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The Automatic Continuous Effusion Shunt (ACES) System is indicated for use in adult (>21 years of age) patients with • chylothorax • intractable aseptic pleural effusion

The ACES System is an implanted pleural-peritoneal shunt system intended to palliate symptoms of recurrent pleural effusion, an accumulation of fluid in the cavity around the lungs. The ACES System comprises a pump that is, generally, a resilient flexible bulb having an inlet and an outlet. The inlet is attached to a first fenestrated barium striped tube that extends from the inlet valve to the patient's pleural cavity. The outlet is connected to a second fenestrated barium striped tube that extends from the outlet valve to the patient's peritoneal cavity. Each one-way valve is connected to a single pump chamber with an internal automatic pump extension and external manual compression and an integrated implant securement flange for suture fixation in the muscular facia. Internal (intercostal) automatic (passive) pump extension is placed between adjacent ribs in the external (subdermal) manual compression (active) pump extension is positioned under the skin and external to the ribs. Using a patient's own respiration, the internal automatic pump extension operates by being successively compressed and decompressed between adjacent ribs, as the patient breathes, whereby pumping the fluid from the pleural cavity to the peritoneal cavity, where it is naturally reabsorbed by the external manual compression pump extension allows for intraprocedural priming of the pump chamber as well as manual compression by the patient, post procedurally, at will or as directed by their physician for movement of fluid from the pleural cavity to the peritoneal cavity.

Here's a breakdown of the acceptance criteria and study information for the Automatic Continuous Effusion Shunt (ACES) System, based on the provided FDA 510(k) summary:

This device is a Class II medical device (Peritoneo-venous shunt), product code KPM. Its primary function is to move fluid from the pleural cavity to the peritoneal cavity in adult patients with chylothorax or intractable aseptic pleural effusion.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily details non-clinical performance and biocompatibility testing. It doesn't present specific numerical acceptance criteria (e.g., "flow rate must be X mL/day") with corresponding numerical performance results. Instead, for most tests, the acceptance criterion is implied as "Pass" and the reported performance is simply "All samples passed the acceptance criteria."

Note: The document states that the biocompatibility evaluation supports an implant duration of 12 months, beyond which removal is recommended, and that chronic toxicity and carcinogenicity were "Not evaluated".

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

The document does not explicitly state the numerical sample sizes for each test in the "Non-Clinical Performance Tests" or "Biocompatibility" sections. For most tests, it simply states "All samples passed the acceptance criteria."

• Test Set Sample Size: Not specified numerically for individual tests.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given this is a 510(k) summary for a US FDA submission, the tests were likely conducted in accordance with recognized international standards (ISO, ASTM) and GLP (Good Laboratory Practice) guidelines, often performed by contract research organizations. The testing appears to be prospective bench and animal (biocompatibility) testing rather than human clinical data.

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

This information is not applicable as the studies described are non-clinical (bench and animal testing). There is no "ground truth" established by human experts in the context of diagnostic performance for these types of engineering and biological safety tests. The ground truth for these tests is defined by the objective measurement and standards outlined in the test methods.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical performance and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies, especially for evaluating diagnostic performance where expert disagreement needs to be resolved.

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

No, a MRMC comparative effectiveness study was not done. The provided document details bench and biocompatibility testing for a medical device (a shunt system), not a diagnostic algorithm that requires human reader interpretation. No mention of AI assistance or human reader improvement appears in this summary.

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

This is not applicable. The ACES System is a physical medical device, not a software algorithm or AI model.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is based on pre-defined engineering specifications, standard test methods (e.g., pressure thresholds, flow rates, tensile strength values), and visual inspection criteria.

For biocompatibility tests, the "ground truth" is based on established biological safety endpoints and accepted international standards (ISO, USP) for reactions in in-vitro assays and animal models. For example, "non-cytotoxic," "non-sensitizer," and "no systemic toxic effects" represent the ground truth for biological safety.

8. The Sample Size for the Training Set

This is not applicable. The ACES System is a physical medical device, not a machine learning model. There is no "training set."

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

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

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Used for more accurate placement of pneumothorax decompression devices than the current standard of care auditory assessments. The Pneumothorax Decompression Indicator is a colorimetric capnography device indicated to detect the carbon dioxide in the gas passing through the device used to treat pneumothorax with suspected tension physiology.

The Pneumeric Capnospot Pneumothorax Decompression Indicator is a capnography device that provides objective, real-time feedback during decompressive thoracostomy. Specifically, the device detects the presence of carbon dioxide in the gas from the decompressed pneumothorax, permitting more accurate placement of the needle or thoracostomy device compared to the current standard of care based upon auditory assessments.

The Pneumeric Capnospot is a therapeutic device intended to guide the placement of pneumothorax decompression needles and thoracostomy devices.

