The GI Windows Flexagon Plus OTOLoc System is intended for use in the creation of side-to-side jejunum-jejunum and ileum-ileum anastomoses in minimally invasive and laparoscopic surgery. Once wound strength is sufficient to maintain the anastomosis, the device is passed from the body. The effects of this device on weight loss were not studied. The GI Windows Flexagon SFM Plus OTOLoc is intended for use in adult patients > 21 years.

The Flexagon SFM Plus OTOLoc device is a magnetic compression anastomosis system, which is a surgical device used for the creation of anastomoses in minimally invasive surgery in the gastrointestinal tract. The system is comprised of self-forming magnets and includes the delivery system. The OTOLoc component provides enterotomy preservation for immediate fluidic flow upon implant, while the alternating dipoles of the Flexagon magnet drives magnetic self-alignment to prevent apposition. The anastomosis formation occurs over time once the remodeling of the targeted tissues is complete. The Flexagon magnets compress the opposing tissues which allows the body to dictate the time required for re-epithelialization. Compression and necrosis of tissue is achieved between magnet devices and is created by the polar attraction of the magnet devices with subsequent healing of tissue around the devices. Once the anastomosis is formed, the magnet device is expelled naturally in approximately 3-6 weeks.

The provided text does not contain acceptance criteria or study details for an AI/software device. The document is an FDA 510(k) clearance letter for a physical medical device, the "Flexagon Plus OTOLoc System," which is a magnetic compression anastomosis system.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study proving an AI device meets them, as the input document is not about an AI device.

The document discusses:

• Acceptance criteria (implicitly met through "Pass" results) for various non-clinical performance tests (biocompatibility, sterilization, packaging, shelf-life, magnetic properties, etc.) and animal studies.
• Clinical performance data for the physical device based on patient outcomes, but not related to an AI's diagnostic or assistive capabilities.

To answer your request, I would need a document detailing the clearance of an AI-powered medical device.

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MammoSTAR Biopsy Site Identifier is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.

MammoSTAR Biopsy Site Identifier is a sterile, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker e that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. MammoSTAR is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

Based on the provided FDA 510(k) clearance letter, the "MammoSTAR Biopsy Site Identifier" is cleared without new device performance data. The clearance is based on the device being identical to its predicate device (K100994) with only one difference being an added contraindication and an extended shelf life, which was verified through testing. Therefore, there is no specific performance data from a new study presented in this document to describe or prove the device meets acceptance criteria.

The document indicates that no new performance data was required because the device is deemed identical to the predicate device, and thus, already meets the established criteria for safety and effectiveness based on the predicate's clearance.

Here's an attempt to answer your request based on the information provided and inferred within the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is a "Change Being Effected (CBE) determination" where the device is considered identical to its predicate except for an added contraindication and an extended shelf-life, explicit "acceptance criteria" and "reported device performance" from a new study are not provided for the claims of equivalency in the typical sense. Instead, the acceptance criteria are implicitly met by being identical to the predicate device, which was previously deemed safe and effective.

The only "performance" mentioned that might resemble a test is the shelf-life verification.

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The Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are intended for use in procedures involving the ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are single-use, non-active implantable devices designed for use in general surgical procedures that require vessel or tissue ligation. The clips are manufactured from a non-absorbable acetal polymer and are provided prepackaged in color-coded cartridges, which are provided as single-use, sterile devices.

The provided FDA 510(k) clearance letter pertains to a new version of a physical medical device (surgical clips), not an AI/Software as a Medical Device (SaMD).

Therefore, the document does not contain any of the information requested in points 2-9, as these points are specific to the evaluation and validation of AI/SaMD products, which involve concepts like:

• Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC): This is relevant for diagnostic or predictive AI systems.
• Sample sizes for test sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training set details: These are critical components of validating AI model performance to ensure its accuracy, robustness, and generalizability.

