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The OASIS MRI System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician. these images provide information that can be useful in diagnosis determination.

Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses: T1, T2, proton density weighted imaging
Diffusion weighted imaging
MR Angiography
Image processing
Spectroscopy
Whole Body

The OASIS MRI System is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting magnet in a gantry design. Magnetic Resonance imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2. A RF emission or echo that can be measured accompanies these relaxation events.

The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.

The provided document, a 510(k) Summary for the OASIS MRI System (K240571), describes the device and its equivalence to a predicate device (OASIS MRI System K211406). The acceptance criteria and performance study details are primarily focused on a new feature, DLR Rise.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for DLR Rise. Instead, the acceptance is based on expert subjective evaluation of image quality metrics and clinical acceptability.

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The OASIS MRI System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The OASIS is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting maqnet in a qantry design.

The provided document is a 510(k) Premarket Notification from Hitachi Healthcare Americas for their OASIS MRI System. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (OASIS MRI System K202030) rather than presenting a detailed clinical study with acceptance criteria for a new device's performance.

Therefore, the document does not contain details about acceptance criteria or a study that specifically proves the device meets those criteria in the way typically expected for an AI/ML medical device.

However, I can extract information related to performance evaluation and testing that was conducted to support the substantial equivalence claim.

Here's an analysis based on the provided text:

No specific acceptance criteria and detailed study proving direct device performance against those criteria are provided in the document. The document primarily focuses on demonstrating substantial equivalence to a predicate device by evaluating changes and ensuring they do not affect safety or effectiveness.

Here's what can be extracted regarding the type of performance evaluation done:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no explicit table of acceptance criteria with corresponding device performance metrics is provided in the document for the new features. The evaluation is primarily framed in terms of demonstrating that new features perform as intended and do not raise new questions of safety or effectiveness compared to the predicate device.

The document states:

• "Performance bench testing was conducted on the applicable new features. Test data confirmed that each new feature perform as intended for diagnostic use."
• "Clinical image examples are provided for each applicable new feature and or coil that we judged to be sufficient to evaluate clinical usability."
• "Clinical images were collected and analyzed, to ensure that images from the new feature meet user needs."

These are qualitative statements about performance rather than quantitative acceptance criteria.

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

• Test Set Sample Size: Not specified. The document states "Clinical image examples are provided for each applicable new feature..." This suggests a qualitative review of examples rather than a statistically powered study with a defined sample size.
• Data Provenance: Not specified. The context implies these are images generated by the OASIS MRI system itself, but no details about the patient population, imaging sites, or whether the data is retrospective or prospective are given.

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

• Number of Experts: Not specified. The evaluations were "judged to be sufficient to evaluate clinical usability" and to "meet user needs," implying expert review, but the number or specific roles of these experts are not detailed.
• Qualifications of Experts: Not specified. The indications for use state that "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination." This indirectly suggests that the "judges" and "users" are likely trained physicians or radiologists, but their specific qualifications (e.g., years of experience, subspecialty) are not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the qualitative nature of the review ("judged to be sufficient," "meet user needs"), it's likely a consensus-based or individual expert assessment rather than a formal adjudicated process (e.g., 2+1, 3+1).

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

• MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The document focuses on demonstrating that the device (i.e., the MRI system itself) with new features is substantially equivalent to the predicate, not on how human readers' performance improves with or without AI assistance. The OASIS MRI System is an imaging device, and the changes described (coils, software functions) are enhancements to image acquisition and processing, not an AI-assisted diagnostic tool.

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

• Standalone Performance: The described device (OASIS MRI System) is an imaging system, not an algorithm intended for standalone diagnostic output. Therefore, a standalone performance evaluation in the context of an "algorithm only" is not applicable or described. The performance testing conducted for the new software functions (IP-Recon, IP-Scan, AutoPose Spine, AutoClip) would relate to their intended function within the MRI system (e.g., image reconstruction accuracy, scan automation effectiveness), not as standalone diagnostic algorithms.

7. The Type of Ground Truth Used

• Ground Truth Type: Not explicitly stated as "ground truth." The evaluation seems to rely on clinical usability and meeting user needs as assessed by qualified individuals (implicitly, physicians/radiologists). This would fall under a form of expert consensus/opinion regarding the quality and utility of the images produced by the new features. There's no mention of pathology, outcomes data, or other objective sources of ground truth.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/not specified. The document describes an MRI system and its software/hardware enhancements. It does not mention a "training set" in the context of machine learning model development. The software functions like IP-Recon, IP-Scan, AutoPose Spine, and AutoClip are likely rule-based or optimized algorithms, not necessarily deep learning models requiring a distinct "training set" in the common sense.

