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The automatic BioPince™ Ultra Full Core Biopsy Instrument is intended for multiple percutaneous full-core sampling of soft tissue, tumors, or masses for histological analysis. Soft tissue sampling includes, but is not limited to, kidney, liver, breast, prostate and various soft tissue lesions.

The BioPince™ Ultra Full Core Biopsy Instrument is an automatic, disposable biopsy instrument that cuts a full core specimen of soft tissue. The instrument is designed to expel the specimen upon re-cocking of the instrument which prepares the instrument for taking another sample (i.e., ready to be fired). The instrument has two firing trigger buttons with an indicator window and safety button. The instrument is available in 14G, 16G, 18G and 20G needle sizes and 10cm, 15cm and 20cm lengths.

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria. The document is a 510(k) summary for the BioPince™ Ultra Full Core Biopsy Instrument, primarily focused on establishing substantial equivalence to predicate devices and outlining the device's intended use and technological characteristics.

However, based on the Performance Tests section, we can infer the overarching acceptance criteria and the nature of the study.

Inferred Acceptance Criteria:

The document states, "Performance testing confirms that the BioPince™ Ultra Full Core Biopsy Instrument is equivalent to that of the predicate devices." This implies that the acceptance criteria for the BioPince™ Ultra were to demonstrate equivalency in performance to its predicate devices concerning their functional aspects. While specific quantitative metrics are not provided, these would typically include aspects relevant to biopsy instruments, such as:

• Ability to obtain a full-core specimen: The device's primary function.
• Specimen expulsion mechanism: Ensuring the sample is released upon re-cocking.
• Reliability of firing mechanism: Consistent operation of the trigger buttons.
• Safety features: Proper functioning of the safety button.
• Material compatibility/biocompatibility: Though not explicitly a "performance test" in the functional sense, it's a key aspect for medical devices.
• Sterility: As a disposable device.

Inferred Study to Prove Acceptance Criteria:

The document states, "Performance testing confirms that the BioPince™ Ultra Full Core Biopsy Instrument is equivalent to that of the predicate devices." This indicates that a comparative performance study was conducted.

Here's an attempt to populate the requested table and sections based on the available information and common practices for 510(k) submissions of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative metrics or detailed results for these performance aspects. The "reported device performance" is a high-level statement of equivalency.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified. It's likely an in-house or contracted laboratory study, common for medical device performance testing, rather than patient data. Given the regulatory submission is from Canada (Angiotech contact) to the US FDA, the provenance could be international, but this is not stated. It is a prospective study if referring to the controlled performance tests conducted specifically for this submission.

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

• This type of performance testing for a biopsy instrument typically does not involve human experts establishing a "ground truth" in the sense of clinical diagnosis or interpretation of images. The ground truth would be objectively measured physical characteristics of the biopsy samples (e.g., core length, tissue integrity) or functional aspects of the device (e.g., successful firing, effective specimen expulsion).
• The "experts" involved would likely be engineers, quality assurance personnel, and potentially histologists or pathologists to evaluate the quality of the tissue samples obtained, but this is not explicitly stated. Their qualifications would be relevant to their specific roles (e.g., biomedical engineers, certified histotechnologists).

4. Adjudication Method for the Test Set

• Since this is performance testing of a physical device against technical specifications and predicate device performance, an adjudication method like "2+1" or "3+1" (which are typically used for disagreements in human expert assessments, e.g., in radiology studies) is not applicable.
• Results would be determined by objective measurements, pass/fail criteria, and comparison to predicate device data or established benchmarks. Any discrepancies during testing would be investigated and resolved through standard engineering and quality control procedures.

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

• No, an MRMC comparative effectiveness study was not done.
  • MRMC studies are typically used to assess the diagnostic performance of a technology (often AI-based imaging tools) by comparing how human readers perform with and without the technology's assistance across multiple clinical cases.
  • The BioPince™ Ultra is a physical biopsy instrument, and its performance is evaluated based on its mechanical function and ability to obtain tissue, not on its interpretation of images or clinical data.

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

• Not applicable.
  • This question pertains to algorithms or AI models. The BioPince™ Ultra is a mechanical device.
  • The performance assessment focused on the device itself (its mechanical and functional attributes) rather than an algorithm.