The product consists of a cylindrical polycarbonate tube containing a carbon dioxide detecting paper. The device has a male luer connector on the distal end of the device to connect to decompression needles and thoracostomy devices, a diaphragm to prevent backflow of gases, a color changing indicator and a female luer on the proximal end of the device that can be used to connect accessories.

The product is shipped non-sterile and labeled for single use only.

The provided text describes a medical device called the "CapnoSpot™ Pneumothorax Decompression Indicator" and its 510(k) submission to the FDA. However, the document does not contain information about a study proving the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy, particularly concerning an AI-driven component or human reader assistance.

The document discusses "Performance Data" in section 6.5, but this section focuses on design verification and shelf-life tests (visual inspection, dimensionals, backflow, cracking pressure, torque, luer leakage, animal data) to ensure the device meets specifications, rather than clinical performance metrics in humans or AI-driven acceptance criteria.

The 510(k) submission for this device is based on substantial equivalence to a predicate device (Turkel Pneumothorax Kit K923028), rather than demonstrating clinical efficacy or AI performance through a comparative study.

Therefore, based on the provided text, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them in the context of sensitivity, specificity, accuracy, or human reader improvement with AI. The document does not provide details on:

1. A table of acceptance criteria and reported device performance related to diagnostic accuracy.
2. Sample size used for a test set, its provenance, or how ground truth was established for such a test set.
3. Number of experts and their qualifications for establishing ground truth.
4. Adjudication method for a test set.
5. Whether an MRMC comparative effectiveness study was done or its effect size.
6. Whether a standalone AI performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for diagnostic performance.
8. Training set sample size or how its ground truth was established.

The "Performance Data" refers to engineering and durability tests, and an "Animal Data" point is mentioned, but no details of a study with acceptance criteria for a diagnostic/AI performance are present.

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The Monarch® Platform, Urology and its accessories are intended to access and visualize anatomical locations within the urinary tract and interior of adolescents and adults, aged 12 and up, for diagnostic and therapeutic procedures with transurethral access or transurethral access in conjunction with percutaneous access.

The Monarch® Platform, Urology, the Ureteroscope, and endourology accessories are indicated to provide endoscopic visualization and access of organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) with transurethral access or transurethral access in conjunction with percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Monarch® Platform, Urology ("Proposed Device") is a capital equipment platform that enables electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible suction catheter for visualization and access to the urinary tract for diagnostic and therapeutic procedures. The ureteroscope and suction catheter move only under continuous and direct physician control, via the Monarch Controller.

The proposed device consists of Monarch® Tower, Monarch® Cart, Monarch® Fluidics Pump, Monarch® Software, Monarch® Controller, Monarch® Ureteroscope and endourology instruments and accessories needed to perform Monarch Urology diagnostic and therapeutic procedures. The device as well as its instruments and accessories are used together during urological diaenostic and therapeutic procedures and are bundled in this 510(k) submission so they can be addressed during one review. The summary descriptions of each component are outlined below.

Monarch® Tower: The Monarch® Tower (Tower) contains the primary procedural display interface for the physician that is provided by a touchscreen monitor for physician viewing and computers running the Monarch software. The monitor has a touchscreen and allows for user input during setup and intra-operative use. The tower has integrated electromagnetic (EM) tracking and video signal processing components. In addition, the tower provides connectivity for the endoscope camera as well as the fluidics pump.

Monarch® Cart: The Monarch® Cart (Cart) contains a touchscreen, three robotic arms and electronic systems required to power and operate the robotic arms. The Cart touchscreens accepts user input and shows instructions for arm deployment and cart functions. The robotic arms possess multiple degrees of freedom. The cart transmits the physician directed movement to the Ureteroscope and other instruments during a procedure.

Monarch® Fluidics Pump: The Monarch® Fluidics Pump (Fluidics Pump) controls the irrigation and suction during a procedure. The Fluidics Pump is connected to the Monarch Tower via an umbilical cable allowing electrical and data communication. The Fluidics Pump provides the physician with the ability to control irrigation and suction levels during a procedure. The Urology Irrigation Cartridge and Suction Set are irrigation and suction tubing provided as sterile accessories to connect the Fluidics Pump to the Ureteroscope and Instruments during ureteroscopy or PCNL procedures.

Monarch® Software: The Monarch® Software provides the user with the ability to safely drive the Monarch® Ureteroscope and Monarch® Mini-PCNL suction catheter around the kidney and within the calyces of interest as well as provides optional navigation guidance to the user to insert the needle to the target during Monarch® PCNL procedure. It receives user input from the Monarch® Controller, computes the appropriate robotic motion to coordinate the movement of the robotic arms and endoscopic devices loaded onto the Cart. It provides a graphical user interface where the endoscopic camera view is shown in real time and displays important system status information.

Monarch® Controller: The Monarch® Controller) is a handheld device that serves as the user interface that allows the physician to control the system during a procedure. An Umbilical cord connects the Controller to the Tower.

