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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 TranQuill barbed device comprised of polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The TranQuill barbed device is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Size 0 through 2-0 in various lengths affixed to various needle types.

The provided text describes a 510(k) premarket notification for a medical device called the TranQuill barbed device, an absorbable surgical suture. The focus of the documentation is to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The documentation mentions "Non-clinical laboratory performance testing," but does not provide specific sample numbers for each test (e.g., number of sutures tested for tensile strength).
• Data Provenance: The testing was "Non-clinical laboratory performance testing," indicating it was conducted in a controlled lab environment. There is no information about the country of origin of the data or whether it was retrospective or prospective, as it pertains to benchtop testing rather than clinical data.

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

• Not applicable. This device is a surgical suture, and the evaluation focused on non-clinical laboratory performance testing to establish substantial equivalence to a predicate device. It did not involve a test set requiring expert interpretation or ground truth establishment in the context of diagnostic or screening performance.

4. Adjudication Method for the Test Set:

• Not applicable. As the study involved non-clinical laboratory performance testing of physical characteristics, there was no need for an adjudication method as would be used in studies involving subjective expert opinions or diagnostic interpretation.

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

• No, an MRMC study was not done. This type of study is typically performed for diagnostic or screening devices to assess human reader performance with and without AI assistance. The TranQuill device is a surgical product, not a diagnostic tool requiring interpretation by multiple readers.

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

• Not applicable. The device is a physical surgical suture, not a software algorithm. Therefore, there is no "standalone performance" in the context of an algorithm.

7. Type of Ground Truth Used:

• Objective Measurement and Standards Compliance: The "ground truth" for this evaluation was based on objective measurements and adherence to established standards and predicate device performance.
  • USP monograph for absorbable sutures: This serves as a "ground truth" or standard for tensile strength.
  • Predicate device characteristics: The performance of the predicate device (Quill Synthetic Absorbable Barbed Suture, Quill™ Self-Retaining System (SRS) comprised of PDO) served as the comparative "ground truth" for barb holding strength and post-hydrolysis tensile testing.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical medical device (suture), not an AI/ML algorithm that requires a training set. The evaluation focuses on physical and mechanical properties.

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

• Not applicable. As there is no training set for a physical device, this question is not relevant.

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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™ PDO Knotless Tissue-Closure Device, Variable Loop Design (Polydioxanone) is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The instrument 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 2 through 3-0 in various lengths affixed to various needle types.

The provided document is a 510(k) summary for a medical device, specifically a surgical suture. It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical laboratory performance testing. This type of regulatory submission does not typically include a clinical study with elements like human readers, ground truth consensus, or AI assistance as it's for a physical medical device, not a diagnostic algorithm.

Therefore, many of the requested categories are not applicable to the information contained within this 510(k) submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission refers to the USP monograph for absorbable sutures and FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003 as the acceptance criteria. The specific quantitative acceptance criteria (e.g., minimum tensile strength values) are not provided in this summary.

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

This document describes non-clinical laboratory performance testing. It does not mention a "test set" in the context of human or patient data. The testing was likely performed on the suture devices themselves in a laboratory setting. No information on the number of devices tested or data provenance (country of origin, retrospective/prospective) for these laboratory tests is provided in this summary.

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

Not applicable. This is a non-clinical, laboratory-based study of a physical medical device. No expert ground truth establishment for a test set is mentioned.

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

Not applicable. This is a non-clinical, laboratory-based study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a non-clinical study for a surgical suture and does not involve human readers, AI, or comparative effectiveness in a diagnostic imaging context.

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

Not applicable. This submission relates to a physical medical device, not an algorithm.

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

The "ground truth" for the non-clinical testing of a surgical suture would be defined by the specific measurement standards and methodologies outlined in the USP monograph and FDA guidance documents for tensile strength, needle attachment, and post-hydrolysis performance. These are objective, quantifiable criteria.

8. The sample size for the training set:

Not applicable. There is no training set mentioned, as this is laboratory testing of a physical product, not a machine learning model.