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

• Ground Truth Establishment for Training Set: Not applicable/not specified, as no training set for a machine learning model is mentioned.

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· Evacuate air and/or fluid from the chest cavity or mediastinum.
· Help re-establish lung expansion and restore breathing dynamics.
Chest Drain Auto transfusion (ATS)
To facilitate collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in postoperative and trauma blood loss management.

Atrium's Auto transfusion (ATS) Chest Drains are sterile, single use, disposable devices that mimic a traditional "3 Bottle Systems".

A closed thoracic drainage system (chest drain and catheter together) are used to restore the chest to a more normalized condition after surgery, trauma, or spontaneous need for air and/or fluid to be removed. The Auto transfusion (ATS) features of the drains facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

This document describes a 510(k) premarket notification for Atrium Medical Corporation's Auto transfusion (ATS) Chest Drains, specifically the Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, and Express Dry Seal Chest Drain. The filing argues for substantial equivalence to previously cleared predicate devices (K043140 and K043582).

Here's an analysis of the acceptance criteria and study information provided (or absence thereof):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with specific quantitative performance metrics. This 510(k) submission is focused on demonstrating substantial equivalence to predicate devices, rather than meeting novel performance criteria through new clinical trials.

The performance is implicitly described as being equivalent to the predicate devices and that the device "performs as well as the predicate devices."

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

• Test Set Sample Size: Not applicable. No dedicated "test set" in the context of clinical performance evaluation is mentioned for the modified device. The document states, "There were no clinical studies of the modified device."
• Data Provenance: Not applicable for a new clinical study. The submission relies on the established safety and performance of the predicate devices and extensive non-clinical testing of the modified devices.

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

Not applicable. No ground truth establishment by experts for a new clinical test set is mentioned.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication method is mentioned.

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 device is an auto transfusion chest drain, which is a physical medical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of a new clinical performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices (K043140 and K043582), as well as compliance with relevant voluntary standards and successful completion of non-clinical tests.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set.

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

Not applicable. The device is not an AI/ML algorithm.

Summary of Acceptance Criteria and "Study" (Non-Clinical) Proving Equivalence:

The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed predicate devices. The "study" that proves this involves a comprehensive non-clinical assessment, outlined as follows:

Acceptance Criteria (Implied for Substantial Equivalence):

• Same Intended Use: The modified devices must have the same indications for use as the predicate devices.
• Similar Technological Characteristics: The modified devices must operate on the same fundamental scientific technology and have similar features. Any differences in technological characteristics must not raise new questions of safety or effectiveness.
• Similar Materials: The major materials of construction must be the same or demonstrably equivalent in terms of safety and biocompatibility.
• Performance: The modified devices must perform as well as the predicate devices.
• Safety: The risks associated with the intended use must be acceptable and compatible with a high level of protection of health and safety.

"Study" (Non-Clinical Testing) Proving Equivalence:

The document states that Atrium Medical's development process required the completion of the following non-clinical activities:

• Specification Review: Ensuring the designs meet predefined criteria.
• Performance Testing: Verifying the functional aspects of the device.
• Biocompatibility Testing: Evaluating the device's interaction with biological systems (e.g., ISO 10993 series).
• Sterility Testing: Confirming the device is sterile and maintains sterility.
• Stability Testing: Assessing the device's ability to maintain its properties over time (shelf life).
• Design Validation: Ensuring the device meets user needs and intended uses.

These non-clinical tests, along with compliance with voluntary standards (Section 9, though not provided in the excerpt), are the basis for demonstrating that the modified devices are safe and effective and perform as well as the predicate devices, thereby supporting the claim of substantial equivalence. The submission also relies on the low complaint rates and reportable events of the predicate devices over the last 5 years as evidence of acceptable clinical safety and performance.

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The OASIS MRI System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-latice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The OASIS is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting maqnet in a qantry design.

The provided text describes a 510(k) premarket notification for the Hitachi OASIS MRI System, focusing on demonstrating substantial equivalence to a predicate device (OASIS MRI System K192851). The document primarily outlines changes made to the device and provides a rationale for why these changes do not affect safety or effectiveness, rather than presenting a detailed study with specific acceptance criteria and performance metrics in the typical sense of a diagnostic AI device.

