Search Results

Airistar Air Purification Systems (Model 1000) are intended for use in filtering airborne particles from air for medical purposes.

The Airistar Air Purification Systems - Model 1000 are medical air cleaners designed to help remove particulate matter from the air. These systems are for home use and use in hospitals, nursing homes, schools, offices, etc.

The Model 500 Airistar Air Purification System contains software and a display panel to program runs times and fan speeds, the panel also displays filter life indicator bar. The Model 1000 Airistar Air Purification System is operated via a power switch and control knobs to adjust the fan speed. Both models have 3 fan speeds and contain a 6 Stage filter system.

The provided text describes the Airistar Air Purification Systems (Model 500 & Model 1000) and its 510(k) submission. However, it does not contain information about specific acceptance criteria, a detailed study proving device performance against those criteria, or most of the requested metrics related to a clinical study. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than comprehensive performance study results.

Here's an analysis based on the provided text, highlighting the absence of information for many of your questions:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria (e.g., a certain percentage of particle removal at a specific size, or a CAD performance metric) are explicitly detailed in the document. The general statement is that "Bench testing has confirmed the devices' ability to remove particles efficiently."

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

• Sample Size: Not applicable. No clinical test set involving patient data is described. The testing referred to is "bench testing."
• Data Provenance: Not applicable. The testing is described as "bench testing," implying laboratory-based testing, not human data.

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

Not applicable. No mention of expert ground truth establishment for a test set is present, as the testing was bench testing.

4. Adjudication method for the test set

Not applicable. No test set involving human data requiring adjudication is described.

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 air purification system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.

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

Not applicable. This is not an AI algorithm; it's a physical air purification device. The "performance" is its physical ability to filter air, which would inherently be "standalone" in its function. The document mentions "bench testing" which is a standalone evaluation of the device's physical capabilities.

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

For the mentioned "bench testing," the ground truth would be established by objective measurements from laboratory equipment (e.g., particle counters) following established testing standards for air filtration efficiency. No human-derived ground truth (like expert consensus, pathology, or outcomes data) is relevant or mentioned.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this device is not an AI/machine learning system.

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

Not applicable. No training set is involved.

Summary of what the document does provide regarding "proof" of meeting criteria:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data against specific, quantitative acceptance criteria.

• Substantial Equivalence: The core argument is that the Airistar Air Purification Systems (Model 500 & Model 1000) have the same intended use and either identical technological characteristics or different ones that do not raise new safety or effectiveness concerns compared to the predicate devices (Hepa-Care Air Cleaner K984116, Mobile Particulate Contamination Control System K023693, Advanced Air Cleaner System K012549).
• Bench Testing: The document states that "Bench testing has confirmed the devices' ability to remove particles efficiently." This is a general statement without specific metrics or protocols detailed.
• Ozone Testing: "Underwriters Laboratory testing showed the UV lamp produced zero ozone." This is a specific performance metric, stating a zero-level finding.

Ask a specific question about this device

Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.

The AIRIS Elite Body Coil (hereby referred to as body coil) is a receive only RF phased array coil, used for obtaining diagnostic images of the abdominal region, in an open Magnetic Resonance Imaging (MRI) system. The body coil consists two mechanical sections: a rigid removable upper section and a base, which is positioned above and below the patient abdomen respectively. The upper section can be connected to the base by the electrical pins. There is a latch on the upper section. The coil consists of four coil elements: a two-turn solenoid, an anterior saddle, a posterior saddle and an anti-turn loop. All the elements are enclosed in a rigid plastic housing. The signal output of each element is independently processed by the system to enhance performance.

The provided text does not contain information about acceptance criteria, a study that proves the device meets specific criteria, or performance data in the format requested. The document is a 510(k) summary for a medical device (AIRIS Elite Rapid Body Coil) that outlines its intended use, function, scientific concepts, and concludes that it is substantially equivalent to a predicate device.

