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The NMI PICC II and NMI PICCIV are indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrations and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III with PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The proposed device has similar design, components and technological characteristics as the predicate intravascular catheters; the only difference between the predicate and proposed devices is the type of ink used on the markings of the catheter shaft.

This document describes a 510(k) premarket notification for the NMI PICC III and NMI PICC IV devices. It focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study proving device meets acceptance criteria through performance. As such, information regarding a study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement is not available in the provided text.

Specifically, the document states:

• "The proposed device has similar design, components and technological characteristics as the predicate intravascular catheters; the only difference between the predicate and proposed devices is the type of ink used on the markings of the catheter shaft."
• "Biocompatibility testing per ISO 10993-1 demonstrates that the new ink on the proposed device does not affect safety and/or effectiveness."
• "The NMI PICC III and NMI PICC IV are substantially equivalent to Navilyst predicate devices based on comparison of technological characteristics and the results of non-clinical tests..."

Therefore, I cannot provide the requested information about acceptance criteria and a study demonstrating device performance as would be found in a clinical trial or performance study report. The provided text outlines a regulatory submission demonstrating equivalence based on non-clinical testing and similar technological characteristics.

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The NMI PICC IV is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC IV is a Peripherally Inserted Central Catheter (PICC). It is a percutaneous, implanted, long-term intravascular catheter. It is available in single and multi-lumen configurations in a wide range of sizes from 3F to 6 F outside catheter diameter. It is rated for maximum power injector settings up to 325 psi and rated for maximum power injection flow rate up to 6 ml/second based on model. It is available kitted with a range of procedural accessories for user convenience and demonstrates resistance to blood components (platelet and thrombus) accumulation.

The NMI PICC IV device's acceptance criteria and studies are described below:

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

The provided document describes the NMI PICC IV device as substantially equivalent to predicate devices based on technological characteristics and non-clinical testing. Instead of specific acceptance criteria as thresholds for performance, the document refers to compliance with established standards and guidance documents. The "reported device performance" is essentially that it met these standards and performed similarly to its predicate.

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

The document does not specify sample sizes for a "test set" in the context of clinical trials. The evaluation was based on non-clinical tests (bench testing) and comparison to a predicate device. There is no mention of human subject data, retrospective or prospective studies, or country of origin for such data.

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

This information is not applicable as the study described is non-clinical (bench testing) and relies on compliance with engineering standards and comparison to a predicate device, rather than expert-established ground truth from clinical data.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as point 3. There was no clinical test set requiring adjudication.

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:

An MRMC comparative effectiveness study was not conducted. This device is a physical medical device (PICC line) and does not involve AI or human image interpretation.

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

A standalone algorithm performance study was not conducted. This device is a physical medical device and does not involve an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance is established by compliance with recognized industry standards (EN ISO 10555-1:2009, EN ISO 10555-3:1997), FDA guidance documents, and demonstrated equivalence to previously cleared predicate devices through non-clinical testing. No clinical "ground truth" (e.g., pathology, outcomes data) was used in the context of this 510(k) submission.

8. The sample size for the training set:

There is no mention of a training set as this is a non-AI, physical medical device. The term "training set" is not relevant to this submission.

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

This information is not applicable as there was no training set used for this device submission.

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The NMI PICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III is a Peripherally Inserted Central Catheter (PICC). It is available in single and multi-lumen configurations in a wide range of sized from 4F to 6F outside catheter diameter. It is rated for maximum power injector settings up to 325 psi and maximum power injection flow rate up to 5 ml/second based on model. It is available kitted with a range of procedural accessories for user convenience and demonstrates resistance to blood components (platelet and thrombus) accumulation.

The provided document describes a 510(k) premarket notification for the NMI PICC III device, which is a peripherally inserted central catheter. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study to meet specific acceptance criteria in the context of an AI/ML device. Therefore, many of the requested categories related to AI/ML device performance studies (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and ground truth establishment methods) are not applicable to this type of regulatory submission.

However, I can extract the information related to the device's technical specifications and the non-clinical tests performed to support its equivalence.

Here's a summary based on the provided text, with "N/A" for sections not applicable to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study for an AI/ML device. Instead, it lists technical specifications and performance characteristics that the device is stated to meet, largely by demonstrating equivalence to a predicate device through non-clinical testing.

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

N/A. This is a non-clinical testing submission for a physical medical device, not an AI/ML diagnostic system with a "test set" of data in the common AI/ML sense. The testing involved physical device samples (implicitly, as part of standard medical device testing, but specific numbers are not given). The tests were conducted according to international standards and FDA guidance.

