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Quil™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.

The Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic nonabsorbable tissue-closure device that is intended for use in the closure of soft tissue, excluding closure of the epidermis. It is comprised of high molecular weight, isotactic polypropylene, undyed, or dyed blue with Phthalocyaninato (2-) Copper. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 0 in various lengths affixed to various needle types.

This document is a 510(k) Pre-Market Notification from the FDA regarding a Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design (K15112). This device is a nonabsorbable polypropylene surgical suture.

Based on the provided text, a "study" in the traditional sense of evaluating an AI or software device to meet acceptance criteria with various types of ground truth and reader studies was not conducted. The document describes a substantial equivalence determination for a medical device (suture), not an AI/software as a medical device (SaMD). Therefore, many of the requested elements for AI/SaMD performance evaluation are not applicable.

Here's an analysis based on the provided text:

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

Since this is a substantial equivalence determination for a physical medical device (suture), the "acceptance criteria" and "reported device performance" are framed around demonstrating equivalence to a predicate device and adherence to recognized standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document refers to "Non-clinical laboratory performance testing." This typically involves in-vitro or bench testing of the physical suture material. No information about sample size, country of origin, or whether the data was retrospective or prospective is provided in this summary. It is laboratory data, not patient data in the context of disease diagnosis.

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

Not applicable. This is not a study involving expert review for establishing ground truth for diagnostic or prognostic purposes. The "ground truth" for a suture's physical properties would be established through standardized laboratory testing methods and measurements.

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

Not applicable. This is not a study requiring adjudication of expert interpretations.

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/SaMD device.

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

Not applicable. This is not an AI/SaMD device.

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

The "ground truth" for this device would be based on the physical and mechanical properties of the suture as measured by standardized laboratory methods (e.g., tensile strength, dimension conformity, material composition checks) as defined by the USP monograph for surgical sutures.

8. The sample size for the training set:

Not applicable. This is not an AI/SaMD device that requires training data.

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

Not applicable. This is not an AI/SaMD device that requires training data and corresponding ground truth.

Summary regarding AI/SaMD criteria applicability:

The provided document describes the FDA's 510(k) clearance for a physical medical device (surgical suture) based on substantial equivalence. It does not provide information relevant to the assessment of an AI/Software as a Medical Device (SaMD), as it is not such a device. Therefore, most of the detailed questions regarding AI/SaMD acceptance criteria, study design, ground truth, and reader studies are not applicable to this document. The "performance tests" mentioned are non-clinical laboratory tests to ensure the physical device meets established material and manufacturing standards and is equivalent to the predicate device.

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The Bio-Seal Lung Biopsy Tract Plug System is indicated to provide accuracy in marking a biopsy location for visualization during surgical resection and to plug pleural punctures associated with percutaneous, transthoracic needle lung biopsies to significantly reduce the risk of pneumothoraces (air leaks).

The Angiotech Bio-Seal Lung Biopsy Tract Plug System is comprised of (1) a pre-formed hydrogel plug and (2) a delivery system, which together are designed for use in conjunction with Fine Needle Aspiration (FNA) biopsy of the lung. During lung biopsy, a 19 gauge coaxial needle is placed at the site to be biopsied, under fluoroscopic guidance. The stylet is removed and a 20 or 22 gauge FNA biopsy needle or biopsy instrument is inserted to obtain the tissue sample. When the FNA biopsy needle or biopsy instrument is removed. the Bio-Seal Lung Biopsy Tract Plug is deployed using the Bio-Seal delivery system through the coaxial needle into the biopsy tract. Upon deployment into the biopsy tract, the hydrogel plug absorbs extracellular fluid and expands to fill the void of the biopsy tract and remains in place for months to mark the biopsy site.

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

Acceptance Criteria and Reported Device Performance for Bio-Seal Lung Biopsy Tract Plug System

1. Table of Acceptance Criteria and Reported Device Performance

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

• Clinical Trial Test Set:

  • Intent-to-Treat (ITT) Population: 339 total patients (170 Bio-Seal, 169 Control)
  • Per Protocol (PP) Population: 287 total patients (150 Bio-Seal, 137 Control)
  • Data Provenance: Multi-centered (15 US centers), prospective, randomized controlled trial.