Specifically, the following information is not available in the provided text:

• A table of acceptance criteria and the reported device performance: The document does not define any specific acceptance criteria (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio thresholds) or provide performance metrics from a study that evaluates the device against such criteria.
• Sample size used for the test set and the data provenance: There is no mention of a test set, its size, or the origin of any data (country, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and their qualifications: No test set means no ground truth establishment for it is discussed.
• Adjudication method for the test set: Not applicable as no test set is mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study information: There is no mention of an MRMC study or any impact of AI assistance on human readers.
• Standalone (algorithm only) performance: This device is a hardware component (a coil for an MRI system), not an algorithm, so standalone algorithm performance is not applicable.
• Type of ground truth used: No ground truth is discussed in relation to performance evaluation.
• Sample size for the training set: Not applicable, as this is a hardware device, not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable.

The document primarily focuses on establishing "substantial equivalence" to a predicate device based on similar technological characteristics and intended use. It describes the physical and performance characteristics of the body coil in a general sense, noting it's a "receive only RF phased array coil" and how it functions within the MRI system, but it does not present a formal study with acceptance criteria and measured performance outcomes. The "performance characteristics" mentioned are descriptive of the device's design (e.g., four channel vs. two in predicate) rather than quantitative results from a performance study.

Ask a specific question about this device

Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.

Model 554HI-12 RAPID Body Coil. Compatible with Hitachi AIRIS-Elite MR Systems.

The provided document is a 510(k) Summary of Safety and Effectiveness for the "Model 554HI-12 RAPID Body Coil." This document is part of a premarket notification for a medical device and thus focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report for a novel AI/software device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert adjudication, and MRMC studies, cannot be found in this document because it pertains to the regulatory review process for a hardware component (an MRI coil) based on substantial equivalence, not a software or AI device's clinical performance study.

However, I can extract the information that is present and explain why other details are absent based on the nature of this document.

Here's a breakdown of the available and unavailable information:

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

The document defines acceptance criteria by stating that the new device has "No change" in specific safety and imaging performance parameters compared to the predicate device. This implies that "no change" is the acceptance criterion for equivalence.

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

• Sample Size for Test Set: Not applicable/not provided. This document describes a new MRI coil seeking clearance through the 510(k) pathway, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a new clinical study with a "test set" in the context of an AI/software device. The "testing" would involve demonstrating the new coil functions within the safety and performance limits when paired with a compatible MRI system, and that these parameters are equivalent to those of the predicate.
• Data Provenance: Not applicable/not provided.

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)

• Number of Experts: Not applicable/not provided.
• Qualifications of Experts: Not applicable/not provided.

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

• Adjudication Method: Not applicable/not provided.

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

• MRMC Study: No, this type of study was not performed. The device is an MRI body coil, not an AI-assisted diagnostic tool for human readers.

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

• Standalone Performance: Not applicable. The device is a hardware component (an MRI coil), not a standalone algorithm.

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

• Type of Ground Truth: Not applicable in the context of a clinical performance study with "ground truth" as typically defined for AI/software. The "ground truth" for this device's assessment would be established engineering and safety standards for MRI coils and comparison to the predicate device's established performance specifications. The "ground truth" for the claims of "no change" would be derived from technical measurements and comparisons.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.

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

• Ground Truth for Training Set Establishment: Not applicable. This is not an AI/machine learning device.

Summary of Device and Regulatory Context for Understanding:

This document is a 510(k) submission for an MRI coil, which is a hardware accessory for an MRI system. The primary goal of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has:

• The same intended use as the predicate device.
• The same technological characteristics as the predicate device, or
• Different technological characteristics that do not raise new questions of safety and effectiveness, and performance data that demonstrates the device is as safe and effective as the predicate device.

In this specific case, the manufacturer is demonstrating that its Model 554HI-12 RAPID Body Coil, when used with the Hitachi AIRIS-Elite 0.3T MRI system, is substantially equivalent to a GE Signa 0.5T system operated with a legally marketed predicate device. The "study" described is a comparison of critical safety and imaging performance parameters, where the finding that there is "no change" in these parameters due to the new coil is the basis for demonstrating equivalence and meeting regulatory requirements. It is not a clinical performance study measuring diagnostic accuracy or reader improvement for a software algorithm.

Ask a specific question about this device

The AIRIS Elite system is an MR 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 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: 2D/3D T1, T2-weighted imaging
T1, T2 proton density measurements
Diffusion weighted imaging
MR. Angiography
Image processing

The AIRIS Elite is a modification of the AIRIS II MRI System. The AIRIS Elite has been revised to increase the clinical utility as compared to the AIRIS II Magnetic Resonance Imaging System.

