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The Encompass™ 15 Channel Head Coil is intended to be used in conjunction with a Magnetic Resorance Scanner for the MR examination of the human brain just before, during, and at the end of brain surgery. The Encompass™ 15 Channel Head Coil can also be used as a standard diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging). When used with magnetic resonance imaging systems, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Qfix and NORAS MRI products GmbH have jointly developed a head coil designed to enable MRI for diagnosis and to inform additional clinical actions, the Encompass™ 15 Channel Head Coil, 3T. The Encompass 15 Channel Head Coil is a diagnostic imaging device for use in 3T environments for obtaining diagnostic MR images to be used to inform procedures which use MR imaging to guide interventional procedures and other treatments. The Encompass™ 15 Channel Head Coil has been specifically designed to interface with the Encompass™ SRS Immobilization System (cleared with K152321 December 4, 2015).

The Encompass™ 15 Channel Head Coil is a ridged receive only coil featuring a 7 Channel Top Coil, an 8 Channel Bottom Coil, and an optional mirror holder. Imaging is performed with a 15-Channel "phased array" co-developed by Qfix and NORAS and manufactured by NORAS. The coils are mounted in a rigid Coil Frame and connection to the MRI is managed by the applicable MRI software. The Encompass™ 15 Channel MRI Head Coil has been designed for use with Siemens Healthineers MAGNETOM 3T systems e.g. MAGNETOM Skyra.

Encompass™ 15 Channel Head Coil has been optimized for use with the Encompass™ SRS Immobilization System. The use of the Encompass™ 15 Channel Head Coil together with the Encompass™ SRS Immobilization System allows immobilization of the patient while obtaining diagnostic MR images to be used to inform procedures which use MR imaging to guide interventional procedures and other treatments.

This FDA 510(k) summary describes the Qfix Encompass™ 15 Channel Head Coil, 3T, which is an MRI head coil. The document primarily focuses on demonstrating substantial equivalence to a predicate device (NORAS OR Head Coil 3T) through non-clinical performance and safety testing. It does not present an independent study with acceptance criteria involving specific performance metrics like sensitivity, specificity, or AUC for an AI/device's diagnostic accuracy.

Therefore, many of the requested elements for an AI/device performance study (like test set sample size, expert ground truth, effect size with AI assistance, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary.

However, based on the provided text, I can infer the general acceptance criteria and describe the general study approach used to demonstrate substantial equivalence for this type of medical device (an MRI coil).

Here's the breakdown:

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

For an MRI coil, "acceptance criteria" and "reported device performance" are typically framed around safety and technical imaging performance, often compared to a predicate device, rather than diagnostic accuracy metrics.

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

• Sample Size: Not applicable in the context of an "AI/device test set." This document describes testing for an MRI coil. The "test set" would primarily refer to technical performance measurements on imaging systems. There's no mention of a defined "test set" of patient images or specific clinical cases for evaluating diagnostic accuracy in the way an AI algorithm would be evaluated.
• Data Provenance: Not applicable for a typical AI/device test set. The performance data comes from non-clinical bench testing conducted by Qfix and NORAS. It indicates testing on "3T Siemens Healthineers MAGNETOM MRI scanners."

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

• Not applicable. No expert review for establishing ground truth on a 'test set' of patient data for diagnostic accuracy is mentioned. The "interpretation by a trained physician" is mentioned in the Indications for Use, which is standard for diagnostic imaging, but this is not part of a study to establish ground truth for algorithm performance.

4. Adjudication method for the test set

• Not applicable. No adjudication method is mentioned as there's no diagnostic accuracy study described involving a test set and experts.

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 performed. This document is for an MRI head coil, not an AI-powered diagnostic device, so AI assistance is not a component.

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

• Not applicable. This device is an MRI head coil, not an algorithm. Its performance is inherent to its physical design and interaction with the MRI scanner. It does not perform a standalone diagnostic function akin to an algorithm.