• Bench Testing Test Set:

  • Shelf Life: 10 samples for accelerated aging, 10 samples for real-time aging (2 samples at each time point: 1, 1.5, 2, 2.5, 3 years).
  • Hydration Rate: 15 Bio-Seal plugs.
  • Dimensional (Plug): 1000 sterile plugs.
  • Dimensional (Main Luer assembly): (b)(4) assemblies (number redacted but plural).
  • Nylon Tube Bond Strength: (b)(4) assemblies (number redacted but plural).
  • Dimensional (Delivery System): (b)(4) delivery systems (number redacted but plural).
  • Functional (Deployment, Protrusion, Ease, Time): 120 devices.
  • Data Provenance: Bench (laboratory) setting.

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

• Clinical Trial: The primary effectiveness endpoint (incidence rate of pneumothorax) was "measured by chest x-rays at 0-60 minutes after procedure, 24 hours after discharge and 30 days post discharge. A blinded, independent reader analyzed the x-rays, whose opinion was used in evaluating the primary endpoint."

  • Number of Experts: One (a single "blinded, independent reader").
  • Qualifications: "Independent reader" implies they are qualified to interpret chest x-rays for pneumothorax, likely a radiologist, but specific qualifications (e.g., years of experience) are not provided. The term "blinded" is a critical qualification ensuring objectivity.

• Animal Studies (Pathology/Inflammation): Not explicitly stated, but for the chronic GLP animal study involving histological evaluation, it can be inferred that veterinary pathologists or similar experts established the ground truth regarding inflammation. The text doesn't specify the number.

4. Adjudication Method for the Test Set

• Clinical Trial (Pneumothorax Endpoint): None explicitly mentioned as an adjudication method where multiple readers disagree. It states a "blinded, independent reader analyzed the x-rays, whose opinion was used in evaluating the primary endpoint." This suggests the single reader's opinion was the definitive determination, rather than a consensus or adjudication process among multiple readers.

• Bench/Animal Studies: Not applicable in the context of human reader 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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
• This device is a physical medical device (lung biopsy tract plug), not an AI algorithm. Therefore, there is no AI component, and no study measuring human reader improvement with or without AI assistance was conducted.

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

• No, this device is a physical medical device. It does not involve an algorithm and is not intended for standalone algorithmic performance evaluation. Its use is hands-on by a physician.

7. The Type of Ground Truth Used

• Clinical Trial:

  • Effectiveness (Pneumothorax): Expert interpretation of chest x-rays by an independent, blinded reader. This is a form of expert consensus/interpretation of imaging.
  • Safety (Adverse Events): Clinically observed adverse events documented in Case Report Forms (CRFs), including pneumothorax, coughing with blood, infections, etc.

• Animal Studies:

  • Resorption/Inflammation: Histological evaluation in swine sacrificed at various time points (7, 14, 90, 180 days). This is based on pathology.

• Bench Studies:

  • Dimensional, Functional, Hydration, Sterility, Shelf-life: Physical measurements, visual inspection, timed observations, and standardized laboratory tests with defined specifications/tolerances.

8. The Sample Size for the Training Set

• Training Set for a Physical Device: This concept generally doesn't apply to a physical medical device in the same way it does to an AI algorithm.
  • However, the text mentions "Research and development acute studies included demonstrating expansion characteristics of a prototype plug under inflation, air leakage in the presence of blood, varying depth placements of the plug, physician preference, and techniques for maneuvering the marker, photographic documentation of placement and extension beyond pleura, and feedback for physician training." This iterative R&D likely involved numerous prototypes and tests (a form of "training" for the device's design and manufacturing process), but a specific "training set" sample size for the final product is not applicable in the AI sense.
  • The Bio-Seal Plug itself "was previously cleared as a lung biopsy site marker device under K041331." This prior clearance and continued use/manufacturing would involve a vast dataset of material characterization and performance data that iteratively refined the design and manufacturing processes, but it's not a discrete "training set."