Since the Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips are physical devices, their acceptance criteria and proof of efficacy are based on benchtop non-clinical performance testing and biocompatibility assessments, which are detailed in the "Performance Data" section (Section J) of the 510(k) summary.

Here's how to interpret the provided document in the context of your request:

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

The document lists the following non-clinical performance tests and biocompatibility assessments that were conducted. While explicit "acceptance criteria" are not numerically stated in this summary for each test (as they typically would be in a full test report), the statement "in order to ensure the device performed equivalently to the predicate" implies that the new device's performance in these tests met established safety and efficacy standards, likely mirroring or demonstrating similar performance to the predicate device.

For the remaining points (2-9), the information is not applicable to a physical device like surgical clips.

• 2. Sample sized used for the test set and the data provenance: Not applicable to physical clips. Testing involves benchtop models or animal studies for implantation, not human data sets.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for physical clips is established through engineering and biological testing standards, not expert annotation of data.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. MRMC studies are for AI/SaMD to compare human performance with and without AI assistance.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This concept applies to AI algorithms.
• 7. The type of ground truth used: For physical devices, ground truth for efficacy and safety is established through validated test methods (e.g., mechanical strength testing, leak resistance, biocompatibility standards, often with reference to predicate devices).
• 8. The sample size for the training set: Not applicable. This relates to AI model development.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the testing performed for a physical medical device (surgical clips) to demonstrate its substantial equivalence to a predicate device, focusing on non-clinical performance and biocompatibility rather than AI/software performance metrics.

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The UltraCor™ Twirl™ Breast Tissue Marker is intended for use to attach to soft breast tissue, including axillary lymph nodes, to radiographically mark the location of the biopsy procedure.

The UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover) consists of a disposable beveled needle applicator containing a Nitinol radiographic marker is intended for long-term radiographic marking of the tissue site. The applicator has a beveled 17g x 10cm needle with 1 cm depth marks and a locking plunger. Each marker shape is deployed from the beveled needle tip into the tissue site.

Here's an analysis of the provided text regarding acceptance criteria and performance studies, based on the requested categories.

Important Note: The provided document is an FDA 510(k) summary for a breast tissue marker. This type of device is a physical implant, not a software-driven AI solution. Therefore, many of the typical questions related to AI/ML device performance (like MRMC studies, training/test set ground truth establishment for an algorithm, expert adjudication for image interpretation, etc.) are not applicable to this document. The "tests" performed here are physical and chemical property tests, not clinical performance studies involving patient images and expert readers.

I will populate the table and address the questions as best as possible given the nature of the device and the provided document.

Acceptance Criteria and Device Performance Study for UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover)

As per the FDA 510(k) Summary (K243642), the device is a physical breast tissue marker. The "performance testing" summarized here pertains to the physical and chemical properties of the marker and its applicator, assessing its safety and effectiveness for its intended use as an implantable marker. It is designed to be substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" with numerical thresholds for these tests, but rather reports "Pass" or lists the type of analysis performed. This is common for biocompatibility and material safety testing where the goal is to demonstrate compliance with standards rather than specific performance metrics against a clinical endpoint.

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

Due to the nature of the device (implantable clip, not an AI diagnostic algorithm), the concept of a "test set" in the context of clinical data/images doesn't apply directly.

• Sample Size: The document does not specify the sample sizes (number of markers or material samples) for each individual non-clinical test (e.g., how many markers were tested for deployment force, or how many rats were used for the subchronic toxicity study). However, the tests performed (biocompatibility, mechanical, radiographic visibility) inherently involve testing a sufficient sample size of the device or its components to ensure statistical reliability and demonstrate compliance with relevant standards.
• Data Provenance: Not applicable in the sense of patient data. The tests are laboratory-based, performed on the device itself or its materials. The document does not state the country of origin for the testing.
• Retrospective or Prospective: Not applicable; these are laboratory and animal studies, not human clinical studies involving observational data.

