Search Results

The Monorail™ Endosseous Implant is intended for use as a self-tapping screw for transitional or intra-bony long-term splinting for any length of time as decided by the Health Care provider.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for a dental implant, the Dentatus Monorail™ Endosseous Implant. It describes the regulatory clearance process, the product name, and its indications for use.

Crucially, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other details requested in your prompt. This type of information is typically found in the 510(k) summary or detailed submission, which is not provided here.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the given text.

Ask a specific question about this device

The MDI Trigger Guard serves as a mechanical stop intended to be used with FDA approved metered dose inhalers. The MDI Trigger Guard is an accessory to a metered dose inhaler to prevent accidental actuation. Intended for use by entire patient population for which metered dose inhalers are approved, excluding children under the age of 8. Device is not reusable. Device is to be used for the life of the metered dose inhaler, then discarded.

The MDI Trigger Guard serves as a mechanical stop intended to be used with FDA approved metered dose inhalers. The MDI Trigger Guard is an accessory to a metered dose inhaler to prevent accidental actuation.

I am sorry, but the provided text from the FDA 510(k) summary for the "MDI Trigger Guard" (K040439) does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving the device meets those criteria.

This document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices, and an "Indications for Use" statement. It explicitly mentions that the FDA's determination of substantial equivalence does not mean the device complies with other requirements, including those related to performance studies.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance: This information is not present in the document.
2. Sample size used for the test set and data provenance: Not available.
3. Number of experts used to establish ground truth and their qualifications: Not available.
4. Adjudication method for the test set: Not available.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details: Not available. The device is a mechanical accessory, not an AI or imaging device that would typically involve such studies.
6. Standalone performance study details: Not available.
7. Type of ground truth used: Not available.
8. Sample size for the training set: This refers to AI algorithms, which is not applicable here.
9. How ground truth for the training set was established: Not applicable.

The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with specific acceptance criteria as you've described for AI/diagnostic devices.

Ask a specific question about this device

The Powered Wheelchair is intended for use to provide mobility to The Towered "Whoolonal" is "the capability of operating a power wheelchair.

Powered Wheelchair

This document is a 510(k) clearance letter from the FDA for a Powered Wheelchair. It is a regulatory approval document and does not contain any information regarding acceptance criteria or the study data that proves the device meets those criteria, as typically found for AI/ML devices.

Therefore, I cannot extract the requested information from the provided text. The document itself is the clearance, not the detailed technical data that led to the clearance.

Ask a specific question about this device

Indications for Use:

• 1. Warming transfusions, infusions, fluids.
• 2. Warming blood infusions and return blood flow.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for a medical device called "ASTOFLO," a blood and infusion warmer. It outlines the FDA's determination of substantial equivalence to a predicate device and provides information on regulatory responsibilities.

The document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. Therefore, I cannot extract the requested information from this text.

Ask a specific question about this device

Heat curing polymer for dental prosthesis used for the repair and extending of dentures, relining for completing metal dentures and for use in orthodontia.

Not Found

I am unable to provide a description of the acceptance criteria and study as the provided document is a 510(k) clearance letter for a dental device (Dentorium Convertible Acrylic) and does not contain information about acceptance criteria or supporting studies. It primarily states that the FDA has found the device to be substantially equivalent to a legally marketed predicate device.

The document discusses the regulatory classification, general controls, and compliance requirements for the device. It also includes an "Indications for Use" section (Page 2), which outlines what the device is intended for and its contraindications.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

Hydrotherapy; Relieve pain and itching.

Hydrotone-Thermal Capsule System

The provided document is a 510(k) clearance letter from the FDA for the Hydrotone-Thermal Capsule System. It confirms that the device is substantially equivalent to a legally marketed predicate device for the indicated uses. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter focuses on regulatory clearance, indicating the device can be marketed. It lists the "Indications for Use" as "Hydrotherapy; Relieve pain and itching." and provides contraindications. It does not include any performance metrics, study design, or results that would typically be found in a study demonstrating the device meets specific acceptance criteria.

Therefore, I cannot provide the requested information based on the given text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device