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TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxilla. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

TRUST is restricted to be used with 510(k) cleared abutment systems, and the design output from TRUST (the patient specific part of the abutment) must be manufactured according to the instruction of the selected Implant system.

TRUST includes design parameters from the 510(k) cleared abutment systems such as implant type, maximum and minimum dimensions (e.g., abutment post height, angulation, gingival marqin diameter, wall thickness). The design parameters, provided by abutment system manufacturers(Truabutment), for an abutment system are available via a Trust server when documentation of the 510(k) clearance of said implant system is confirmed by Rgorithm.

TRUST has no patient contact being a software only device. (stand-alone software)

The provided text describes a 510(k) premarket notification for a dental abutment design software called TRUST. However, it does not contain any information regarding acceptance criteria, reported device performance, or any study details like sample size, ground truth establishment, or expert qualifications.

The document primarily focuses on establishing substantial equivalence to a predicate device (Abutment Design, K200100) by comparing intended use, technological characteristics, and hardware/software requirements.

Here's a breakdown of what is and is not present in the provided text:

What is present:

• Device Name: TRUST
• Indication for Use: "TRUST is intended as an aid to the restoration of chewing function in partially edentulous mandibles and maxillae. TRUST is a software device intended to be used by a dental practitioner or dental laboratory staff for designing the patient specific component of one-piece type abutment. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device."
• Predicate Device: Abutment Design (K200100)
• Confirmation of Non-clinical Testing: "Software, hardware, and integration and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005. The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures."
• Cybersecurity Analysis: "The cybersecurity analysis was performed in accordance with the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued on October 02, 2014."
• Clinical Testing Statement: "Clinical testing is not a requirement and has not been performed."

What is explicitly missing or not described in the provided text, and therefore cannot be filled in based on this input:

• A table of acceptance criteria and the reported device performance. The document states that "All test results have been reviewed and approved, showing the TRUST to be substantially equivalent to the primary predicate device," but it does not provide the specific criteria or the performance metrics themselves.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (While it mentions "software only device," it doesn't quantify its standalone performance or discuss specific studies.)
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

Conclusion:

The provided document describes a device (TRUST software) and its intended use, and states that non-clinical testing and cybersecurity analysis were performed to demonstrate substantial equivalence to a predicate device. However, it does not provide the specific details of acceptance criteria, device performance, or study methodology that would be required to complete the requested table and information points about test and training sets, ground truth, and expert evaluation.

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The Line One Trust Dam is used as a barrier when engaging in oral/vaginal sex and oral/anal sex to help reduce the transmission of bodily fluids, harmful germs, and sexually transmitted diseases.

This oral dam is made of natural rubber latex, which completely covers a person's pubic areas during oral genital stimulation. This dam has a smooth surface (both sides), nominal lay flat width 154 mm, nominal length 250 mm, and nominal thickness 0.07mm. It is non- lubricated, and food grade cornstarch is used as a dressing material.

The condoms from which the oral dams are made conform to current established national and international voluntary standards which include ASTM D3492:2008; and have been previously cleared by the USFDA (ref: K070830).

The condoms will be offered in the following Colors and Flavors:

1. Yellow Banana
2. Red Strawberry
3. Green Mint

The provided document is a 510(k) Pre-Market Notification for a male latex condom (Trust Dams). This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with detailed acceptance criteria and expert-read studies.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria for an AI/algorithm-based device and the study proving it meets those criteria. Specifically:

• No acceptance criteria table or reported device performance is present because this is a physical medical device (condom), not an AI algorithm. The performance is assessed against established standards for latex condoms.
• No sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details are provided, as these are concepts relevant to AI/algorithm validation, not to the pre-market notification for a physical medical device like a condom.
• No training set details are relevant here.

The document indicates that the device (Trust Dams) is made from natural rubber latex condoms that conform to established national and international voluntary standards, specifically ASTM D3492:2008 Male Latex Condom Standard. The predicate device is "Sheer Glyde Dams (K990067)", and the condoms from which the oral dams are made were previously cleared by the USFDA (K070830).

The "technological characteristics" section states: "This oral dam has the same technological characteristics as the listed predicate device identified above. The latex condoms (sheaths) from which the dams are made conform with the ASTM D3492:2008 Male Latex Condom Standard." This conformity to an established industry standard is the primary basis for demonstrating substantial equivalence for this type of device.

In summary, the provided text does not contain information about an AI or algorithmic device study. It details the 510(k) submission for a physical medical device (latex dam) and bases its substantial equivalence on adherence to existing condom standards.

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1 - Intended Use: The DHD TRUST is intended for use as a nebulizer.

• 2 Indications:
• The DHD TRUST provides additional hydration to help loosen secretions for patients whom extended therapy is required.
• The DHD TRUST delivers aerosolized medications and diagnostic formulations.
• 3 Target Patient Population
  Patients with asthma, pneumonia, COPD, or any other condition in which appropriate medications would be nebulized.

The DHD TRUST is indicated for use as a single patient use nebulizer. TRUST is a small plastic device that threads onto a regulated flow meter supplying air or oxygen. A reservoir bottle threads to the bottom of TRUST to hold water and/or medication. Trust has a secondary port on the side of the device to allow for supplemental air, oxygen, or heliox.

The provided text describes a 510(k) premarket notification for the DHD Healthcare Corporation's "TRUST" nebulizer. It details the device's intended use, technological characteristics, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm or software. The study mentioned relates to particle size delivery for a physical medical device (nebulizer) and aims to show equivalence to a predicate device, not performance benchmarks for an AI system.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance for an AI/ML device, nor can I discuss sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided document.

The "Summary of Studies" section only states:
"Testing of particle size delivery was performed in accordance with the guidance document "REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS". The results of this testing shows particle size delivery to be equivalent between TRUST and the predicate."

This describes a physical performance test for a nebulizer, not an AI/ML model.

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This Device is A latex Condom: designed to Prevent PREGNANCY & help reduce the Risk. OF TRANSMISSION TO sexually transmitted diseases.

latex Condom

This document is a 510(k) clearance letter from the FDA for two brands of condoms: Trustex® and Impulse® Mint Flavored Condoms in Green Color. As such, it does not contain the information requested about acceptance criteria and a study proving a device meets them.

The letter acknowledges that the device is "substantially equivalent" to legally marketed predicate devices and therefore can be marketed. It discusses regulatory compliance, labeling requirements (including expiration dating), and general responsibilities under the Federal Food, Drug, and Cosmetic Act.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for any study.
• Information on expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.

Therefore, I cannot provide the requested information from this document.

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