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The Duo-Flow® Side X Side double lumen catheter is intended for short-term central venous access for hemodialysis, apheresis and infusion.

The Duo-Flow® Side X Side double lumen catheter is a radiopaque, polyurethane tube with two D-shaped lumina. The lumina can be distinguished by the color-coded luers:

• Red Adaptor = proximal lumen
• Blue Adaptor = distal lumen
  The proximal lumen provides "arterial" outflow from the patient; the distal lumen provides "venous" return.
  The catheter comes in a variety of sizes and is offered with curved or straight extensions.
  The Duo-Flow® Side x Side Catheter removes and returns blood through two segregated lumen passages. Each lumen is connected to an extension line with color-coded female luer connectors. The transition between lumen and extension is housed within a molded hub. Both arterial and venous lumens contain side-holes. The catheter incorporates Barium Sulphate to facilitate visualization under fluoroscopy or Xray. All sizes of the Duo-Flow® Side x Side Catheter are available in a Basic Set intended to be used in an Interventional Radiology or Operating Suite. The Set includes primary insertion componentry for the Modified Seldinger Insertion Technique.

The provided FDA 510(k) clearance letter describes the 14F Duo-Flow® Side X Side Double Lumen Catheter and its substantial equivalence to a predicate device. However, this document does not detail an AI/algorithm-based medical device performance study.

The submission is for a physical medical device (a catheter) and focuses on demonstrating substantial equivalence through non-clinical (bench) testing and comparison of technical specifications with a previously cleared predicate device. Therefore, many of the requested details regarding AI/algorithm performance (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable to this particular FDA clearance.

Here's an analysis based on the information provided, highlighting the acceptance criteria and how the device meets them within the context of a physical device submission and not an AI/algorithm study:

Acceptance Criteria and Reported Device Performance (Non-AI/Algorithm Device)

The acceptance criteria for this physical medical device are derived from establishing substantial equivalence to a predicate device (Duo-Flow® Side x Side Double Lumen Catheter, K192807) through a combination of identical intended use, similar technological characteristics, and satisfactory non-clinical performance testing. The "performance" here refers to physical and mechanical attributes, not diagnostic or predictive accuracy.

Table of Acceptance Criteria and Reported Device Performance (Focus on Substantial Equivalence and Bench Testing):

Details Not Applicable to this Submission (as it's not an AI/Algorithm Device):

The following information requested in the prompt is not applicable to this 510(k) submission, as it pertains to AI/algorithm-based medical devices or clinical studies that were explicitly stated as "not required nor performed":

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device clearance based on bench testing. No "test set" in the context of diagnostic data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No diagnostic test set or adjudication was involved.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device. The document explicitly states "Clinical testing was not required nor performed to support the substantial equivalence of these devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" concept does not apply to the physical and mechanical performance testing of a catheter.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable. This is a physical device, not an AI model.

In summary, the FDA 510(k) K250836 clearance for the 14F Duo-Flow® Side X Side Double Lumen Catheter is for a physical medical device. The "acceptance criteria" and "study" described in the document are focused on demonstrating substantial equivalence to a predicate device through comparison of intended use, technological characteristics, and comprehensive non-clinical (bench) performance testing. There is no information regarding AI/algorithm performance or clinical studies in this submission.

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The Duoblade Plus SE (Models: DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH), and Duoblade Prime (Models: DB1P, DB1P-T, DB1P-H, DB1P-TH) are intended for general electrosurgical applications, including cutting and coagulation. These models are designed without shaft extension functionalities. The Model: DB1EP, DB1EP -T, DB1EP-H, DB1EP-TH are compatible with the smoke evacuation system, removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The Electrosurgical Cutting and Coagulation Device and Accessories (Model: Duoblade Plus SE, Duoblade Prime) is a single-use, monopolar RF device designed to be used with a qualified Generator as part of the Surgery System. It uses high-frequency energy (RF Monopolar Energy) to generate heat for tissue cutting and coagulation. It can be operated using the integrated hand switch or a qualified Footswitch. The device's design simplifies functionality by excluding shaft extension features. The models of Duoblade Plus SE and Duoblade Prime are identified according to with/without a suction function (removing smoke), and a swivel function.

• Suction & swivel function (Duoblade Plus SE): DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH
• No Suction & swivel function (Duoblade Prime): DB1P, DB1P-T, DB1P-H, DB1P-TH
  The scope of the submission only includes the addition of model without functions, such as swivel function, shaft extension function and appearance change for marketing purpose.