This submission is a 510(k) summary for the AIRIS Elite Magnetic Resonance Imaging Device. It claims substantial equivalence to a predicate device, the AIRIS II MRI System. The document does not provide acceptance criteria or a study demonstrating that the device meets such criteria in the way typically expected for a new or modified AI/ML-based medical device.

Instead, this document focuses on demonstrating that the AIRIS Elite is substantially equivalent to existing technology (the AIRIS II MRI System) by comparing their technological characteristics and intended use. The core argument is based on the idea that the modifications (enhanced RF sub-system and gradient sub-systems) do not fundamentally alter the device's function or safety profile, and thus a full performance study with acceptance criteria is not required in the same manner as for a de novo device or a device with a significant change in intended use or technological principle.

Therefore, many of the requested sections (Table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types and establishment methods) are not applicable or not present in this type of submission.

Here's a breakdown based on the information provided and the nature of a 510(k) for an incremental device improvement:

1. Table of acceptance criteria and the reported device performance:

• Not applicable/Not provided in this document. This 510(k) focuses on demonstrating "substantial equivalence" to a predicate device rather than meeting specific quantifiable performance metrics against acceptance criteria for a novel device. The performance is implicitly deemed acceptable because it's equivalent to a device already cleared by the FDA.

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/Not provided. No specific test set or clinical study data is presented for performance evaluation in this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate device and the incremental nature of the changes.

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/Not provided. No ground truth establishment for a specific test set is mentioned.

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

• Not applicable/Not provided.

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/Not provided. This is an MRI system, not an AI-assisted diagnostic tool.

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

• Not applicable/Not provided. This is an MRI system, not an algorithm.

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

• Not applicable/Not provided.

8. The sample size for the training set:

• Not applicable/Not provided. This is an MRI system, not a machine learning model requiring a training set in this context.

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

• Not applicable/Not provided.

Summary of the Acceptance Criteria and "Study" as presented in the Document:

The "acceptance criteria" for the AIRIS Elite, as demonstrated in this 510(k) submission, are centered around the concept of Substantial Equivalence to its predicate device, the AIRIS II MRI System (K001334, K974212).

Here's how the document addresses the "study" and "acceptance criteria":

• Acceptance Criteria (Implicit - Substantial Equivalence): The primary and overarching acceptance criterion is that the AIRIS Elite must be substantially equivalent to the AIRIS II MRI System in terms of:

  • Intended Use: The document explicitly states, "The technological characteristics and intended use are identical to the Predicate Device." (Section 6.0 Conclusions). The intended use is defined as providing physiological and clinical information, obtained non-invasively, producing images that display internal structures of the head, body, or extremities, and useful in diagnosis when interpreted by a trained physician (Section 3.0).
  • Technological Characteristics: The device must be similar enough, such that any differences do not raise new questions of safety or effectiveness. The document notes, "The technological characteristics of this device are similar to the primary predicate device. There has been no change to the magnet design or control system, but the RF sub-system and gradient sub-systems have been enhanced." (Section 5.0).

• "Study" (Comparison and Rationale for Equivalence): The "study" in this context is the comparison presented within the 510(k) itself.

  • Comparison Basis: The submission provides a direct comparison between the AIRIS Elite and its predicate, the AIRIS II.
  • Lack of Clinical Data: The document does not contain a separate clinical study with new performance data. Instead, it argues that the modifications (enhanced RF and gradient subsystems) do not alter the fundamental principles of operation or intended use to such an extent that new clinical performance data is required to establish safety and effectiveness. The enhancements are framed as increasing "clinical utility" rather than changing the diagnostic capability or fundamental safety.
  • Conclusion: Hitachi Medical Systems America concludes, based on the described similarities and enhancements, that the AIRIS Elite is substantially equivalent to the AIRIS II MRI System (Section 6.0). The FDA's letter (K032232) confirms this finding of substantial equivalence.

In essence, for this type of 510(k) submission for an incremental improvement, the regulatory "acceptance" is based on demonstrating that the new device is fundamentally the same as a previously cleared device, and therefore inherits the established safety and effectiveness profile of that predicate device without requiring a new, comprehensive performance study that would generate the detailed data you've asked for.

