Search Results

Cartridge Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.

Dental Aspirating Syringes/Self Aspirating Syringes include standard, petite and medium sizes. All syringes are made of stainless steel and have aluminum handles. Syringes are reusable, sterilizable and packaged non-sterile.

This document is a 510(k) Premarket Submission for a Cartridge Dental Syringe (K092943). It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as it's a premarket notification document for a medical device seeking market clearance, not a study report.

The document indicates that the device is a simple cartridge syringe for dental anesthetic injections and is being found "substantially equivalent" to existing devices on the market. This type of submission relies on demonstrating that the new device has similar technological characteristics and intended use as a legally marketed predicate device, rather than requiring new clinical performance data against specific, quantitative acceptance criteria.

Therefore, it is not possible to fill out the requested table and information points from the provided text.

Explanation of what this document is (and isn't):

• 510(k) Premarket Submission: This is a regulatory pathway in the US for medical devices that are substantially equivalent to a legally marketed predicate device. It demonstrates that the new device is as safe and effective as the predicate.
• Substantial Equivalence: This means the device has the same intended use and the same technological characteristics as the predicate, or it has different technological characteristics but does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the predicate device.
• Absence of Acceptance Criteria and Performance Study: For many Class I and Class II devices seeking 510(k) clearance, extensive clinical studies with quantifiable acceptance criteria are not required if substantial equivalence can be established through technological comparison, design features, and material properties. The FDA letter confirms the device classification (Class II) and that it's subject to general controls, indicating that a full PMA (Premarket Approval) with extensive clinical trial data was not necessary.

Ask a specific question about this device

The Pacs Unit ARRI OSCAR NET/CD will be used to acquire, display, process, archive, retricve, and transmit diagnostic medical images and information about these images in a single user or network enviroment. The typical users are trained medical professionals.

The device is intendet to be used to convert an medical film/S-VHS Tape -Image into a digital format(DICOM), electronic storage for an medical image and electronic tranfer of medical image data.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ARRI-Oscar Net/CD device.

Key Observation: The provided 510(k) submission document does not contain specific acceptance criteria or performance study data in the way one typically expects for a device performance study (e.g., sensitivity, specificity, accuracy metrics). Instead, it lists harmonized standards that the device adheres to, and briefly describes its intended use. This document is primarily concerned with establishing substantial equivalence to a predicate device and ensuring compliance with regulatory standards.

Therefore, the answers to many of the questions will be "Not Applicable" or "Not Provided" in the given document.

Description of Acceptance Criteria and Study

The provided document describes the ARRI OSCAR NET/CD, a Picture Archiving and Communication System (PACS), intended to convert medical film/S-VHS tape images into a digital format (DICOM) for electronic storage and transfer. The acceptance criteria, as presented in this document, are primarily based on adherence to recognized technical and safety standards, rather than specific performance metrics like diagnostic accuracy. The "study" alluded to is the 510(k) submission process itself, where the manufacturer demonstrates substantial equivalence to a legally marketed predicate device (MEDIMAGE) and compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable / Not provided. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on a clinical performance study with a test set of medical images.
• Data Provenance: Not applicable / Not provided.

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

• Number of Experts: Not applicable / Not provided.
• Qualifications of Experts: Not applicable / Not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable / Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or performed according to this document. The device is a PACS system for digitizing and managing images, not an AI diagnostic tool that assists human readers.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This device is a PACS system designed for image management, not a diagnostic algorithm. Its performance is related to its ability to accurately digitize, store, and transmit images, and comply with technical standards.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the context of this device (a PACS system), the "ground truth" would be related to the accuracy and integrity of the digitized images, successful data transfer, adherence to DICOM standards, and compliance with the listed safety and performance standards. No specific ground truth type (e.g., pathology, outcomes data) is mentioned for evaluating diagnostic performance, as that is not the device's primary function.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable / Not provided. This document does not describe a machine learning algorithm that would require a training set.

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

• Ground Truth for Training Set: Not applicable / Not provided.