The provided FDA 510(k) clearance letter and summary are for an electrosurgical device (Duoblade Plus SE, Duoblade Prime), not an AI/software device that would involve a test set, ground truth experts, or MRMC studies. The document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of features, materials, and established non-clinical tests relevant to electrosurgical devices (e.g., biocompatibility, sterility, electrical safety, thermal effects on tissue).

Therefore, I cannot extract the information required by your prompt regarding acceptance criteria, test set details, ground truth establishment, or human reader effectiveness studies, as these concepts are not applicable to the type of device described in this 510(k) submission.

The document states:

• "No clinical studies were considered for this submission." This directly indicates that there was no human-in-the-loop performance study, nor any evaluation of "how human readers improve with AI vs without AI assistance" because there's no AI component.
• "The thermal effects of a subject device are the same as the predicate device." This highlights that the performance demonstration relies on equivalence to a previously cleared device, not on new independent performance metrics against a defined acceptance criterion of the type you've outlined. The non-clinical test mentioned ("Thermal effects on tissue") is a comparative study against a positive control device, not a test with a specific quantitative acceptance criterion for the new device on its own.

In summary, because this 510(k) submission is for a physical electrosurgical device and not an AI/software product, the requested information about acceptance criteria for AI performance, test sets, ground truth experts, and MRMC studies is not present in the provided text.

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HYHUB™ and HYHUB™ Duo vial access devices are indicated for patients 17 years of age or older to allow a drug to be transferred from vials without using a needle, as prescribed, in a home environment or clinical setting.

The HYHUB™ and HYHUB™ DUO vial access devices (VAD) are a stand-alone, single-use, disposable, non-pyrogenic, gamma sterilized device, which are intended to support the infusion of two medicinal liquids, as prescribed, in a home environment or clinical setting. The VAD is designed to accommodate up to two (2) or four (4) dual vial units (DVU) to be docked onto the VAD infusion tray which allows the transfer of medicinal liquids in a sequential, needleless manner using standard connections for syringes, applicable pumps, and infusion sets.

The FDA 510(k) clearance letter for the HyHub™ and HyHub™ Duo Vial Access Devices (K243404) does not contain the level of detail typically found in a clinical study report or a summary of clinical performance for AI/ML-based devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through bench testing, biocompatibility testing, and a comparison of technological characteristics.

Therefore, many of the requested categories relating to acceptance criteria for AI inference, dedicated test sets, expert adjudication, MRMC studies, standalone algorithm performance, and detailed training data are not applicable or cannot be extracted from this document. The document describes a medical device, not an AI/ML algorithm.

However, I can extract the information relevant to the performance testing that was conducted to demonstrate this device meets its requirements for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like the HyHub, "acceptance criteria" are generally tied to meeting specific performance standards based on recognized test methods or internal protocols. The document does not explicitly state numerical acceptance criteria for each test alongside performance data in a single table, but it lists the tests performed and implies successful completion for substantial equivalence.

Since the document does not provide specific numerical acceptance criteria and reported performance results for each test (e.g., maximum allowable leak rate vs. measured leak rate), I can only present the categories of tests performed.

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

This information is not provided in the FDA 510(k) letter. The document mentions "bench tests" and "biocompatibility evaluation," implying a set of physical devices were tested rather than a "test set" of data in the AI/ML context. No details on the number of units tested per bench test are given, nor is information on geographical origin or retrospective/prospective nature of data for this type of hardware device.

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

This information is not applicable for this type of device and submission. The "ground truth" for a vial access device is its physical performance against established engineering and biocompatibility standards, not expert interpretation of medical images or data.

4. Adjudication Method

Not applicable for this device type. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or labeling of data, typically for AI/ML device validation.

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

No. An MRMC study is not mentioned because this device is a physical vial access device, not an AI/ML diagnostic or assistive tool for human readers.

6. Standalone Performance Study (Algorithm Only)

No. This is a physical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on established engineering and biocompatibility standards, and physical performance measurements.

• Bench Testing: Objective measurements against documented specifications for leak rates, particulate generation, flow rates, residual volumes, connector compatibility, and package integrity.
• Biocompatibility Testing: Results from established in-vitro and in-vivo tests (e.g., cytotoxicity, sensitization, systemic toxicity, hemolysis) against defined biological safety endpoints as per ISO 10993-1.
• Sterility Validation: Demonstration of a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137 (for gamma radiation) or ISO 11135 (for ethylene oxide).
• Pyrogenicity: Testing to confirm the device is non-pyrogenic.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

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

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The EasyFlow Aortic Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass for up to 6 hours.

The EasyFlow Duo Cannula with guidewire is intended for use with cardiopulmonary bypass as an arterial return femoral cannula for up to 6 hours.