Monarch® Ureteroscope: The Monarch® Ureteroscope (Ureteroscope) is comprised of an endoscope that provides vision, illumination, and a working channel to the distal tip of the device. The Ureteroscope can be navigated by the user within the bladder, urinary tract, and kidney. It contains a working channel to accommodate compatible commercially available working channel instruments. The Ureteroscope can be articulated 2-directions (along a single plane) when manually driven or can be articulated 4-directions (along two planes) when mounted to the electromechanical arms under command by the physician using the endoscopic controller. The shaft of the ureteroscope can also be rolled 155° in either direction to reorient the camera and working channel. The Ureteroscope is packaged within the Monarch® Ureteroscopy Kit. The Monarch® Ureteroscopy Kit also includes Ureteroscope Valve, Ureteroscope Driver and Laser Driver (accessories for Ureteroscopy procedure).

Procedural specific instruments and accessories for the proposed device are outlined below, these devices are single-use devices and sterilized via EO.

• Monarch® Mini-PCNL Suction Catheter: The Monarch® Mini-PCNL Suction Catheter ● (Suction Catheter) is part of the Monarch® Mini-PCNL Kit. The Suction Catheter is a flexible device that is inserted into the kidney via antegrade tract under direct visualization from the ureteroscope. It has a center lumen which allows for the suction of stone debris and can articulate in 4 directions. The suction catheter is manipulated by one robotic arm under the control of a physician who is concurrently controlling the Ureteroscope.
• Dilation Set: The Dilation Set is part of the Monarch® Mini-PCNL Kit. The Dilation Set ● includes:
  • 8Fr dilator
  • 10Fr catheter
  • Percutaneous Sheath Dilator ●
• Percutaneous Sheath: The Percutaneous Sheath is part of the Monarch® Mini-PCNL Kit. The Percutaneous Sheath consists of an inner metal sheath with a threaded connection and a metal outer sheath. It is designed to establish percutaneous access and designed to allow simultaneous irrigation and suction of fluid to support removal of kidney stones. The outer sheath has a molded hub with an angled luer connection for irrigation and an insertion depth marking on the distal end.

The provided text describes performance data but does not specify quantifiable acceptance criteria for the Monarch® Platform, Urology device. Instead, it states that the device was tested against internal design specifications and applicable performance standards to demonstrate safety and effectiveness, and that "all intended user needs evaluated met their acceptance criteria." However, what those specific quantitative acceptance criteria were for different aspects (e.g., accuracy, reliability, image quality) and the reported performance against them are not detailed in the provided document.

Therefore, the following information is based on what can be extracted or inferred from the provided sections, recognizing the absence of explicit quantitative acceptance criteria and specific performance metrics for the device itself.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, the document does not provide a table of explicit acceptance criteria with specific quantitative targets and corresponding reported device performance values. The general statements are that all tests "Passed" or "met acceptance criteria."

Therefore, I cannot construct the requested table with specific numerical values for acceptance criteria and reported device performance.

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

The document mentions "live porcine model" for Design Validation and "Acute Animal Safety" studies.

• Sample Size for Test Set: Not explicitly stated as a numerical count for either the Design Validation or Acute Animal Safety studies. The phrasing "live porcine model" and "live animal model" are general.
• Data Provenance: The studies were conducted using "live porcine model" and "live animal model," indicating animal testing (pre-clinical). The location or country of origin is not specified, but it suggests a controlled laboratory setting. The studies are prospective in nature, as they involve active testing and data collection.

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

The document mentions "intended users" and "representative users" in the context of Human Factors and Usability evaluation and Design Validation. However, it does not specify the number of experts used to establish ground truth for any test set or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth for any test set. The term "ground truth" itself is not explicitly used in the context of expert review in the provided text.

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

The document does not mention or describe a Multi Reader Multi Case (MRMC) comparative effectiveness study. The Monarch® Platform is described as a capital equipment platform with electromechanical articulation and control, and software for navigation, but there is no indication of an AI component designed to assist human readers in interpretation or diagnosis, nor any study comparing human performance with and without AI assistance.

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

The document describes the Monarch® Platform as a system that requires "continuous and direct physician control" and where "Device movement is only at the command of the physician." The software provides "optional navigation guidance." This indicates that the device is designed for human-in-the-loop operation, and the description does not support the idea of a standalone (algorithm-only) performance study.

7. The Type of Ground Truth Used

Based on the descriptions:

• Design Validation and Acute Animal Safety: The "ground truth" for these studies would implicitly be established through direct observation, physiological measurements, and potentially post-mortem examination in the animal models, assessing safety and functionality in a simulated use environment. This is a form of direct-measurement or observation-based ground truth specific to animal model performance.
• Other tests (Reprocessing, Sterility, Biocompatibility, Electrical Safety, Software, Verification Testing, Human Factors): These rely on adherence to established standards and internal specifications, where "ground truth" is defined by the objective pass/fail criteria of technical tests rather than expert consensus on diagnostic images or pathology.

