulation. The PFS-043 is a rectal applicator that is used with the UMP Liberty PFS System (PFS), which is a battery powered electrostimulation device that applies electrical stimulation through electrodes on the applicator.

The device consists of an injection molded thermoplastic applicator that supports two stainless steel electrode rings that apply electrical stimulation to a patient in order to help train neuromuscular tissue in the pelvic floor for improvement or restoration of urinary continence in men and women. The electrical stimulation energy is conducted to the electrodes via a two conductor cable and connector that plugs into the Liberty Stimulator.

The provided text is a 510(k) summary for a medical device called the "Liberty Rectal Pelvic Floor Exerciser (PFS-043)". This document describes the device and claims substantial equivalence to previously cleared devices. It does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for an AI/ML device or diagnostic tool.

Therefore, I cannot fulfill the request for information on acceptance criteria, reported performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

The document states:

• "Laboratory tests of the UMP PFS-043 probe and the ICAA applicator demonstrated that they provide equivalent electrical stimulation of the pelvic floor muscles."

This is the only mention of a "test" or "study," but it lacks all the specifics requested in your prompt. It indicates equivalence in electrical stimulation, which implies a functional assessment, but no details on the methodology, acceptance criteria, results, sample size, or any other specific elements of the requested output are provided.

In summary, the provided document is a regulatory submission for substantial equivalence based on technological characteristics and functional testing, not a detailed performance study with the metrics and methodologies you've asked about.

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