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

• As above, for a physical device, a "training set" ground truth isn't established in the AI sense. Instead, the design and manufacturing process is refined through:
  • Bench Testing: Extensive iterative testing and characterization of materials, dimensions, and functional performance with defined engineering specifications and physics-based outcomes.
  • Animal Studies: Acute and chronic animal studies provided in-vivo data on tissue reaction, expansion characteristics, and resorption.
  • Physician Feedback: Early prototype evaluations and preference studies guided the design for usability and effectiveness.
  • Prior Regulatory Clearances: Previous successful clearances (e.g., K041331) established a foundational understanding of the device's behavior and safety, confirming ground truth for its core components.

Essentially, the "ground truth" for developing the device was derived from a combination of scientific principles, engineering validated measurements, and biological responses observed in preclinical models.

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Quill™ PDO Knotless Tissue-Closure Device, comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The Quill™ Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) is a synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)] monofilament suture material, dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the length that eliminate the need to tie knots during approximation. The device is available in various lengths in diameter sizes 2 through 4-0 with various needles attached to each end.

This document describes the K120827 Quill™ PDO Knotless Tissue-Closure Device. The provided text does not contain a specific table of acceptance criteria or detailed results of a study that directly proves the device meets quantitative criteria. Instead, it relies on a demonstration of "substantial equivalence" to predicate devices through performance testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a table of acceptance criteria or quantitative performance metrics. The submission relies on a qualitative statement of substantial equivalence.

Reported Device Performance (Qualitative):
"The results of this testing demonstrates that the Quill™ Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) is substantially equivalent in safety and performance to the predicate devices."

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

The text states: "Pre-clinical animal performance testing was conducted to confirm and support the information provided in the QuillTM Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) Instructions for Use."

• Sample Size for Test Set: Not specified.
• Data Provenance: "Pre-clinical animal performance testing." The country of origin is not specified, but it's typically understood to be conducted under the manufacturer's internal protocols. This is a form of prospective testing.

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

This information is not provided. The "ground truth" for this device's performance would primarily be derived from the animal model's physiological response to the suture (e.g., tissue approximation efficacy, absorption rate, inflammatory response) rather than expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation of medical data (e.g., in diagnostic imaging studies) to establish a consensus ground truth. For animal performance testing of a physical device, the assessment would be based on direct observation, physical measurements, and histological analysis, not on expert adjudication of interpretations.

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

No, an MRMC comparative effectiveness study was not done. Such studies are relevant for diagnostic AI tools where human readers are interpreting data. This submission is for a physical medical device (suture) and its performance in animal models, not an AI algorithm assisting human interpretation.

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

No, this is not applicable. A standalone study typically refers to the performance of an AI algorithm without human involvement. This submission is for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for this type of device performance testing would be based on:

• Direct observation and measurement of the suture's physical interaction with tissue (e.g., tissue approximation).
• Histological analysis of tissue response (e.g., inflammation, foreign body reaction, absorption characteristics).
• Mechanical testing (e.g., tensile strength over time, knot security) although the text specifically mentions "Knotless" suggests this might be different.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device; its development relies on engineering principles and materials science, not machine learning training.

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

This information is not applicable/not provided for the same reasons as point 8.

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Quill™ PDO Knotless Tissue-Closure Device, comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The Quill™ Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) is a synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)] monofilament suture material, dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the length of the device, and a welded loop at the distal end which is used to form the secondary variable loop, used to secure the device at the distal end. The device is available in diameter Size 0 in various lengths affixed to various needle types.

The Quill™ PDO Knotless Tissue-Closure Device (Polydioxanone) was evaluated through non-clinical laboratory performance testing to establish its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:
The sample size for the non-clinical laboratory testing is not specified in the provided document. The data provenance is from non-clinical laboratory testing, indicating that it's a prospective study conducted specifically for this device evaluation. The country of origin of the data is not explicitly stated, but the submission is to the US FDA.

