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The Power-V PICC is indicated for patients that require repeated venous access for infusion or injection therapy. The Power-V PICC is indicated for peripheral access to the central venous system for intravenous therapy. The Power-V PICC is indicated for dwell times less than or greater than 30 days. The maximum recommended infusion rate is 5 ml/sec. The maximum pressure of power injectors used with the Power-V PICC catheter may not exceed 300 psi.

The Power-V PICC is a family of peripherally inserted central venous catheters designed to allow for contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted pcriphcrally. Each Power-V PICC has a kink resistant, reverse tapered catheter design. The Power-V PICC is indicated for dwell times greater than 30 days. The Power-V PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 cc/sec with a maximum power injection pressure of 300 psi (scc Appendix B). The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations (scc Appendix C).

The Power-V PICC is illustrated in the drawings at the end of this section. The Power-V PICC product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen. All catheters are 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with luer lock fittings for access attachment.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Power-V PICC device.

It's important to note that the provided text is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed scientific study report. As such, information regarding rigorous clinical trial design, statistical analysis, and detailed performance metrics as you might find for a novel drug or a high-risk device is largely absent. The focus of a 510(k) is to demonstrate equivalence to a legally marketed predicate device.

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state "acceptance criteria" in the form of numerical thresholds for a specific test. Instead, it refers to the device meeting "all functional requirements and specifications" and demonstrating substantial equivalence to predicate devices. The key performance aspect mentioned is related to power injection capabilities.

The "Intended Use" section reiterates: "The maximum recommended infusion rate is 5 ml/sec. The maximum pressure of power injectors used with the Power-V PICC catheter may not exceed 300 psi." |
| Biocompatibility (conformance with standards). | "Biocompatibility testing on the device was in conformance with ISO 10993-1, and GLP TRIPARTIE." |
| Functional requirements and specifications. | "The Power-V met all functional requirements and specifications." (No specific details provided on these requirements.) |
| Substantial equivalence to predicate devices. | "The design, methods of manufacturing, and materials used in the Power-V device are substantially equivalent to the predicate devices." (Implies meeting similar performance as predicate devices, but no direct quantitative comparison is given). |

Study Details (Based on the provided 510(k) Summary)

The text describes engineering and biocompatibility testing rather than a clinical study in the traditional sense, especially a study involving human subjects or extensive retrospective data analysis for performance metrics beyond physical device capabilities.

1. Sample size used for the test set and the data provenance:

   • The document refers to "Power-V PICC catheter assemblies" being tested for power injection. It does not specify the number of catheter assemblies used in this test.
   • Data provenance: The testing appears to be prospective laboratory/bench testing conducted by the manufacturer (HDC Corporation) or a contracted lab. There is no mention of country of origin for the data or whether it's retrospective.
   • For biocompatibility, it states "Biocompatibility testing on the device was in conformance with ISO 10993-1, and GLP TRIPARTIE." This would involve specific biological tests on materials, not human testing or data from patients.

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

   • This concept is not applicable to the type of testing described. The "ground truth" for power injection performance or biocompatibility is established by the physical and chemical properties of the device and its behavior under controlled laboratory conditions, as measured by instruments and analyzed against engineering specifications and relevant standards. There is no involvement of clinical experts for "ground truth" similar to image interpretation.

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

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation or classification is involved, often for clinical outcomes or image reading. The tests described are objective, physical/chemical tests.

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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving AI or human interpretation, to assess reader performance. The Power-V PICC is an intravascular catheter with mechanical and biocompatibility performance as its primary focus.

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

   • No, this is not applicable. The Power-V PICC is a physical medical device, not an algorithm or AI system. Its performance is measured directly, not through an algorithm's output.

6. The type of ground truth used:

   • For power injection: Engineering specifications and measurement data. The ability to withstand 5 cc/sec at 300 psi is measured directly using appropriate laboratory equipment.
   • For biocompatibility: Conformance to international standards (ISO 10993-1, GLP TRIPARTIE), which specify acceptable biological responses to materials. This involves a series of in-vitro and in-vivo tests to assess toxicity, irritation, sensitization, etc.

7. The sample size for the training set:

   • Not applicable. This device is not an AI or machine learning model, so there is no concept of a "training set."

8. How the ground truth for the training set was established:

   • Not applicable for the reason above.

Summary of the "Study" Proving Acceptance:

The "study" in this context refers to bench testing and biocompatibility testing performed by or for HDC Corporation to demonstrate that the Power-V PICC meets its functional specifications and adheres to relevant safety standards. The core claim is not one of clinical superiority or a complex diagnostic performance, but rather that the device is substantially equivalent to existing, legally marketed predicate devices in terms of its design, materials, manufacturing, and basic functional capabilities, particularly its power injection functionality and biocompatibility. The regulatory pathway of a 510(k) relies heavily on this concept of substantial equivalence, meaning rigorous, comparative clinical trials are usually not required if equivalence can be demonstrated through non-clinical means.

