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Archworx is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Archworx is intended to position teeth by way of continuous gentle force.

Devices are intraoral thermoformed plastic aligner trays for tooth malocclusion correction.

The provided text describes the regulatory clearance of an orthodontic device called "Archworx." It details the device's intended use, manufacturing process, and comparison to a predicate device for substantial equivalence. However, the document does not contain information about the acceptance criteria and the results of a study (especially a clinical or AI-related study) that proves the device meets those criteria.

Specifically, the document mentions:

• Biocompatibility testing: "Biocompatibility testing was conducted...and that the device met the acceptance criteria for all tests." It does not specify what these criteria were or provide the results.
• Bench Performance Testing: "Physical properties testing was conducted, and testing information was obtained from the material manufacturer. All the physical properties testing met the pre-specified acceptance criteria." Again, the criteria and results are not detailed.
• Verification and Validation Testing: "Yes, Performed. For 3 different patient cases, aligners were evaluated at 3 different points through the sequence for each sequence point, 3 critical dimensions based on intended positions of these critical tooth structures. Testing indicated the aligner designed in the software meets the planned location, positions and all dimensions as expected; and as prescribed." This is the closest to study results, but it's very high-level and lacks specific quantitative data or acceptance criteria. It also doesn't fit the typical structure of an AI/human-in-the-loop study.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or details about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training sets, or how ground truth was established, as this information is not present in the provided text.

The information provided is largely for a 510(k) submission for a physical medical device (orthodontic aligners), not an AI/ML-driven device that would necessitate the study details inquired about. The only software mentioned is "3Shape Ortho System Software (K180941)" which is used for scanning and designing models, implying it's a tool used in the manufacturing process rather than an AI-driven component of the "Archworx" device itself that requires clinical performance validation as per the prompt's implied context (e.g., diagnostic AI).

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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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The UTA is intended for use to fabricate and support provisional restorations that aid in creating proper emergence profiles and support gingival architecture throughout the healing phase. It is for use in single tooth restorations in the maxilla or mandible, with non occlussal loading. The UTA can be used for up to one hundred eighty days (180) intra orally.

The UTA is compatible with AstraTech 3.5/4.0 & 4.5/5.0, Biohorizons 3.2/4.5/6, Biomet 3.4, 4.1 & 5, Nobel Biocare Branemark, Nobel Biocare Active Internal RP(4.1/5)&NP(3.5), Nobel Biocare Select NP(3.5)& RP/WP(4.3/5), Nobel Biocare Replace 4.3, Straumann Bone Level NC &RC (4), and Zimmer 3.75, 4.5 &6.

UHA are placed on top of implants to protect the inner components of the implants throughout the healing phase. UHA creates support for gingival architecture and can be used with cement-retained temporary prostheses. It should be placed in non occlusal loading. It can be used for up to 180 days.

The UHA is compatible with AstraTech 3.5/4.0 & 4.5/5.0, Biohorizons 3.2/4.5/6, Biomet 3.4, 4.1 & 5, Nobel Biocare Branemark, Nobel Biocare Active Internal RP(4.1/5)&NP(3.5), Nobel Biocare Select NP(3.5)& RP/WP(4.3/5), Nobel Biocare Replace 4.3, Straumann Bone Level NC &RC (4), and Zimmer 3.75, 4.5 &6.

UHA is a healing abutment which is a PEEK screw-retained post. UTA is a screwretained temporary abutment which is a PEEK post with a predefined apex so a preformed tooth can be attached. Screws are available for Astra Tech 3.5/4.0 &4.5/5.0, Biohorizon 3.2/4.5/6.0, Biomet 3.4/4.0/5.0, Nobel Biocare Branemark, Nobel Biocare Active Internal 4.1/5.0(RP/WP) & 3.5(NP), Nobel Biocare Select 4.3/5.0(RP/WP) & 3.5(NP), Nobel Biocare Replace 4.3, Straumann Bone Level 4.0 NC &RC, Zimmer 3.75/4.5/6.0.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes used for the test sets in the static and fatigue testing. It generally refers to testing "with Astra Tech in both screw sizes," "Biomet 3i in both sizes," "Nobel Select 3.5," and "Nobel Biocare Branemark." This suggests that multiple abutments for various implant systems were tested, but specific numbers are not provided.