3. Number of Experts and Qualifications:
This was a non-clinical laboratory study involving physical performance tests according to a standard. Therefore, there were no human experts used to establish ground truth in the traditional sense of medical image or diagnostic interpretation. The "ground truth" was the adherence to objective performance standards outlined in the USP monograph.

4. Adjudication Method:
As this was a non-clinical laboratory study with objective performance criteria, there was no adjudication method as typically applied in studies involving human interpretation or subjective assessments. Performance was measured against predefined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was performed. This was a non-clinical performance study to demonstrate compliance with material and mechanical standards, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study:
Yes, a standalone non-clinical performance study was done. The device's performance (tensile strength and needle attachment) was evaluated against the USP monograph for absorbable sutures, without human intervention in the performance of the device itself.

7. Type of Ground Truth Used:
The ground truth used was objective performance standards defined by the USP Monograph for Absorbable Sutures for tensile strength and needle attachment. This is a scientific and regulatory standard.

8. Sample Size for the Training Set:
Not applicable. This was a non-clinical laboratory performance study, not a study involving machine learning or AI models that require a training set.

9. How the Ground Truth for the Training Set Was Established:
Not applicable. As no training set was used, no ground truth needed to be established for it.

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Quill™ Quadrahelix Knotless Tissue-Closure Device is indicated for soft tissue approximation excluding closure of the epidermis

The Quill™ Quadrahelix Knotless Tissue Closure Device is a non-absorbable isotactic polymer comprised of polypropylene per 21 CFR 878.5010. It is available sterile, undyed (beige) in suture and needle configurations in USP Size 3-0. Each suture has bi-directional quadrahelix barbs along the long axis of the suture monofilament. The Quill™ Quadrahelix Knotless Tissue Closure Device approximates tissue by using the opposing barbs on the suture surface to imbed in the tissues after the surgeon precisely places the suture within the tissues.

Based on the provided text, here's an analysis of the 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 test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions "Non-clinical laboratory performance testing was conducted."

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 testing described is "Non-clinical laboratory performance testing," which implies physical tests rather than expert-driven evaluation of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The study is non-clinical laboratory testing, not a human-reader-based assessment that would require adjudication.

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

No MRMC comparative effectiveness study was done. The study was non-clinical laboratory testing for physical properties of the suture.

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

This concept is not applicable to the device described. The device is a physical surgical suture, not a software algorithm. The "standalone" testing refers to the device's physical properties without human intervention during the test itself (e.g., pulling strength tests).

7. Type of Ground Truth Used

The ground truth used for this device would be engineering specifications and established standards for tensile strength and wound security for surgical sutures. For example, specific forces (e.g., in Newtons) that a suture of a certain size must withstand without breaking or losing its wound-holding capacity.

8. Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical product, not a machine learning algorithm that requires a "training set."

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

This information is not applicable to this device.

Summary of the Study:

The study was a non-clinical laboratory performance testing focused on the physical properties of the Quill™ Quadrahelix Knotless Tissue-Closure Device. The key performance metrics assessed were tensile strength and wound security strength. The study concluded that the device conforms to defined product requirements for these metrics and is substantially equivalent to the predicate devices. The details regarding the specific methodologies, sample sizes, and quantitative results of these non-clinical tests are not included in the provided 510(k) summary. The "ground truth" was established by pre-defined engineering and manufacturing specifications for surgical sutures.

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The multiple-lumen catheter permits venous access to the central circulation. The Angiotech antimicrobial surface is intended to help provide protection against bacterial colonization on the catheter surface and it may help reduce catheterrelated infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for longer than 30 days use.

The Angiotech® CVC Multi-lumen Central Venous Catheter with MEDI-COATTM Antimicrobial Surface is a 7-French, polyurethane triple lumen, 15 or 20-cm catheter with a MEDI-COAT containing 48.8 µg/cm of 5-fluorouracil.