7. The Type of Ground Truth Used

• The ground truth for this device's performance testing would be objective physical measurements and functional verification. Examples include:
  • Histological confirmation: Examination of tissue cores obtained to ensure they are full-core, intact, and suitable for histological analysis. This might involve pathology review, but not as "experts establishing ground truth" in a diagnostic sense for the device's performance, but rather confirming the quality of the output.
  • Engineering specifications: Ensuring firing force, needle throw length, specimen retention/expulsion, and safety features meet design requirements.
  • Comparison to predicate device performance: Directly matching or exceeding the performance characteristics of the legally marketed devices mentioned (BioPince™ Full Core, Tru. Core™, V-Core™, Easy Core™).
  • It does not involve outcomes data in the clinical sense for this type of submission.

8. The Sample Size for the Training Set

• Not applicable / Not specified.
  • "Training set" refers to data used to develop and train algorithms (e.g., in machine learning). The BioPince™ Ultra is a mechanical device, not an algorithm.
  • Any "training" in the context of this device would refer to design iterations, prototype testing, and manufacturing process validation, not a data training set for an AI.

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

• Not applicable.
  • As explained above, there is no "training set" in the context of an algorithm for this device. Design and testing iterations (if any) would use engineering principles and physical measurement for validation.

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The InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy.

The V-Mark Breast Biopsy Site Marker is made of a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The site markers are deployed through an applicator that fits in commercially available biopsy probes. The V-Mark Breast Biopsy Site Marker marks the site of biopsy tissue sample, and is visible for up to 6 weeks by x-ray, ultrasound and MRI. The body then metabolizes the marker over time. The V-Mark contains a titanium component for permanent radiographic visibility. The V-Mark Breast Biopsy Site Marker has been modified to remove the contrast agent that was incorporated into the polymer to provide radiopacity. The titanium component of the device provides for permanent radiographic visibility, eliminating the need for contrast agent in the resorbable polymer. V-Mark Breast Biopsy Site Markers are made of 75/25% poly(D,L-lactide-co-glycolide) copolymer. No other changes have been made to the formulation other than the elimination of the contrast agent. The site markers are deployed into the biopsy needle tract using a hand held applicator with a two finger-push control rod that delivers a single marker. The site markers are deployed through an applicator that fits commercially available biopsy probes or coaxial needles including the J&J Ethicon Mammotome biopsy probe, the Pro-Mag Coaxial Introducer with Blunt Obturator, the Bio-Pince Co-axial Introducer with Blunt Obturator, the Medical Device Technologies V-Core Co-axial Introducer, and the Suros Vacuum Assisted Biopsy System. For physicians who desire to perform biopsy under ultrasound guidance, a delivery system cannula with an echogenic tip is also available for multiple coaxial applications.

The acceptance criteria and study details for the InterV brand V-Mark® Breast Biopsy Site Marker with Titanium Anchor are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes a special 510(k) where the primary change is the removal of a contrast agent from the polymer while retaining a titanium component for radiographic visibility. The acceptance criteria are implicitly tied to the performance of the original predicate device (Medical Device Technologies, Inc. InterV brand V-Mark Breast Biopsy Site Marker, K051421). The key performance aspects are related to the marker's visibility and deployment.

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

• Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of a clinical study with patients. The performance data seems to be derived from engineering/bench testing. The document mentions "Finished product testing of the device without contrast, including deployment through the delivery system."
• Data Provenance: The data appears to be from internal laboratory/bench testing ("All testing was performed post sterilization"). No country of origin is specified for the data itself, but the manufacturer is based in Gainesville, Florida, USA. The testing is retrospective in the sense that it's comparing a modified device to a previously approved one, but the specific tests performed on the modified device would be prospective for that particular modification.

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

• Not applicable. This was not a human-in-the-loop study requiring ground truth established by experts. The evaluation focused on material properties and mechanical performance.

4. Adjudication method for the test set:

• Not applicable. There was no need for adjudication for this type of performance testing.

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. This study is not an MRMC comparative effectiveness study and does not involve AI assistance or human readers.