8. The Sample Size for the Training Set

The document describes pre-market testing and validation for a medical device (Monarch® Platform, Urology). It does not mention a "training set" in the context of machine learning or AI, as the primary focus seems to be on the electromechanical system and software components rather than a learning algorithm that requires a training set.

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

As no "training set" for an AI/ML algorithm is mentioned, this question is not applicable based on the provided text.

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The SecurAcath device is intended to secure catheters by means of a subcutaneous anchor.

The SecurAcath Device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage

The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.

The provided text is a 510(k) summary for a medical device called SecurAcath. It focuses on demonstrating substantial equivalence to a previously cleared device, not on proving the device meets general acceptance criteria through a specific clinical study with detailed performance metrics like sensitivity, specificity, or accuracy, which is typical for AI/ML-based medical devices or diagnostics.

The changes described are primarily related to manufacturing processes and materials (e.g., laser marking instead of pad printing, slight material formulation change in polypropylene, different anti-block additive in packaging, and an extended shelf life). The "performance data" section mentions engineering tests to confirm the device still meets product specifications after these changes.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth types, training set details) are not applicable (N/A) for this type of submission because the device is a physical medical device (catheter securement system), not an AI/ML diagnostic or imaging device. The "acceptance criteria" here refer to ensuring the manufacturing changes do not negatively impact the device's original functionality and safety.

Here's an attempt to answer the questions based on the provided text, indicating N/A where information is not present or relevant to this type of device:

Description of Acceptance Criteria and Proving Device Meets Criteria (SecurAcath Device)

The device in question, SecurAcath, is a physical medical device (a catheter securement system), not a software or AI/ML-based diagnostic device. The acceptance criteria and "study" described in the provided document revolve around demonstrating that manufacturing/material changes to the device do not negatively impact its performance, safety, or effectiveness compared to its predicate device. The study performed is a series of engineering performance tests and material characterizations, not a clinical trial or AI model validation study.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with specific thresholds (e.g., tensile strength > X N) alongside numerical reported performance values. Instead, it states that tests were performed to demonstrate the device "meets product specifications" and "is not negatively impacted by the material change or marking process change." The acceptance is qualitative in the sense that the new device performs "as intended" and "continues to meet the same specifications as its predicate devices."

• Joint Tensile Strength
• Base & Cover Interaction
• Hinge performance
  (No specific numerical data provided, but it states results demonstrate "device functions as intended.") |
  | Marking Durability | Testing performed per IEC 60601-1 for durability of markings. The laser marking does not impact safety and effectiveness. |
  | Biocompatibility | Meets ISO 10993-1. (Same as predicate) |
  | Sterilization & Sterility | EtO and SAL of 10-6. (Same as predicate, new packaging configuration passed testing) |
  | Shelf Life | Extended to 4 years. Shelf life product was 2X sterilized, passed design verification testing including pouch seal peel and bubble leak tests. The extension does not impact safety and effectiveness. |
  | Packaging Integrity | New packaging configuration passed ISTA 2A, ASTM D4169, sterile barrier performance testing and ISO 10993-7 testing. The new configuration does not impact safety and effectiveness. |

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

• Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML model. The "tests" mentioned are engineering and material verification tests (e.g., dimensional, functional, durability). The number of samples used for these engineering tests is not specified in this summary.
• Data Provenance: N/A for this type of device; no patient data or clinical data is mentioned for performance evaluation in this premarket notification. The tests are lab-based.

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

• N/A. This is an engineering/manufacturing change submission for a physical device. There is no "ground truth" derived from expert interpretation (e.g., radiologists, pathologists) in the context of a diagnostic or imaging study. The "truth" is established through engineering specifications and industry standards.

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

• N/A. No expert adjudication of data is mentioned or relevant.

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

• N/A. This is a physical medical device, not an AI/ML-assisted diagnostic device. No MRMC study was performed.

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

• N/A. Not an algorithm.

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

• N/A. The "ground truth" for this device's "performance" is its adherence to engineering specifications, material compatibility standards (e.g., ISO 10993), and functional requirements that ensure continuous safe and effective operation after manufacturing changes.

8. The sample size for the training set:

• N/A. This is a physical device, not an AI/ML model that requires training data.

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

• N/A. Not applicable as no training set exists for this type of device submission.

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The BIOTEQ Drainage Catheter Set (One Step Type) is designed for percutaneous drainage of abscess fluid, cyst, gall bladders, nephrostomy, urinary, and others fluids.

The BIOTEQ Drainage Catheter Set (One Step Type), BT-PD1-series percutaneous drainage catheter with hydrophilic coating, is a percutaneous drainage catheter used for drainage of abscess and fluid collections. The catheter is made from a soft, biocompatible plastic, a material that is radiopaque for X-rays. The distal end of catheter contains a "J", a pigtail or close loop and drainage holes. The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These sets are classified according to the catheter size (5F~16F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either Direct Access Technique or Seldinger Technique to provide access.