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

This is not applicable as the device is a physical marker and its performance evaluation involves laboratory testing and animal studies (e.g., biocompatibility) rather than human expert interpretation of images for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation of data requiring adjudication for this type of device and performance testing.

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

No, a MRMC study was not done. This type of study is specifically designed for evaluating diagnostic algorithms or imaging techniques where human readers interpret medical images. The UltraCor™ Twirl™ Breast Tissue Marker is a physical implantable device, and its safety and performance are assessed through physical, chemical, and, in some cases, animal biocompatibility testing. It is not an AI-based diagnostic tool.

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

The "ground truth" for the performance tests outlined here is established through:

• Standardized Physical and Chemical Measurements: For tests like marker differentiation, visibility, retention, deployment accuracy, force, and corrosion, the ground truth is determined by objective, measurable physical and chemical properties and engineering specifications.
• Biocompatibility Standards: For the extensive biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation), the "ground truth" is compliance with international standards (e.g., ISO 10993 series) and observed biological responses in in vitro and in vivo models. "Pass" indicates that the material did not induce unacceptable biological reactions.

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. This is not an AI/ML device that requires a training set.

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The AtriClip LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

The AtriClip PRO-Mini LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip (AtriClip Mini) preloaded on a Single Use Clip Applier along with a Selection Guide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure exclusion of the left atrial appendage (LAA). The Clip is then deployed and is left as a permanent implant, and excludes the LAA, resulting in electrical isolation of the LAA. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm. The PRO-Mini device is a disposable device with a handle, leftright and up/down articulation knobs, articulation lock, deployment tab, shaft, suture anchors, and end effector containing the AtriClip Mini.

This document outlines the FDA's clearance for the AtriClip PRO-Mini LAA Exclusion System (PROM) based on its substantial equivalence to previously cleared predicate devices. The information provided primarily focuses on the device's technical characteristics and the non-clinical bench testing performed to demonstrate this equivalence. It does not describe a study involving algorithms, AI, human readers, or clinical performance metrics that would typically have acceptance criteria like sensitivity, specificity, or AUC when evaluating diagnostic or prognostic devices.

Therefore, many of the requested sections (2-6, 8-9) are not applicable or cannot be extracted from this document as they pertain to clinical or AI/algorithm-based studies, which are not described here.

Here's the information that can be extracted or inferred from the provided text, focusing on the device's substantial equivalence through bench testing:

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

Based on the provided text, the acceptance criteria are generalized as demonstrating "equivalence in performance" and not raising "any new issues of safety." The reported performance is that the device "met the predetermined acceptance criteria." Specific quantitative acceptance criteria are not detailed in this document, nor are specific quantitative performance results.

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

This information is not provided in the document. The document refers to "bench testing," which implies laboratory-based tests rather than patient data.

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)

This information is not provided as the study is non-clinical bench testing, not a study requiring expert clinical interpretation for ground truth establishment.

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

This information is not provided as the study is non-clinical bench testing, and adjudication methods are typically used for expert clinical review of cases.

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 and is not described in this document. This document pertains to the clearance of a physical medical device (implantable clip system) based on non-clinical bench testing, not an AI or imaging device involving human readers.

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

Not Applicable. This document describes a physical medical device, not an algorithm or AI system.

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

For the non-clinical bench testing, "ground truth" would likely be established by engineering specifications, material standards, and validated testing methodologies to measure mechanical properties, reliability, and tissue interaction. The document doesn't explicitly state the methodology for establishing this "ground truth" for each bench test, but it is implied by the nature of such testing.

8. The sample size for the training set

Not Applicable. This document describes the clearance of a physical medical device based on non-clinical bench testing, not an AI or algorithm-based device that would require a training set.

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

Not Applicable. As no training set is described or implied, the establishment of its ground truth is not relevant.

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ZIPCLIP is indicated for use in surgical procedures to occlude blood vessels.

