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The TEMBO Embolic System is a gelatin agent intended for use in the embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature.

The TEMBO Embolic System consists of biocompatible, dry resorbable particles of porcine gelatin in a 10 mL syringe with a non-vented luer lock cap. The TEMBO Embolic System is a gelatin agent and a sterile, single use, medical device intended for the embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature. The TEMBO Embolic System particles are hydrated using commercially available contrast media or contrast mixed with saline. Once hydrated, the material is injected into the target blood vessel via a commercially available microcatheter for occlusion of target vasculature. The dry TEMBO Embolic System gelatin particles are between 85 µm.

The provided text describes the TEMBO Embolic System, but it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

The document is an FDA 510(k) clearance letter and a 510(k) Summary. This type of document focuses on demonstrating substantial equivalence to a predicate device through bench testing, biocompatibility, sterility, shelf-life, and limited animal studies. It does not typically include information about clinical studies with human participants that establish diagnostic performance metrics like sensitivity, specificity, or accuracy, as would be relevant for devices that provide diagnostic output or alter human reader performance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance (in a clinical/diagnostic context).
• Sample size used for the test set and data provenance (for diagnostic performance).
• Number of experts used to establish ground truth and their qualifications (for diagnostic performance).
• Adjudication method (for diagnostic performance).
• MRMC comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used (for diagnostic performance).
• Sample size for the training set (for an AI algorithm).
• How ground truth for the training set was established.

What the document does provide regarding performance and studies:

• Performance Data (Bench Testing and Functional Testing): The document lists several types of performance testing, including Visual Verification, Particle Size (Dry), Iodinated Contrast Media Chemical Compatibility, Delivery Ease, Embolic Persistence, Pepsin Digestion, pH of Hydrated Gelatin, Pot Life, Simulated Use Testing (Ability to Create an Embolization, Depth of Penetration, Minimal Non-target Embolization, Directed Delivery of Embolic Material, Embolic Material Withstands Confirmation Angiography, Embolic Delivery Through Microcatheter System, Ability to Start and Stop Embolic Delivery), and Compatibility with Female Luer Connections. It states, "All performance testing met predetermined specifications."
• Biocompatibility Testing: A comprehensive list of biocompatibility tests was successfully completed according to ISO 10993-1.
• Sterility: Sterilization via gamma radiation to a SAL of 10⁻⁶, with a validated bacterial endotoxins test.
• Shelf Life: Demonstrated for 6 months.
• Animal Testing:
  • One study on 11 swine evaluated the acute embolization effect in renal arteries and systemic impact over 28 days, assessing target tissue embolization and non-target embolization/device migration.
  • An additional study on 8 swine compared the embolic effect of TEMBO to EmboCube and Gel-Bead at 7 days.

Conclusion based on the provided text:

The TEMBO Embolic System is a vascular embolization device. The provided FDA submission documents demonstrate its substantial equivalence through mechanical, chemical, and biological testing, including animal studies, but do not involve any diagnostic or AI-related evaluation processes that would require acceptance criteria for reader performance, ground truth establishment by experts, or MRMC studies. The "acceptance criteria" referred to in the document pertain to engineering and biological specifications of the device itself ("predetermined specifications" for bench and functional testing).

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The Instylla Delivery Kit is intended to be used for the intra-venous administration of radiographic contrast media, saline and other aqueous solutions.

The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link).

The Instylla Delivery Kit with modified packaging is a sterile, single patient use device intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions. The device consists of a double-barreled syringe holder which holds and couples two (2) commercially available needleless syringes with calibrated hollow barrels and movable plungers. A single plunger clip is attached to both syringe plungers to facilitate the simultaneous injection of two distinct fluids when depressed.

The syringes of the Instylla Delivery Kit are composed of polycarbonate. The plunger clip and holder are composed of Acrylonitrile Butadiene Styrene (ABS).

I am sorry, but the provided text does not contain the detailed information needed to construct the complete response regarding acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter and summary for a delivery kit, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with specific acceptance criteria and detailed study parameters as requested.

While the document mentions "Performance testing... met the predetermined acceptance criteria," it does not explicitly list these criteria in a table or describe the study in the comprehensive manner you've outlined (e.g., sample size, data provenance, expert details, adjudication, MRMC studies, standalone performance details, ground truth specifics, training set details).