7. The type of ground truth used

• For an MRI coil, "ground truth" relates to the accuracy and quality of the image acquisition, not diagnostic findings from patient cases. The "ground truth" (or reference standard) in this context would be:
  • Engineering specifications and standards: Adherence to NEMA standards for MRI performance (e.g., SNR, uniformity).
  • Safety standards: Compliance with IEC 60601-1 series and ISO 14971.
  • Predicate device performance: Functional equivalence and demonstrated improvements over the NORAS OR Head Coil 3T.

8. The sample size for the training set

• Not applicable. This device is hardware (an MRI coil), not an AI algorithm, so there is no "training set."

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

• Not applicable. As there is no training set for an AI algorithm.

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The Encompass™ SRS Headframe provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning. repositioning, and immobilization. The Encompass™ SRS Headframe allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

Qfix, has made a modification to its previously cleared Encompass™ SRS Immobilization System (cleared in K152321). In this modified variant of the Encompass™ SRS Immobilization System, the essential geometry of the head portion of the Encompass™ SRS Standalone Device is isolated to create a separate attachment which can be affixed to patient positioning devices that accept S-type thermoplastic masks, such as Qfix's Portrait™ Intracranial, Head and Neck Device (a device for use with S-type thermoplastics). Ofix intends to initially market the subject device for use with the Encompass™ SRS Fibreplast® System with optional IntegraBite™ (also cleared in K152321) and its devices which share a hole pattern and geometry with its Portrait™ Intracranial, Head and Neck Device. Examples of such devices include the kVue™ Portrait™ Intracranial. Head and Neck Insert and the Symphony® Portrait™ Transfer Device (cleared in K160627). This creates a flexible solution for a variety of imaging and radiotherapy treatment applications using stereotactic radiosurgery, such as radiation oncology and the treatment of noncancerous conditions and malformations such as trigeminal neuralgia.

The provided text is a 510(k) summary for the Qfix Encompass™ SRS Headframe, a medical device for patient immobilization during radiation therapy. It claims substantial equivalence to a previously cleared predicate device rather than presenting a novel AI/software-as-a-medical-device (SaMD) study. Therefore, the information typically requested about AI/SaMD acceptance criteria, test set details, expert ground truth, MRMC studies, and training set information is not present in this document.

However, I can extract information related to the device's performance claims and general testing.

Here's a breakdown of what can be extracted based on the provided text, and what cannot be extracted because it's not an AI/SaMD submission:

Acceptance Criteria and Device Performance (General Device Performance):

The document does not provide a table of explicit, quantifiable acceptance criteria with corresponding performance data in the typical sense of a SaMD validation study. Instead, it makes a general claim about performance relative to its predicate device.

Information NOT available in the provided text (typical for AI/SaMD studies):

2. Sample size used for the test set and the data provenance: Not applicable to this device type and submission. The document mentions "testing using healthy volunteers" for non-clinical bench testing but does not specify a sample size for these volunteers.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical immobilization device is typically established through direct measurement (e.g., motion studies, calibration) rather than expert interpretation of images or data.
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, as this is not an AI-assisted device for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, ground truth for accuracy claims would be based on physical measurements (e.g., displacement measurements during motion studies) rather than expert interpretation or pathological findings.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

Summary of Device and Study Type:

This 510(k) submission is for a physical medical device (Encompass™ SRS Headframe) used for patient immobilization during radiation therapy. The submission relies on demonstrating substantial equivalence to a previously cleared predicate device (Encompass™ SRS Immobilization System, K152321). Therefore, the "study" described is primarily non-clinical bench testing and testing with healthy volunteers to ensure the modified device maintains the performance characteristics (e.g., sub-millimetric accuracy, compatibility) and safety profile of the predicate device, rather than a clinical trial or AI/SaMD validation study with diagnostic endpoints.

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ENCOMPASS Eagle 3D is intended to acquire two-dimensional digital panoramic and cephalometric radiographies, and multi-field of view 3D computed tomography images of dento-maxillo-facial region for the purpose of advanced diagnosis at the direction of qualified dental healthcare professionals

The ENCOMPASS Eagle 3D is a complete 3-in-1 system for dental imaging capable of make Tomography, Digital Panoramic Profiles and Digital Cephalometric Profiles. The machine uses a CCD sensor technology with the traditional scintillator technologies and auto image processing that speeds up the diagnostic and improves the clinic workflow. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current).