Here's a breakdown of the acceptance criteria and study information for the Angiotech CVC, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details various tests performed, but it mostly lists the types of tests without specific numerical acceptance criteria. For the clinical performance, the acceptance criterion seems to be non-inferiority to the predicate device regarding bacterial colonization prevention.

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

• Sample Size: The sample size for the clinical trial is not explicitly stated. It mentions "adult patients in an ICU setting."
• Data Provenance: The data is from a prospective, randomized clinical trial. The country of origin is not specified but is implicitly assumed to be the USA, given the FDA 510(k) submission.

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

This information is not provided in the given text. Clinical trials often involve medical professionals for assessment, but the text does not detail the number or qualifications of experts specifically for establishing ground truth related to the outcomes (e.g., bacterial colonization, infections).

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as this an medical device, not an AI/Software device subject to such studies.
• Effect Size: Not applicable.

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

• No, this is a physical medical device (Central Venous Catheter) with an antimicrobial coating, not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device's performance is inherently "standalone" from human intervention in its antimicrobial action.

7. Type of Ground Truth Used

For the clinical trial, the "ground truth" was established by clinical outcomes data from patients. This includes:

• Prevention of bacterial colonization on catheters.
• Rate of catheter-related bloodstream infection.
• Rates of catheter insertion site infections.
  These outcomes would be determined through standard microbiological and clinical diagnostic procedures.

8. Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI/software device that undergoes "training." The device's efficacy relies on its physical and chemical properties and its antimicrobial coating, which are developed through engineering and laboratory testing rather than machine learning training.

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

This information is not applicable for the reasons stated above (not an AI/software device). The development and testing of the antimicrobial coating (5-FU) and the catheter itself would involve various laboratory and pre-clinical studies, with "ground truth" derived from established scientific methods for assessing antimicrobial efficacy, material properties, and biocompatibility.

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The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.

The Skater® Biliary Drainage Catheter is a polyurethane catheter with SLIP-COAT™, a lubricious hydrophilic coating.. The catheter comes in a pigtail-loop, locking-type, end configuration with drainage holes. The catheters are provided in 8 French, 10 French, and 12 French sizes with a length of 40 cm. Accessories include a metal stiffening cannula, a plastic stiffening cannula, and a standard luer locking hub.

This document is a 510(k) Summary for the Skater® Biliary Drainage Catheter, detailing its regulatory submission to the FDA. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a performance study with detailed acceptance criteria and expert reviews in the way typically found for AI/ML-driven diagnostic devices.

Therefore, the requested information, particularly regarding specific acceptance criteria, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment in the context of a performance study, is largely not present in this document. The document describes product characteristics and safety/performance testing, which are manufacturing and preclinical assessments, not clinical performance studies for diagnostic accuracy.

Here's a breakdown of what can be gleaned from the provided text, and what cannot:

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

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

• Not explicitly stated for a clinical performance study. The document refers to "in vitro bench tests" and "biocompatibility testing," which are typically laboratory-based assessments, not clinical trials with human subjects or large datasets. No specific sample sizes for these tests are provided.
• Data Provenance: Not applicable in the context of a clinical performance study. The tests mentioned are laboratory/bench tests, not trials with patient data.

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

• Not applicable. This information is relevant for diagnostic accuracy studies involving expert human review of images or data to establish a ground truth. The document describes bench and biocompatibility testing, which do not involve expert human interpretation for ground truth.

4. Adjudication method

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert human interpretation, which is not described as part of the testing 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

• No. This type of study is for evaluating AI-assisted diagnostic performance. The Skater® Biliary Drainage Catheter is a medical device (catheter) and not an AI-powered diagnostic tool, so an MRMC study is not relevant to its regulatory submission.

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

• No. This concept is for AI algorithms. The device itself is a physical medical instrument.