The data provenance is not explicitly stated, but based on the context of a 510(k) submission to the FDA, it is highly likely that these were prospective laboratory studies conducted specifically for this submission. The country of origin is not mentioned, but the submitting company is based in Dayton, Ohio, USA, suggesting the testing was likely conducted in the USA or by labs commissioned by the US-based company.

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

This information is not applicable as the evaluation involved physical testing (static and fatigue) of medical devices, not an assessment of data where expert ground truth would typically be established (e.g., image interpretation). The "ground truth" in this context is determined by the physical properties and performance of the devices under specified test conditions.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above. Adjudication methods are typically relevant for human-involved assessments (e.g., expert consensus on medical images).

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as the evaluation involved physical testing of medical devices, not human interpretation of medical cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a physical medical implant (temporary abutment), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.

7. Type of Ground Truth Used

The "ground truth" was established through physical testing and engineering standards. Specifically:

• Static Strength: The ultimate force or load the abutment could withstand before failure.
• Fatigue Life: The number of cycles the abutment could endure under a specified load before failure.
• Material Composition: Verified through material analysis to confirm PEEK.

The comparison was made against the performance of legally marketed predicate devices under the same test conditions.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical implant, not an AI model or software that requires a training set.

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

This information is not applicable for the reasons stated above.

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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

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., <4% difference in irrigation flow, <8% difference in aspiration capability) act as implicit performance targets based on comparison to predicate devices.
• Sample size used for the test set and the data provenance: The document mentions "Laboratory tests" but does not specify the sample size (e.g., number of devices tested, number of measurements taken) or the provenance of the data (country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for these tests would be the measured performance of the predicate device. Expert consensus is not a factor for these types of engineering/laboratory tests.
• Adjudication method: Not applicable, as expert adjudication is not relevant for these types of laboratory tests comparing physical attributes.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No, this type of study is not mentioned or described. The device is a surgical tool, and the focus is on its physical performance rather than diagnostic accuracy or human interpretation of images.
• Standalone (i.e., algorithm only without human-in-the-loop performance) study: No, this is not applicable as the device is a physical electrosurgical tool, not an AI algorithm.
• Type of ground truth used:
  • For irrigation flow and aspiration capability: The "ground truth" was the measured performance of the predicate device (MMP #0055).
  • For coagulation capabilities: The "ground truth" was the performance of the UMP ACE electrodes, as the ICE electrodes use the "same UMP DBL electrodes."
• Sample size for the training set: Not applicable, as this is a physical medical device, not an AI model that requires a training set.
• How the ground truth for the training set was established: Not applicable for the same reason as above.

Attempt to present the information in the requested format, acknowledging missing details:

Acceptance Criteria and Device Performance Study for Utah Medical Products Inc.'s ICE electrodes

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. The text only refers to "Laboratory tests."
• Data Provenance: Not specified. It can be inferred that these were internal laboratory tests conducted by Utah Medical Products, Inc.

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

• Number of Experts: Not applicable. The ground truth for these engineering tests was based on direct measurement of physical properties of the predicate devices.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Expert adjudication is not relevant for objective laboratory measurements of device performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• No, an MRMC comparative effectiveness study was not done. The device is a surgical instrument, not a diagnostic imaging or AI-driven system that would typically undergo such a study.

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

• No, a standalone (algorithm-only) performance study was not done. The device is a physical electrosurgical tool, not an AI algorithm.

7. The type of ground truth used

• Ground Truth Type: For irrigation fluid flow and aspiration capability, the ground truth was the measured performance of the identified predicate device (MegaDyne Medical Products, Inc.'s All-In-One Hand Control #0055). For coagulation capabilities, the ground truth was the performance of Utah Medical Products, Inc.'s ACE-311 and ACE-511 Aspiration/Coagulation Electrodes, as the ICE electrodes use the same core coagulating components (UMP DBL electrodes).

8. The sample size for the training set

• Sample Size: Not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

• Ground Truth Establishment: Not applicable.

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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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