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Trinity's Heart Cath Tray is a sterile prepackaged disposable unit. It contains the non-reinforced gowns, femoral angio drape, OR cloth towels, absorbent towels, 16 oz sponge bowl, 32 oz sponge bowls, bowl guidewire with lid, 2 oz medicine cups, gauze sponges, straight mosquito forceps, 25 ga x 5/8" needle, 22 ga x 1 1/2" needle, 5cc L/L syringe, 10cc L/L syringe, 20cc L/L syringe, 10cc L/S syringes, towel clips, #11 blade scalpel, table cover, and band bag, neccessary for the performance of the Heart Cath surgical procedure..

Trinity's Heart Cath Tray is a sterile prepackaged disposable unit. It contains the non-reinforced gowns, femoral angio drape, OR cloth towels, absorbent towels, 16 oz sponge bowl, 32 oz sponge bowls, bowl guidewire with lid, 2 oz medicine cups, gauze sponges, straight mosquito forceps, 25 ga x 5/8" needle, 22 ga x 1 1/2" needle, 5cc L/L syringe, 10cc L/L syringe, 20cc L/L syringe, 10cc L/S syringes, towel clips, #11 blade scalpel, table cover, and band bag, neccessary for the performance of the Heart Cath surgical procedure..

This document is a 510(k) clearance letter from the FDA for a medical device called "Heart Cath Tray". It is not a study report or a technical document describing acceptance criteria and device performance. Therefore, I cannot extract the requested information.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which means its safety and effectiveness are considered to be similar to devices already on the market. However, it does not provide details of specific performance criteria or the results of a study to demonstrate those criteria.

To answer your questions, I would need a technical report, a clinical study summary, or a comprehensive PMA/510(k) submission that details the performance data and acceptance criteria for the device.

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Trinity's Dental Tray is a sterile prepackaged disposable unit. It contains the gowns, table cover, mayo stand cover, OR towels, bowl, medicine cup, sponges, scalpels, tongue depressor, foam tray, Yankauer, suction tubing, and towels necessary for the performance of basic dental procedures, including but not limited to general cleaning, cavity filling, root canal, and tooth removal.

Trinity's Dental Tray is a sterile prepackaged disposable unit. It contains the gowns, table cover, mayo stand cover, OR towels, bowl, medicine cup, sponges, scalpels, tongue depressor, foam tray, Yankauer, suction tubing, and towels necessary for the performance of basic dental procedures, including but not limited to general cleaning, cavity filling, root canal, and tooth removal.

The provided document is a 510(k) premarket notification letter from the FDA for a "Dental Tray, Sterile, Disposable" manufactured by Trinity Laboratories, Incorporated.

This document does not contain any information regarding acceptance criteria, device performance studies, or details about artificial intelligence (AI) performance. The letter is solely an FDA notification of substantial equivalence for a medical device.

Therefore, I cannot provide the requested information. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or the number/qualifications of experts for a test set.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for a training set or how ground truth for a training set was established.

This document is a regulatory approval for a physical medical device (a sterile, disposable dental tray) and not a submission or report for an AI/software as a medical device.

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Trinity's Circumcision Tray is a sterile prepackaged disposable unit. It contains the gauze sponges, straight mosquito forceps, curved mosquito forceps, adson tissue forceps, probe wtih eye, PVP swabsticks, OR scissors, multi-compartment pouch, #10 blade scalpel, and fenestrated cloth OR towel necessary for the performance of the circumcision surgical procedure..

Circumcision Tray is a sterile prepackaged disposable unit. It contains the gauze sponges, straight mosquito forceps, curved mosquito forceps, adson tissue forceps, probe wtih eye, PVP swabsticks, OR scissors, multi-compartment pouch, #10 blade scalpel, and fenestrated cloth OR towel.

This document is a 510(k) premarket notification letter from the FDA regarding a "Circumcision Tray." It does not contain information about acceptance criteria or a study proving device performance as requested. The document primarily discusses the substantial equivalence determination for the device and clarifies regulatory aspects, including an issue with a drug component (PVP Swabsticks) included in the tray.

Therefore, I cannot provide the requested information based solely on the provided text. The requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) would typically be found in the 510(k) submission itself, not in the FDA's decision letter.

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CRP-LEX-SYSTEM is intended to be used, in hospital and other The appropriate clinical laboratories, to detect CRP levels in patient serum specimens around the 8ug/ml (0.8mg/d1) concentration.

The CRP-LEX method is by latex slide agglutination. At CRP levels at or above this noted concentration, agglutination of the CRP-LEX, latex particles should be observed. A screening (qualitative) and semi-quantitative procedure (dilution of the patient specimen) has been included and described.

CRP-LEX™ SYSTEM A Latex To Detect C-Reactive Protein In Serum. The CRP-LEX method is by latex slide agglutination.

This document is a marketing authorization letter for the CRP-LEX™ SYSTEM, a device intended to detect C-Reactive Protein (CRP) in serum. It is not a study report, and therefore does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices. It states the "Indications For Use" which describe what the device is intended to do, but not the performance metrics of a specific study.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• Acceptance Criteria & Reported Performance: The document provides the intended use: "to detect CRP levels in patient serum specimens around the 8ug/ml (0.8mg/d1) concentration" and that "At CRP levels at or above this noted concentration, agglutination of the CRP-LEX, latex particles should be observed." This describes the functionality and threshold for detection, not specific performance metrics like sensitivity, specificity, accuracy, or their acceptance criteria from a validation study.
• Sample Sizes (Test & Training): Not mentioned in this regulatory letter.
• Data Provenance: Not mentioned.
• Number of Experts & Qualifications: Not mentioned.
• Adjudication Method: Not applicable for a device described in this type of letter.
• MRMC Comparative Effectiveness Study: Not mentioned, and generally not applicable for a diagnostic test like this unless comparing it to human readers interpreting raw data (which is not the case for a latex agglutination test).
• Standalone Performance: The described "CRP-LEX method is by latex slide agglutination." The performance of this method is inherent to the device itself. However, the details of its standalone performance (e.g., sensitivity, specificity values) are not provided.
• Type of Ground Truth: The device detects CRP levels. The "ground truth" for a device like this would typically be established by a reference method for CRP quantification, but this is not detailed in this regulatory letter.
• Ground Truth for Training Set: Not mentioned.

In summary, the provided document is a regulatory approval letter based on a 510(k) submission, confirming substantial equivalence. It does not provide the detailed study results and performance metrics that your request asks for. To find that information, one would typically need to consult the 510(k) summary, peer-reviewed publications, or the manufacturer's internal validation reports, which are not included here.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device