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

N/A. Ground truth in this context refers to engineering specifications and performance characteristics tested against established standards, not diagnostic data adjudicated by experts.

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

N/A. Not applicable to engineering tests of a physical device.

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

N/A. This is a 510(k) for a physical medical device, not an AI-assisted diagnostic system.

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

N/A. Not applicable to a physical medical device.

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

The "ground truth" for this device's performance is based on engineering specifications, established international standards (EN ISO 10555-1, EN ISO 10555-3), and FDA guidance documents. Performance attributes like flow rates, pressure ratings, and material resistance are measured against these objective criteria.

8. The sample size for the training set

N/A. There is no AI/ML "training set" for this physical medical device.

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

N/A. Not applicable.

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The NMI PICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III with PASV Valve Technology is indicated for short- or long-term access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The NMI HPICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring.

The proposed device has identical materials, design, components and technological characteristics as the predicate intravascular catheters.

Both the proposed and predicate devices are, in brief,

• . intended for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling and power injection of contrast media,
• available in single and multi-lumen configurations in a wide range of sized from 3 to 6 . FR outside catheter diameter,
• . rated for maximum power injector settings up to 325 psi,
• rated for maximum power injection flow rate up to 6 ml/second based on model, .
• available kitted with a range of procedural accessories for user convenience; and .
• demonstrative of enhanced resistance to blood component (platelet and thrombus) . accumulation.

The provided text describes a 510(k) summary for medical devices (PICC lines) and focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria in the context of an AI/ML device.

Therefore, many of the requested categories for AI/ML device studies cannot be answered from the provided document.

Here's an analysis based on the information available:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state "acceptance criteria" in the traditional sense for a new software or AI/ML device performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" is primarily described by the predicate device's characteristics and the non-clinical tests confirming the similarity of the new device.

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

• Sample Size: Not applicable in the context of human data validation or an AI/ML model test set. The "testing" referred to is non-clinical bench testing (biocompatibility, mechanical properties) of the physical device.
• Data Provenance: Not applicable. The "study" is a non-clinical evaluation of the physical device's characteristics and materials.

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

Not applicable. There is no mention of human experts establishing ground truth for a test set in this document, as it pertains to a physical medical device.

4. Adjudication method for the test set:

Not applicable. There is no test set or human adjudication described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No. This document describes the substantial equivalence of a physical medical device (PICC lines), not an AI/ML system.

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

Not applicable. This is not an algorithm or AI/ML device.

7. The type of ground truth used:

Not applicable. The "ground truth" for this medical device's performance is based on established engineering principles, material science, and performance standards for intravascular catheters, as demonstrated through non-clinical testing.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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The NMI HPICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for central venous pressure monitoring and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.

The NMI PICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids. medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III with PASV Vale Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec.

for short or long-term peripheral access to the central venous system for intravenous therapy. including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, and for power injection of contrast media.

The PICC Maximal Barrier Nursing Kit is a packaging configuration containing a specified NMI PICC, along with (1) procedural aides typically used for PICC placement and (2) maximal barrier precaution devices based upon recommendations of Center of Disease Control and Prevention (CDC).

The Navilyst Medical PICC Maximal Barrier Nursing Kit is a medical device that combines a Peripherally Inserted Central Catheter (PICC) with procedural aides and maximal barrier precaution devices. The 510(k) premarket notification K131038 states that the device's performance evaluation was conducted based on a risk analysis and included testing in accordance with national/international standards and FDA guidance documents.

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:

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

The document does not explicitly state the sample sizes used for the packaging standards testing or EO sterilization testing. It mentions that "All packaging is manufactured from packaging materials that are well characterized and commonly used in the medical industry." However, it does not specify the number of units tested.

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. The studies were conducted by Navilyst Medical.

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

This information is not provided in the document. The performance evaluation relied on standardized testing, not expert-based ground truth for the device's main components. The "maximal barrier precaution devices" are based on recommendations from the Center of Disease Control and Prevention (CDC), implying general clinical best practices rather than specific expert review of test outcomes.

4. Adjudication Method for the Test Set:

An adjudication method (such as 2+1 or 3+1) is not mentioned in the document. The testing described (packaging, sterilization) typically relies on objective measurements against established standards, rather than subjective expert review requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of results, which is not applicable to the PICC Maximal Barrier Nursing Kit, whose performance is primarily evaluated through physical and biological property testing.