Based on the available text, I can only provide the following:

Device: Instylla Delivery Kit

Regulatory Class: Class II

Product Code: FMF (Piston Syringe)

Intended Use: For the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.

Performance Data Summary (from the text):

• Performance testing of the final, sterilized Instylla Delivery Kit with modified packaging included bench testing and functional testing.
• Tests Conducted:
  • Syringe Force Performance
  • Fluids Compatibility
  • Delivery Integrity
• Outcome: "The Instylla Delivery Kit with modified packaging met the predetermined acceptance criteria ensuring substantial equivalence to the predicate devices. No new safety or performance issues were raised during testing."
• Standards Compliance: The syringes are compliant with FDA recognized standards ISO 7886-1 and ISO 594-2.
• Biocompatibility: Evaluation conducted per FDA Guidance Document Use of International Standard ISO 10993-1. No new testing was performed on the subject device as contact materials and manufacturing processes were identical to predicate devices.
• Sterility: Sterilized via validated ethylene oxide (EO) process to a Sterility Assurance Level (SAL) of 10^-6, per ISO 11135. EO and ECH levels acceptable per ISO 10993-7. Bacterial endotoxin test (BET) validated for <20 EU/device.
• Packaging: Testing conducted per ISO 11607-1, subjected to simulated distribution challenge conditions per ISTA 3A.
• Shelf Life: 6 months. Shelf-life testing conducted to demonstrate performance and sterile barrier maintenance.

Missing Information (not found in the provided text):

• A detailed table of acceptance criteria and reported device performance (with specific numerical values for criteria and results).
• Sample size used for the test set.
• Data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method.
• If a multi-reader, multi-case (MRMC) comparative effectiveness study was done and its effect size.
• If a standalone (algorithm only) performance study was done. (This device is a physical medical device, not an AI algorithm, so this question is not applicable in this context).
• Type of ground truth used.
• Sample size for the training set. (Not applicable for a physical device).
• How the ground truth for the training set was established. (Not applicable for a physical device).
• Clinical Performance Data: "No clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device" due to identical technological characteristics, indications for use, material, manufacturing, and sterilization processes as the predicate devices.

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The Instylla Microcatheter 1.2 is intended for use in super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter 1.2 can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.

The Instylla Microcatheter 1.2 includes a single lumen, multipurpose catheter intended for use in the peripheral vasculature. The basic operating principle is to advance the microcatheter through an outer guiding catheter and track coaxially over a steerable guidewire in order to access the treatment site. The microcatheter lumen is able to accommodate steerable guidewires that are ≤0.010in (0.25mm) in diameter. Once the target region has been accessed, the microcatheter can be used to deliver diagnostic, embolic, or therapeutic materials into vessels. The microcatheter has a 1.2Fr (0.40mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.012in (0.30mm) along its length. The proximal end of the microcatheter incorporates a standard luer hub to enable the attachment of accessories, and a strain relief with a feature that allows for flexibility and securement inside a Tuohy-Borst with side-port adapter, for maintaining position inside a guiding catheter as needed. The microcatheter has a radiopaque marker at the distal tip to aid in fluoroscopic visualization. A 4Fr Tuohy-Borst with side-port adapter, a short extension adaptor, a long extension adapter and a duckbill check-valve are also included. The Instylla Microcatheter is available in 122cm, 142cm and 162cm usable lengths.

This FDA 510(k) summary describes a device, the Instylla Microcatheter 1.2, which is essentially a modification of a previously cleared predicate device (Instylla Microcatheter K200744). Therefore, the acceptance criteria and performance data mainly focus on demonstrating that the modified device's performance is equivalent to or better than the predicate, especially regarding the changes made.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the Instylla Microcatheter 1.2 "met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device." However, specific numerical acceptance criteria values and reported performance values are not explicitly provided in this summary for most tests. The summary lists the types of tests performed.

Note: The document explicitly states "The Instylla Microcatheter 1.2 met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device." This general statement serves as the reported performance for all the tests, even though specific numerical results are not provided in this summary.

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

The document does not explicitly state the sample sizes used for the various bench and functional tests, biocompatibility tests, sterility tests, or shelf-life studies. It only lists the types of tests performed.

Regarding data provenance: All listed tests are laboratory-based (bench testing, functional testing, biocompatibility, sterility, shelf life) and were conducted by the manufacturer, Instylla, Inc., in the United States. There is no indication of retrospective or prospective data from patient use, as clinical studies were deemed unnecessary.