Easyflow & Easyflow Duo are single-use, non-toxic, non-pyrogenic fluid path devices and supplied sterile and individually packaged.

The Easyflow & Easyflow Duo are composed of the cannula and a malleable obturator inserted into the cannula to allow the placement of the cannula along the Artery.

The cannula is an open lumen PVC polymer tube incorporating wire reinforcement in distal sections. The distal sections of the cannula are perforated with multiple holes at multiple stages to allow fluid flow. The clear proximal section is not reinforced to allow clamping; the proximal end terminates in a 3/8" barbed connector for standard cardiopulmonary bypass tubing

In the Easyflow Duo models the device has a 0.035" hole punched in the very distal tip of the cannula and the obturator has an approx. 0.035" internal diameter central lumen to accommodate a 0.035" guide wire used to drive the cannula along the vessel till its final placement. Once the cannula is positioned onto the vessel the surgeon removes the obturator from the cannula tubing and connects it to the arterial line.

The Easyflow is packaged as sterile stand-alone device while the Easyflow Duo is packaged into a tray containing also a Guidewire, a Needle and Vascular Dilators in order to have a kit for vascular access packaged together with the cannula.

The Easyflow & Easyflow Duo are the modified version of the disposables currently marketed as the Easyflow cannula (K060101) and the Easyflow Duo cannula (K091542). Both modified and unmodified cannulae models are recommended for use as an arterial return cannula during cardiopulmonary bypass up to six hours

The provided FDA 510(k) Clearance Letter for the Easyflow Cannulae does not contain any information related to a study proving the device meets acceptance criteria for an AI/ML (Artificial Intelligence/Machine Learning) powered medical device.

This document describes a medical device (cannulae for cardiopulmonary bypass) which is a physical, single-use, non-toxic, non-pyrogenic fluid path device. The clearance is based on "substantial equivalence" to predicate devices, meaning it has similar indications for use and technological characteristics, with the primary change being the removal of phthalates (DEHP and DnHP) from the PVC materials.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device, as this information is not present in the provided text.

The information you asked for, such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, are all highly specific to the validation of AI/ML algorithms, which are not relevant to the Easyflow Cannulae as described in this FDA clearance.

In summary, based on the provided document, there is no AI/ML component to the Easyflow Cannulae, and thus no such study or acceptance criteria as you've outlined would be applicable or present.

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The EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V has been designed to be used with a video system center, light source, documentation equipment, monitor, endo therapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

The EVIS EXERA III DUODENOSCOPE TJF-Q190V has been designed to be used with an video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. The TJF-Q190V is compatible with Olympus system "Video System Center OLYMPUS CV-190 and XENON LIGHT SOURCE OLYMPUS CLV-190 (K112680)." TJF-Q190V is also compatible with Olympus system "EVIS X1 Video System Center OLYMPUS CV-1500 (K222584)."

The subject device consists of a flexible insertion section, control section and endoscope connector section with equipped charge-coupled device (CCD) chip which delivers images.

The light from the light source travels through the light guide to the light guide lens at the distal end. The light source can offer both white light for normal observation and narrow band imaging (NBI). The CCD chip transduces the incident light from the objective lens to electrical signal. The video processor transduces the electrical signal to video signal.

There is an instrument channel located inside of the flexible insertion section. EndoTherapy accessories can be inserted through the instrument channel. A forceps elevator is located at the distal end of the insertion section to elevate endo therapy accessories for endoscopic treatment.

A sterile, single-use distal cover (MAJ-2315) has been designed to be attached to the OLYMPUS TJF-Q190V to cover the distal end of the insertion tube and fit around the forceps elevator. MAJ-2315 is to be discarded after clinical use. MAJ-2315 and TJF-Q190V were previously cleared under 510(k)s K193182, K202661 and K220587.

The provided 510(k) clearance letter for the Olympus TJF-Q190V Duodenoscope indicates that the clearance is based on adhesive modifications to the device. This implies that the acceptance criteria and the study proving the device meets these criteria would primarily relate to the durability and safety of the new adhesive material and its impact on the overall performance of the endoscope, particularly concerning reprocessing and material integrity.

However, the provided text does not contain the detailed information typically found in a clinical study report or a summary of non-clinical performance data that would explicitly list acceptance criteria and device performance in the format requested. The document states:

• "Verification/validation activities were performed subsequent to a risk assessment evaluation of the device modifications per the Olympus Quality Management System."
• "Results of the following testing demonstrate that the changes to the device do not adversely affect device performance: Performance Testing - Bench, Sterilization and Shelf-Life - Residual Toxicity of Reprocessing Chemicals, Biocompatibility Evaluation."
• "No clinical data were collected."