The GEM ZIPCLIP (ZIPCLIP) is a sterile, single-use automatic microclip applier. Each device contains 15 titanium microclips. When applied on a vessel, microclips remain with the patient as permanent implants. ZIPCLIP is for prescription use only and the use environment is the operating room. The ZIPCLIP device is a pre-loaded, disposable, single-patient use mechanical assembly comprised of plastic and metal components. The applier device has (2) scissor-like handles that, when driven medially, close the distal jaws forming a closed clip the device in the open configuration. When released, the handles return to their resting state and the closed clip disengages from the applier. Simultaneously, a new clip is automatically loaded into the distal jaws for consecutive firing. When ZIPCLIP is empty a lockout clip (anodized gold in color) deploys between the jaws, preventing them from closing. The ZIPCLIP is a mechanical assembly comprised of plastic and metal components. The clips are composed exclusively of titanium (Grade 1) and are supplied sterile in a preloaded channel that is incorporated into the number of clips per applier is fifteen (15). The clips are stacked and contained internal to the device. Clips cannot be reloaded once the stack is deployed and the applier is disposed of once emptied. Note, the ZIPCLIP preloaded microclips that can be used with the ZIPCLP device.

Here is an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your request.

Please note: The provided document is a 510(k) summary for a medical device (GEM ZIPCLIP, an implantable clip) and primarily focuses on demonstrating substantial equivalence to a predicate device. It describes performance testing but does not detail acceptance criteria in the format of specific thresholds for metrics like sensitivity, specificity, accuracy, or human reader improvement, which are typical for AI/ML-based medical devices or diagnostic tools. The document describes a traditional medical device (a surgical clip) and its mechanical performance rather than the performance of a software algorithm. Therefore, many of your requested points related to AI/ML device studies (e.g., ground truth establishment for training sets, MRMC studies, standalone algorithm performance, AI assistance effect size) are not applicable to this document's content.

Acceptance Criteria and Device Performance for GEM ZIPCLIP

As per the provided 510(k) Summary for the GEM ZIPCLIP, the device is a sterile, single-use automatic microclip applier containing titanium microclips for occluding blood vessels. The performance testing described is focused on the mechanical and functional aspects of the device, rather than the diagnostic capabilities typical of AI/ML software.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific, quantitative acceptance criteria (e.g., success rates, tensile strength thresholds) with corresponding numerical reported performance values. Instead, it states the purpose of the testing and implies successful meeting of implicit performance criteria necessary for safe and effective occlusion.

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

• Sample Size for Test Set: The document does not specify the exact number of test units (e.g., appliers, clips) or the number of vessels or simulations used in the bench testing. It broadly states that "bench performance testing" was performed.
• Data Provenance: The testing was "bench testing" conducted by Baxter (Synovis Micro Companies Alliance is part of Baxter, as indicated by the contact email). This implies a controlled laboratory environment.
  • Country of Origin: Not explicitly stated, but typically assumed to be the country of the manufacturer or its testing facilities (likely USA, given the FDA submission).
  • Retrospective or Prospective: Not applicable as this relates to clinical data. The bench testing would be considered prospective in its execution (i.e., tests were planned and executed to gather performance data).

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

This concept is not applicable to this type of device and study. The "ground truth" for a surgical clip is its physical performance (e.g., does it close properly, does it occlude a vessel, does it stay closed). This is assessed via engineering and mechanical testing, not by expert interpretation of images or clinical outcomes in the diagnostic sense.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple human readers or experts are involved in interpreting complex data (e.g., medical images) to establish a consensus "ground truth." For the mechanical testing of a surgical clip, direct measurements and observable outcomes determine performance.

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

No, a MRMC study was not done. This type of study is specifically designed for evaluating diagnostic devices, especially those involving AI, to measure the impact of AI assistance on human reader performance. As the GEM ZIPCLIP is a mechanical surgical device and not a diagnostic tool, an MRMC study is not applicable. Therefore, there is no effect size reported for human readers improving with AI assistance.