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

This information is not applicable as there was no "test set" in the context of clinical data requiring expert review to establish ground truth. The acceptance criteria for this device relied on engineering performance specifications, biocompatibility standards, and sterility validations.

4. Adjudication Method for the Test Set

This information is not applicable. Since no clinical test set requiring expert adjudication was conducted, there was no adjudication method used. The evaluation centered on technical specifications and regulatory standards.

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

No, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states: "The fundamental technological characteristics, indications for use, material, manufacturing and sterilization processes are the same as the predicate devices and therefore, no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device." This means there was no study comparing human readers with and without AI assistance.

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

This question is not applicable as the device is a physical medical catheter, not an AI algorithm or software. Therefore, there is no "standalone" algorithm performance to assess.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation was primarily based on:

• Engineering Specifications and Bench Test Results: Performance against predefined technical thresholds for properties like trackability, kink resistance, pushability, flow rate, tensile strength, etc.
• International Standards and Regulatory Guidance: Compliance with standards for biocompatibility (ISO 10993 series), sterilization (ISO 11135, AAMI TIR28, ISO 10993-7), and endotoxin levels.
• Prior Predicate Device Performance: The underlying assumption is that the predicate device (Instylla Microcatheter K200744) was safe and effective, and the modified device's equivalence to the predicate (or improvement where specified, e.g., smaller OD/ID) served as its "ground truth" for safety and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The development and testing of the device rely on engineering principles, materials science, and physical testing, not data training.

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

This question is not applicable for the same reasons mentioned in point 8.

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The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.

The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link).

The provided document describes the Instylla Delivery Kit (K202544), which is a medical device intended for the administration of radiographic contrast media, saline, and other aqueous solutions. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to a predicate device (K191659). This particular submission focuses on a modified version of the Instylla Delivery Kit with 3mL syringes, whereas the predicate device used 1mL syringes.

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

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

The document does not provide a formal table of specific, quantitative acceptance criteria. Instead, it states that "The Instylla Delivery Kit with 3mL syringes met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device."

Here's a summary of the performance tests conducted and the general outcome:

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

The document does not explicitly state the sample sizes used for the bench and functional testing. It mentions "Performance testing of the final, sterilized Instylla Delivery Kit with 3mL syringes included bench testing and functional testing." Without specific numbers, the sample size remains unknown.

Data provenance: All testing appears to be retrospective bench and functional testing conducted by the manufacturer, Instylla, Inc. There is no information provided regarding the country of origin of the data beyond the company's location (Bedford, Massachusetts).

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 document describes a 510(k) submission for a piston syringe device, not an AI or diagnostic imaging device that typically requires expert-established ground truth for performance evaluation. The "ground truth" here is defined by engineering specifications, material properties, and regulatory standards.

4. Adjudication method for the test set

This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used for reconciling discrepancies in expert interpretations, which is not relevant for the type of testing described here.

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

There was no MRMC comparative effectiveness study done. This type of study is relevant for AI-powered diagnostic devices, which is not the subject of this 510(k) submission.

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

There was no standalone (algorithm-only) performance study conducted. This device is a physical medical device (syringe kit), not an algorithm or AI system.

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

For the performance specifications (e.g., disconnection force, glide force, particulate matter), the "ground truth" is based on predetermined engineering specifications, validated test methods, and compliance with recognized industry standards like ISO 7886-1, ISO 594-2, USP <788>, ISO 11135, and ISO 10993-7. For biocompatibility, the ground truth was established by prior testing of the predicate device against ISO 10993-1.

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

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

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The Instylla Microcatheter is intended for use in super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.

The Instylla Microcatheter includes a single lumen, multipurpose catheter intended for use in the peripheral vasculature. The basic operating principle is to advance the microcatheter through an outer guiding catheter and track coaxially over a steerable guidewire in order to access the treatment site. The microcatheter lumen is able to accommodate steerable guidewires that are ≤0.014in (0.36mm) in diameter. Once the target region has been accessed, the microcatheter can be used to deliver diagnostic, embolic, or therapeutic materials into vessels.

