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The Pinpoint™ GT Safety Introducer Needle is intended for patients requiring percutaneous access to place a guidewire for subsequent placement of catheters or other medical procedures requiring introducer needle access. The Pinpoint™ GT Safety Introducer Needle may be used in any appropriate patient population.

Bard Access Systems, Inc.'s, Pinpoint™ GT Safety Introducer Needle is designed for percutaneous access to introduce a guidewire. The Pinpoint™ GT Safety Introducer Needle contains a magnet which emits a passive magnetic field that can be detected by Ultrasound Systems equipped with Pinpoint™ GT Technology. The Pinpoint™ GT Safety Introducer Needle, when used with the Pinpoint™ GT System creates a virtual image of the needle on the Ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

The provided text describes a 510(k) premarket notification for the Pinpoint™ GT Safety Introducer Needle, arguing for its substantial equivalence to a predicate device. However, it does not include a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-driven device.

The document relates to a physical medical device (introducer needle) and the performance tests described are for the physical properties and safety of this device, not for an AI algorithm's diagnostic or predictive performance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI/algorithm.
• Sample size used for the test set and data provenance for AI.
• Number of experts and their qualifications for establishing ground truth for AI.
• Adjudication method for AI.
• MRMC comparative effectiveness study results for AI.
• Standalone performance for an algorithm.
• Type of ground truth used for AI.
• Sample size for the training set for AI.
• How ground truth for the training set was established for AI.

The Pinpoint™ GT Safety Introducer Needle is a physical device, not an AI-powered diagnostic/predictive tool. The "Pinpoint™ GT Technology" mentioned is described as a passive magnet that interacts with an Ultrasound System to create a "virtual image of the needle on the Ultrasound display." This indicates a hardware-software integration for visualization, not an AI algorithm performing diagnostic interpretation or prediction.

What the document does provide regarding acceptance criteria and performance:

The document states that a series of verification and validation tests were performed "in accordance with Design Controls as per 21 CFR §820.30" and various ISO standards and guidance documents.
"The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device."

Summary of Performance Tests (Bench, Biocompatibility):

Bench Tests:

• Dimensional Analysis
• Assembly Leak
• Hub to Cannula Bond Strength
• Needle Stiffness
• ISO Luer Compliance
• Guidewire Compatibility
• Safety Mechanism Override
• Visual Inspection
• Corrosion
• Usability and Simulated Use
• Blood Flash
• Echogenicity
• Magnet Testing
• Particulate testing (USP )

Biocompatibility Testing:

• Cytotoxicity
• Sensitization
• Intracutaneous
• Acute Systemic Toxicity
• Pyrogenicity
• Rabbit Blood Hemolysis
• Unactivated partial Thromboplastin Time Assay
• Dog Thrombogenicity

The document asserts that the device met the acceptance criteria for these tests (which would be defined by the referenced standards and internal protocols), thereby demonstrating substantial equivalence to the predicate device. Specific numerical acceptance criteria or detailed results of these tests are not provided in this summary document. It only states that the criteria were met.

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The Merit Safety Introducer Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices. It also incorporates a safety mechanism to minimize needlestick injuries.

The Merit Safety Introducer Needle is used for providing a puncture site in blood vessels for the introduction of vascular access devices. It incorporates a safety mechanism/quard to minimize needlestick injuries. The needle consists of a stainless steel one wall cannula and a clear standard female Luer lock hub for immediate bleed-back visualization. The hub of this introducer needle is designed with an ergonomic feel for ease of handling and is offered with a standard hub or a Seldinger shield. The needles are available in 18 gauge and 21 gauge with a usable length of 7 cm. The safety mechanism is color coded for needle gauge identification. The design of the Merit Safety Device Introducer Needle allows clinicians to easily activate the safety mechanism by advancing it to the end of the needle to shield the needle bevel after use. The safety mechanism automatically senses the end of the needle and locks the safety mechanism covering the needle tip which reduces the risk of accidental needlestick injuries by shielding the needle tip. A visual, tactile, and audible confirmation of the locking component over the needle confirms lockout of the safety guard over the needle. The safety mechanism cannot be deactivated and remains protective through disposal into a sharps container. The safety mechanism can be activated over quide wires. The Merit Safety Introducer Needle is a single use device that is supplied sterile and non-pyrogenic for use in the adult population.