Ask a specific question about this device

The AIRIS II Magnetic Resonance Diagnostic Device with the CTL Phased Array Coil P/N MR-CTL-51 provides for continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies.

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 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.

Aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.

The AIRIS II MRI Magnetic Resonance Diagnostic Device is being enhanced by one additional RF Coil (CTL Phased Array Coil) to increase the clinical utility of the AIRIS II in the stationary configuration.

The CTL Phased Array Coil P/N MR-CTL-51 provides for continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies, and utilizes a proprietary multiple receiver coil configuration (8 elements) operating in the phased array mode. The coil operates in three modes: C, T/L, and L. A multi-position switch is used to select between the modes, by routing a current through PIN diode-activated high impedance tanks.

The C-spine section of the coil is nearly identical in design to the USAI QD C-spine coil P/N MR-QCS-51, and features a removable nosepiece bridge. The T/L and L sections are combinations of flat elements in the coil's base and removable loop sections, connecting to mounting blocks at the edge of the coil.

AIRIS II software did not need to be revised in order to support full functionality of this CTL Phased Array Coil.

The provided document, K994378, describes a 510(k) submission for an "Additional RF Coil for AIRIS II (CTL Phased Array)" and does not contain detailed information about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for AI/ML-based medical devices.

Instead, this submission is for a hardware enhancement (a new RF coil) for an existing Magnetic Resonance (MR) diagnostic device. The regulatory review process for such a device at the time (late 1990s) focused on demonstrating substantial equivalence to a predicate device, primarily through technical specifications, functional descriptions, and indications for use, rather than extensive performance studies with acceptance criteria as one might expect for a diagnostic or AI-driven software.

Based on the provided text, here's what can be extracted and what information is not present:

Missing Information:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, or how ground truth was established for a performance study. These types of studies are not described because this submission is not for a new diagnostic algorithm.

Information Extracted from the Document:

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

   • This document does not provide a table of acceptance criteria or reported device performance in the context of diagnostic accuracy, sensitivity, or specificity.
   • The "performance" described is related to the physical and functional characteristics of the new RF coil and its compatibility with the existing AIRIS II MRI system.
   • The submission focuses on demonstrating that the new CTL Phased Array Coil, when added to the AIRIS II, still functions as an MR diagnostic device and provides continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies, similar to the predicate device and the existing AIRIS II capabilities. The performance is implied by its ability to perform these imaging tasks.

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

   • Not applicable. This is a hardware modification (RF coil) for an existing MRI system. The document does not describe a "test set" of patient data for evaluating a diagnostic algorithm.
   • The "testing" mentioned would be related to engineering validation of the coil's electrical and mechanical performance, and its integration with the MRI system, not clinical diagnostic accuracy based on a patient dataset.

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

   • Not applicable. This is not a study requiring expert ground truth for diagnostic accuracy.

4. Adjudication method 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 is a hardware component for an MRI system, not an AI/ML-based diagnostic aid.

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

   • Not applicable. This is a hardware component, not a standalone algorithm.

7. The type of ground truth used:

   • Not applicable.

8. The sample size for the training set:

   • Not applicable. This is a hardware component, not an AI/ML system requiring a training set.

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

   • Not applicable.

Summary based on the K994378 document:

The K994378 submission for the CTL Phased Array Coil for the AIRIS II MRI system is a 510(k) Pre-market Notification seeking to demonstrate substantial equivalence to a previously cleared device (the Hitachi AIRIS II, K974212 and the USAI QD C-spine coil P/N MR-QCS-51).

The "study" for this type of submission is essentially the demonstration that the new coil performs its intended function (providing continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies) and integrates seamlessly with the existing AIRIS II system without altering its fundamental scientific concepts, physical, or performance characteristics in a way that would raise new questions of safety or effectiveness.

The document implicitly "proves the device meets acceptance criteria" by stating its technological characteristics are "Identical to the Predicate Device" (Section 5.0) and describing its function as an enhancement that "provides for continuous imaging of the cervical, thoracic, and lumbar spine and adjacent anatomies," which aligns with the predicate device's capabilities. The FDA's clearance letter (MAR - 7 2000) confirms that the agency found the device "substantially equivalent" for its stated indications for use, thereby implicitly accepting that it meets the necessary criteria for safe and effective operation as an MRI coil.