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

Not Applicable. The GEM ZIPCLIP is a physical medical device (surgical clip applier), not a software algorithm. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is:

• Physical Verification/Measurement: Successful deployment, proper closure of clips, and effective occlusion on "simulated vessels" using "benchtop models."
• Material Properties Testing: Verification of titanium material (Grade 1) and MR-Conditional properties.
• Functional Observation: Observing the mechanical actions of the applier (e.g., automatic loading, lockout mechanism).

Essentially, the "ground truth" is established by direct engineering and biomechanical testing demonstrating the functional capabilities and material characteristics of the device.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI/ML algorithm, so 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 algorithm, this question is not relevant to the GEM ZIPCLIP device.

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The implanted SmartClip® is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

The SmartClip® is an ethylene oxide sterile, single use device composed of a soft tissue marker preloaded in a delivery system. The marker is intended to be placed within soft tissue. The marker is visible using radiography (including mammographic imaging), ultrasound and MRI.

Marker:
A sterile, single use device permanently implanted marker is approximately 8 mm long and 1.25mm wide. The marker is placed into the barrel of the introducer and maintained prior to insertion by a biocompatible bone wax plug. The marker can be implanted into various types of soft tissue (e.g., lung, gastrointestinal system, and subsequently be detected by means of radiography (including mammographic imaging, ultrasound and MRI.

Delivery System:
The Delivery System consists of a stylet-lock to prevent accidental deployment and 17ga introducer needle with male luer lock nut. The stainless steel needle is approximately 2.2 cm. The marker is preloaded inside the needle and retained by a bone wax plug. The male luer lock nut provides secure attachment to the proximal end of a biopsy needle. When the stylet is completely depressed the marker and bone wax plug are deployed from the end of the proximal end of the biopsy needle.

The provided text is a K233639 510(k) Summary for the Elucent Medical, Inc. SmartClip Secure Soft Tissue Marker. It details the device, its intended use, and a summary of testing performed to demonstrate substantial equivalence to a predicate device. However, it does not include specific acceptance criteria or a detailed study description with performance metrics for how the device meets those criteria.

Here's a breakdown of what is and is not available in the provided text regarding your request:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: The document states that "Tested units met the acceptance criteria as defined in formal verification protocols," but it does not list these criteria or the specific performance results against them.
• Sample sizes used for the test set and the data provenance: Only general types of tests are listed (e.g., Simulated Use, Mechanical Integrity). The specific sample sizes for these tests are not provided, nor is the data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present, as clinical testing was deemed "not applicable" for this submission.
• Adjudication method for the test set: Not applicable, as no human reader studies are described.
• 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: This device is a physical tissue marker, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As clinical testing was not applicable, ground truth in the context of diagnostic accuracy is not discussed. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.
• The sample size for the training set: Not applicable, as this is a physical device, not a machine learning model.
• How the ground truth for the training set was established: Not applicable.

Information available in the provided text (related but not directly answering the core request about AI performance):

The document focuses on non-clinical testing to demonstrate the safety and effectiveness of the device. It lists the categories of tests performed:

• Simulated Use
• Mechanical Integrity
• Imaging Assessment
• MR Compatibility
• Biocompatibility (ISO 10993-1)
• Packaging (ISO 11607-1)
• Shelf Life
• Sterilization (ISO 11135)

The conclusion states: "SmartClip® Secure Soft Tissue Marker was verified to meet the all the product requirements and specifications. Tested units met the acceptance criteria as defined in formal verification protocols, meeting all requirements."

*In summary, the provided document is a 510(k) summary for a physical medical device (soft tissue marker) and does not contain the detailed information you requested regarding acceptance criteria and study data for AI performance or diagnostic accuracy studies. The submission is based on demonstrating substantial equivalence through non-clinical performance and safety testing against engineering standards.