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

• No. This device is not an algorithm; it is a physical medical device. The "standalone" performance here refers to the device's physical and material properties, which were tested without human-in-the-loop performance in a clinical scenario for this submission.

7. The type of ground truth used:

• The "ground truth" for the performance evaluation appears to be the original design specifications and the established performance of the predicate device (K051421). For example, "Wire retention in the polymer without contrast was equivalent to retention in polymer with contrast" implies the predicate device's wire retention served as the benchmark. Similarly, meeting "original design specifications" for deployment implies those specifications served as the ground truth.

8. The sample size for the training set:

• Not applicable. This submission concerns a modification to an existing physical device and does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable, as there is no training set mentioned or implied.

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The InterV brand V-Mark Breast Biopsy Site Marker with Titanium Anchor is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy.

The V-Mark biopsy site marker is made of two components; a resorbable copolymer, a polyester derivative of lactic and glycolic acids, and a titanium anchor. Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The titanium anchor provides a permanent component to the marker of the biopsy site. The site markers are deployed through an applicator that fits commercially available biopsy probes or coaxial needles including the J&J Ethicon Mammotome 11 gauge biopsy probe, the Pro-Mag Coaxial Introducer with Blunt Obturator, the Bio-Pince Co-axial Introducer with Blunt Obturator, and the Medical Device Technologies V-Core Co-axial Introducer. The V-Mark device marks the site of biopsy tissue sample, and is visible for up to 6 weeks by x-ray, ultrasound and MRI. The body then metabolizes the copolymer portion of the marker over time. The titanium anchor provides permanent radiographic visibility.

The provided documents do not contain a detailed study demonstrating that the device meets specific acceptance criteria. The 510(k) submission is a "Premarket Notification" which indicates the device is substantially equivalent to a legally marketed predicate device. This process typically relies on demonstrating equivalence rather than proving performance against predefined acceptance criteria from a new clinical study.

However, based on the intended use and technological characteristics described, we can infer what the implicit performance characteristics are and how they were asserted rather than rigorously proven with a clinical study in this specific documentation.

Here's a breakdown based on the available text:

Inferred Acceptance Criteria and Reported Device Performance (Asserted)

Study Information (Based on limitations of the provided document):

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

   • Sample Size: Not specified in the provided documents. The 510(k) summary provided appears to be a description of the device and its intended use, rather than a clinical study report with a test set. This type of submission would usually rely on bench testing and material characterization to support claims, and potentially existing predicate device data, rather than a new clinical "test set" in the context of human subjects.
   • Data Provenance: Not specified. It's likely that any supporting data would have come from internal testing or literature reviews for the materials used, rather than a specific clinical study with a defined test set of patients.

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

   • Not applicable/Not specified. A clinical "ground truth" for a test set is not described or required for this type of 510(k) submission, which focuses on substantial equivalence of a physical implantable marker. The claims appear to be based on the known properties of the materials (resorbable polymers, titanium) and in vitro or ex vivo testing for visibility characteristics.

3. Adjudication method for the test set:

   • Not applicable/Not specified.

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:

   • Not applicable. This device is a physical biopsy site marker, not an AI-powered diagnostic tool.

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

   • Not applicable. This device is a physical biopsy site marker, not an AI algorithm.

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

   • Not explicitly stated as a "ground truth" for a clinical study. The claims regarding visibility and resorption are based on the known physical and chemical properties of the device materials (poly(D,L-lactide-co-glycolide) copolymer and titanium) and likely supported by in vitro or ex vivo laboratory testing. For example, radiopacity of materials can be characterized in a lab without human subjects.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that would require a training set.

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

   • Not applicable.

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The CanaliZer Hydrophilic Guide Wire is designed for use in the peripheral vasculature with medical devices requiring a 0.035" or 0.038" outer diameter guidewire. The CanaliZer is not intended for use in the coronary arteries.

The guidewires are constructed from a Nitinol core coated with Tecoflex EG85-A polyurethane to provide a wire with a maximum OD of 0.035" or 0.038". The polyurethane formulation contains BaSO4 for radiopacity. A hydrophilic coating is applied to the distal portion of the guidewire to facilitate wire movement within 0.035" or 0.038" diameter devices. The guidewires are available in lengths of 150, 180 and 260 cm. Two tip shapes are also available, straight and angled. Both tip shapes are provided on wires of standard stiffness, and a stiffer design. The family of guidewires has a CE mark and is in commercial distribution in Europe.