Ask a specific question about this device

The device is used for the diagnosis and quantitative. evaluation of 35 mm cine radiographic images, which i originating from radiographic imaging like Angiography.

The device contains a visible light source covered with a translucent front that is intended to be used to view medical cine radiographic images (CFR 21 part 892.1890). It also allows to be used for wall projection. The medical device is not part of a diagnostic x-ray system.

The device may only be operated in cathlabs, lecture halls and doctors' consulting rooms. The device is only for use by medical professionals.

The ARRIPRO 35 was designed to fulfil the special requirements in view of an increasing demand for image quality and evaluation precision of 35 mm cardangiofflm material which could only be met with the innovative development of a practice-oriented projector. This projector which was developed using state-of-the-art technology for ease of operation, has an outstanding image quality for the projection, diagnosis and quantitative evaluation of 35 mm cine radiographic images.

The ARRIPRO 35 St / TV has the following functions: Rapid Film Transport and Simple Operation, Optimized Image Quality with Flicker Free Projection, High Speed Shuttle, Revolving Lamp Holder, Optimum Wall Projection, Computer and Video Connections, B&W-CCD-TV Camera.

The provided text is related to a 510(k) submission for a radiographic film illuminator, the "Arripro 35 St / TV." However, it is a premarket notification document, which is primarily focused on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results with acceptance criteria and device performance metrics in the way a clinical trial or performance study report would.

Therefore, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information can be extracted:

• Type of Device: This is a radiographic film illuminator, a viewing apparatus for 35mm cineradiographic images. It's a Class II device.
• Regulatory Context: The document details a 510(k) submission, meaning the manufacturer is seeking to market a new device that is substantially equivalent to a legally marketed predicate device (CAP 35BIII / CINE 275). This process typically relies on demonstrating that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety or effectiveness.
• "Study" Information (Implicit): The "study" in this context is the submission itself, which primarily refers to compliance with various DIN and EN standards. These standards implicitly contain performance requirements for viewing apparatus.

Extracted Information and Why Other Information is Missing:

1. Table of Acceptance Criteria and Reported Device Performance: This is not explicitly provided in the document. The document lists several DIN and EN standards that the device applies for, such as:

   • DIN 6856, Part 1: "Demands for the manufacture and the operation of viewing apparatus for the evaluation of transparent images in medical diagnostics."
   • DIN 6856, Part 2: "Quality-guaranteeing measures in medical diagnostics, - testing procedures, measuring instruments."
   • EN 60950 / IEC 950: Safety of Information Technology Equipment.
   • EN 61010-1: Safety requirements for electrical equipment for measurement, control, and laboratory use.
   • EN 55011 / CISPR 11: Industrial, scientific and medical (ISM) radio-frequency equipment – Electromagnetic disturbance characteristics.

   These standards contain the acceptance criteria (e.g., specific illumination levels, flicker rates, safety parameters, electromagnetic compatibility). The document states the device applies these standards, implying compliance, but does not present a table of specific criteria and the device's measured performance against them. The description of "Optimized Image Quality with Flicker Free Projection" is a qualitative claim rather than a metric.

2. Sample size used for the test set and the data provenance: There is no information in this document about a test set in the sense of patient data or clinical images. The "testing" referred to would be engineering tests for compliance with the listed standards.

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 is not applicable/not provided. There is no mention of a human-read test set or ground truth establishment by medical experts for the purpose of this 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable/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. The device is a film illuminator, not an AI software, and no MRMC study is mentioned.

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 illuminator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This is not applicable/not provided.

8. The sample size for the training set: This is not applicable/not provided. There is no "training set" as this is not an AI device.

9. How the ground truth for the training set was established: This is not applicable/not provided.

In summary: The provided document is a 510(k) summary for a radiographic film illuminator. It focuses on demonstrating substantial equivalence through compliance with recognized industry standards and describing the device's technological characteristics. It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically associated with clinical performance studies or AI device evaluations.

Ask a specific question about this device