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The PeritX™ Drainage Kits are indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.

The PeritX™ Peritoneal Catheter System is indicated for intermittent, long-term drainage of symptomatic, recurrent, malignant and nonmalignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms relate to recurrent ascites. The use of the PeritX™ Peritoneal Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intra hepatic portosystemic shunt or LVP. The PeritX™ Peritoneal Catheter is indicated for adults only.

The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

For Pleural Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long-term drainage of symptomatic, recurrent, pleural effusion, including malignant pleural effusion and other recurrent effusions that do not respond to medical management of the underlying disease. The devices are indicated for the palliation of dyspnea due to pleural effusion and providing pleurodesis (resolution of the pleural effusion). The PleurX™ Low Profile Catheter is indicated for adults only.

For Peritoneal Use: The PleurX™ LP Catheter Mini Kit is indicated for intermittent, long term drainage of symptomatic, recurrent, malignant and non-malignant ascites that does not respond to medical management of the underlying disease and for the palliation of symptoms related to recurrent ascites. The use of the PleurX™ Low Profile Catheter for non-malignant ascites is limited to patients who are intolerant or resistant to maximum medical therapy, refractory to large volume paracentesis (LVP) and are not candidates for a trans-jugular intrahepatic portosystemic shunt or LVP. The PleurX™ Low Profile Catheter is indicated for adults only.

The Lockable Drainage Line is used to drain fluid using standard wall suction, water seal drainage system, vacuum bottle, or other appropriate method.

The PeritX™ Valve Kit is indicated for use in adults only. The PeritX™ Valve Kit is designed for health care facility use only. There is no change to the PeritX™ Valve Kit within this submission.

For Pleural Use: The Catheter Access Kit is intended to provide access to the PleurX™ Catheter to inject and withdraw fluids.

For Peritoneal Use: The Catheter Access Kit is intended to provide access to the PeritX™ Catheter for aspiration and catheter maintenance.

The Lockable Drainage Line is indicated for use only with the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter for intermittent drainage.

The Lockable Drainage Line Kit is indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage. The Lockable Drainage Line Kit is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, or other appropriate method (portable suction).

The PleurX™ Supplemental Insertion Kit intended to aid in the percutaneous insertion of a PleurX™ Catheter into the pleural space and PeritX™ Catheter into the peritoneal space.

The Procedure Pack is indicated for dressing of the PleurX™ Pleural Catheter and PeritX™ Peritoneal Catheter and exit site.

The PleurX™ Drainage Kits are indicated for use only with the PleurX™ Catheter and PeritX™ Catheter for intermittent drainage.

The PeritX™ Drainage Bag is indicated for use only with the PeritX™ Peritoneal Catheter for intermittent drainage.

The subject device, the PeritX™ Peritoneal Catheter System, includes the PeritX™ Peritoneal Catheter and PleurX™ Low Profile Catheter, sterile, single use indwelling peritoneal catheters, the PeritX™ Valve Kit, Catheter Access Kit, Lockable Drainage Line, Lockable Drainage Line Kit, PleurX™ Supplemental Insertion Kit, Procedure Pack, PleurX™ Drainage Kits, and the PeritX™ Drainage Bag that allow for the management of ascites at home.

The PeritX™ Drainage Kit (for vacuum-initiated drainage) is a sterile, single use fluid collection device used with the Peritoneal Catheter to drain fluid from the peritoneal cavity to relieve symptoms associated with malignant and non-malignant ascites. The PeritX™ Drainage Kit includes the PeritX™ Drainage Bag and Procedure Pack. The PeritX™ Drainage Kit is offered in two sizes (1L and 2L).

This document is a 510(k) summary for the PeritX™ Peritoneal Catheter System. It describes a medical device, which is a peritoneal dialysis system and accessories. This is a Class II device. The document states that performance testing was conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided text in the context of device acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria for the performance tests conducted. Instead, it lists the types of non-clinical tests performed to evaluate "technological characteristics and performance criteria". The conclusion states that the device's performance is "comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device."