Ask a specific question about this device

The PA/QD Shoulder Coil provides imaging of the shoulder articular anatomy and other large joints.

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 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 When interpreted by a trained physician, these images provide relaxation time (T2), and flow. information that can be useful in diagnosis determination.

• Head, Body, Spine, Extremities Anatomical Region: Nucleus excited: Proton Diagnostic uses:
• Diagnostic uses:

2D T1- / T2-weighted imaging T1. T2, proton density measurements MR Angiography image processing

• Imaging capabilities:
• 2D, 3D Spin Echo (SE)
• 2D, 3D Fast Spin Echo (FSE)
• 2D Inversion Recovery (IR)
• 2D. 3D Fast Inversion Recovery (FIR)
• 2D,3D Gradient Echo (GE)
• 2D, 3D Steady state acquisition with rewinded GE (SARGE)
• 2D, 3D RF-spoiled SARGE (RSSG)
• 2D, 3D Time-reversed SARGE (TRSG)

MR Angiography (half echo, high resolution/high definition, sloped slab profile, magnetization transfer contrast)

• 2D, 3D TOF
• 2D, 3D TOF RSSG
• ECG, Peripheral Gating
• RF Coil Uniformity

Adaptive Image post-processing

ACR/NEMA/DICOM 3 compliant

• Aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.

The AIRIS and AIRIS II MRI Magnetic Resonance Diagnostic Devices are being enhanced by one additional RF Coil (PA/QD Shoulder Coil) to increase the clinical utility of the AIRIS and AIRIS II in the stationary configuration. The Shoulder Coil can operate either in the quadrature mode or in the phased array mode with the AIRIS II, and in the quadrature mode only with the AIRIS. The coil is available in Large and Standard sizes for both MRI systems, to accommodate a wide variety of physical patient sizes, and to achieve maximal coil filling factors.

The provided document is a 510(k) Summary for a new RF Coil (PA/QD Shoulder Coil) for existing MRI systems (AIRIS and AIRIS II). This submission is for an enhancement to an already cleared device, primarily adding a new accessory. Therefore, the document does not contain a comprehensive clinical study with acceptance criteria and performance metrics in the way one would expect for a novel diagnostic algorithm or a new primary imaging modality.

Instead, the submission focuses on demonstrating substantial equivalence to the predicate device, meaning it asserts that the new coil performs similarly and introduces no new safety or effectiveness concerns. The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate MRI systems and the ability of the new coil to function within those established parameters.

Here's an attempt to answer your questions based on the provided text, acknowledging the limitations of a 510(k) for an accessory:

Acceptance Criteria and Device Performance Study for the PA/QD Shoulder Coil

As this 510(k) submission (K992650) is for an additional RF Coil (PA/QD Shoulder Coil) for existing, cleared MRI systems (Hitachi AIRIS and AIRIS II), the "acceptance criteria" and "study" described are focused on demonstrating that the new coil functions as intended within the established safety and performance envelope of the predicate devices. The submission emphasizes substantial equivalence to the predicate MRI systems and their existing coils, rather than a de novo clinical trial with specific diagnostic performance metrics.

The implicit acceptance criteria are that the new shoulder coil allows the AIRIS and AIRIS II systems to continue to produce high-quality diagnostic images of the shoulder joint, consistent with the performance of the predicate devices for other anatomical regions or with previous coils. The performance is "proven" through the assertion that the device's technological characteristics are identical to the predicate device in terms of fundamental MR physics and imaging capabilities, and that the new coil enhances clinical utility without altering the core functional mechanism or safety profile.

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

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 describe a specific clinical "test set" or a formal clinical study with patient data in the realm of diagnostic performance. For an accessory like an RF coil, "testing" would typically involve engineering verification and validation (e.g., phantom imaging, signal-to-noise measurements, image uniformity, SAR testing) to ensure it meets technical specifications and functions correctly with the existing MRI system. Such technical data is not detailed in this 510(k) summary, which is a high-level overview. There is no mention of country of origin or retrospective/prospective data.

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

Not applicable. As no clinical "test set" and corresponding ground truth determination are described, there is no mention of experts for this purpose.

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

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

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

Not applicable. This submission is for an MRI coil, not an AI-powered diagnostic tool, and no MRMC study or AI component is mentioned.

