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Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.

RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Spinal and Epidural needles are supplied in bulk nonsterile, or sterile by ethylene oxide gas in peel open packages and are intended for one-time use.

The RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles feature an ISO 80369-6 compliant connector that is about 20% smaller than the predicate device. The ISO 80369-6 hub design reduces the risk of cross connection when used with luer connectors developed under the same series of standards.

RELI® NRFit® Spinal Needles and Phoenix NRFit® Spinal Needles are composed of a stainless-steel cannula and stylet, a hub, and plunger. The spinal needle is supplied with either the Quincke Point (K-3 Point) or the Pencil Point tip configuration.

Quincke point spinal needles feature fitted, close tolerance stylet and cannula bevel to minimize coring and trauma; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size; some sizes are also available with short bevel. Available in sterile and non-sterile packaging.

Pencil point spinal needles feature an atraumatic point with side-port dispensing to reduce loss of CSF; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size. Some sizes are available with tapered design to counter bending and minimize flexing during insertion. Available in sterile and non-sterile packaging.

The RELI® NRFit® Epidural Needles and Phoenix NRFit® Epidural Needles are composed of a stainlesssteel cannula, a polycarbonate hub and detachable wing, a stainless-steel stylet and plunger as Tuohy (Huber point) tip configuration in various needle gauge sizes and lengths.

Epidural needles feature large clear hub for enhanced tactile feel; wide metric marking for maximum visibility and accuracy in placement; color coded stylet/hub to identify needle gauge size. Epidural needles are available in sterile and non-sterile packaging.

The provided text is a 510(k) summary for medical devices (spinal and epidural needles) and does not describe the acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and non-clinical performance testing (biocompatibility, functional, sterilization).

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document as it pertains to a different type of medical device assessment.

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The RELI® Safety Blood Collection Tube Holder and the RELI® Blood Collection Tube Holder are intended to enable withdrawal of blood samples from a patient.

The RELI® Safety Blood Collection Tube Holder is designed to prevent accidental needle stick injuries.

The RELI® Safety Blood Collection Tube Holder and RELI® Blood Collection Tube Holder are intended to be used in combination with conventional multiple sample blood collection needles (up to 1 ½" in length) and vacutainers for safe handling and disposal immediately following routine venipuncture procedures.

The Safety Blood Collection Tube Holder is designed with a user activated safety shield to cover the needle immediately following venipuncture procedure to help prevent needle stick injuries and safely dispose of the device in compliance with OSHA requirements.

The safety shield can be activated by gently pressing the shield toward the needle in one of two ways without the need for user to approach the sharp end:

1. Press shield toward exposed needle on a stable surface or
2. With thumb behind the shield, press shield onto exposed needle.

An audible click is heard when the safety shield has been properly activated and the Safety Blood Collection Tube Holder with enclosed needle is safe to discard.

The Safety Blood Collection Tube Holder is clear with safety shield available in clear, blue, or orange color options. The Blood Collection Tube Holder is clear. The devices can be used with conventional multi-sample needles up to 1 ½ inches in length.

The provided text describes a 510(k) premarket notification for a medical device (blood collection tube holders) and provides a summary of its characteristics and limited performance testing. However, it does not include the detailed type of information you've requested about acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.

The document is for a Class II medical device (Hypodermic Single Lumen Needle accessory) – a physical blood collection tube holder – not an AI/software as a medical device (SaMD) or a device that directly leverages AI for diagnostic or treatment purposes. Therefore, the concepts of "ground truth," "expert consensus," "MRMC studies," "training set," or "AI assistance" are not applicable to this particular FDA submission.

The "Performance Testing - Non-Clinical" section details physical performance tests relevant to a blood collection tube holder, such as:

• ISO 80369-7: Mating with bidirectional blood collection needle.
• ASTM F 1980-2007: Accelerated aging for sterility (though the device itself is non-sterile, the packaging would need to maintain sterility if it were a sterile product).
• Simulated Use Testing: 500 samples with 100% successful use, no device failures, and no incomplete enclosures of the sharp. This appears to be a functional test rather than a clinical study.