The provided document is a 510(k) summary for a medical device (BIOTEQ Drainage Catheter Set (One Step Type)). It details the device's indications for use, description, and a comparison to predicate devices to establish substantial equivalence.

However, the document explicitly states in "5.10 Clinical Testing" that "No clinical test data was used to support the decision of substantial equivalence."

Therefore, I cannot provide the details requested in your prompt regarding acceptance criteria and studies that prove the device meets those criteria from this document, as no clinical testing was performed or submitted for this 510(k) clearance.

Specifically, the following information cannot be extracted because no clinical study was conducted:

1. A table of acceptance criteria and the reported device performance: No performance data from clinical studies is presented.
2. Sample sizes used for the test set and the data provenance: No test set was used for clinical performance evaluation.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as no clinical ground truth was established by experts.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (this device is not an algorithm).
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (this is not an AI/ML device that requires a training set).
9. How the ground truth for the training set was established: Not applicable.

The document focuses on non-clinical testing (Sterilization Validation, Shelf-life, Biocompatibility, Performance) to demonstrate substantial equivalence to legally marketed predicate devices, rather than clinical performance data against specific acceptance criteria. The "Performance" referred to in Section 5.9 is likely related to physical performance characteristics of the device (e.g., flow rate, material strength, radiopacity, etc.), and not clinical outcomes.

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The SecurAcath device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short or long-term securement of percutaneous indwelling catheters for abscess/general drainage

The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.

The provided text is a 510(k) Summary for the SecurAcath device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI/ML device.

Therefore, I cannot fully answer your request as it pertains to AI/ML device evaluation criteria. The document describes a medical device for catheter securement and its equivalence to a predicate, not an AI/ML system.

However, I can extract the general type of performance data mentioned and explain why it doesn't fit the AI/ML framework you've outlined:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists "Performance tests" that were conducted, but it does not provide specific acceptance criteria or quantitative performance metrics for these tests. Instead, it makes a general statement: "Test results demonstrate that the device functions as intended."

2. Sample Size for Test Set and Data Provenance: Not applicable as this is not an AI/ML study. The document refers to "Performance tests" but does not detail the sample sizes for these tests or the provenance of any data.

3. Number of Experts and Qualifications for Ground Truth: Not applicable as this is not an AI/ML study. The device's performance evaluation would involve engineering and clinical testing, not expert adjudication of AI outputs.

4. Adjudication Method: Not applicable.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.

6. Standalone (Algorithm Only) Performance: Not applicable as this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used: Not applicable in the AI/ML sense. The "ground truth" for this device would be established through engineering specifications, biomechanical testing outcomes, and clinical observations of catheter securement effectiveness, rather than expert interpretation of data.

8. Sample Size for Training Set: Not applicable as there is no AI/ML training involved for this device.

9. How Ground Truth for Training Set Was Established: Not applicable.

In summary, the provided FDA 510(k) summary is for a physical medical device (catheter securement device) and therefore does not contain the information requested regarding acceptance criteria and studies for an AI/ML device. The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, technological characteristics, and general performance testing (e.g., dimensional verification, functional tests, securement reliability, human factor design validation).

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The Gordon Large-Bore Curved Drainage Catheter is intended for abscess drainage.

The Nephrostomy Pigtail Drainage Catheter and Percutaneous Nephrostomy Set are intended for external urine drainage from the renal pelvis.

The Pigtail Drainage Catheter Needle Set is intended for percutaneous external drainage in multiple applications (e.g., nephrostomy, abscess drainage and other abdominal cavity drainage procedures).

The Multipurpose Drainage Catheters and Sets are intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique.

The Gordon Large-Bore Curved Drainage Catheter is a drainage catheter that aspirates abscess cavity contents. The catheters are manufactured from radiopaque polyether-urethane material with hydrophilic coating on the surface of the catheter and are designed with six sideports at the distal curve. The catheters are available in diameters ranging from 16 to 22 French and in a length of 40 cm. The device includes flexible and rigid catheter introduction stiffening cannulas that aid in the placement of the catheter.

The Nephrostomy Pigtail Drainage Catheter is a drainage catheter used to drain urine from the kidney. The catheter is manufactured from radiopaque polyurethane tubing with a distal pigtail tip. The catheter is manufactured with six drainage sideports spaced within the pigtail curve. The catheter is available in a diameter of 8.3 French and in a length of 30 cm. The catheter is supplied with a Peel-Away straightener. The Percutaneous Nephrostomy Set is composed of the 8.3 Fr Nephrostomy Pigtail Drainage Catheter and several set components, including dilators, a wire guide, a Trocar needle, a Chiba needle, a connecting tube with a stopcock, and a fixation device.