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

Not applicable. As there is no training set, there is no ground truth for a training set to be established.

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Polypropylene suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.

The Polypropylene Surgical Suture and Quill™ Polypropylene Tissue-Closure Devices are sterile, synthetic Knotless nonabsorbable surgical suturing devices that are intended for use in the closure of soft tissue. They are comprised of high molecular weight, isotactic polypropylene, undyed, or dyed with Phthalocyaninato (2-) Copper. The proposed blue modification is a change in supplier of the polypropylene resin raw material. The devices are supplied either single or doublearmed with various needle types, and are available in USP diameter Sizes 2 through 11-0, as applicable.
The Quill™ Polypropylene devices are designed with either small opposing bi-directional or uni-directional barbs along the long axis of the suture monofilament. The uni-directional products contain a welded primary loop and secondary loop design at the distal end, opposite the attached needle.

The provided text describes the performance tests conducted for the Polypropylene Surgical Suture and Quill™ Polypropylene Knotless Tissue-Closure Devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the devices conform to the USP (United States Pharmacopeia) monograph for nonabsorbable sutures regarding diameter and tensile strength.

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

The document does not specify the exact sample sizes used for the non-clinical laboratory performance testing. It only mentions that "Non-clinical laboratory performance testing was conducted." The data provenance is implied to be retrospective as it involves testing of manufactured devices to confirm adherence to existing standards and comparison to predicate devices, rather than a prospective study to generate new clinical data. The country of origin for the data is not explicitly stated but is implied to be in the USA given the FDA context.

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

This information is not applicable as the ground truth for these non-clinical performance tests is established by adherence to a standardized monograph (USP) and direct physical/chemical testing, not by expert interpretation or consensus.

4. Adjudication Method for the Test Set:

This information is not applicable for non-clinical laboratory performance testing. Adjudication methods are typically used in clinical studies or studies involving human judgment (e.g., image interpretation).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the effect size:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical laboratory performance study, not a clinical study involving human readers.

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 surgical suture, not a software algorithm or AI-driven system.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical performance tests is based on established industry standards and physical/chemical properties, specifically:

• The USP (United States Pharmacopeia) monograph for nonabsorbable sutures for diameter and tensile strength.
• Chemical characterization and biological risk assessment to evaluate chemical equivalency.

8. The Sample Size for the Training Set:

This information is not applicable as the study described is a non-clinical performance test for a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as above (no training set for a physical medical device).

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Quill™ 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.

The provided text describes a medical device, the Quill™ Polypropylene Knotless Tissue-Closure Device, and its regulatory submission. It does not contain information about a study with acceptance criteria, reported device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document is a 510(k) summary for a substantial equivalence determination by the FDA, primarily relying on performance testing against existing standards and comparison to predicate devices, rather than a clinical study evaluating diagnostic or therapeutic efficacy with defined acceptance criteria for such metrics.

Therefore, I cannot provide the requested information based on the given text. The document focuses on:

• Device Description: A sterile, synthetic nonabsorbable tissue-closure device with barbs and a loop design, made of polypropylene.
• Indications for Use: Soft tissue approximation, excluding epidermis closure.
• Substantial Equivalence Claims: Based on material composition and intended use being identical to a predicate barbed suture, and design being identical to other knotless tissue-closure devices.
• Performance Tests: Non-clinical laboratory testing to confirm compliance with USP monograph for nonabsorbable sutures regarding tensile strength and needle attachment, performed according to FDA's Class II Special Controls Guidance Document: Surgical Sutures.

Since the device is a surgical suture, the "acceptance criteria" discussed are related to physical and mechanical properties (tensile strength, needle attachment) rather than diagnostic performance metrics (e.g., sensitivity, specificity) expected in studies involving AI algorithms or human reader performance.

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

The QuillTM PDO Knotless Tissue-Closure Device, Variable Loop Design (Polydioxanone) is a sterile, synthetic absorbable tissue- closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The instrument 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, 2-0 and 3-0 in various lengths affixed to various needle types.