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The NeuroTrace III can be used as an objective monitor using accelerometry for measuring the muscle contraction following stimulation of the acceleromotive motor neuron, as a peripheral nerve stimulator (without the objective respecific first in a subjective monitoring and for locating specific nerves. It is measuring raneword 191 basyolock procedures to obtain effective regional anesthesia blocks.

Not Found

The provided document does not contain information regarding acceptance criteria or a study that proves the device (NeuroTrace III) meets specific performance criteria.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed performance study with acceptance criteria.

Therefore, I cannot populate the requested table or answer the questions related to study design, sample sizes, ground truth establishment, or expert involvement. The information is simply not present in the provided text.

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The V-Cath® Poly PICC is indicated for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 4FR or larger catheter is recommended.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the V-Cath® Poly PICC (K033853) does not contain the specific information required to answer your request regarding acceptance criteria and a study proving device performance.

The letter primarily:

• Identifies the device: V-Cath® Poly PICC
• States the clearance: Substantially equivalent to legally marketed predicate devices.
• Specifies the Regulation Number and Product Code: 880.5200, FOZ
• Lists the Indications for Use: "for the patient that requires repeated access for infusion or injection therapy. It can also be used for blood sampling although a 4FR or larger catheter is recommended."
• Outlines general regulatory compliance directives for the manufacturer.

It does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study (sample size, data provenance, ground truth, adjudicated methods, MRMC study, standalone performance, training set details).

To obtain this information, you would typically need to consult the original 510(k) submission document itself, which would contain the preclinical and clinical data submitted to the FDA to demonstrate substantial equivalence. The clearance letter only summarizes the FDA's decision based on that submission.

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The Seldinger Safety Needle Introducer incorporates a retractable needle safety mechanism to minimize needle stick injuries when used to introduce a guidewire (.018 inches maximum) into the vascular system.

Not Found

This document is a 510(k) clearance letter for a medical device called the "Seldinger Safety Needle Introducer." It is a regulatory document from the FDA, not a study report. Therefore, it does not contain the information requested about acceptance criteria and a study proving device performance.

The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This indicates that the clearance is based on substantial equivalence to existing devices, not on a new study demonstrating performance against specific acceptance criteria.

Thus, the requested details such as:

• A table of acceptance criteria and reported device performance
• Sample size and data provenance for the test set
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone performance
• Type of ground truth used
• Sample size and ground truth establishment for the training set

cannot be found in this document.

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The Pandin Continuous Nerve Stimulating Catheter permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques. It is indicated for use up to 72 hours.

Not Found

This document, K022752, is a 510(k) premarket notification for the Pandin Continuous Nerve Stimulating Catheter. It establishes substantial equivalence to predicate devices but does not contain acceptance criteria or a study proving that the device meets acceptance criteria.

The provided text focuses on the administrative aspects of the 510(k) submission, including:

• Device Name: Pandin Continuous Nerve Stimulating Catheter
• Common Name: Continuous Nerve Stimulating Catheter
• Classification Name: Kit, Conduction Anesthetic
• Intended Use: Permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques, indicated for use up to 72 hours.
• Predicate Devices: StimuCath Continuous Nerve Block Set (K021567), Neurotrac (K831715), and CLA Kit (Nerve Block Infusion) (K994059).
• Substantial Equivalence Argument: The Pandin device is single patient, single use, intended to facilitate placement of a Peripherally Inserted Conductive Catheter for regional nerve block procedures, similar to its predicates. It's used procedurally the same as the StimuCath™ and contains the identical Tuhoy needle used in the CLA™ kit.
• FDA Response: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot extract the requested information (performance data, sample sizes, expert qualifications, ground truth details, MRMC studies, or training set information) from the provided text because it is not present in the document. The 510(k) summary for this device does not include details of performance testing or clinical studies for acceptance criteria.

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The Safe-T-Peel® Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.

single patient, single use, stainless steel needle introducers with splittable sheaths, intended to facilitate the placement of Peripherally Inserted Catheters (PICs). Additionally the Safe-T-Peel® Safetv Needle/Introducer contains a splittable plastic sheath identical to the one used in the TFX Medical Introducer Assembly (K993191).

The provided text describes a 510(k) summary for the HDC Corporation's Safe-T-Peel® Safety Needle/Introducer. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as would be found in a clinical trial or a specific standalone performance assessment.

Therefore, many of the requested elements (acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone study, ground truth type, training set size, training set ground truth establishment) cannot be directly extracted from the provided text for a performance study as typically understood for AI/algorithm-based devices.