This means the clearance was based on non-clinical (bench) testing. Therefore, I cannot provide information on clinical performance metrics, multi-reader multi-case studies, or the establishment of ground truth by human experts, as these were not part of the submission for this particular change.

Given the limited information, I will infer the implied acceptance criteria based on the described non-clinical tests.

Implied Acceptance Criteria and Reported Device Performance

Based on the provided information, the acceptance criteria would be related to the non-clinical performance of the device with the new adhesive, ensuring it is equivalent or superior to the predicate device, especially concerning durability against reprocessing and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance (Inferred)

Study Proving Device Meets Acceptance Criteria:

The study involved non-clinical, bench-level verification and validation activities.

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

• Sample Size: Not explicitly stated. For bench testing, this would typically involve a defined number of devices or components subjected to various tests (e.g., durability cycles, chemical exposure). The exact number of units or test replicates is not provided in the summary.
• Data Provenance: The manufacturing site is Aizu Olympus Co., Ltd., Japan. The testing would have been conducted in a controlled lab environment. This was a retrospective evaluation of a design modification, and the data would be laboratory-generated.

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

• This question is not applicable as "No clinical data were collected." The "ground truth" for non-clinical bench testing would be defined by engineering specifications, material standards, and validated test methods, rather than expert human interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set:

• Not applicable. As no clinical data or human evaluations were involved for this specific submission.

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

• No, a MRMC study was not done. The document explicitly states, "No clinical data were collected." Therefore, there is no information on how human readers might improve with or without AI assistance, as AI is not mentioned and no human reading study was conducted.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is a duodenoscope, a physical medical instrument, not an AI algorithm. There is no mention of a software algorithm or standalone performance in the context of AI.

7. Type of Ground Truth Used:

• For the non-clinical testing, the "ground truth" would be based on:
  • Engineering Specifications: Device design parameters, material specifications.
  • Regulatory Standards: ISO standards for biocompatibility (e.g., ISO 10993), sterilization, and other relevant performance standards for endoscopes.
  • Validated Test Methods: Established laboratory protocols for evaluating material durability, chemical resistance, and device functionality.
  • Predicate Device Performance Baseline: The performance characteristics of the legally marketed predicate device (K202661) served as a benchmark for substantial equivalence.

8. Sample Size for the Training Set:

• Not applicable. This submission focuses on a hardware modification (adhesive) to an existing device, not the development or training of a software algorithm.

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

• Not applicable. As there was no training set for a software algorithm.

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The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view.

The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) – resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) – Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option.

The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The Low Dose Lung Cancer Screening (LD LCS) option indication for Arineta's SpotLight and SpotLight Duo scanners is being expanded to include small patients, as defined by AAPM (American Association of Physicists in Medicine). This expansion ensures comprehensive coverage of the intended lung cancer screening population, following the previous clearance of the LD LCS option for medium and large patients under K241200.

The proposed LD LCS option for the SpotLight and SpotLight Duo includes scan protocols with CTDI that comply with AAPM's requirements for the whole LD LCS population patient size groups, as detailed in the following table:

There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied.

The proposed full LD LCS protocols option, as the cleared K241200, will be activated by service or production personnel, with no additional installation required (option activation only).

This FDA 510(k) clearance letter describes the acceptance criteria and study proving the SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option (specifically for small patients) meets these criteria.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are largely based on image quality and nodule detectability being maintained at low dose levels, specifically for small patients (50-70 kg) within the AAPM guidelines for CTDI. The reported performance confirms these criteria are met.

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The Plum Duo™ Precision IV Pump is intended for administration of parenteral fluids, medications, and whole blood and blood products through the following routes of administration: intravenous, intra-arterial, and subcutaneous.

The Plum Duo™ Precision IV Pump is intended for use in clinical environments in the hospital and other outpatient healthcare facilities by licensed healthcare professionals. These healthcare professionals are trained in the use of the infusion pump and the administration of therapies consistent with the intended use.

The Plum Duo™ Precision IV Pump is intended for adults, pediatric (including infants and children), and neonatal patient populations.