The microcatheter has a 1.7Fr (0.56mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.016in (0.41mm) along its length. The proximal end of the microcatheter incorporates a standard luer hub to enable the attachment of accessories, and a strain relief with a feature that allows for flexibility and securement inside a Tuohy-Borst adapter, for maintaining position inside a guiding catheter as needed. The microcatheter has a radiopaque marker at the distal tip to aid in fluoroscopic visualization. A 4Fr Tuohy-Borst with side-port adapter, a short extension adaptor, a long extension adapter and a duckbill check-valve are also included. The Instylla Microcatheter is available in 122cm, 142cm and 162cm usable lengths.

This document describes the Instylla Microcatheter with check-valve connector and asserts its substantial equivalence to a previously cleared predicate device (Instylla Microcatheter, K191731). As such, the study focuses on verifying that the modified device meets the same performance criteria as the predicate, rather than establishing entirely new acceptance criteria or conducting a clinical effectiveness study.

Here's an analysis of the provided information based on your request:

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 each specific bench and functional test. It refers to these as "testing" and "evaluation." Given the nature of a 510(k) submission focusing on substantial equivalence for a minor modification (addition of a duckbill check-valve connector), these tests are typically conducted on a representative sample of devices.

• Provenance: This is a retrospective comparison to the predicate device. The tests are performed "in-house" by the manufacturer (Instylla, Inc.) to demonstrate that the modified device performs comparably to the previously-cleared device. The data provenance is effectively manufacturer-generated test data. No specific country of origin for test data is mentioned beyond the company's US location.

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

Not applicable to this type of submission. This is a bench and functional testing report for a device modification, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" for these tests is based on established engineering and biological standards (e.g., ISO for sterility, defined limits for endotoxins/biocompatibility observations).

4. Adjudication Method for the Test Set

Not applicable. As described above, this is laboratory-based testing against predefined specifications, not judgmental classification 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

Not applicable. This is not an AI/Software as a Medical Device (SaMD) submission. It concerns a physical medical device (microcatheter).

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 algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests described (functional, biocompatibility, sterility, shelf life) is based on:

• Engineering Specifications: For functional tests like accessory compatibility, the ground truth is whether the device meets its design specifications and operates as intended.
• International Standards: For biocompatibility (ISO 10993-1) and sterility (ISO 11135), the ground truth is adherence to the validated methods and acceptable limits defined by these standards.
• Predetermined Acceptance Criteria: The document mentions "predetermined acceptance criteria" for functional testing, implying a comparison to established benchmarks, likely derived from the predicate device's performance or industry best practices.

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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The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.

The Instylla Delivery Kit is comprised of two 1mL delivery syringes, a syringe holder, and a plunger clip (link).

This document describes a 510(k) premarket notification for the "Instylla Delivery Kit," a piston syringe for administering medical solutions. The document does not contain any information about acceptance criteria or a study proving the device meets said criteria in the context of performance metrics like sensitivity, specificity, accuracy, or any AI/algorithm performance. The provided text details bench and functional testing for mechanical and material properties, rather than clinical performance or AI evaluation.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data in the context of an AI device.

However, I can extract information related to the device's non-AI performance testing, as detailed in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance testing that was conducted, but it does not explicitly state specific acceptance criteria values or detailed quantitative reported performance metrics. It generally states that these tests were performed "to verify specifications fundamental to the device" and that the syringes are "compliant against FDA recognized standards ISO 7886-1 and ISO 594-2."

2. Sample size used for the test set and the data provenance:
Not applicable, as this is bench and functional testing of a physical device, not an AI/algorithm test set. No "data provenance" in the sense of patient data is mentioned for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for physical device testing typically involves laboratory measurements and adherence to engineering specifications and standards.

4. Adjudication method for the test set:
Not applicable.

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. The document explicitly states: "no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device" due to its substantial equivalence to predicate devices and the nature of the device (a piston syringe).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/algorithm device.

7. The type of ground truth used:
For the non-AI performance tests, the "ground truth" would be established by:

• Engineering specifications and design requirements: For visual inspection, dimensional verification, and functional testing.
• International Standards: ISO 7886-1, ISO 594-2 for syringe compliance.
• Biocompatibility Standards: ISO 10993-1 for biocompatibility tests.
• Sterilization Standards: ISO 11135 for sterility.
• Established Test Methods: For particulate matter, endotoxin, and shelf life.

8. The sample size for the training set:
Not applicable, as this is not an AI/algorithm device.

9. How the ground truth for the training set was established:
Not applicable, as this is not an AI/algorithm device.

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The Instylla Microcatheter is intended for use in small vessel or super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.