The provided text refers to a premarket notification for a medical device called the "InterV® brand CanaliZer Hydrophilic Guide Wire." This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, the requested information regarding acceptance criteria, a study proving performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not available in the provided text.

The document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This process typically relies on comparing the technological characteristics of the new device to a predicate device, and often includes bench testing to confirm compliance with recognized standards or demonstrate equivalence, but not necessarily a full clinical study with acceptance criteria and reported performance in the way a new drug or a novel high-risk device might.

The relevant sections provided are:

• Premarket Notification [510(K)] Summary: This section describes the device, its intended use, and technological characteristics, and identifies predicate devices.
• FDA Review Letter: This letter from the FDA confirms that they have reviewed the 510(k) and found the device substantially equivalent to predicate devices for its stated indications for use.
• Indications for Use: This section reiterates the intended use of the device.

In summary, the provided content is for a 510(k) submission, which does not typically include the detailed study information as requested.

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The SnareLok Bone Marrow Biopsy Needle is intended for harvesting bone and/or bone marrow specimens.

The biopsy instrument is a sterile disposable device which features a cannula assembly containing an outer cannula with an inner spiral snare tube at the distal tip. The device has a handle with a snare lever that can be rotated 180° to engage the snare when a biopsy sample needs to be taken. Finally the device has a stationary stylet to prevent coring during advancement, and a stylet cap which mates to the handle. Three sizes are available; 8, 11 and 13 gauge needles. The 8 and 11 gauge needles are sold in 4" and 6" lengths and have a tip configuration identical to the geometry of the existing Medical Device Technologies Manan Bone and Bone Marrow Biopsy Needle. The 13 gauge needles are sold in 2" and 3" lengths and have a less tapered tip configuration identical to a bone marrow needle currently manufactured by Ranfac.

The provided text is a 510(k) summary for the SnareLok Bone Marrow Biopsy Needle. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's characteristics and intended use. The document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot populate the requested table or answer the specific questions below based on the provided input.

Here's a breakdown of why the information is missing and an explanation of the type of information typically found in such studies:

• Acceptance Criteria and Device Performance: The document describes the device and its intended use but does not present any quantitative performance metrics (e.g., successful biopsy retrieval rates, tissue integrity scores, time to complete procedure) or associated acceptance criteria.
• Sample Size and Data Provenance: Without a study being mentioned, there's no information on sample sizes, country of origin, or whether it was retrospective or prospective.
• Experts and Ground Truth: There's no mention of experts or the establishment of ground truth as no performance study is described.
• Adjudication Method: Not applicable as no study is mentioned.
• MRMC Comparative Effectiveness Study: Not applicable. This type of study is more common for imaging-based diagnostic AI devices where human reader performance is compared with and without AI assistance. The SnareLok is a mechanical biopsy needle.
• Standalone Performance: Not applicable as no performance study is mentioned.
• Type of Ground Truth: Not applicable.
• Training Set Sample Size and Ground Truth Establishment: Not applicable as this device is a physical instrument, not an AI/software device that would require training data.

General Explanation of What Would Be Included in a Performance Study for a Biopsy Needle (if it were present):

If a performance study for a biopsy needle were included, it would typically involve:

1. Acceptance Criteria: Predetermined thresholds for various performance metrics, such as:
   • Specimen Adequacy Rate: The percentage of retrieved samples that are deemed sufficient for diagnosis by a pathologist. (e.g., >= 95%)
   • Specimen Length/Integrity: Average length of retrieved core samples and subjective grading of fragmentation. (e.g., average length >= X mm, = 98%)
   • Ease of Use/Handling: Often assessed qualitatively through surgeon feedback.
   • Complication Rates: Incidence of adverse events (e.g., hemorrhage, infection, pain). (e.g.,

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The Fibrex™ Catheter Patency Device is intended to disrupt fibrin sheath formation on both the external and internal surface of vascular access catheters, thus restoring functional patency.