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

This question is not applicable as the PICC Maximal Barrier Nursing Kit is a physical medical device, not an algorithm or AI system. Its performance relates to its physical characteristics, sterility, and packaging integrity, not software performance.

7. The Type of Ground Truth Used:

The ground truth used for this device's evaluation was primarily established by national/international standards and recognized FDA guidance documents. For example, ISO 10993-7 sets acceptance limits for ethylene oxide residuals, and ISO 11607 outlines requirements for packaging systems. The "successful results" indicate that the device met these objective, pre-defined criteria.

8. The Sample Size for the Training Set:

This question is not applicable as there is no "training set" for this device. The device is not based on a learning algorithm that requires training 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 NMI PICC III is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

The NMI PICC III with PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood and for power injection of contrast media.

The NMI PICC III are flexible radiopaque catheters with suture wing for catheter securement, extension tubes(s) which connect to proximally located luer lock adapter(s) with and without a pressure activated safety valve (PASV), available in single lumen and multi-lumen configurations and a reverse tapered shaft to aid in staunching bleeding at the insertion site.

The lumens are differentiated by proximally located colored extension tube clamps and/or colored luer adaptors, which identify lumen size, if the lumen is rated for power injection the maximum power injection flow rates, and "NO CT" for non-power injectable lumens.

All NMI PICC III models have been designed with the option of being used with power injectors for the administration of contrast media for imaging studies such as Computerized Tomography (CT) scans and Magnetic Resonance Imaging (MRIs). Models with at least one non-valved lumen are also indicated for central venous pressure monitoring. All catheters are available packaged with a variety of procedural accessories as a convenience to suit specific clinician preference that meet of the PICC placement practice at their institution and in standard kit configurations.

Endexo technology has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vitro and in vivo models. Preclinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The acceptance criteria for the NMI PICC III device and the studies that demonstrate its performance are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices and demonstrating compliance with relevant standards through various tests. The 'acceptance criteria' are implicitly defined by successful completion of these tests, which ensure the device meets specified functional and safety requirements. The reported device performance is generally qualitative (e.g., successful passed testing) rather than specific numerical metrics, with the exception of maximum power injection flow rates.

Acceptance Criteria (Implied by successful testing) & Reported Device Performance

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

• Test Set Sample Size: The document does not specify the exact sample sizes (number of devices or animal subjects) used for each individual test (e.g., Luer connection strength, power injection, in-vitro blood loop, in-vivo ovine study). It only states that the testing was "successfully passed."
• Data Provenance: The studies are described as preclinical ("in vitro and in vivo models") and conducted by the sponsor (Navilyst Medical, Inc.) to support the 510(k) submission. The in-vivo study used an "ovine model," indicating animal testing. The country of origin for the data is not specified beyond being generated by the sponsor for a US FDA submission. The studies are prospective in design for the purpose of evaluating the device's performance against pre-defined criteria.

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

• For the technical and performance tests (e.g., Luer connection, power injection, valve integrity, chemical compatibility), the "ground truth" is established by the specified engineering standards (ISO, FDA guidance) and internal product specifications. These usually involve objective measurements and calibrated equipment, rather than expert human interpretation.
• For the in-vitro and in-vivo thrombus reduction studies, the "ground truth" would be the measured thrombus accumulation. The document does not mention the involvement of external experts to establish this ground truth; it is assumed to be determined by the study investigators. No specific number or qualifications of experts are mentioned for establishing ground truth for any of the performance studies.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (like 2+1 or 3+1 consensus) for the test sets. The performance evaluation relies on objective measurements against established standards and internal specifications, along with direct quantitative or comparative outcomes from in-vitro and in-vivo studies.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is a medical catheter, not an imaging AI diagnostic tool that would typically involve human readers interpreting images. The studies conducted are focused on the physical and biological performance of the catheter itself.

6. Standalone Performance Study (Algorithm Only)

Not applicable. The NMI PICC III is a physical medical device (catheter), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the loop performance)" does not apply.

7. Type of Ground Truth Used

The ground truth for the performance studies is based on:

• Objective Measurements: For tests like Luer connection strength, power injection flow rates, and central venous pressure monitoring capabilities, the ground truth is obtained through direct instrumental measurements.
• Compliance with Standards: Meeting the requirements of international standards (EN ISO 10555-1, EN ISO 10555-3, ISO 10993-1) and FDA guidance documents.
• In-vitro Quantifiable Data: For thrombus reduction, the ground truth is based on quantitative measurements of thrombus accumulation in in-vitro blood loop models.
• In-vivo Observational Data: For thromboresistance, the ground truth is derived from observations and measurements in an ovine animal model over specified indwelling times.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or artificial intelligence. The device's design and manufacturing processes are developed through engineering and material science principles, not through data-driven training sets.