The Instylla Microcatheter device is a single lumen, multipurpose catheter intended for use in the peripheral vasculature. The basic operating principle is to advance the microcatheter through an outer guiding catheter and track coaxially over a steerable guidewire in order to access the treatment site. The microcatheter lumen is able to accommodate steerable guidewires that are ≤ 0.014 in (0.36 mm) in diameter. Once the target region has been accessed, the microcatheter can be used to deliver diagnostic, embolic, or therapeutic materials into vessels.

The Instylla Microcatheter has a 1.7Fr (0.56mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.016 in (0.41mm) along its length. The proximal end of the microcatheter incorporates a standard luer hub to enable the attachment of accessories, and a strain relief with a feature that allow for flexibility and securement inside a Tuohy-Borst adapter, for maintaining position inside a guiding catheter as needed. The Instylla Microcatheter has a radiopaque marker at the distal tip to aid in fluoroscopic visualization. A 4Fr Tuohy-Borst with side-port adapter, a short catheter extension and a long catheter extension adapter are also included. The Instylla Microcatheter is available in 122, 142 and 162 cm usable lengths.

The provided text describes Instylla, Inc.'s K191731 510(k) submission for their Instylla Microcatheter. The document outlines the device's characteristics, its comparison to predicate devices, and the performance and safety studies conducted to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text, while noting limitations in the information for certain requested points:

Acceptance Criteria and Device Performance for Instylla Microcatheter (K191731)

The acceptance criteria for the Instylla Microcatheter revolved around demonstrating substantial equivalence to a predicate device (CrossCath Support Catheter, K093052) through various performance benchmarks and safety assessments. Since this is a 510(k) submission, the "acceptance criteria" are implied by the comprehensive pre-clinical testing conducted to show that the device performs as safely and effectively as the predicate, and does not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly list numerical "acceptance criteria" values for each test, but it clearly states that the Instylla Microcatheter "met the predetermined acceptance criteria" for all tests and that "No new safety or performance issues were raised during testing."

Given the context of a 510(k), the implied acceptance criterion for each test is that the Instylla Microcatheter performs comparably to the predicate device or within recognized safety and effectiveness standards for such devices.

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

The document does not explicitly state the specific sample sizes for each individual bench test (e.g., how many catheters were tested for kink resistance). It broadly mentions "bench testing and functional testing to verify specifications" and "testing was also conducted to demonstrate the subject device is substantially equivalent to the predicate device."

• Test Set Sample Size: Not explicitly stated for specific tests. It implies a sufficient number of devices were tested to meet statistical significance for product verification and validation.
• Data Provenance: The studies were pre-clinical bench and lab-based testing performed by the manufacturer, Instylla, Inc. The country of origin for the data is not specified beyond being generated by a US-based company (Waltham, MA). The data is prospective in the sense that it was generated specifically for this 510(k) submission, not retrospectively analyzed from existing patient data.

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

• This question is not applicable to this type of submission. The "ground truth" for device performance in a 510(k) pre-clinical bench testing context is established by engineering specifications, recognized industry standards, and comparison to the predicate device's known performance characteristics, not by expert consensus on clinical data. The tests themselves are designed to objectively measure physical and chemical properties and performance.

4. Adjudication Method for the Test Set

• This question is not applicable as there were no subjective clinical interpretations requiring adjudication. Performance against predetermined specifications and predicate device equivalence are evaluated based on objective test results.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The fundamental technological characteristics, indications for use, marker material, manufacturing and sterilization processes are the same as the predicate devices and therefore, no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device."

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

• This question is not applicable as the Instylla Microcatheter is a physical medical device, not an artificial intelligence (AI) algorithm. Therefore, "algorithm only" or "human-in-the-loop" performance does not apply.

7. The Type of Ground Truth Used

• For the performance testing, the "ground truth" was based on:
  • Engineering Specifications: Predetermined design and performance requirements for the microcatheter.
  • Industry Standards: Adherence to relevant international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 for sterilization).
  • Predicate Device Equivalence: The performance of the Instylla Microcatheter was evaluated against the known characteristics and performance of the legally marketed predicate device (CrossCath Support Catheter).

8. The Sample Size for the Training Set

• This question is not applicable as the Instylla Microcatheter is a physical medical device, not an AI algorithm that requires a "training set" of data.

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

• This question is not applicable for the same reason as point 8.

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