Therefore, the requested information, particularly regarding specific numerical acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods, is not explicitly available in the provided text as it would be for an AI/CADe device. The submission focuses on demonstrating that modifications to an existing MRI system (hardware, coils, software updates) do not negatively impact its performance compared to the predicate.

Here's an analysis based on the information available in the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in a quantifiable table as requested. The document asserts "substantial equivalence" as the primary "acceptance criterion" indirectly. The performance evaluation is focused on demonstrating that new features and changes "perform as intended for diagnostic use" and that the device modifications "do not raise different questions of safety and effectiveness."

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

The document mentions "Clinical image examples are provided for each applicable new feature." It describes these examples as "sufficient to evaluate clinical usability."

• Sample Size: Not specified. It's implied to be a collection of "examples" rather than a statistically powered test set for quantitative performance.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It likely refers to internal testing data.

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

• Number of Experts: Not specified. The phrase "we judged to be sufficient to evaluate clinical usability" suggests internal evaluation.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size of human readers improvement with AI vs without AI assistance

• MRMC Study: No, this is not an AI/CADe device. The submission concerns an MRI system itself and its modifications, not an AI-powered diagnostic aid. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or needed.

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

• Standalone Performance: No, this is not an AI/CADe device. The assessment is on the MRI system's ability to produce diagnostic images. The "standalone" performance here refers to the system meeting technical standards (NEMA, IEC) and producing images deemed clinically usable.

7. The type of ground truth used

The "ground truth" implicitly used for the clinical image examples is expert judgment of clinical usability of the images. This is not pathology, outcomes data, or a pre-established consensus for specific findings, but rather an assessment that the images produced by the modified system remain suitable for diagnosis by a trained physician.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is an MRI system, not a machine learning algorithm that requires a "training set" in the context of AI.

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

• Training Set Ground Truth Establishment: Not applicable, as it's not an AI/ML device.

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The OASIS MRI System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head. body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician. these images provide information that can be useful in diagnosis determination.

The OASIS is a Magnetic Resonance Imaging System that utilizes a 1.2 Tesla superconducting maqnet in a qantry design.

After reviewing the provided text, it's immediately clear that this document is a 510(k) Premarket Notification from the FDA for a new version of an MRI system (OASIS MRI System).

The key takeaway is that this document DOES NOT describe a study involving an "AI" or "algorithm" with human-in-the-loop performance, nor does it provide detailed quantitative acceptance criteria and study results for such a device.

Instead, it's a submission for the OASIS MRI System w/ V6.0F being substantially equivalent to its predicate device, the OASIS MRI System (K093044). The "performance evaluation" mentioned focuses on demonstrating that new features (like updated coils, operating systems, and software versions) do not negatively impact the device's safety and effectiveness and that the system performs as intended for diagnostic use.

The "performance evaluation" is primarily rational analysis and bench testing, with "clinical image examples" provided for usability, rather than a rigorous clinical performance study with defined quantitative acceptance criteria. There's no mention of:

• Specific quantitative metrics like sensitivity, specificity, AUC.
• Sample sizes for test sets in the typical sense of a clinical trial.
• Ground truth establishment by experts for specific diagnostic performance.
• MRMC studies or human reader improvement with AI assistance.
• Standalone algorithm performance.

Therefore, I cannot fulfill most of your request directly from the provided text, as the information regarding the acceptance criteria and the study design for an AI/algorithm-based device is not present. The document focuses on demonstrating substantial equivalence of a general MRI system, not the performance of an AI application within it.

I can, however, extract information about the predicate device and the general approach to demonstrating equivalence, which might give you some insight into the FDA 510(k) process for MRI systems, but not for an AI/algorithm.

Based on the provided document, here's what can be extracted, and where limitations exist regarding your specific request:

Limitations: The document does not describe the acceptance criteria and a study for an AI/algorithm-based device. It is a 510(k) submission for a new version of an MRI system (hardware and software updates) demonstrating substantial equivalence to a legally marketed predicate device. Therefore, many of the requested points related to AI/algorithm performance, ground truth establishment, expert readers, and MRMC studies are not applicable or not detailed in this context.