However, based on the principle of substantial equivalence, the "acceptance criteria" here is that the device performs similarly to the predicate devices, particularly regarding safety features. The "study" proving this comes in the form of comparing the device's characteristics and functionality to those of already approved predicate devices.

Here's an attempt to address the prompt based on the available information, highlighting what can and cannot be provided:

Acceptance Criteria and Study for HDC Corporation's Safe-T-Peel® Safety Needle/Introducer

The provided 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with explicit acceptance criteria and quantitative results for device performance against a predefined metric. For a 510(k) submission of this nature, the "acceptance criteria" revolve around demonstrating that the new device has the same intended use, similar technological characteristics, and comparable safety/performance to the predicate devices. The "study" involves a comparative analysis of these attributes.

1. Table of Acceptance Criteria and Reported Device Performance

As a 510(k) submission seeking substantial equivalence for a medical device rather than a software algorithm, explicit "acceptance criteria" in terms of sensitivity, specificity, or similar statistical metrics are not provided in this document. Instead, the acceptance criteria relate to structural and functional similarity to predicate devices, particularly for safety features.

2. Sample size used for the test set and the data provenance

Not applicable/provided. This device is a physical medical device, not an AI/algorithm. The "test set" for substantial equivalence is the comparison against the characteristics and performance of the predicate devices. The data provenance would be the design specifications and testing data of the device itself and of the predicate devices, which are not detailed in this summary.

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

Not applicable/provided. The concept of "ground truth" established by experts for a test set (as typically used for AI/algorithm evaluation) does not apply directly to this 510(k) summary for a physical medical device. The "truth" here is established by regulatory approval of the predicate devices and the demonstration of equivalence through design and performance testing (not detailed in this summary).

4. Adjudication method for the test set

Not applicable/provided. See explanation for point 3.

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 is a physical safety needle/introducer, not an AI/algorithm-assisted diagnostic tool.

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

Not applicable. This is a physical safety needle/introducer.

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

Not applicable. For this device submission, the "ground truth" is effectively the established safety and efficacy of the predicate devices, against which the new device is compared to demonstrate substantial equivalence, based on design features, materials, and functional testing.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no "training set" in the context of an algorithm.

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

Not applicable. See explanation for point 8.

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The CLA Kit (Nerve Block Infusion Kit) is intended for the injection of local anesthetic to achieve peripheral nerve conduction blocks, by use of an insulated hollow needle for electrical stimulation to locate peripheral nerves, and the injection of local anesthetic either directly through the needle, or for up to 72 hours via a catheter inserted through the needle.

CLA Kit (Nerve Block Infusion Kit)

This document is a 510(k) clearance letter for the "CLA Kit (Nerve Block Infusion Kit)". It does not contain information about acceptance criteria or a study proving that a device meets such criteria. It primarily focuses on the FDA's determination of substantial equivalence to legally marketed predicate devices and outlines regulatory responsibilities.

Therefore, I cannot provide the requested information based on the provided text.

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The Entero-Test® HP is an in-vitro diagnostic device to be used for the collection of fluid/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceutical capsule.

The Entero-Test® HP is collection device encased in a gelatin capsule. It can be used to collect fluids/mucous in the upper gastrointestinal tract of adults. A pH stick and a color chart are included in each package for the purpose of identifying the pH of the fluids/mucous.

Here's an analysis of the acceptance criteria and study details based on the provided text for the Entero-Test® HP device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the exact sample sizes for the clinical tests conducted in the U.S. and China. It only refers to "the studies" and "both study sites."

The data provenance is stated as: U.S. and China (indicating different geographical locations for the studies). The studies were conducted to compare the device's performance to an established "gold standard," implying they were prospective in nature for data collection related to device performance.

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

The document states that Biopsy is considered the "gold standard" for determining the presence of Helicobacter pylori. While biopsy interpretation typically involves pathologists, the document does not specify the number or qualifications of experts consulted for interpreting the biopsy results that served as the ground truth.

4. Adjudication method for the test set

The document does not mention any specific adjudication method used for establishing the ground truth (biopsy results) for the test set.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device described (Entero-Test® HP) is a specimen collection device, not an AI-powered diagnostic tool requiring human reader interpretation in the context of AI assistance. The study compared the device's collection effectiveness against a gold standard (biopsy).

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

The Entero-Test® HP is a physical specimen collection device. Its "performance" refers to its ability to collect a sample, not an algorithm's classification or diagnostic ability. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device. The study evaluated the device's effectiveness in collecting a good sample.

7. The type of ground truth used

The type of ground truth used was Biopsy results, explicitly stated as the "gold standard" for determining the presence of Helicobacter pylori.

8. The sample size for the training set

The document does not mention a training set as this device is a specimen collection tool, not a machine learning algorithm that requires training data. The studies described are performance validation studies.

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

As there is no training set for this type of device, this question is not applicable.

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