The Fibrex™ Catheter Patcncy Device is a tri-axial delivery catheter assembly comprised of an outer catheter storing an inner guide structure and an inner stripping coil. The inner guide structure is for directing and guiding the stripping coil through the catheter to the free end of the catheter and back up around the exterior surface of the vascular catheter. The stripping coil is formed of a shape memory or super-elastic material, wherein the stripping coil is preformed to assume a helical shape wrapping about the outer surface of the vascular catheter in a manner providing for the stripping of build-up from the outer surface of the vascular catheter when the stripping coil is moved relative to the vascular catheter. The tri-axial delivery catheter assembly is attached to an injection molded plastic hand assembly that controls the movement of the guide catheter and subsequent insertion of the stripping coil. The delivery catheter assembly is adapted for selectively coupling to a luer connector secured to the venous lumen of a traditional vascular catheter. The outer catheter of the Fibrex™ device is made from a biocompatible Polyimid/PTFF. composite. The inner dual lumen tube is made from nylon. A Nitinol wire is housed in one lumen of the guide curve catheter to provide directional memory for the actuation and operation of the Nitinol stripping coil . Both the outer catheter and the guide catheter contain distal marking bands made from gold.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Fibrex™ Catheter Patency Device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in terms of specific performance metrics or thresholds. Instead, it frames the testing as a comparison to a predicate device.

• Intended use
• French Sizes
• Length
• Lumens
• Distal end configuration
• Intended anatomical location of distal end
• Proximal end configuration
• Materials
• Labeling
  Result: "found to be comparable to the predicate device." |

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document mentions an "animal study" but does not specify the number of animals or the specific experimental setup (e.g., number of catheters tested, number of observations).
• Data Provenance: The study was an "animal study," implying it was conducted in a controlled laboratory environment. The country of origin is not specified but is likely the US given the submission to the FDA. The study is implicitly prospective for the duration of the animal experiment.

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

The document does not specify the number of experts used or their qualifications for evaluating the results of the animal study or the other functional and safety tests. The determination of "comparable to the predicate device" would have involved expert assessment, but details are not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth for the test set. Given the nature of the tests (animal study, ring retention, tensile tests), it's likely standard laboratory protocols were followed, but no specific adjudication process like 2+1 or 3+1 is mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided text. The device is a physical medical device (catheter) and not an AI-based diagnostic or assistive technology that would typically involve human readers.

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

This question is not applicable as the Fibrex™ Catheter Patency Device is a physical medical device, not an algorithm or software. Its performance is inherent to its mechanical and material properties, not an algorithm's output. The "standalone performance" is essentially the results of the functional and safety tests described.

7. Type of Ground Truth Used

The ground truth for the animal study (fibrin stripping capabilities) would have been established through direct observation and measurement within the animal model, potentially involving histological analysis or other methods to quantify fibrin sheath disruption. For ring retention and tensile tests, the ground truth is established by physical measurement against engineering specifications or observed performance characteristics. The overarching "ground truth" for the 510(k) submission is the demonstration of substantial equivalence to a legally marketed predicate device.

8. Sample Size for the Training Set

This question is not applicable. The Fibrex™ Catheter Patency Device is a physical medical device, not an AI or machine learning model that requires a training set.

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

This question is not applicable as there is no training set for a physical medical device.

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The PBN Guidewires are intended for use to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

The PBN Guidewires are made from a stainless steel or nitinol core wire surrounded by a stainless steel or tungsten spring. The PBN Guidewires will be provided uncoated, hydrophilic coated, or PTFE coated. The PBN Guidewires will be provided in the following diameters and lengths: .018 in. and .020 in. diameter, and 40 cm to 300 cm in length.

The provided text describes the PBN Guidewires and their substantial equivalence to a predicate device, focusing on functional and safety testing as well as technical comparison. However, it does not include specific acceptance criteria or an in-depth study report with detailed performance metrics, sample sizes for test sets, ground truth establishment, or human reader studies.

Based on the provided information, I can only extract limited details regarding acceptance criteria and the "study" (which is referred to as "Functional & Safety Testing" and "Technical Comparison").