Information Extracted (with caveats for non-AI focus):

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

   • Acceptance Criteria (Implied for Substantial Equivalence): The primary "acceptance criterion" for this 510(k) is that the modified OASIS MRI System (V6.0F) is substantially equivalent to its predicate (OASIS K093044) in terms of safety, effectiveness, and intended use, despite specific updates in coils, operating system, CPU, and application software. This is demonstrated by showing that new features "perform as intended for diagnostic use" and that differences do not "raise different questions of safety and effectiveness."
   • Reported Device Performance: The "performance" is qualitative, focusing on whether new features function correctly and that fundamental safety/performance characteristics (like signal-to-noise ratio, uniformity, acoustic noise, electrical safety, EMC) remain acceptable or are not negatively impacted.
   • Table 1: Performance Analysis

     Testing Type	Rationale Analysis	Reported Device Performance
     Performance Testing - Bench	Performance bench testing was conducted on the applicable new features.	Test data confirmed that each new feature perform as intended for diagnostic use.
     Performance Testing - Clinical	Clinical image examples are provided for each applicable new feature and that we judged to be sufficient to evaluate clinical usability.	[Details of usability are not quantified, but the judgment was "sufficient"]

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

   • The document mentions "clinical image examples" for usability but does not specify a sample size for a clinical test set in the way one would for an AI performance study.
   • Data Provenance: Not specified. The clinical images are "examples" and likely collected by Hitachi, but whether they are retrospective or prospective, or from specific countries, is not stated.

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

   • Not applicable directly. This document is for an MRI system, not an AI/algorithm that requires expert-established ground truth for diagnostic accuracy. The "clinical image examples" were "judged to be sufficient to evaluate clinical usability," which implies interpretation by presumably qualified personnel (likely radiologists or technologists), but the number and qualifications are not specified nor is there a formal "ground truth" establishment process described for a test set.

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

   • Not applicable. There is no formal adjudication method described for a test set, as this is not a study assessing diagnostic performance of an algorithm.

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, an MRMC comparative effectiveness study was NOT done. This document does not describe a study involving AI assistance for human readers.

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

   • No, a standalone algorithm performance study was NOT done. This document describes a medical imaging device (MRI system), not an AI algorithm.

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

   • Not applicable in the context of an AI algorithm. For the MRI system itself, the "ground truth" for demonstrating substantial equivalence relies on established industry standards (NEMA, IEC) for image quality, safety parameters (e.g., acoustic noise, SAR), and the system's ability to produce images useful for diagnosis, interpreted by a "trained physician". This is not a ground truth for a specific diagnostic outcome.

8. The sample size for the training set:

   • Not applicable. This document describes an MRI system, not an AI model requiring a training set. The changes are primarily software version updates and new coils for an existing hardware platform.

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

   • Not applicable. See point 8.

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The device is intended to be used for the tanning of human skin.

The series of tanning bed/booths are available in four configurations. Units consist of LPI, Inc. branded and OEM tanning beds and booths.

• ESB -14, 16, 18, 24, and Oasis 36(booth)
• Solar Storm 16R, 24S, 24R, 24C, 32S, 32R, 32C, 36ST, 48ST(Booth)
• Solar Wave 16, 24
• . Sunco - 16XS, 24XS, 32XS, and 48Vertical (Booth)
  Each configuration consists of a metal structure with lamps placed equally distant horizontally (booths) and arranged in manner to provide the tanner an even tan. The user of tanning beds lies down on the bench section and pulls down the canopy cover, which is equipped with a counterweighted gas springs/shocks in order for this section of the bed to open and close. The user of a tanning booth stands within the sections of the booth. The section of the booth (door) also has gas springs/shocks and wheels to close the door. All units have electronic type ballasts that powers the lamps. Each unit is also equipped with a settable electronic timer which is controlled by a time setting of 10, 15, or 20 minutes. Timers are also equipped with an "off" button to allow user to turn off the lamps any time prior to the duration of the set timer.

This document is a 510(k) summary for tanning units (tanning beds/booths). It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device. Instead, it demonstrates substantial equivalence to predicate devices and adherence to existing regulations for sunlamp products.

Therefore, many of the requested sections about specific acceptance criteria, study sizes, expert involvement, and AI performance metrics are not applicable to this document.

Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is not available:

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

This document does not present a table of acceptance criteria for a new performance claim, nor does it report device performance in terms of metrics like sensitivity, specificity, or accuracy (which would be relevant for an AI/ML device). Instead, it confirms adherence to established standards and guidelines for sunlamp products.

The key "performance criteria" that are implicitly met are:

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

Not applicable. This is not a study involving a test set of data as for an AI/ML device. The "testing" refers to quality control and compliance checks on the physical tanning units.

