Search Results

The Genie is an accessory to a syringe that provides a mean of sterile access to drug vials without the use of conventional needles (needleless). These devices are designed to improve user safety by reducing the exposure that health-care workers are subjected to regarding aerosolizing hazards and accidental needle sticks.

The Genie™ is intended for use as an accessory to an I.V. set. The Genie™ is used to adapt a standard medication vial for needle free access and to maintain the sterile system. In addition, the Genie™ automatically equalizes vial pressure as fluids are withdrawn and therefore reduces the risk for health-care workers for exposure to potentially hazardous drug aerosols, spills or needle sticks that can occur during the preparation, administration and dispensing process.

The provided text describes a 510(k) submission for the Genie™ vial access device, which is an accessory to a syringe. The submission focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics. Therefore, many of the requested categories for a study proving device acceptance criteria cannot be fully addressed from the provided document.

Here's a breakdown of what can and cannot be extracted from the text:

1. A table of acceptance criteria and the reported device performance

The document states: "The Genie™ vial access device has been tested post sterilization and passed all acceptance criteria." However, the specific acceptance criteria (e.g., maximum leakage, pressure equalization rate, sterility maintenance duration) and the quantitative results (reported device performance) are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text only mentions that the device "has been tested," but does not detail the testing methodology, sample size, or the nature of the data (e.g., if it was from real-world usage or laboratory testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the document describes a device submission based on substantial equivalence and testing, not a study involving expert assessment or ground truth establishment in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

This is not applicable to this device. The Genie™ is a physical accessory designed to improve user safety by reducing exposure to hazards, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable to this device as it is a physical medical accessory, not an algorithm.

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

The concept of "ground truth" as typically applied in AI/diagnostic studies does not directly apply here. Instead, the device's performance would be judged against functional and safety standards (e.g., sterility, pressure equalization, leakage) through laboratory testing. The document implies that the "ground truth" for demonstrating safety and effectiveness was based on passing these established acceptance criteria.

8. The sample size for the training set

This is not applicable as this document does not describe an AI/算法 development process involving a training set.

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

This is not applicable as this document does not describe an AI/算法 development process involving a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

Based on the provided text, the "study" demonstrating the device meets acceptance criteria appears to be a series of "post sterilization" tests to ensure functionality, safety, and effectiveness.

• Study Type: The document describes the process as "The Genie™ vial access device has been tested post sterilization and passed all acceptance criteria." This implies a laboratory-based testing regimen and engineering verification/validation rather than a human-centered clinical trial or an AI performance study.
• Purpose: To demonstrate that the Genie™ vial access device functions as intended (providing sterile access, equalizing pressure, reducing exposure to hazards) and is safe, thereby establishing substantial equivalence to predicate devices (K001368, specifically mentioned for its pressure equalization mechanism).
• Key Finding: The device "passed all acceptance criteria" and "meets the functional claims and intended use."

The document focuses on explaining that the device is substantially equivalent to existing predicate devices due to shared intended use, indications for use, and materials, with the main difference being the internal versus external balloon for pressure equalization. The overall claim for safety and effectiveness is tied to passing these unspecified acceptance criteria.

Ask a specific question about this device

Sultan Genie Magic Mix™ Ultra Hydrophilic Impression Material is intended for use as a dental impression material, compatible with all techniques including dual-phase, monophase and dual impression techniques. The material is dispensed from an automatic mixing machine system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria or study details for a device. The document is a 510(k) clearance letter from the FDA for a dental impression material, outlining its substantial equivalence to a predicate device and its intended use. It does not include performance metrics or study designs.

Ask a specific question about this device

Sultan Genie Ultra Hydrophilic Impression Material is intended for use as a dental impression material. The material is dispensed from an automatic mixing cartridge system and placed into dental impression trays (metal or plastic) and is used to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.

Not Found

This is a 510(k) clearance letter from the FDA for Sultan Genie™ Ultra Hydrophilic Impression Material, classifying it as substantially equivalent to a predicate device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically expected for an AI/ML medical device.