The Pigtail Drainage Catheter Needle Set includes a drainage catheter used in multiple drainage applications, including nephrostomy, abscess drainage, and other abdominal cavity drainage procedures. The catheters are manufactured from radiopaque polyurethane tubing with a pigtail distal curve configuration. Four, six, or eight sideports are spaced evenly within the pigtail curve. The catheters are available in diameters of 5.0, 6.0, 7.0 and 8.3 French and in lengths of 15 or 25 cm. The Pigtail Drainage Catheter Needle Set is supplied with a Peel-Away straightener and a rigid stiffening cannula composed of a stainless steel needle, trocar stylet, and loading obturator.

The Multipurpose Drainage Catheters are used in a variety of drainage applications, e.g., nephrostomy, biliary, and abscess. There are 13 types of multipurpose drainage catheters and/or sets that fall into three different groups depending on the type of loop-locking mechanism, i.e., catheters without a locking mechanism, catheters with a Mac-Loc locking mechanism, and catheters with a Cook-Cope locking mechanism. Six product lines (Amplatz Universal Drainage Catheter and Set, Straight or Straight-Drain™ Drainage Catheter, Multipurpose Drainage Catheter, Universal Curved Drainage Catheters, Ring Biliary Duct Drainage Catheter, and Soft-Shaft Malecot Drainage Catheters) are designed without a locking mechanism. Four product lines (Multipurpose Drainage Catheter and Set, Dawson-Mueller Drainage Catheter and Set, Multipurpose Small Pigtail Drainage Catheter, and Biliary Drainage Catheters) are designed with a Mac-Loc® Locking Mechanism. Three product lines (Multipurpose Drainage Catheter, Biliary Drainage Catheter, and Cope Proximal Biliary Loop Catheter) are designed with a Cook-Cope or Luer lock Cook-Cope locking mechanism. The catheters are available in diameters ranging from 5.0 to 20.0 French and in lengths ranging from 15 to 60 cm. All catheters are manufactured from radiopaque polyether-urethane material. Most of the catheters are designed with distal curve configurations. The catheters may have a hydrophilic coating applied to their surface. The catheter size, number of sideports, distal tip configuration, and loop-locking mechanism are specific to the product type and drainage set specification. Many of these devices are supplied with a flexible and/or rigid stiffening cannula, as well as a catheter fixation device. The Multipurpose Drainage Set is composed of the Multipurpose Drainage Catheter and several set components, including a wire guide, dilator(s), a Neff percutaneous introducer set, and a connecting tube with a stopcock.

The provided text describes a 510(k) premarket notification for various drainage catheters. This document focuses on the substantial equivalence of new devices to existing predicate devices, rather than presenting a standalone study with specific performance metrics against pre-defined acceptance criteria for a novel device. Therefore, much of the requested information, particularly regarding a "study that proves the device meets the acceptance criteria" in the context of clinical performance, is not available.

The document outlines acceptance criteria in terms of various performance and biocompatibility tests conducted on the catheters to ensure reliable design and performance under specified design requirements. For all these tests, it is stated that "all pre-determined acceptance criteria were met." However, the specific quantitative acceptance criteria for each test and the detailed reported device performance against these criteria are not provided.

Here's a breakdown of the available and unavailable information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria and Reported Device Performance (as inferred from the document)

Note: The document explicitly states for physical and biocompatibility testing: "For these tests, all pre-determined acceptance criteria were met." However, the specific quantitative values for these criteria (e.g., "tensile strength of X N" or "flow rate of Y mL/hr") are not detailed in this submission. This is typical for a 510(k) where the focus is on demonstrating equivalence to predicates through adherence to recognized standards.

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

• Sample Size: Not specified for any of the performance or biocompatibility tests.
• Data Provenance: The tests were "conducted in accordance with applicable standards," which suggests they were performed internally by Cook Incorporated or by a contracted laboratory. The country of origin of the data is implicitly the USA (Cook Incorporated is based in Bloomington, IN, USA). The studies appear to be prospective in nature, in that they were conducted for the purpose of demonstrating equivalence for this submission.

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

• Not Applicable: This type of information is generally relevant for studies involving diagnostic accuracy or clinical judgment (e.g., reading medical images). The testing described here is primarily laboratory and bench testing of physical and biological properties. Experts were likely involved in developing the product and interpreting the results, but not in establishing a "ground truth" for a test set in the way you've described.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for diagnostic endpoints, to resolve disagreements among multiple expert readers. This document does not describe such a study.

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

• No: A MRMC comparative effectiveness study was not done. The document does not describe any studies involving human readers or AI assistance.

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

• No: This document describes medical devices (catheters), not an algorithm or AI system. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

• Not Applicable (Clinical/Diagnostic Context): As mentioned above, the "ground truth" in the context of clinical diagnostic accuracy is not relevant here. For the performance and biocompatibility tests, the "ground truth" is established by the specifications of applicable ISO and USP standards. For instance, if a tensile test is performed, the "ground truth" is whether the material's tensile strength meets the specified minimum value as per the standard.

