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The Blunt Nerve Block Needle is intended for the administration of anesthetic agents to provide regional anesthesia.

The Blunt Nerve Block Needle consists of a stainless steel cannula with an atraumatic distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a stainless steel wire shaft and a molded plastic hub. The Blunt Nerve Block Needle will be provided as a sterile, single use, disposable device and will be available in a variety of lengths and gauges.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study.

Crucially, this document is a 510(k) summary for a "Blunt Nerve Block Needle." Medical devices of this type typically do not have performance acceptance criteria in the same way as AI/software devices. Therefore, many of the requested elements for an AI product's study will not be present. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This submission is for a physical medical device (a needle), not a diagnostic AI or imaging device that would typically have a "test set" of data. The submission relies on a comparison to a predicate device.
• Data Provenance: Not applicable. The "study" isn't a data-driven performance study in the AI sense, but rather a regulatory comparison.

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

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

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. This is not an AI/software device, so an MRMC study is not relevant or included.
• Effect Size of Human Reader Improvement with AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: No. This is a physical device, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For this submission, the "ground truth" equivalent is the established safety and effectiveness of the predicate devices (Pajunk Sprotte Needles). The Epimed needle is deemed safe and effective because it is substantially equivalent to these already-approved devices, which are presumed to have established their "truth" through prior regulatory pathways and clinical use.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no concept of a "training set" for this type of medical device submission.

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

• How Ground Truth was Established: Not applicable.

Summary of the "Study" (or lack thereof, for AI purposes):

The submission for the Epimed International, Inc. Blunt Nerve Block Needle is a 510(k) Premarket Notification based on substantial equivalence to predicate devices. It does not involve a study with acceptance criteria, test sets, or ground truth in the way an AI/software medical device would.

Instead, the "study" is a non-clinical comparison that asserts:

• The device has similar physical and technical characteristics to the Pajunk Sprotte Needles (K911260, K911221, K911202).
• The device has the same intended use as the predicate devices: "For the administration of anesthetic agents to provide regional anesthesia. Not for use with an Epidural Catheter."
• No bench testing of performance characteristics was conducted as the submission relies solely on this similarity and intended use to the predicates.

The conclusion is that because it is sufficiently similar to an already legally marketed device with a known safety and effectiveness profile, the new device is also considered safe and effective, and therefore, substantially equivalent.

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The TAO ASPIRATORTM is a device to hold a 10cc syringe for performing fine needle aspiration of a palpable mass with one hand, while stabilizing the mass to be aspirated with the other hand. It is equipped with a release button for automatically drawing back the syringe plunger, and is designed to be held in a pencil-grip manner. This device places the hand relatively close to the needle tip while the hand is in a position of natural function, enabling the needle movement using fine motor control of the hand.

The PLASTIC FINGERTM is an accessory to the TAO ASPIRATORTM to facilitate specimen procurement. It facilitates needle removal so that air can be drawn into the syringe, and the aspirated material in the needle and needle hub can then be expressed onto slides. It can also be used to grip slides for fixation and staining.

The TAO ASPIRATORTM is a device to hold a 10cc syringe for performing fine needle aspiration of a palpable mass with one hand, while stabilizing the mass to be aspirated with the other hand. It is equipped with a release button for automatically drawing back the syringe plunger, and is designed to be held in a pencil-grip manner. This device places the hand relatively close to the needle tip while the hand is in a position of natural function, enabling the needle movement using fine motor control of the hand.

The PLASTIC FINGERTM is an accessory to the TAO ASPIRATORTM to facilitate specimen procurement. It facilitates needle removal so that air can be drawn into the syringe, and the aspirated material in the needle and needle hub can then be expressed onto slides. It can also be used to grip slides for fixation and staining.

The provided text is a 510(k) premarket notification letter from the FDA for the TAO ASPIRATOR™ and PLASTIC FINGER™. This document confirms the substantial equivalence of the devices to legally marketed predicates and outlines their indications for use.

Crucially, the document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria.

The 510(k) clearance process focuses on substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. While a manufacturer would typically have internal testing and validation data to support their 510(k) submission, this specific FDA letter does not describe or summarize those studies or their acceptance criteria.

Therefore, I cannot provide the requested information based on the given input. The categories in your request (acceptance criteria table, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are all relevant to study design and results, which are not present in this regulatory correspondence.

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The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU) or generator, to an electrosurgical electrode and subsequently to the target tissue. The device is disposable and sold sterile.

This device has a molded plastic housing. The mode switch selects the appropriate electrosurgical function (CUT or COAG). Exiting the housing is a ten foot cable which has a standard 3-prong plug to connect to the generator. The electrode packaged with this pencil will be either a coated electrode or a regular bare electrode, and with or without a holster. TThis device is a single use, disposable. lt is sold sterile.

I am sorry, but based on the provided text, I cannot extract the acceptance criteria and the study details you requested. The document describes an electrosurgical device and its predicate devices, intended use, and technological characteristics. It mentions that "MegaDyne voluntarily complies with ANSI/AAMI HF 18-1993" but does not provide specific performance data, acceptance criteria, or details of a study that proves the device meets such criteria.

The information you are looking for, such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, is not present in this 510(k) summary. This document seems to focus on demonstrating substantial equivalence based on existing product characteristics and standards, rather than presenting detailed new performance study results.

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