The Merit Safety Introducer Needle's acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below. It is important to note that this document is a 510(k) summary for a medical device and thus focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Merit Safety Introducer Needle were based on a risk analysis and compliance with various recognized and unrecognized international standards and FDA guidance documents. These standards cover aspects like device dimensions, material properties, safety mechanism function, biocompatibility, and sterilization. The document reports that the subject device "meets the requirements that are considered essential for its intended use."

The table below summarizes the performance tests conducted, which implicitly define the acceptance criteria for each aspect. The exact quantitative acceptance limits for each test are not provided in this summary, but the general outcome of meeting the requirements is stated.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each individual performance test (bench or biocompatibility). The testing was conducted by the manufacturer, Merit Medical Systems, Inc. The data provenance is internal to the manufacturer and would be considered prospective for the purpose of demonstrating substantial equivalence. There is no information regarding country of origin of the data beyond the manufacturer's location in the USA.

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

This type of device (introducer needle) does not typically involve human expert interpretation for "ground truth" in the same way an imaging AI device would. The "ground truth" for the performance tests would be defined by the specifications of the device and the standards against which it is tested. For example, for "dimensions," the ground truth is the specified dimension range. For "biocompatibility," the ground truth is the pass/fail criteria for the specific biological tests outlined in ISO 10993. Therefore, no external "experts" were used to establish a subjective ground truth on a test set as would be the case for diagnostic AI.

4. Adjudication Method for the Test Set

Given the nature of the device and the testing performed (bench and biocompatibility), there was no adjudication method (e.g., 2+1, 3+1) involving human readers or interpretation. The performance tests are objective measurements against established standards.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted or is applicable for this device. This device is an introducer needle with a safety mechanism, not an AI-assisted diagnostic or decision-making tool that would involve human readers interpreting cases.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This question is not applicable. The Merit Safety Introducer Needle is a physical medical device, not a software algorithm. Therefore, there is no "standalone performance" in the context of an algorithm without human interaction. The safety mechanism is an integral part of the physical device's design.

7. Type of Ground Truth Used

The ground truth used for performance validation was based on:

• Engineering specifications and design requirements: For bench tests like dimensions, bond strength, Luer connections, and forces.
• Recognized international standards and FDA guidance documents: For both bench performance (e.g., ISO for needles, Luer fittings, catheters) and biocompatibility (e.g., ISO 10993 series, USP pyrogenicity). These standards define the specific test methods and acceptance criteria.

8. Sample Size for the Training Set

This question is not applicable. This device is a physical medical device and does not involve machine learning algorithms that require training sets of data.

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

This question is not applicable as there is no training set for this device.

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The LumiLoc™ Safety Introducer Needle is intended to be used for percutaneous procedures utilizing a sheathed introducer trocat/needle for guidewire introduction during percutaneous gastrointestinal procedures.

The LumiLoc™ Safety Introducer Needle's engineered integral safety guard is passively activated by the clinician upon removal of the trocar/needle from the introducer sheath.

The LumiLoc™ Safety Introducer Needle helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip.

The LumiLoc™ Safety Introducer Needle consist of a stainless steel trocar/needle with a colored translucent hub and a colored translucent safety guard, a sheath attached to a translucent hub having a standard female Luer lock hub connector. The trocar/needle hub has a bevel-up orientation indicator. The sheath hub utilizes a phosphorescent material. The LumiLoc™ Safety Introducer Needle's sheath hub has an integral Seldinger shield. The stainless steel trocars/needles have a specialty coating to enhance percutaneous entry.

The LumiLoc™ Safety Introducer Needle incorporates an intuitive easy to use safety guard which is an integral part of the device. The LumiLoc™ Safety Introducer Needle's engineered integral safety guard is passively activated by the clinician upon removal of the trocar/needle from the introducer sheath and helps to reduce the risk of accidental trocar/needlestick injuries by locking a safety guard over the trocar/needle tip. A visual. tactile, or audible confirmation of the locking component over the trocar/needle confirms lockout of the safety guard over the trocar/needle.