The provided text describes the ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-ray device and its substantial equivalence to a predicate device (PREXION 3D ECLIPSE). However, it does not detail a study with specific acceptance criteria and reported device performance in the way a clinical performance study for an AI/ML SaMD would.

Instead, the document focuses on demonstrating substantial equivalence based on technical specifications and performance testing against the predicate device, a common approach for traditional medical devices like X-ray systems.

Here's a breakdown of the information that is available, formatted to address your request as much as possible, along with explanations of why some requested information is not present:

Acceptance Criteria and Device Performance for ENCOMPASS Eagle 3D

The device is an X-ray system, and its "performance" is primarily assessed by comparing its technical specifications and image quality characteristics (like MTF and DQE) to those of a legally marketed predicate device. The underlying acceptance criterion is that the new device should be substantially equivalent to the predicate device in terms of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

For an X-ray device, "acceptance criteria" for demonstrating substantial equivalence are typically aligned with relevant electrical, mechanical, environmental, and radiation safety standards, as well as key imaging performance metrics (e.g., resolution, noise). The "reported device performance" is then how the new device measures up against these (often implicitly defined by the predicate's performance).

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

The document states: "In accordance with the FDA guidance document on Solid State X-Ray Imaging Devices, clinical images were acquired with both the new device and the predicate device."

• Sample Size: The exact number of clinical images or cases used is not specified.
• Data Provenance: The country of origin and whether the data was retrospective or prospective are not specified. It is implied to be prospective data collection for the purpose of the submission since images were "acquired with both the new device and the predicate device" for comparison.

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

• Number of Experts: "a licensed dentist" assessed the clinical images. This implies one expert.
• Qualifications of Experts: "a licensed dentist." No further details on experience or specialization are provided in this summary.

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

• Given that only "a licensed dentist" performed the comparison, there was no adjudication method (like 2+1 or 3+1 consensus) in the traditional sense, as there was only one reviewer.

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

• No MRMC comparative effectiveness study was done. This device is an X-ray imaging system, not an AI/ML-driven diagnostic software. The comparison was primarily on the physical and imaging characteristics of the hardware and the quality of the images produced, rather than reader performance with or without AI assistance.

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

• No standalone algorithm performance study was done. This is a hardware device for image acquisition, not a software algorithm.

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

• For the clinical image comparison, the "ground truth" was implicitly established by the judgment of a single licensed dentist who compared images from the new device and the predicate device for diagnostic ability, sharpness, and quality. This is a form of expert assessment or expert-generated truth. There's no mention of pathology or outcomes data being used for this comparison.
• For the technical performance metrics (MTF, DQE), the "ground truth" comes from standard physical measurements using phantoms and calibrated equipment.

8. The sample size for the training set

• Not applicable / Not specified. This device is an X-ray imaging system, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The device is trained/calibrated during manufacturing and installation processes, but this is distinct from an AI model's training data.

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

• Not applicable / Not specified. As explained above, there isn't a "training set" in the AI/ML sense for this hardware device.

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For Panoramic or Cephalometric diagnostic radiographic use in dental, oral surgery, and orthodontic practices.

The ENCOMPASS HF100-Eagle Panoramic X-Ray Machine with CCD sensor is a complete system for dental imaging capable of Digital Panoramic Profiles and Digital Cephalometric Profiles. The machines use a sensor CCD sensor technology with the traditional scintillator technologies and auto image processing that allow a speed up the diagnostic and improve the clinic workflow. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current). ONLY THE SENSOR HAS CHANGED.

The provided text describes the ENCOMPASS HF100-Eagle Panoramic/Cephalometric X-Ray with CCD sensor. Based on the information, here's a description of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance

The device sought substantial equivalence to its predicate device (K110371, Encompass made for Panoramic Corp.). The acceptance criteria appear to be focused on achieving comparable diagnostic quality, sharpness, and overall image quality to the predicate device, as well as meeting relevant safety and performance standards.