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

Not applicable. Ground truth establishment by experts is not described for this type of device submission.

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

Not applicable.

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 device is a tanning unit, not an AI-assisted diagnostic or interpretive system.

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

Not applicable.

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

The "ground truth" implicitly used here relates to established regulatory standards and guidance for sunlamp products (e.g., maximum UV irradiance, electrical safety standards, biocompatibility standards). These are not clinical outcomes or expert consensus on clinical data.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

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These devices are used to drain obstructed biliary ducts.

The following devices are used for endoscopic biliary stent placement:
Guiding Catheter
Pushing Catheter
Fusion® Pushing catheter
Stent Introducer Set

The following devices (with preloaded stent, if applicable) are intended for endoscopic biliary stent placement to drain obstructed bile ducts:
Oasis® One Action Stent Introduction System
Fusion® Oasis® One Action Stent Introduction System
Oasis® One Action Stent Introduction System with preloaded Cotton-Leung® Biliary Stent.
Oasis® One Action Stent Introduction System with preloaded ST-2 Tannenbaum® Biliary Stent.

The intended use of all Cook biliary stents is to drain obstructed biliary ducts. A variety of stents in different sizes are available across the device range to accommodate various patient anatomies, the size and location of the obstruction and physician preference. They are offered in French sizes of between 5Fr and 11.5Fr, and in labelled lengths of between 1cm and 21cm.The subject devices and their components can be supplied as stent only, introducer only (guiding or pushing catheter), introduction system (guiding and pushing catheter) or as stent sets combining stent and introducers/introduction systems.

The stent sets can contain one or several of the following stent placement components; a flap protector/ pigtail straightener, a guiding catheter, a pushing catheter or a dedicated introducer system. The flap protector/ pigtail straightener can be provided to aid in introduction of the device over the wire (pigtail stents) and introduced into the working channel of the endoscope. The function of the guiding catheter is to guide the stent as part of its introduction to its intended location. The guiding catheter also has a Hub that allows for contrast injection. The function of the Pushing Catheter is to advance the stent, over a pre-positioned wire guide or Guiding Catheter, to its intended location within the anatomy, and to maintain the position of the Stent as it being deployed. Some introducers / introduction systems have a port that will allow use of the device in a short wire configuration. The stents are polymeric with some of the stents have radiopaque bands. The stent designs include centre, duodenal and centre bend shapes and anti-migration features such as pigtails and flaps. To facilitate stent insertion and removal the stent ends are tapered or buffed. Side-ports on the stents assist in drainage. All stents are deployed endoscopically over a guide wire in the same manner under fluoroscopic and endoscopic monitoring.

The document describes the submission of Cook Ireland Ltd.'s various biliary stents and associated introducers/introduction systems (collectively, "the device") for 510(k) premarket notification to the FDA. The purpose of the submission is to demonstrate substantial equivalence to legally marketed predicate devices. The listed acceptance criteria and performance data pertain to the performance, safety, and effectiveness of these medical devices.

From the provided text, there is no specific table of acceptance criteria and reported device performance with numerical metrics for the clinical effectiveness of the device (e.g., success rates, complication rates). The document focuses on demonstrating substantial equivalence through comparison of technological characteristics and non-clinical testing.

Here's an extraction of the relevant information regarding the acceptance criteria and the study that proves the device meets them, based on what's available in the text:

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

The document does not provide a table with specific numerical acceptance criteria and corresponding reported performance for clinical effectiveness. Instead, it states that "Design validation and verifications activities (performance testing) performed support the performance, safety and effectiveness of these subject devices and demonstrate no change in the safety and effectiveness profile previously established with the predicate device."

The criteria are implicitly based on demonstrating that the new devices do not raise new questions of safety or effectiveness compared to the predicate devices and meet design input requirements.

Reported Performance Categories:
The performance data is summarized by the types of non-clinical testing performed:

• Biocompatibility evaluation
• Simulated use
• Dimensional and visual testing
• Tensile strength testing
• MRI conditional testing
• Radiopacity
• Flow rate
• Shelf life testing

The conclusion states that the test results "met the design input requirements based on the intended use, and do not raise new questions of safety or effectiveness." This implies that the performance in these non-clinical tests was acceptable relative to the predicate devices and device specifications.