Therefore, it is not possible to fill out the requested table or answer the questions based on the provided document because the document describes a physical medical device and its mechanical/functional testing, not an AI-powered device or a study involving human readers or AI performance metrics.

The document's purpose is to demonstrate substantial equivalence to a predicate device based on similar indications, technology, and performance, primarily concerning the physical characteristics and safety mechanism of the blood collection tube holder.

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VAKU-8™ Blood Collection Needles are designed for routine blood collection by a qualified practitioner

VAKU-8™ Single use Multi Sample blood collection needles are composed of a stainless steel needle tube that is ground at both ends and affixed to a plastic hub. A rubber sleeve covers the backend needle tube and hub tip. The front end needle is used to withdraw blood once placed in the patient. The needle tube is protected by a plastic needle cover on either end. The "front end needle" is designed to withdraw blood from the patient. The "back end needle" is covered by a rubber sleeve and is designed with a threaded hub that can be attached to a blood collection tube holder. The tube holder facilitates attachment to a evacuated blood collection tube. Each needle is individually packaged sterile utilizing two plastic end covers. A perforated label serves to simplify identification of needle size and also acts as a seal of integrity.

The provided text describes the 510(k) submission for the VAKU-8™ Blood Collection Needle, establishing its substantial equivalence to a predicate device. The information details the device, its intended use, a comparison with the predicate device, and various tests and certifications.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on the device conforming to British Standard 4843 for measurements and tolerances, color coding according to ISO 6009, and comparable physical and performance characteristics to the predicate device. The "Bench Mark Study of Blood Collection Needle" provides the reported performance.

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

The document does not explicitly state the specific sample size for the "Bench Mark Study of Blood Collection Needle" or for any performance tests that directly compared the VAKU-8™ to its predicate. It mentions:

• "Samples are drawn from each batch produced as per defined sampling plan, performance tests are conducted as per the standards cited above and defined criteria for acceptance are applied." (Section 13)
• "Samples are drawn from each sterilization load and subjected to the tests for sterility as per USP." (Section 15)
• "Freedom from Pyrogen is determined by taking samples from each sterilizer load and subjected to the test 'freedom from Pyrogenic materials' as per USP" (Section 15)

This indicates that testing is done on batches and sterilization loads, but the exact number of samples per test is not specified.

The data provenance is not explicitly mentioned in terms of country of origin for the test data, nor is it specified if it's retrospective or prospective. However, given that it's a 510(k) submission for a new device, the performance data would be prospective, obtained during the development and validation of the VAKU-8™.

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

The document does not provide information about the number of experts or their qualifications used to establish ground truth for the test set. The tests appear to be a mix of objective measurements against standards (BS 4843, ISO 6009) and functional assessments (e.g., "Comfortable," "OK") that would likely be evaluated by trained personnel, but specific expert involvement is not detailed.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1, none) is mentioned or implied for the performance tests. The assessments seem to be based on direct measurement or functional observation against a standard or predicate.

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

No MRMC comparative effectiveness study was done. This type of study is typically associated with diagnostic imaging devices or algorithms where human interpretation is a key component, and the device aims to assist or replace human readers. The VAKU-8™ is a physical medical device (blood collection needle) where human interaction is primarily mechanical (e.g., proper technique by a qualified practitioner), not interpretative.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The concept of a "standalone" performance for an algorithm is not applicable to this device, as it is a physical medical instrument, not an algorithm. Performance tests are conducted on the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the VAKU-8™ is established through:

• Objective Measurements/Standards: Conformance to British Standard 4843 for measurements and tolerances, and ISO 6009 for color coding.
• Predicate Device Performance: Direct comparison of physical attributes and functional characteristics (e.g., "Removal of Covers," "Fitment with holder," "Maximum load," "Shaft friction") against the established performance of the legally marketed predicate device (K992699).
• Biocompatibility Certifications: Testing of materials (e.g., Topilene PP) to meet USP Class VI Plastic requirements.
• Sterilization and Pyrogenicity Standards: Conformance to EN 550 for sterilization validation and USP tests for sterility and freedom from pyrogenic materials.