The Plum Duo™ Precision IV Pump is a large volume pump (LVP) with two independent pump channels that can deliver fluid to a patient from 1 to 4 lines independently. In addition, although the channels can operate independently, patient parameters can be shared across the channels to aid in ease of programming. The Plum Duo™ Precision IV Pump can only be used with dedicated PlumSet™ administration sets (not subject of this filing). Each pump channel accepts a cassette that is part of a PlumSet™ administration set and can connect to a primary and/or secondary container. The fluid is delivered from the upstream lines either serially (piggyback) or concurrently through the cassette to the downstream line. Each pump channel cassette has an independent downstream line (patient line), so the clinician can connect each downstream line to a single infusion site or two separate infusion sites. The flow rate accuracy precision has been improved (lower allowed variance) by implementing the new motor mechanism, as well as increased precision for programming concentration, flow rate and VTBI entries. The overall delivery accuracy of the system has improved to +/- 3% per TIR 101 standard condition testing and +/-5% for non-standard conditions.

The provided FDA 510(k) clearance letter and summary for the Plum Duo™ Precision IV Pump discuss the device's technical specifications and how it meets regulatory requirements for significant equivalence to a predicate device. However, this document does not describe the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML-driven medical device, as implied by the user's detailed request.

The Plum Duo™ Precision IV Pump is an infusion pump, a hardware medical device with embedded software, not an AI/ML diagnostic or prognostic tool. Therefore, the requested information (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) does not apply to this specific device or the information provided in the 510(k) summary.

The 510(k) summary focuses on "Non-Clinical Testing" which includes:

• Verification testing of product requirements
• Human factors validation testing
• Reliability goals testing
• Safety assurance case following FDA Guidance for Infusion Pumps
• Flow rate and bolus accuracy testing per AAMI TIR101
• Software verification and validation per relevant FDA guidance documents (2005 and 2021 draft for software functions), which are focused on traditional software engineering principles, not AI/ML model performance.
• Human factors evaluations per FDA guidance and IEC 62366-1
• Electrical and Electromagnetic Compatibility testing per IEC 60601-1 and IEC 60601-1-2
• Cybersecurity testing per FDA guidance documents (2014 and 2016)
• Risk management activities per ISO 14971:2019 +A11 2021

Conclusion based on the provided document:

The provided document does not contain the information required to answer the specific questions about acceptance criteria and study proving an AI/ML device meets them. The device described, the Plum Duo™ Precision IV Pump, is an infusion pump, and its clearance relies on non-clinical performance and safety data relevant to its mechanical and software functions, not AI/ML-driven insights or diagnostics.

Therefore, I cannot populate the table or answer the specific questions regarding AI/ML study design and ground truth establishment for this device based on the given text. The text explicitly states: "Clinical evaluation is not required for this submission to support substantial equivalence." This further indicates that the type of studies and data provenance you are asking about (which are typical for AI/ML diagnostic devices) were not part of this 510(k) submission.

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Niti-S Duodenal Comfort Stent is indicated for the palliative treatment of pyloric or duodenal obstructions caused by malignant neoplasms.

Niti-S Colonic Comfort Stent is indicated for the palliative treatment of colorectal strictures produced by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

The Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent consist of an implantable metallic stent and an introducer system.

The stent is made of nitinol wire and is designed as a flexible, fine mesh tubular prosthesis with several radiopaque markers. The Niti-S Duodenal Comfort Stent has a diameter of 22 mm, while the Niti-S Colonic Comfort Stent is available in diameters of 22 mm and 24 mm. Both stent types are available in lengths of 60 mm, 80 mm, 100 mm, and 120 mm.

The stent delivery system accommodates a 0.035 in (0.89 mm) guidewire. It is advanced over the guidewire and passed through an endoscope into the duodenum or colon. Fluoroscopy is recommended to ensure accurate device placement.

This document is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) for medical devices. It primarily focuses on the substantial equivalence determination for the Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent.

Crucially, this document does not describe studies involving AI or software-based medical devices with performance metrics like sensitivity, specificity, or AUC. It is for a physical medical device (stent and delivery system) and the performance testing mentioned are mechanical and material integrity tests.

Therefore, I cannot provide the information requested regarding acceptance criteria and studies proving the device meets those criteria in the context of an AI/software device. The questions about sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are all irrelevant to the content of this document.

The "Performance Testing" section (page 7) lists the following non-clinical tests:

• Packaging strength and dye penetration
• Sterility verification
• Deployment accuracy test
• Deployment force test
• Dimensional test
• Tensile strength test (SDS)
• Trackability and visualization test
• Repositioning force test

These are standard engineering and material science tests for physical medical devices to ensure they function as intended and are safe. The document states that the results "demonstrate that the Niti-S Duodenal Comfort Stent and Niti-S Colonic Comfort Stent are as safe and effective as the predicate device and supports a determination of substantial equivalence."

In summary, the provided document does not contain the information requested about AI device performance studies.

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