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

Not applicable. This is for an MRI coil, not a standalone algorithm.

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

Not applicable, as no clinical ground truth determination is described in this summary. The "ground truth" for an MRI coil would be its ability to accurately reflect the NMR properties of the tissue it images, which is assessed through technical performance and image quality.

8. The sample size for the training set

Not applicable. No training set is mentioned as this device is not an AI/machine learning model.

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

Not applicable. No training set or ground truth establishment for a training set is mentioned.

Ask a specific question about this device

By providing in-suite scan control and viewing of MR images, the AIRIS II with the Interventional MR Package aids in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user.

The MR system is an imaging device, and is intended to provide the plysician 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 AIRIS II MRI Magnetic Resonance Diagnostic Device is being enhanced by optional hardware to aid in the performance of minimally invasive, diagnostic, and therapeutic procedures of the head, body, and extremities which may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation, as selected and evaluated by the clinical user. Additional hardware includes QD Interventional Body Coil (IBC), in-suite image display and scanner control, physician kneelers, directed gantry illumination, and surgical drapes to provide a sterile field. The Latchable Joint/Large Extremity Coil, P/N MR-JCL-52, currently in commercial distribution supports imaging of the head and neck during interventional procedures of those anatomies.

AIRIS II software did not need to be revised in order to support full functionality of this additional hardware. MR Fluoroscopy was not made as an explicit marketing claim of the AIRIS II 510(k) K974212, however, the capabilities were available at the time of the submission (Cf. K974212, Attachment F, Functional Specification, 2D/3D SG and 2D/3D SG (RSSG) images acquisition sequences).

The provided text is a 510(k) summary for the Hitachi AIRIS II Interventional MR Package. It primarily focuses on demonstrating substantial equivalence to a predicate device and describing the technical characteristics and intended use of the MR system.

Crucially, this document does not contain any information about a performance study, acceptance criteria, or specific performance metrics for the device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth methods from the provided text.

The document states:

• "Identical to the AIRIS II 510(k) K974212." for device function.
• "Identical to the Predicate Device." for technological characteristics.
• The FDA letter confirms substantial equivalence based on the indications for use.

This implies that the device is considered equivalent to existing, legally marketed devices, and no new performance study data with specific acceptance criteria is presented in this summary for the "Interventional MR Package". The primary purpose of this 510(k) appears to be to introduce optional hardware that enhances the capabilities of an already-cleared MRI system, rather than to demonstrate novel performance characteristics requiring a new, detailed clinical performance study.

Ask a specific question about this device

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 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 AIRIS MRI Magnetic Resonance Diagnostic Device is being enhanced by two additional RF Coils (QD HP [High Performance] Wrist Coil, and Shaped Shoulder Coil) to increase the clinical utility of the AIRIS in the stationary configuration.

The QD HP [High Performance] Wrist Coil P/N MR-QWC-51 is a new addition to the complement of coils intended for use with AIRIS. The coil utilizes a proprietary multiple receiver quadrature coil design for improved S/N Ratio.

The Shaped Shoulder coil P/N MR-SC-51 is identical to the Latchable Large Extremity coil, which was documented in a Memo-to-File document as identical to the original Large Extremity Coil for AIRIS, with the exception that the coil geometry has been curved for easier coil positioning over the anatomy of interest. Safety and effectiveness of the coil are unchanged from the original, and this coil will replace the original coil.

AIRIS software did not need to be revised in order to support full functionality of these coils.

This document describes the submission K980691 for Additional RF Coils for AIRIS (QD HP Wrist, Shaped Shoulder) by Hitachi Medical Systems America. However, this submission focuses on establishing substantial equivalence for the coils as medical devices, not on a new AI/algorithm device that would typically have the detailed performance metrics requested in your prompt.

Therefore, many of the fields for acceptance criteria and study design are not applicable or cannot be determined from the provided text, as the submission is not for an AI diagnostic device. The provided text is a 510(k) summary for a Magnetic Resonance Diagnostic Device (AIRIS MRI) and associated RF coils, not an AI/ML product.