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

• Sample Size: The document does not specify the sample sizes for each type of non-clinical test (e.g., how many stents were tested for tensile strength or flow rate).
• Data Provenance: The studies are described as "Performance testing" and "Design validation and verifications activities" conducted by Cook Ireland Ltd. under their "design control system." This indicates the data is from internal laboratory testing. The country of origin for the data is not explicitly stated beyond Cook Ireland Ltd. being the submitter. The studies are non-clinical (laboratory/bench) studies, not human clinical trials. Therefore, terms like retrospective or prospective human data are not applicable here.

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

• Not applicable. The "ground truth" here is based on engineering specifications, material science, and established biological safety standards (ISO 10993-1). No human experts are used to establish a clinical ground truth for the test set; rather, engineering and scientific experts conduct and interpret the results of the non-clinical tests.

4. Adjudication method for the test set:

• Not applicable. This concept typically applies to clinical trials where human readers or evaluators make assessments that need to be adjudicated for consistency or accuracy. For non-clinical bench testing, results are typically objective measurements against pre-defined specifications.

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 device is a medical implant (biliary stent) and associated delivery systems, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant.

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

• Not applicable. This device does not involve an algorithm or AI. The performance studies are mechanical, material, and biocompatibility tests of the physical device.

7. The type of ground truth used:

• The "ground truth" for the non-clinical tests is based on engineering specifications, material properties, and established industry standards (e.g., ISO 10993-1 for biocompatibility). For example, tensile strength testing would compare measurements to a pre-defined maximum and minimum acceptable tensile strength for the material and design. Radiopacity is assessed against a standard for visibility under fluoroscopy.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning product that requires a training set. The "design input requirements" and predicate device data serve as the basis for evaluating the new devices.

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

• Not applicable. As above, there is no training set for this type of medical device. The "ground truth" for evaluating the performance of the device itself comes from engineering and scientific principles, as well as the performance history of the predicate devices.

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The Oasis Medical Lacrimal Intubation Set is intended for use for nasolacrimal intubation in patients of age and older. Indications for nasolacrimal intubation performed with the Oasis Medical Lacrimal Intubation device are:

• · Canalicular pathologies (e.g., congenital or acquired stenosis, lacerations)
• · During dacryocystorhinostomy
• · Congenital lacrimal duct obstruction

The Oasis Lacrimal Intubation Set with Retrieval Device (Model Summary: 6004) is a sterile (via gamma sterilization-VDmax method-25kGy), single-use, hand held, and ophthalmic surgical device. The device consists of a twelve inch medical grade silicone tube that is secured at each end to two 4 ½", 23 gauge stainless steel, olivetipped probes along with a 3″ plastic handled retriever with a stainless steel hook. The Oasis Lacrimal Intubation Set with Retrieval Device is used by a physician for nasolacrimal intubation.

This document describes the Oasis Lacrimal Intubation Set with Retrieval Device and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or device performance metrics in a pass/fail format. Instead, it focuses on demonstrating equivalence to a predicate device across several characteristics. The "performance" is implicitly deemed acceptable if it's equivalent to the legally marketed predicate.

However, we can infer the areas of assessment and the reported findings for each:

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

The document describes non-clinical bench testing. It does not specify a numerical "sample size" in terms of patients or independent test articles for each specific test performed. However, it indicates:

• Bench tests: A "series of bench tests" was conducted.
• Biocompatibility tests: These were conducted for Cytotoxicity, Sensitization, and Irritation.
• Provenance: The tests were conducted by "independent laboratories and internal comparative bench testing." No country of origin for the data is specified, nor is whether the testing was retrospective or prospective (it would inherently be prospective for product development).

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

This document describes a medical device (intubation set), not a diagnostic AI device requiring expert ground truth for interpretation. Therefore, these categories are not applicable. The "truth" here is established by engineering specifications, material properties, and functionality comparison against a predicate device.

4. Adjudication Method for the Test Set

Not applicable, as this is bench testing of a physical device, not a diagnostic assessment requiring expert adjudication of findings.

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

No. This is a 510(k) submission for a physical medical device, not a diagnostic AI system requiring MRMC studies.

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

No. This question applies to AI/software as a medical device. This is a physical device, so this is not applicable.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Engineering specifications and standards: For dimensional attributes, material properties (e.g., USP Class VI for silicone).
• Functional comparison to a predicate device: For durability and overall performance (e.g., "performed equivalently to the predicate device").
• Standardized biocompatibility test protocols: For cytotoxicity, sensitization, and irritation.