8. The Sample Size for the Training Set

This information is not applicable. The VAKU-8™ Blood Collection Needle is a physical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable, as the device does not involve a "training set."

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As described in 21 CFR section 880.5200, Cathy IV Cannula is used to administer fluids intravenously. Cathy IV Cannula may be used for writtence of propoduce intravenously. Cathy IV Califiala may be accurity of the may of procedure.

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This document is a 510(k) clearance letter from the FDA for a device called "Cathy IV Cannula." It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Unfortunately, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. It is a regulatory approval document, not a detailed technical report on device validation.

Therefore, I cannot provide the requested information based on the input text. The document confirms the device's regulatory classification, product code, and that it can be marketed, but it lacks the scientific and performance data you're asking for.

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Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.

"Phoenix" Epidural and Spinal Needles.

The provided text is a 510(k) clearance letter for "Dr. Japan's Phoenix Brand Spinal and Epidural Needles" and related documentation, dated June 2, 2000. It concerns the substantial equivalence of this device to legally marketed predicate devices.

This type of document (a 510(k) clearance letter from the FDA) does not contain information about acceptance criteria, detailed study designs, sample sizes, ground truth establishment, or multi-reader multi-case studies. It confirms that the device has been found substantially equivalent to a predicate device based on the information provided in the 510(k) submission, allowing it to be marketed.

Therefore, I cannot extract the requested details from the provided text. The document is strictly about the regulatory clearance, not the technical performance details of a new device's study.

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Chromic Gut surgical sutures are indicated for use as absorbable sutures in gegeral soft tissue approximation and/or ligation, including use in ophthalmic procedures, out NOT for use in cardiovascular and neural tissue.

Catgut plain surgical sutures are indicated for use as absorbable sutures in general soft Catgut plain surgical sutures are indicated of assessments of the subscribed on the researces, but NOT tissue approximation and neural tissue.

Polyglycolic acid sutures are indicated for use as absorbable sutures in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but NOT for use in cardiovascular and neurological tissues.

Silk sutures are indicated for use as non-absorbable sutures in general soft tissues Silk sutures are indicated for use as non-acolorodolorouse in cardiovascular, ophthalmic, neural tissue.

Polyester sutures are indicated for use as non-absorbable sutures in general soft tissue r oreximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.

Nylon sutures are indicated for use as non-absorbable sutures in general soft tissue rylon battleoo and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.

Polyproylene sutures are indicated for use as non-absorbable sutures in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neural tissue.

Not Found

This documentation is a 510(k) premarket notification for various types of surgical sutures and needles. The core of a 510(k) is to demonstrate that a new device is "substantially equivalent" to an already legally marketed predicate device. This process does not involve establishing new acceptance criteria or conducting studies to demonstrate the device meets new performance standards in the same way a PMA (Premarket Approval) would.

Instead, the "study" demonstrating the device meets "acceptance criteria" in this context is the submission and review of information to establish substantial equivalence to a predicate device. The "acceptance criteria" are not reported device performance metrics against specific targets, but rather the FDA's regulatory requirements for demonstrating this substantial equivalence.

Here's an attempt to answer your questions based on the provided document, acknowledging the limitations inherent in a 510(k) submission:

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

For a 510(k) submission, the "acceptance criteria" are typically demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, or that any differences do not raise new questions of safety and effectiveness. There isn't a table of quantitative performance metrics with "reported device performance" against explicit thresholds in the way a PMA clinical trial would present.

Instead, the performance is implicitly compared to the predicate device's established safety and effectiveness. The document lists the general indications for use for each suture type, which functionally serve as the "performance" demonstrated to be equivalent to the predicate.