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" as this is not an AI/ML device.

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

• Not Applicable: There is no "training set" as this is not an AI/ML device.

In summary, this 510(k) notification demonstrates substantial equivalence by comparing the technological characteristics of the new devices to predicate devices and by conducting various performance and biocompatibility bench tests in accordance with recognized standards, all of which "met the acceptance criteria." It does not involve complex clinical trials, expert adjudication, or AI performance studies that would require the specific details you've requested for those types of evaluations.

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The Mini Stick ENVI Non-Vascular Introducer Kit is utilized to facilitate the introduction and placement of a 0.035 in (0.89 mm) or 0.038 in (0.97 mm) diameter guidewire for non-vascular procedures.

The Mini Stick ENVI Non-Vascular Introducer Kit contains one or more of the following components. Reference unit label for specific devices: Triaxial Sheath/Dilator assembly with stiffening cannula; 18G (1.4 mm) or 21G (0.9 mm) needle with stylet; 0.018 in (0.46 mm) floppy tip guidewire; 0.035 in (0.89 mm) or 0.038 in (0.97 mm) heavy duty guidewire. For user convenience, all kit components are also available in multiple kit configurations as sterile, standalone devices.

The provided document is a 510(k) Premarket Notification for a medical device called the "Mini Stick ENVI Non-Vascular Introducer Kit." This document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical performance data.

Therefore, the concepts of acceptance criteria for diagnostic performance, a test set, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to this type of submission. This device is an introducer kit, and the evaluation is primarily focused on its physical and functional characteristics, not on diagnostic accuracy of an AI or image-based system.

Here's an analysis based on the information provided, explaining why certain sections of your request are not relevant:

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

The document does not explicitly state "acceptance criteria" in the context of diagnostic performance metrics like sensitivity, specificity, accuracy, etc., because it's a physical medical device, not a diagnostic algorithm. However, it lists performance tests conducted to demonstrate the device's functional integrity and safety. We can infer the "acceptance criteria" were successful completion of these tests in accordance with the cited ISO standards.

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

Not applicable. This device is not a diagnostic tool or algorithm that uses a "test set" of patient data. The "tests" mentioned are non-clinical engineering and material tests, which would involve specific numbers of device components or assemblies, not patient samples or data provenance.

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

Not applicable. Ground truth, in the context of diagnostic performance, is not relevant here. The "truth" in this context is whether the device physically meets its intended specifications and safety standards, determined by engineering and scientific testing, not expert interpretation of diagnostic images or clinical data.

4. Adjudication method for the test set

Not applicable for the same reasons as above. Adjudication methods are used to establish a consensus ground truth from multiple expert interpretations, which is not relevant for the functional testing of a physical introducer kit.

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. MRMC studies are for evaluating the performance of diagnostic systems (often AI-assisted) with human readers. This device is an introducer kit, not a diagnostic system.

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

Not applicable. There is no algorithm associated with this device.

7. The type of ground truth used

Not applicable in the diagnostic sense. The "ground truth" for this device's performance is established by its manufacturing specifications and compliance with international standards for medical devices (e.g., ISO 11070, ISO 594-2, ISO 10993-1) as demonstrated through physical and chemical testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; 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 an AI/ML model, there is no ground truth to be established for it.

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The EMS-200 is a dental device which combines in a single LCD unit an endo motor which ablates the tooth to expand the root canal, a dental obturator to fill and pressurize various shaped packing elements and an electronic apex locator which assists the operator the location of the front tip in the root canal, for use by trained dental professionals.

The EMS -200 dental unit is device that combines the 1) Endo-motor Handpiece (K133298) which ablates the tooth to expand the root canal, a 2) Endodontic Obturation Unit which is used to fill and pressurize various shaped packing elements, and 3) Electronic apex locator (K112508) which is used to ensure the location of the front tip in root canal through changes of electric resistance value into one unit. The working of each of the components is displayed through a single touch screen.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the EMS-200 dental device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative, pass/fail manner with specific thresholds. Instead, the document compares the EMS-200's functional specifications to its predicate devices. The primary 'acceptance' is that the new device is "substantially equivalent" to legally marketed predicate devices and introduces "no new issues of safety and efficacy."

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

The document does not explicitly state sample sizes for specific test sets in a detailed manner that would typically be found in a clinical study report.

• Test Set: For bench testing (e.g., ISO 14457 comparison), no specific "sample size" of devices or cases is mentioned. For usability testing, it states "testing by the intended user" but doesn't specify the number of users.
• Data Provenance: The studies appear to be non-clinical bench tests performed by the manufacturer, Meta Systems Co., Ltd., based in Korea. The document does not indicate the country of origin for any data related to user testing (e.g., where the "intended user" for usability testing was located). All testing described seems to be prospective in nature as it's for a new device submission.