LumiLoc™ Safety Introducer Needles will be marketed to the clinical end-user as sterile single use devices. Additionally, the device will be placed in Percutaneous Endoscopic Gastrostomy (PEG) procedural trays. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the procedural tray or kit manufacturer. The LumiLoc™ Safety Introducer Needies will be incorporated into a procedurai tray or kit, packaged and sterilized.

The provided text describes the LumiLocTM Safety Introducer Needle and its regulatory submission. It does not contain information about an AI/ML device or its performance characteristics. This device is a physical medical instrument, not a software algorithm. Therefore, many of the requested categories related to AI/ML device evaluations (e.g., sample size for training set, MRMC studies, ground truth establishment, number of experts for ground truth) are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and the study that "proves" it meets them, based on the context of a 510(k) submission for a traditional medical 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: 500 LumiLoc™ Safety Introducer Needles.
• Data Provenance: The study was a "simulated use study." This implies a controlled laboratory or clinical simulation environment rather than actual patient data. The country of origin is not specified, but the submission is to the US FDA, so the testing was likely conducted in the US or under US regulatory standards. It's prospective in the sense that the testing was performed specifically for this submission.

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

• Number of Experts: Not explicitly stated, but the study involved "clinicians" performing the simulated insertions and activations. The exact number of clinicians is not provided.
• Qualifications of Experts: Described as "clinicians." Specific qualifications (e.g., years of experience, specialty) are not detailed in this summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not described. This was a direct performance test where the device's physical function (activation, no injuries, no failures) was observed. There isn't a "ground truth" to adjudicate in the typical sense of subjective interpretations. The outcomes (e.g., "no sharps injuries," "no failures") are direct observational results.

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

• MRMC Study: No, this is not an AI/ML device. This type of study is not applicable.

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

• Standalone Performance: Not applicable, as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the objective observation of the device's physical performance during the simulated use study.
  • Successful insertion: Observed directly.
  • Safety guard activation: Observed directly.
  • Lack of sharps injuries: Observed directly.
  • Lack of failures: Observed directly.
  • The "material testing" mentioned also contributed to proving substantial equivalence, suggesting engineering specifications and quality control data likely formed part of the ground truth for material properties.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical device, not an AI/ML model that requires a training set. The development process would involve iterative design and testing, but not a "training set" in the computational sense.

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

• How Ground Truth for Training Set Was Established: Not applicable.

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The Safety Introducer Needle is an anti-needlestick device that provides access to the vascular system for the introduction of a guidewire.

The Safety Introducer Needle incorporates an active safety clip mechanism designed to minimize inadvertent needlesticks when the needle is used to introduce a guidewire.

The Safety Introducer Needle consists of a standard needle with an user-activated safety mechanism clip, clip puller and needle hub. The Safety Introducer Needle ranges in size from 18 - 21 gauges and has needle lengths between 1.5 - 2.75 inches. The needle can be made with an echogenic tip. An echogenic tip allows the tip of the needle to be located using Ultrasound techniques. The needle hubs are color coded to aid in recognition of needle gauge size. The safety clip mechanism reduces the risk of accidental needlestick injuries by shielding the needle. The safety clip mechanism will activate once the puller is pulled down the length of the needle.

This looks like a 510k submission for a medical device called "Safety Introducer Needle". In this specific document, there is no discussion of acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on the administrative aspects of the 510(k) submission, confirming the device's classification, and its substantial equivalence to predicate devices.

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

Here's how I can tell the provided text doesn't contain the requested information:

• No mention of "acceptance criteria," "performance study," "test set," "sample size," "ground truth," or "experts." The document is primarily about regulatory approval.
• The "Description" section details the physical characteristics and safety mechanism, but not performance metrics.
• The "SUBSTANTIAL EQUIVALENCE" section compares the new device to existing ones based on indications for use, materials, and function, but not on quantitative performance outcomes from a study.
• The FDA letter confirms regulatory clearance, not a performance evaluation detailed in the submission.

To answer your request, I would need a document that describes the design verification and validation testing, which would typically include acceptance criteria and the results of studies conducted to demonstrate the device meets those criteria.

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