The provided text pertains to a traditional dental impression material, not an AI/ML-based device. Therefore, the details requested (such as sample size for test/training sets, expert qualifications, HRMC studies, standalone performance, etc.) are not applicable to this submission.

The "acceptance criteria" and "study" mentioned in the context of this document would refer to the standards for dental impression materials (e.g., rheology, dimensional stability, tear strength, hydrophilic properties, biocompatibility) and the non-clinical bench testing or potentially limited clinical evaluations demonstrating that the Sultan Genie™ material performs comparably to the identified predicate devices for its intended use.

Based on the provided text, I cannot furnish the requested information because it is not an AI/ML device submission.

However, I can extract the relevant information from this document:

• Device Name: Sultan Genie™ Ultra Hydrophilic Impression Material
• Intended Use: As a dental impression material, dispensed from an automatic mixing cartridge system, placed into dental impression trays (metal or plastic) to accurately reproduce intra-oral structures (teeth & gums) to provide models for study and/or fabrication of prosthetic devices.
• 510(k) Number: K030414
• Regulatory Class: II
• Product Codes: ELW

To reiterate, the questions posed in your prompt (e.g., sample size for test set, expert qualifications, MRMC study, standalone performance) are designed for AI/ML device submissions, which this document is not.

Ask a specific question about this device

The Genie Cup™ Integrated Screening Device is a professional use, rapid, multiple immunoassay tool for the qualitative detection of the major metabolites of the following drugs of abuse in urine at the SAMHSA specified (except for methamphetamines) cutoff concentrations.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving a device meets them. The document is a 510(k) clearance letter from the FDA for the "Genie Cup™ Integrated Screening Device."

While it mentions the intended use and cutoff concentrations for certain substances, it does not include:

• A table of acceptance criteria and reported device performance. It lists cutoff concentrations but not the performance metrics against those cutoffs (e.g., sensitivity, specificity).
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Details about standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size and ground truth establishment for the training set.

The document primarily focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the device. It refers to "established economics of the major metabolites of Sep" and SAMHSA specified cutoff concentrations, suggesting that the device's design aligns with existing standards, but it doesn't present the specific rigorous study data you're asking for.

Ask a specific question about this device

Genie P&R is designed to display and process data acquired by nuclear medicine cameras for review by physicians. Genie P&R can retrieve data from nuclear imaging systems and archive the data.

Genie P&R is a computer workstation used for the retrieval, archival, processing, analysis and management of nuclear medicine images (data). It consists of a UNIX based workstation (high resolution color monitor, keyboard, mouse, CD ROM), ethernet network connection and system software. Optional optical disk archive and laser filming/color hardcopy are available.

This document describes a legacy device, the GE Medical Systems Genie Processing and Review Workstation, cleared in 1997. As such, the information provided is typical of the regulatory submissions from that era and does not contain the detailed study information (e.g., acceptance criteria, detailed performance metrics, ground truth establishment, sample sizes, MRMC studies) that are now standard for AI/ML-based devices. The submission primarily focuses on substantial equivalence to a predicate device rather than comprehensive performance studies with predefined acceptance criteria.

Therefore, many of the requested data points are not explicitly available or described in the provided text.

Acceptance Criteria and Reported Device Performance

The submission does not explicitly define acceptance criteria in terms of quantitative performance metrics for the device itself. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing its functionalities to those of the predicate device.

Study Information (Based on Provided Text)

1. Sample size used for the test set and the data provenance: Not specified. The document states "Summary Of Studies" but then only describes the device's capabilities without detailing any specific performance studies with test sets.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
4. 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: An MRMC comparative effectiveness study was not conducted or reported. This type of study is typically for evaluating the impact of AI on human reader performance, which is not relevant for this device which functions as a processing and review workstation.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a 'Processing And Review Workstation', implying human-in-the-loop for image review. No standalone algorithm-only performance is described as the device's purpose is to facilitate human review.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified.
7. The sample size for the training set: Not applicable/not specified. This device is described as a workstation for processing and review, not an AI/ML algorithm that would typically require a training set in the modern sense.
8. How the ground truth for the training set was established: Not applicable/not specified.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device