Table of Acceptance Criteria and Reported Device Performance:

The study primarily focuses on demonstrating equivalence through various engineering and functional tests rather than clinical efficacy, given it's a 510(k) submission for a device system with a new accessory.

Details of the Study:

• 1. Table of Acceptance Criteria and the Reported Device Performance:
  As noted above, specific quantitative acceptance criteria are not presented in the provided text. The reported device performance is a general statement of comparability and equivalent safety and effectiveness to the predicate device.

• 2. Sample Size Used for the Test Set and Data Provenance:
  The document lists various non-clinical tests (e.g., Visual Inspection, Tensile Strength, Volume Capacity, Drop Test, Resistance to Leakage). However, it does not specify the sample size used for any of these tests. The data provenance is implied to be from internal testing conducted by Bard Peripheral Vascular, Inc. within the USA. The data is non-clinical, likely from laboratory testing.

• 3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
  This information is not provided in the document, as the testing described is non-clinical (engineering and functional tests), not involving expert-established ground truth in the typical clinical sense.

• 4. Adjudication Method for the Test Set:
  This information is not provided as the tests are non-clinical and do not involve human interpretation or adjudication in the context of clinical studies.

• 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
  No MRMC comparative effectiveness study was done. The document focuses on non-clinical performance testing for substantial equivalence.

• 6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
  This question is not applicable as the device is a physical medical device (catheter system and accessories), not a software algorithm with standalone performance metrics.

• 7. Type of Ground Truth Used:
  The "ground truth" for the non-clinical tests performed would be defined by engineering specifications, material properties, and functional requirements. For example, a tensile strength test would have a specified minimum strength that the device must meet. This is derived from design requirements and industry standards, not from expert consensus, pathology, or outcomes data in the clinical sense.

• 8. Sample Size for the Training Set:
  This information is not applicable as the device is a physical medical device and does not involve AI or machine learning models that require a "training set."

• 9. How the Ground Truth for the Training Set Was Established:
  This information is not applicable for the same reason as point 8.

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The Trilogy Tissue Marker is intended for use to attach to breast tissue at the surgical breast biopsy or percutaneous breast biopsy to radiographically mark the biopsy procedure, and be permanently visible under MRI, x-ray and ultrasound.

The Trilogy Tissue Marker is a sterile, single use device comprised of a disposable delivery device preloaded with a tissue marker. The disposable delivery device includes an introducer needle comprised of a plastic molded deployment handle, a thumb slide, a 14 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. Trilogy tissue markers are made of a non-resorbable polymer embedded with a nitinol shape, allowing for permanent visibility under ultrasound, x-ray, and MRI. This device offers the choice of three unique tissue marker shapes (i) Ring (ii) Cross (iii) Ribbon.

The provided document is a 510(k) summary for the Trilogy Tissue Marker. It details a comparison between the subject device and a predicate device (EasyMark™ Tissue Marker) to demonstrate substantial equivalence, rather than a study about acceptance criteria for an AI device. Therefore, much of the requested information regarding AI device acceptance criteria and study design is not available in this document.

However, I can extract the information related to the device performance and the testing conducted to support its substantial equivalence with the predicate device.

Here's a breakdown of the available information:

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

The document does not detail specific quantitative acceptance criteria or performance metrics in a readily extractable table form. Instead, it lists the types of performance tests conducted and states that the device meets "all system requirements" and is "substantially equivalent" to the predicate device.

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 does not provide details on the sample sizes used for the "Non-Clinical Bench Performance Testing." It also does not specify data provenance (e.g., country of origin or retrospective/prospective nature), as the testing appears to be primarily bench-based (laboratory testing).

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)

This information is not applicable and not provided. The study described is not a clinical study involving expert interpretation of medical images or data from human subjects. It focuses on the physical and functional aspects of a medical device (a tissue marker).