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

This document, being an FDA 510(k) clearance letter, does not contain details about specific test sets, sample sizes, or data provenance from studies. A 510(k) submission primarily relies on comparisons to predicate devices and potentially presents bench testing or material characterization data to support substantial equivalence. It is not a clinical trial report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable for a 510(k) submission in the way you're describing for, for example, a diagnostic AI. The "ground truth" here is the prior regulatory clearance and established safety/effectiveness of the predicate devices. The experts involved are FDA reviewers (e.g., those in the Division of Surgical, Orthopedic and Restorative Devices) who evaluate the submitted information against regulatory standards. Their qualifications are their expertise in medical device regulation and the relevant medical fields.

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

Not applicable. There isn't a "test set" and a process of adjudicating findings from it in the context of this 510(k) clearance letter.

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

Not applicable. This device is surgical sutures and needles, not an AI or diagnostic imaging device.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for a 510(k) is the legally marketed predicate device. The manufacturer demonstrated that their Ailee Sutures and Needles are "substantially equivalent" to existing, cleared sutures and needles. This equivalence is established through comparison of:

• Intended use
• Technological characteristics (e.g., material composition, dimensions, sterilization method, mechanical properties)
• Performance data (e.g., tensile strength, knot security, absorption profile for absorbable sutures, biocompatibility, sterility) to show they are at least as safe and effective as the predicate device, or that any differences do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device.

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

Not applicable. This is not a machine learning/AI device.

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Device to be used to administer IV Solution or medication to patient.

"TUTOPLUS" Sterile Disposable Intravascular Administration Set

I'm sorry, but this document is not a study. It is a 510(k) premarket notification letter from the FDA to Myco Medical Supplies, Inc. regarding their "TUTOPLUS" IV Administration Set.

Therefore, I cannot extract the requested information as it is not present in this document. This letter only indicates that the device has been found substantially equivalent to predicate devices and can be marketed. It does not contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

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Used to control flow rate of IV Solution or medication to patient.

Not Found

I apologize, but the provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for medical devices named "TUTODROP 1" and "TUTODROP 2." This document primarily indicates that the devices have been found substantially equivalent to previously marketed devices.

It does not contain the type of detailed study information, acceptance criteria, or performance data that would allow me to answer your specific questions regarding device acceptance criteria and a study proving device performance. The purpose of this letter is regulatory clearance, not a technical report of a study.

Therefore, I cannot provide the requested information from the given input.

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To be used to administer medication or draw sample. To be used in applications that require clarity that only glass can offer or applications that require smooth plunger movement / control that is not possible with plastic syringe. Also to be used in applications where use of plastic syringe may cause contamination due to reaction of plastic with dispensed substance. May also be used in applications that require stability at extreme temperature.

"GlassVan" Glass Syringe

There's a critical misunderstanding here. The provided text is a 510(k) clearance letter from the FDA for a medical device: "Glass Van" Glass Syringes.

This document does not contain any information about a study proving the device meets acceptance criteria in the way you've described for an AI/algorithm-based device.

Instead, a 510(k) clearance is based on demonstrating substantial equivalence to a predicate, legally marketed device. This typically involves showing that the new device has the same intended use and technological characteristics as the predicate, or if it has different technological characteristics, that those differences do not raise new questions of safety and effectiveness.

Therefore, I cannot provide the information requested in your bullet points because the input document does not contain that type of data.

To be clear:

• There's no mention of acceptance criteria in terms of accuracy, sensitivity, specificity, etc., as typically applied to performance studies of diagnostic algorithms.
• There's no study described with a test set, training set, experts, ground truth, or MRMC study.

The FDA letter confirms that the "Glass Van" Glass Syringes are substantially equivalent to a previously marketed device, allowing them to be marketed. This is a regulatory pathway, not a performance study report for an AI or algorithm.

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