Here's a breakdown of what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The actual numerical acceptance criteria for "tensile strength," "torqueability," etc., are not provided in the document. The performance is stated as "comparable to the predicate device," which itself serves as the de facto acceptance standard in this 510(k) submission.

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

• Sample Size: Not specified. The document states "The PBN guidewires were subjected to tensile strength, torqueability, tip flexibility, and coating adherence/integrity tests" and "The following attributes of the PBN guidewire were examined," but no number of samples or units tested is provided.
• Data Provenance: Not specified, but generally, such testing for a 510(k) submission would be conducted by the manufacturer (MDTECH Medical Device Technologies, Inc.) or a third-party lab on behalf of the manufacturer, and would be prospective testing of their devices.

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 this submission relates to a medical device's physical and functional properties, not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The "ground truth" here is the physical measurement and comparison to a predicate device.

4. Adjudication method for the test set

• Not applicable. This submission focuses on engineering and performance testing against a predicate device, not on expert consensus or adjudication of diagnostic findings.

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. This is a submission for a physical medical device (guidewire), not an AI algorithm or diagnostic tool that would involve human readers or AI assistance.

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

• No, this is not applicable. This device is a guidewire, a physical medical instrument, not a software algorithm.

7. The type of ground truth used

• The "ground truth" for this device's evaluation is the performance and attributes of the identified predicate device (Microvenia Corporation Guidewires, K991898). The PBN Guidewires were determined to be substantially equivalent if their functional and safety characteristics, as well as specified attributes, were "comparable" to the predicate.

8. The sample size for the training set

• Not applicable. This document describes the evaluation of a physical medical device (guidewire), not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set was used.

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The En-Snare™ Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.

The En-Snare™ Endovascular Snare and Catheter is comprised of stranded nitinol/platinum cables mechanically secured to a nitinol wire inserted into an intravascular catheter and manipulated by use of an external pin vise. The catheter is made from biocompatible FPE that has been used extensively in intravascular catheters.

Here's an analysis of the provided text regarding the En-Snare™ Endovascular Snare and Catheter, focusing on acceptance criteria and the study that proves the device meets them:

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 size used for the functional and safety testing (test set). It only mentions "The En-Snare™ Endovascular Snare and Catheter were subjected to..." which implies a set of devices or tests. The data provenance is not specified, but it's implied to be internal testing conducted by Medical Device Technologies, Inc. and is retrospective as it refers to testing already completed.

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

The document does not mention the use of experts to establish a "ground truth" for the functional and safety testing in the typical sense of clinical or diagnostic performance. The ground truth for these engineering performance tests would be defined by established engineering standards and specifications.

4. Adjudication Method for the Test Set:

Not applicable. The "adjudication method" usually refers to a process for resolving discrepancies in expert opinion for clinical ground truth. For functional and safety engineering tests, the results would be objectively measured and compared against defined thresholds or the predicate device's performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This is a medical device for retrieving and manipulating foreign objects, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.

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 device. The "standalone performance" concept doesn't apply to a physical medical device like an endovascular snare and catheter.

7. The Type of Ground Truth Used:

For the functional and safety testing, the "ground truth" was established by objective engineering measurements and comparison against the performance of the predicate device. The document states that the results "indicated that they are comparable to the predicate device."

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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The MicroCruiser® Plus Introducer Set is intended for use in the introduction and placement of guidewires and/or catheters.

The MicroCruiser® Plus Introducer Set is comprised of an .018" diameter guidewire, a guidewire introducer needle, and a coaxial introducer that has a diameter suitable for catheter introduction and placement. The introducer tubing is made from biocompatible polyurethane that has been used extensively in both short and long term catheters. The introducers are provided in the following French sizes: 3 (Inner)/4 (Outer), 3 (Inner)/5 (Outer), and 4 (Inner)/6 (Outer), and in lengths of 10 cm.

This document is a 510(k) summary for the MicroCruiser® Plus Introducer Set. It outlines the device description, indications for use, and a comparison to a predicate device for substantial equivalence. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot provide the requested information based on this document. The provided text is a regulatory submission for device clearance, not a study report detailing performance metrics and validation.

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