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

This information is not applicable and not provided, as the study is not an AI performance evaluation involving multiple readers or complex ground truth 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study relates to the performance of AI systems in assisting human readers, which is not the subject of this 510(k) submission.

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

A standalone performance study of an algorithm was not done. This submission is for a physical medical device (tissue marker), not an AI algorithm.

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

The concept of "ground truth" as typically used in AI studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. The "ground truth" for the bench performance testing of this physical device would stem from objective measurement standards and engineering specifications. For instance, "Accuracy of Marker Deployment" would be evaluated against designed specifications for marker placement, and "Tissue Marker Migration Potential" would be assessed against defined metrics for stability.

8. The sample size for the training set

This information is not applicable and not provided, as this is not an AI device that requires a training set.

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

This information is not applicable and not provided, as this is not an AI device.

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The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can only be implanted for less than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI 2 System), the MOLLI Marker is located and surgically removed with the target tissue.

The MOLLI 2 System is intended only for the non-imaging detection of the MOLLI Marker that has been implanted in a site intended for surgical removal.

The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can only be implanted for less than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by nonimaging guidance (MOLLI 2 System), the MOLLI Marker is located and surgically removed with the target tissue. The MOLLI 2 System is intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

This FDA 510(k) summary focuses on design modifications to an existing device, the MOLLI 2 System, specifically introducing new MOLLI Wand configurations (MOLLI OncoPen, MOLLI OncoPen Prime, MOLLI OncoPen Elite) and corresponding software/hardware updates. As such, the submission primarily relies on non-clinical testing to demonstrate substantial equivalence, rather than a full de novo clinical study with detailed performance outcomes like sensitivity and specificity.

Therefore, many of the requested detailed points regarding acceptance criteria, study design for performance metrics like sensitivity/specificity, expert consensus, and effects on human reader performance are not explicitly available or described in this type of submission. The provided text outlines what non-clinical tests were conducted to support the changes.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "Performance Testing including Multi Marker Localization System Accuracy, Wand Essential Performance (Accuracy and Feedback) and Multi Tissue Accuracy Testing" was performed. However, it does not provide specific acceptance criteria values (e.g., "accuracy must be > 95%") nor the reported numerical performance values. It only concludes that "The results of these reports indicate that the subject device is substantially equivalent to the predicate device."

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

Not specified in the provided text. The testing was non-clinical (laboratory/benchtop) rather than human subject testing, so "country of origin of the data" and "retrospective or prospective" do not apply in the typical sense of clinical trials.

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

Not applicable/specified. For non-clinical performance testing, the ground truth would typically be established by calibrated instruments or predefined scenarios, not human experts.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where human readers interpret data, not for non-clinical device performance testing.

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

No, a MRMC comparative effectiveness study was not done. The submission focuses on non-clinical testing for design changes.

6. Standalone (Algorithm Only) Performance

The "MOLLI 2 System" is a device that includes hardware (wands, tablet) and software. The performance testing described (Multi Marker Localization System Accuracy, Wand Essential Performance, Multi Tissue Accuracy) would be considered standalone performance of the device's ability to detect and localize markers, without a human "interpretation" component in the clinical sense. However, the exact metrics and results are not provided.

7. Type of Ground Truth Used

For the non-clinical performance testing, the ground truth would typically be established through:

• Engineering specifications / Known values: For accuracy tests, the true position or characteristics of the marker would be precisely known or set.
• Calibrated measurement tools: Instruments used to measure the output of the device would be calibrated to provide true values.
• Controlled experimental setups: Scenarios designed to simulate real-world use with known parameters.

8. Sample Size for the Training Set

Not applicable. This is a 510(k) for device modifications, not an AI/ML algorithm development submission requiring a "training set" in the machine learning sense. The software modifications are to support communication and compatibility with new hardware, implying changes to control logic rather than a learning algorithm.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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