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

• Number of Experts: Not specified.
• Qualifications: "Intended user" for usability testing, but no specific professional qualifications (e.g., "dental professionals" as per Indications for Use) or experience levels are mentioned for those users. For other tests (e.g., bench tests), the "ground truth" is typically defined by the test standard itself or the specifications of the predicate device, not by expert consensus in this context.

4. Adjudication Method for the Test Set

No adjudication method is mentioned for any of the testing described. Decisions are based on conformance to specifications or 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

No MRMC comparative effectiveness study was mentioned.
The EMS-200 is a dental device combining an endo motor, obturator, and electronic apex locator. These are mechanical/electronic tools for dental procedures, not an AI-assisted diagnostic or interpretative system that would involve "human readers" or AI for image analysis. Therefore, a study of this nature is not applicable to this device description.

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

A standalone performance evaluation was implicitly done for each component (Motor, Apex Locator, Pack, Fill) through:

• Bench testing: "Bench testing for conformance to ISO 14457"
• Safety testing: Compliance with various IEC, ISO, EN standards.
• Biocompatibility testing: Compliance with ISO 10993-1.
• Software validation: "Software documentation and validation for software of moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices."

The device itself is a standalone system in the sense that the individual functions (e.g., apex location) operate based on the device's algorithms or mechanics. The "human-in-the-loop" for this device refers to the dental professional using the device, not assisting an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance evaluations (e.g., accuracy of apex locator, temperature ranges for pack/fill, motor speed/torque) is primarily established by:

• Predicate device specifications: The comparison table clearly shows the EMS-200's specifications are benchmarked against those of the K133298, K112508, and K031664 predicate devices.
• International standards: Conformance to relevant ISO, IEC, EN standards defines the "ground truth" for safety, electrical compatibility, software, and sterilization.
• Referenced literature: For Gutta percha temperature, "Referenced literature articles regarding the temperature of gutta percha" are cited.

8. The Sample Size for the Training Set

No training set is mentioned as this is not an AI/machine learning device. The device's operational parameters are based on engineering design and historical predicate device performance, not a learned model from a dataset.

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 Valved Safety Centesis Catheter is indicated for the therapeutic aspiration of fluids from body cavities.

The Valved Safety Centesis Catheter is a drainage, centesis catheter with a self sealing valve and a passive safety needle-shielding feature. The catheter is designed with drainage holes located around the distal tip of the catheter to facilitate the drainage of fluid. The catheter surface and tapered end is designed for smooth transition through the tissue, while the inner surface is designed for easy retraction of the insertion needle. The insertion needle comes with a vent plug that allows air to exit and does not allow fluid to exit. The echogenic needle tip provides a guidance for proper catheter placement using ultrasound. The needle hub is clear and locks within the catheter hub. The catheter is radiopaque and can be visualized using fluoroscopy. The hub of the catheter contains a luer adapter to facilitate attachment of drainage collection devices and a bevel indicator for needle bevel orientation reference. The device is provided individually packaged sterile.

The provided text is a 510(k) summary for a medical device called the "Valved Safety Centesis Catheter." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the information required to answer your specific questions related to acceptance criteria, a study proving performance against acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

This document focuses on demonstrating substantial equivalence through performance testing (functional and biocompatibility) and comparing technical characteristics to a predicate device, rather than a clinical study establishing performance against predefined acceptance criteria for AI or diagnostic purposes.

Here's why the requested information isn't present in this document:

• Device Type: This is a physical medical device (a catheter), not a software or AI-driven diagnostic tool. The questions you've asked (e.g., sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance) are typically relevant for AI/ML-driven diagnostic devices or software that provides interpretations.
• Regulatory Focus: The 510(k) process for this type of device primarily aims to show that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. This is often achieved through bench testing (functional and biocompatibility) and comparing design features, not clinical trials requiring human reader analysis or complex ground truth establishment for diagnostic accuracy.
• Lack of AI/Diagnostic Component: There is no mention of any AI component, image analysis, or diagnostic output from this catheter that would necessitate the kind of rigorous validation against human expert performance or established ground truth that your questions imply.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device meets acceptance criteria, as the provided document does not contain this type of information for a device like the Valved Safety Centesis Catheter.

The document does mention "Performance Testing" which includes flow rate, tensile strength, pressure testing, and safety feature verification. These are functional performance criteria for a physical device, not diagnostic performance criteria.

To be absolutely clear, here's what the document does say about testing:

• Performance Testing Areas: Visual Inspection, Radio-detectability, Echogenicity, Flow rate, Occlusion, Tensile strength, Pressure testing, Penetration force, Safety feature verification.
• Biocompatibility Testing: Completed considering ISO 10993-1 recommendations.
• Clinical Testing: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device."

This explicitly states that no clinical studies were performed, which further confirms why information on human readers, ground truth establishment by experts, or MRMC studies would not be present.

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