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

Not applicable, as there is no "training set" for this physical medical device.

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For short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

The proposed Peripherally Inserted Catheter is a Flexible radiopaque catheter with similar technological characteristics as the predicate devices. It is available in single and multi-lumen configurations with markings along the 55cm shaft length; with extension tube(s) and suture wing for cather securement; and each lumen is differentiated by a proximally located female luer lock adaptor with valve and colored hubs that indicate lumen size.

The provided text describes a 510(k) submission for the "NMI PICC II" device, a peripherally inserted central catheter. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document outlines the device's administrative details, its intended use, and states that "Performance testing included in-vitro testing in accordance with ISO 10555-1 and ISO 10555-3; high performance testing rates and valve integrity testing; and biocompatibility evaluation in accordance with ISO 10993-1." It concludes with a determination of substantial equivalence to predicate devices based on the guidance document.

Therefore, I cannot provide the requested information from the given text. The details you've asked for (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not present in this 510(k) summary.

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For short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

The proposed PICC has similar technological characteristics as the predicate devices. lt is a flexible catheter with proximally located luer lock adapter(s) with a pressure activated safety valve, extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL) and effective (usable) length of 55 cm. The radiopaque catheter is marked with depth indicators along its length. The lumens are differentiated by proximally located colored hubs that indicate lumen size. Maximum power injection flow rates are indicated on the luer adapter(s). The proposed PICC may be provided as a stand alone device or in kits with other legally marketed products as a convenience to the user to accommodate their particular needs.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

It appears that the provided FDA 510(k) summary (K091261 for Navilyst Medical's PICC) does not contain the detailed information required to fully answer all aspects of your request regarding acceptance criteria and a specific study's results.

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and general performance testing. It does not present a specific clinical study with detailed performance metrics against predefined acceptance criteria in the format you've requested.

However, I can extract what is available and highlight where information is missing based on your prompt.

Analysis of K091261 for Acceptance Criteria and Study Information

Summary of Findings:

The 510(k) submission primarily relies on in-vitro testing and biocompatibility assessments to demonstrate substantial equivalence, rather than a clinical study with detailed performance outcomes against specific, quantitative acceptance criteria. Therefore, most of the requested fields cannot be filled directly from the provided text.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Why it Can't be Fully Addressed from provided text:

The provided text only lists the types of performance testing conducted (ISO 10555-3, high pressure injection, valve integrity, biocompatibility). It does not:

• Specify quantitative acceptance criteria for each test (e.g., "tensile strength must be >X N," "flow rate must be >Y mL/s at Z psi").
• Report specific performance values or statistical outcomes from these tests.
• Describe a clinical study with patient outcomes.

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

• Sample Size for Test Set: Not specified. The document mentions in-vitro testing but does not provide the number of units tested.
• Data Provenance: In-vitro laboratory testing. The country of origin for the lab testing is not specified but would typically be conducted at the manufacturer's R&D facilities or a contract lab. This is not clinical data (retrospective or prospective).

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

• Not applicable. This information is relevant for studies involving human interpretation (e.g., imaging, diagnostics). The tests described are in-vitro physical and material tests, not expert-adjudicated clinical data.

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Testing involves objective measurements against established engineering standards, not expert adjudication.

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

• No. An MRMC study was not done. This device is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers. The submission does not describe any clinical study, let alone an MRMC study.
• Effect Size of Human Readers (with/without AI): Not applicable.

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

• Not applicable. This is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

• For the in-vitro tests: The "ground truth" is defined by established engineering standards (e.g., ISO 10555-3) and internal design specifications for mechanical, flow, and biocompatibility properties. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• Not applicable. This concept typically applies to machine learning algorithms. The development of a physical medical device involves design, prototyping, and in-vitro testing, but not a "training set" in the AI sense.

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

• Not applicable. See point 8.

Conclusion:

The provided 510(k) summary for K091261 demonstrates substantial equivalence through a comparison of technological characteristics with predicate devices and compliance with relevant in-vitro and biocompatibility standards. It does not present a clinical study with detailed performance metrics against quantitative acceptance criteria in the manner you've outlined for AI or diagnostic devices.

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