7. The type of ground truth used

• Benchmarking/Standard Measurements: For dimensional inspection, LAL, bioburden, EO/EC residual, and potentially other in vitro tests, the "ground truth" would be established by industry standards, validated measurement methods, and predefined acceptance limits (e.g., a specific dimension, a maximum endotoxin level, sterility).
• Biocompatibility Standards: For biocompatibility, the ground truth is established by recognized international standards (e.g., ISO 10993 series) and specific in vitro/in vivo tests designed to evaluate potential adverse biological reactions.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of medical device submission, as it does not involve machine learning or AI models. The device is evaluated through engineering, chemical, and biological testing, not by training an algorithm.

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

• Not applicable. As there is no training set, this question is not relevant.

In summary: This 510(k) submission confirms that the Skater® Biliary Drainage Catheter underwent various safety and performance tests (dimensional, process, biocompatibility, aging, LAL, bioburden, EO/EC residual) and was found comparable to its predicate devices. However, it does not involve the type of clinical performance study details (e.g., test set, expert review, AI accuracy metrics) that would be pertinent to AI/ML diagnostic tools.

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The Skater® Biliary Drainage Catheter is indicated for percutaneous biliary drainage.

The Skater® Biliary Drainage Catheter is made from hydrophilic coated polyurethane. The catheter comes in a pigtail-loop, locking-type end configuration with drainage holes. The catheters are provided in 8 French, 10 French, and 12 French sizes with a length of 40 cm. Accessories include a metal stiffening cannula, a plastic stiffening cannula and a standard luer locking hub.

The provided text describes a 510(k) submission for the "Skater® Biliary Drainage Catheter" and focuses on demonstrating its substantial equivalence to a predicate device, rather than proving it meets specific acceptance criteria through a clinical study or performance goals set for a new, non-inferiority claim.

Here's a breakdown based on the information provided, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria/Performance Goals: The document does not explicitly state quantitative "acceptance criteria" or performance goals in terms of specific metrics (e.g., accuracy, sensitivity, specificity, or success rates) for the device's clinical function. Instead, it aims to demonstrate substantial equivalence to a predicate device.

Reported Device Performance:
The document does describe the types of tests performed.

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

The document mentions "in vitro bench tests" but does not specify sample sizes for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective) as it pertains to clinical performance data, because no clinical performance study is described. The tests conducted appear to be laboratory-based engineering and material property tests.

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

This information is not applicable and not provided. The device comparison is based on bench testing and material characteristics, not on interpretations by medical experts for clinical ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As no expert-based ground truth establishment or clinical performance study is detailed, no adjudication method would have been used.

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

An MRMC study was not done. This type of study is commonly used for diagnostic accuracy of image-based AI devices, which is not the nature of this device. The submission is for a medical catheter, and the evidence provided focuses on physical and material characteristics compared to a predicate device.

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

A standalone study was not done. This is also relevant for AI/software devices, which this catheter is not. The performance evaluation is for the physical device itself.

7. Type of Ground Truth Used

The "ground truth" for the tests performed (functional, leakage, tensile strength, physical dimensions) would have been the engineering specifications and established testing standards for medical devices of this type, as well as comparison against the performance of the predicate device. It is not based on expert consensus, pathology, or outcomes data, as these are typically used for clinical performance evaluations.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical catheter, not an AI or machine learning algorithm, so there is no "training set."

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

This information is not applicable and not provided for the same reason as point 8.

Summary of the Study:

The study described is a series of in vitro bench tests and biocompatibility testing designed to demonstrate that the "Skater® Biliary Drainage Catheter" is substantially equivalent to the "Boston Scientific Corporation, Flexima™ Biliary Catheter (K023870)" predicate device. The tests covered functional performance, leakage, tensile strength and elongation of the catheter body, physical dimensions, and catheter body to hub tensile strength. The conclusion is that the new device performs "comparably" to the predicate in these areas, and that the combined results of these tests and biocompatibility testing demonstrate its safety and effectiveness. The report does not involve clinical trials, expert reviews of clinical cases, or AI performance metrics.

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