Table of Acceptance Criteria and Reported Device Performance:

Overall Result: "All test results were satisfactory." and the clinical summary states the images were found to have comparable diagnostic quality, sharpness, and overall quality.

Study Details:

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The text only mentions "the predicate and new device pan and ceph images."
   • Data Provenance: Not specified. It does not mention the country of origin of the data, nor whether the data was retrospective or prospective.

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

   • Number of Experts: "a licensed dentist" (singular).
   • Qualifications of Experts: A "licensed dentist." No further details on experience level (e.g., years of experience, specialization) are provided.

3. Adjudication method for the test set:

   • Adjudication Method: Not specified. With only one expert reviewing, there was no adjudication process (like 2+1 or 3+1 consensus). The assessment was based on a single licensed dentist's review.

4. 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, an MRMC study was not done. The evaluation involved a single licensed dentist comparing images from the new device and the predicate device, not assessing human reader performance with or without AI assistance. This device is an X-ray machine with a new sensor, not an AI-assisted diagnostic tool.

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

   • Standalone Performance: Not applicable in the context of an X-ray imaging device itself. The device produces images for human interpretation. The "resolution figures" and technical performance tests (safety, EMC, X-ray standards) could be considered standalone performance metrics for the device's technical capabilities, but not a standalone diagnostic "algorithm" performance.

6. The type of ground truth used:

   • Ground Truth Type: Expert opinion/consensus. In this case, it was the opinion of a single "licensed dentist" who evaluated the diagnostic quality, sharpness, and overall quality of the images. There is no mention of pathology or outcomes data being used as ground truth.

7. The sample size for the training set:

   • Sample Size: Not applicable. The device is an X-ray machine with a new sensor, not a machine learning model that requires a "training set" in the conventional sense. The "auto image processing" mentioned is likely built-in firmware/software rather than a continually learning AI.

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

   • Ground Truth Establishment: Not applicable, as there is no mention of a training set for a machine learning model.

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The Encompass® 10/12 Hip Stem is intended for use in total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.

The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis
2. Previously failed surgery
3. Proximal femoral neck fractures or dislocation
4. Idiopathic avascular necrosis of the femoral head
5. Non-union of proximal femoral neck fractures
6. Treatment of fractures that are unmanageable using other forms of therapy
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis

The Encompass® 10/12 Hip Stem is a one-piece, straight femoral stem, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stem is manufactured from wrought titanium alloy Ti-6Al-4V EU per ASTM F136. The proximal portion of the stem is subsequently plasma-sprayed with Commercially Pure Titanium per ASTM F1580. The stem has a neck with a 10/12 trunnion taper for modular attachment to femoral heads. To accommodate various patient anatomies, the stem is offered with and without collars and in a variety of sizes, including the following ranges: lengths (115-143mm), horizontal offsets (32-46mm), and vertical offsets (29-36mm), with a resection angle of 130°, and neck angle of 132°.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The document does not report any clinical studies or human test subjects. The performance testing was non-clinical (mechanical testing of the device itself).
• Data Provenance: Not applicable. All testing mentioned is non-clinical laboratory testing.

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

• Not applicable. As no clinical studies were performed, there was no human test set requiring expert adjudication for ground truth. The "ground truth" for non-clinical performance testing is based on established engineering standards (ISO).

4. Adjudication Method for the Test Set

• Not applicable. No clinical studies were performed.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a hip stem prosthesis, not an AI or imaging-based diagnostic tool that would typically involve human readers.

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

• Not applicable. This device is a medical implant, not an algorithm, so the concept of "standalone performance" in the context of AI does not apply.

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

• For the non-clinical performance studies, the "ground truth" is established by adherence to internationally recognized engineering and medical device standards (e.g., ISO 7206-6, ISO 7206-4, ISO 21535). These standards define acceptable performance parameters for hip stem prostheses.