Here’s what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as performance metrics in the way an AI/ML product would have (e.g., sensitivity, specificity). The acceptance criterion is "substantial equivalence" to the predicate device (Hitachi AIRIS).
• Reported Device Performance:
  • QD HP Wrist Coil: "New addition to the complement of coils intended for use with AIRIS. The coil utilizes a proprietary multiple receiver quadrature coil design for improved S/N Ratio." (No quantitative S/N ratio improvement stated, but "improved" implies enhanced performance).
  • Shaped Shoulder Coil: "identical to the Latchable Large Extremity coil... Safety and effectiveness of the coil are unchanged from the original, and this coil will replace the original coil." (This implies performance is at least equivalent to the original coil).

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

• Not Applicable / Not Provided: This submission is for hardware components (RF coils) of an MRI system, not an AI diagnostic algorithm. There is no "test set" in the context of diagnostic performance metrics like those for AI. The evaluation would typically involve engineering tests, phantom studies, and possibly limited clinical imaging to confirm image quality and safety, but these details are not provided in this 510(k) summary.

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

• Not Applicable / Not Provided: As this is not an AI diagnostic algorithm, there is no "ground truth" establishment by experts in the context of assessing diagnostic accuracy. The "trained physician" mentioned in the "Indications for Use" section refers to the end-user of the MRI system, not an expert panel for performance evaluation of the coils themselves for a 510(k) submission.

4. Adjudication method for the test set

• Not Applicable / Not Provided: There is no "test set" or adjudication method described for performance evaluation in the context of diagnostic accuracy.

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

• Not Applicable: This submission is not for an AI-assisted device. Therefore, no MRMC study or effect size related to AI assistance would be conducted or reported.

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

• Not Applicable: This submission is for MRI hardware (coils), not an algorithm.

7. The type of ground truth used

• Not Applicable / Not Provided: No "ground truth" as typically defined for diagnostic accuracy studies. The safety and effectiveness would be demonstrated through engineering specifications, comparison to the predicate, and possibly phantom studies or limited human subject imaging to confirm image quality.

8. The sample size for the training set

• Not Applicable / Not Provided: This is not an AI/ML device, so there is no training set.

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

• Not Applicable / Not Provided: No training set or associated ground truth.

Ask a specific question about this device

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 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 AIRIS Magnetic Resonance Diagnostic Device is being enhanced by the AIRIS II System-level upgrade to increase the clinical utility of the AIRIS in the stationary configuration. The AIRIS II is provided in a stand-alone configuration, and as an upgrade path to existing AIRIS installations.

AIRIS II System-level upgrade enhancements include a new Back End user interface featuring a workstation-based User Console, implementing a graphical user interface operating system and task card-style operations (OpenWindows™). A new Front End provides real-time system control, data acquisition and reconstruction, implements all image acquisition sequences available on current AIRIS, and provides two additional types of image acquisition sequences: TRSG (time-reversed steady-state acquisition with rewinded gradient echo) and RSSG (rf spoiled steady-state acquisition with rewinded gradient echo). Other enhancements include increased gradient strength, a patient physiological gating package, and phased-array RF coils.

This document is a 510(k) summary for the AIRIS II, a Magnetic Resonance Diagnostic Device. It claims substantial equivalence to the Hitachi AIRIS with Version 4.0 Operating System Software. The document describes the device's function, scientific concepts, physical and performance characteristics, intended use, and technological characteristics.

There is no information provided in the given text regarding acceptance criteria, a study proving device conformance, reported device performance, sample sizes, data provenance, ground truth establishment, expert involvement, adjudication methods, or MRMC studies.

The document states that the DEVICE TECHNOLOGICAL CHARACTERISTICS are "Identical to the Predicate Device." This implies that the current submission relies on the predicate device's existing substantial equivalence for its technological characteristics, rather than presenting a new study for the AIRIS II's performance.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document is primarily focused on describing the enhancements of the AIRIS II over the AIRIS, its intended use, and its equivalence to a predicate device for regulatory purposes.

Ask a specific question about this device

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 MR system produces transverse, coronal, sagittal, 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, surgery planning, or therapy monitoring.