This 510(k) submission describes a Quill™ PDO Knotless-Tissue Closure Device, Variable Loop Design (Polydioxanone), which is an absorbable surgical suture. The device is a sterile, synthetic absorbable tissue-closure device comprised of polyester [poly (p-dioxanone)], with uni-directional barbs and a welded primary and secondary loop design at the distal end. It is available in diameter Size 0, 2-0, and 3-0 in various lengths affixed to various needle types.

The submission focuses on demonstrating substantial equivalence to a predicate device (K113744 Quill™ PDO Knotless Tissue-Closure Device, Variable Loop Design, Size -0-) by confirming that the new device, which differs only in suture diameter, meets established performance standards for absorbable sutures.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the new device has "the same design and materials as the Quill™ PDO Knotless Tissue-Closure Device predicate device, including the same intended use and technological characteristics as the predicate device. The only difference between the proposed and predicate device is the suture diameter." This implies the acceptance criteria for these performance aspects are to meet or exceed the performance of the predicate device and the general USP standards.

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

The document specifies "Non-clinical laboratory performance testing was conducted." It also mentions "Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vitro post-hydrolysis tensile testing."

• Sample Size: The document does not explicitly state the sample size used for the non-clinical laboratory performance testing or the in vitro post-hydrolysis tensile testing.
• Data Provenance: The tests are described as "non-clinical laboratory performance testing" and "in vitro," indicating they were conducted in a laboratory setting, likely by the manufacturer, Angiotech. There is no information regarding the country of origin of the data or whether the data was retrospective or prospective in the context of animal or human studies, as these were material and mechanical property tests.

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

This type of information is not applicable to this submission. The "ground truth" for this medical device (surgical suture) is established by adherence to recognized standards for material properties (e.g., USP monograph) and performance measures like tensile strength and needle attachment, rather than expert interpretation of images or clinical outcomes that require expert consensus.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of ambiguous cases (e.g., diagnostic imaging). For non-clinical, laboratory-based material property testing, the "ground truth" is determined by objective measurements and reference to established standards.

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 submission is for a surgical suture, not an AI-assisted diagnostic device. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this device.

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

Not applicable. This submission is for a surgical suture, not an algorithm or AI device.

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

The "ground truth" in this context is based on:

• Established Standards: Primarily the USP monograph for absorbable sutures.
• Mechanical and Material Properties: Objective measurements of tensile strength, needle attachment, and in vitro post-hydrolysis tensile strength.
• Predicate Device Performance: The new device's performance was compared to that of the legally marketed predicate device (K113744) to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. "Training set" refers to data used to train machine learning models. This submission is for a surgical suture, not an AI or machine learning device.

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

Not applicable. As stated above, there is no training set for this type of device submission.

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

The QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. 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 Sizes 1 to 3-0, in various lengths affixed to various needle types.

This document describes the premarket notification (510(k)) for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design.

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 a specific sample size for the "test set" in the context of human data or clinical study. The performance testing described is non-clinical laboratory performance testing. Therefore, the concept of data provenance (e.g., country of origin, retrospective/prospective) related to human subjects is not applicable here.

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

Not applicable. The ground truth for this device's performance is established through non-clinical laboratory testing according to established standards (USP monograph) and direct comparison to predicate devices, not through expert consensus on a test set of images or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a test set requiring adjudication in the context of this device's performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 surgical suture, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and 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 device is a physical surgical suture, not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth used for this device includes:

• USP Monograph Standards: For tensile strength and needle attachment. These are well-defined, established standards for absorbable sutures.
• Predicate Device Performance Data: For in vitro post-hydrolysis tensile testing, the performance of the predicate devices serves as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for a physical medical device (suture) and does not involve AI or machine learning.

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

Not applicable, as there is no training set for this 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™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

The Quill TM Monoderm TM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. 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 Sizes 2-0 to 0 in various lengths affixed to various needle types.