8. The Sample Size for the Training Set

No. This question applies to AI/software as a medical device. This is a physical device, so this is not applicable.

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

No. This question applies to AI/software as a medical device. This is a physical device, so this is not applicable.

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The Hitachi Oasis MRI with Spectroscopy is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.

This package is indicated for use as follows:

Anatomical Region: Head, whole body Nuclei Excited: "H

MR Spectroscopy is an imaging and analysis feature that can provide unique information about tissue within a human body. Spectroscopy can be used to complement or augment information and images obtained through other MR imaging and analysis techniques.

The acquisition of spectroscopic information is fundamentally the same as for other MR imaging techniques. For example, a modified spin echo sequence is used to collect data for one or more voxels of tissue. This data collection utilizes existing MR hardware and software, for example, the main magnetic field, gradient coils, RF transmitter, RF receiver coils, and memory or "K-Space".

The analysis of the collected data is what differentiates MR Spectroscopy from other more conventional MR imaging and analysis techniques. The data that is collected from the MR pulse sequence as described above is processed through MR spectroscopy algorithms. After computation and analysis on this data, information is displayed for the operator/reviewer. Spectroscopy data may be displayed in multiple ways, for example as data, graphs or images.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Hitachi Oasis MRI with Spectroscopy:

Device: Oasis MRI with Spectroscopy

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided documentation does not specify a separate test set, its sample size, or the provenance of any data used for a performance study. The submission relies on substantial equivalence to a predicate device.

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

This information is not provided as the submission relies on substantial equivalence and does not detail a separate performance study with a test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided as the submission relies on substantial equivalence and does not detail a separate performance study with a test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this submission. The basis for approval is substantial equivalence to a predicate device, not a head-to-head comparison demonstrating improved human reader performance with AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of the algorithm without human-in-the-loop performance was not performed or reported in this submission. The document describes the system as a diagnostic device where the spectral data is "interpreted by a trained medical practitioner."

7. Type of Ground Truth Used

The concept of a "ground truth" for a performance study is not directly applicable or mentioned in this submission, as the basis for approval is substantial equivalence to a predicate device rather than a de novo clinical performance study against a defined ground truth. The device's utility is described as providing information useful in diagnosis when interpreted by a medical practitioner.

8. Sample Size for the Training Set

This information is not provided. The submission does not describe the development or training of new algorithms for which a training set would be required. It focuses on the capabilities of the spectroscopy package using existing MR hardware and software.

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

This information is not provided, as a training set and its ground truth establishment are not discussed in the context of this substantial equivalence submission.

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The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The OASIS Specialty Coils are receive-only devices that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved crosssectional images that display the internal structure of the images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The indications for use for the OASIS Specialty Coils are as follows:

• The MR-IBC-120, OASIS RAPID Breast Coil is a recieve-only multiple array . device used for MRI imaging of the breast.
• The MR-NVC-120, OASIS NV Coil is a recieve-only multiple array device used . for MRI imaging of the head and neck.

The MR-IBC-120, OASIS RAPID Breast Coil is a recieve-only multiple array device used for obtaining diagnostic images of the breast with the OASIS MRI System. The MR-NVC-120, OASIS NV Coil is a recieve-only multiple array device used for obtaining diagnostic images of the head and neck with the OASIS MRI System.

The provided 510(k) summary (K080062) for the Hitachi Medical Systems America, Inc. OASIS RAPID Breast Coil and OASIS RAPID NV Coil does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a premarket notification for a Class II medical device, essentially asserting its substantial equivalence to previously cleared predicate devices. The focus of this type of submission is on demonstrating that the new device has "technological characteristics similar to the predicate devices" and is "substantially equivalent" in terms of its intended use, function, and scientific concepts. It is not a clinical performance study demonstrating the device meets specific acceptance criteria for diagnostic accuracy or other performance metrics.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, number or qualifications of experts, or adjudication methods for any test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance. (This device is a receive-only coil, not an AI-powered diagnostic tool, so this would not be applicable).
• Details regarding standalone algorithm performance studies.
• Information on the type of ground truth used.
• Sample size for training sets or how ground truth for training sets was established. (Again, this is a hardware component, not a trainable algorithm).

The document is purely a regulatory submission focused on demonstrating substantial equivalence for an MRI coil, which is a hardware component of an MRI system, not a software algorithm that would typically undergo the types of performance validation studies you're asking about.

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