In order to ensure the availability for evaluating the accuracy of MRI results, intended patients are those subjects for whom it is anticipated that adequate. independent confirmation of any lesion apparently detected with the MR system can be obtained. With the exception of normal volunteers, eligible patients must have suspected or documented neoplastic, degenerative, infectious, or developmental disease process strongly suspected or established by physical exam, history, or conventional histologic, biochemical, bacteriological, or imaging techniques, or have surgical or aspiration biopsy pending that will be used to establish a diagnosis. The intended patients are primarily drawn from a pool of those subjects undergoing diagnostic evaluation by physicians who are skilled in diagnosis and treatment of the disease process(es) under consideration.

The AIRIS RF Transmit Coil offers improved RF Field Uniformity at the edge of the Imaging Volume to accommodate larger patients. MR images are obtained by placing the patient or area of interest within a powerful, highly uniform, static magnetic field. A portion of the protons (hydrogen nuclei) within the patient align with this main magnetic field, similar to small bar magnets. These protons precess, or rotate about the axis of the main magnetic field, much like a spinning child's top. The frequency of rotation is directly proportional to the strength of the main magnetic field, and is given by the Larmor equation, w = 2n y Bo, where w is the frequency of rotation, y is the gyromagnetic ratio, and Bo is the strength of the main magnetic field. In the case of Hydrogen protons, the precessional frequency is 4.26MHz for a magnetic field strength of 0.1Tesla. This precessional frequency of rotation is the resonant frequency of the protons. A resistive, permanent, or cryostat magnet provides the strong, homogeneous static magnetic field.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

Key Takeaway: The provided document (K961876) describes a "Revised RF Transmit Coil" for an MRI system. This is a 510(k) submission, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria and performance data like one would find for a novel AI/software medical device.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone performance studies is not present in this document. The submission is primarily a descriptive summary of the device's function, scientific concepts, physical/performance characteristics, and intended use, asserting its technological characteristics are "Identical to the Predicate Device."

1. Table of Acceptance Criteria and Reported Device Performance

   Acceptance Criteria

   Reported Device Performance

   Not explicitly stated in the document. For a 510(k) submission, acceptance criteria are generally implied by demonstrating substantial equivalence to a predicate device. This often involves showing that the new device does not raise new questions of safety or effectiveness, and performs as intended. Specific quantitative metrics for sensitivity, specificity, accuracy, or other clinical performance are typically not part of this type of submission for a hardware component unless it fundamentally changes the diagnostic imaging capabilities in a way that is not comparable to the predicate. Instead, the focus is on physical and performance characteristics being equivalent or improved without adverse impact. The core acceptance criterion seems to be "improved RF Field Uniformity" and "technological characteristics identical to predicate."

   The document states: "The AIRIS RF Transmit Coil offers improved RF Field Uniformity at the edge of the Imaging Volume to accommodate larger patients." Beyond this qualitative statement, no specific quantitative performance metrics or a direct comparison against concrete acceptance criteria are provided.

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

   • Test Set Sample Size: Not applicable / Not provided. This document describes a hardware component (RF transmit coil) for an MRI machine, not a software algorithm that would typically use a "test set" in the context of AI or diagnostic performance studies. The evaluation implicitly refers to the performance of the MRI system with the new coil.
   • Data Provenance: Not applicable. There is no mention of data-driven experiments with human subjects or retrospective/prospective data collection for performance evaluation in the way an AI algorithm would be evaluated. The "performance" assessment appears to be based on engineering design and bench testing demonstrating improved RF field uniformity.

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

   • Not applicable. Ground truth, in the context of diagnostic accuracy, is not established for this type of hardware submission. The document discusses "diagnostic determination" by a "trained physician" for the overall MR system, but this is the general clinical use case, not a specific ground truth establishment for a study of the coil itself.

4. Adjudication method for the test set

   • Not applicable. There is no test set or adjudication process described.

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 document pertains to an MRI hardware component, not an AI or software algorithm. Therefore, an MRMC study related to AI assistance would not be relevant here.

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable. For a hardware device like an RF coil, "ground truth" would typically relate to its physical properties and RF field characteristics (e.g., measured uniformity, power output) rather than diagnostic accuracy against pathology. These technical specifications are implicitly evaluated against engineering standards and the performance of the predicate device.

8. The sample size for the training set

   • Not applicable. There is no software algorithm being trained; therefore, no training set is mentioned or implied.

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

   • Not applicable. As there is no training set, no ground truth for a training set was established.

Ask a specific question about this device