This document describes the 510(k) submission for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design. The device is an absorbable surgical suture. The submission focuses on demonstrating substantial equivalence to predicate devices through performance testing.

Acceptance Criteria and Device Performance Study Information:

This 510(k) summary does not include detailed acceptance criteria or a "performance table" in the typical sense of a diagnostic device's metrics (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by the requirements of the USP monograph for absorbable sutures and FDA's Class II Special Controls Guidance Document for Surgical Sutures. The device's performance is demonstrated by meeting these standards.

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document states "Non-clinical laboratory performance testing was conducted." However, it does not specify the sample size used for the various tests (tensile strength, needle attachment, in vitro post-hydrolysis tensile testing).

The data provenance is non-clinical laboratory testing. The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as these concepts are generally not applicable to laboratory performance testing of this nature.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This type of information is not applicable to this device's submission. The "ground truth" for a surgical suture is defined by established engineering and material science standards (e.g., USP monographs, FDA guidance). Expert review, as in clinical or imaging studies, is not part of establishing the performance for these specific non-clinical tests.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically relevant for clinical studies where multiple reviewers assess outcomes or image interpretations. For laboratory performance testing, the results are objectively measured against established standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret data, often with and without AI assistance, to assess the impact of AI on their performance. The Quill™ Monoderm™ device is a surgical suture, not a diagnostic tool requiring human interpretation in this context.

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

This information is not applicable. The device is a physical surgical suture, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical performance testing is based on established industry standards and regulatory requirements. Specifically:

• USP monograph for absorbable sutures for tensile strength and needle attachment.
• FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.
• The characteristics and performance of the legally marketed predicate devices to which equivalence is claimed.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a surgical suture, not a machine learning model that requires a training set. The performance testing described is for product verification and validation, not for algorithm training.

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

This information is not applicable as there is no training set for this type of medical device submission.

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

The Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone. undyed, or dyed with D&C Violet No. 2. 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 2-0 in various lengths affixed to various needle types.

The provided document is a 510(k) summary for the Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design. It describes the device, its indication for use, and a general statement about performance testing. However, it does not contain specific acceptance criteria, detailed study results, or the other requested information to fully address all parts of your prompt.

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

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative values or pass/fail thresholds. The document generally refers to conforming to the USP monograph for absorbable sutures and demonstrating substantial equivalence.
• Reported Device Performance: The document states that "The results of this testing demonstrates that the Quill™ Monoderm™ Knotless Tissue-Closure device, Variable Loop Design, is substantially equivalent to the predicate devices." No specific performance metrics (e.g., actual tensile strength values, degradation rates) are provided.

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

• Sample Size: Not specified.
• Data Provenance: The document only mentions "testing" and "simulated use tensile testing in porcine tissue and in vitro post-hydrolysis tensile testing." It does not specify country of origin, retrospective or prospective nature, or where the testing was conducted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is a surgical suture, and the performance tests described are mechanical and material characterization studies, not image interpretation or diagnostic studies that would require expert consensus for ground truth.

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

• Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not an AI/imaging device.

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

• No. This is not an AI/imaging device.

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

• For the non-clinical laboratory performance testing (tensile strength, needle attachment), the "ground truth" would be established by standardized measurement techniques and USP monograph specifications.
• For the simulated use tensile testing in porcine tissue and in vitro post-hydrolysis tensile testing, the "ground truth" would be the measured physical properties of the device and the predicate devices, compared against each other.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device that requires a training set. The performance tests are experimental studies, not algorithm training.

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

• Not applicable. See point 8.

In summary: The provided 510(k) summary offers a high-level overview of the device and the types of performance testing conducted to support substantial equivalence. It lacks the detailed quantitative data, sample sizes, and specific methodologies that would be required to fully answer most of your detailed questions, particularly those related to clinical studies, AI performance, or expert-adjudicated ground truth, as those concepts do not apply to this type of device and submission.

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