8. The Sample Size for the Training Set

• Not applicable. As no clinical studies or AI/algorithm development are reported, there is no "training set." The device is a physical implant.

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

• Not applicable. There is no training set.

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For Panoramic or Cephalometric diagnostic radiographic use in dental, oral surgery, and orthodontic practices.

The ENCOMPASS HF100- Eagle Panoramic X-Ray Machine is a complete system for dental imaging capable of: Film Panoramic Profiles Film Cephalometric Profiles Digital Panoramic Profiles Digital Cephalometric Profiles The digital machines use a sensor with CdTe/CMOS technology for imaging that allows for direct conversion between x-ray photons into voltage levels making it less noisy than traditional scintillator technologies. The equipment has three movement axes (two in orthogonal directions and one rotational) making it possible to execute elaborate imaging profiles. It features a complex profile movement around the dental arch and radiographic emission compensation in the spinal region, when necessary reconstructing the dental arch into a plane image. Each individual profile prioritizes a set of characteristics improving diagnostic capabilities. For example, the standard panoramic prioritizes image layer width, constant vertical magnification and homogeneous exposure along the whole image. Likewise, the low dosage profile prioritizes the reduction of dosage (time and anodic current).

The provided text describes a 510(k) premarket notification for the ENCOMPASS HF100- Eagle Panoramic/Cephalometric X-Ray device. This document focuses on demonstrating substantial equivalence to a predicate device and safety and performance testing for overall device functionality, rather than presenting a study to prove a specific algorithm's performance against defined acceptance criteria for diagnostic accuracy.

Therefore, the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies for AI algorithm performance is not available in the provided text.

The document primarily addresses:

• Device Description: It's an X-ray machine for dental, oral surgery, and orthodontic practices.
• Safety and Performance: Electrical, mechanical, environmental safety, and X-ray specific compliance testing are mentioned. It states "Accuracy testing and software validation was performed. All test results were satisfactory." However, it does not detail what accuracy was tested or what the acceptance criteria were for this 'accuracy testing'.

Summary of available information:

1. A table of acceptance criteria and the reported device performance: Not explicitly stated for diagnostic accuracy criteria of an algorithm. The document mentions "Accuracy testing and software validation was performed. All test results were satisfactory." but does not provide specific metrics or criteria.
2. Sample size used for the test set and the data provenance: Not applicable/not provided for an algorithm performance study. The document refers to general device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
4. Adjudication method for the test set: Not applicable/not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not for an AI algorithm.
6. If a standalone was done: The "Accuracy testing and software validation" mentioned is for the overall device functionality, but not presented as a standalone clinical performance study for an AI algorithm.
7. The type of ground truth used: Not applicable/not provided for an AI algorithm performance study.
8. The sample size for the training set: Not applicable/not provided. This device is not described as having a machine learning component requiring a training set.
9. How the ground truth for the training set was established: Not applicable/not provided.

Conclusion:

This 510(k) summary focuses on the safety and effectiveness of the physical X-ray device and its equivalence to a predicate, not on the performance of a specific AI algorithm intended for diagnostic interpretation. The "accuracy testing" mentioned is likely related to the physical output and image quality of the X-ray machine itself, not a diagnostic algorithm's performance.

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The device is intended for use in total hip arthroplasty. The device is intended for uncemented, press-fit use only.

• 1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
• 2. Previously failed surgery.
• 3. Proximal femoral neck fractures or dislocation.
• 4. Idiopathic avascular necrosis of the femoral head.
• 5. Non-union of proximal femoral neck fractures.
• 6. Treatment of fractures that are unmanageable using other forms of therapy.
• 7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the Encompass™ Press-Fit Hip Stem. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Therefore, I cannot provide the requested information.

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Encompass.Net™ device is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Encompass.Net™ receives imaging studies over a network from Empiric Systems servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

Encompass.Net™ is a fully web-based system that operates in a Microsoft Internet Explorer (Version 6.0 and above) environment. Encompass.Net™ is run in a Windows 2003 environment, using Microsoft's Internet Information Server functions. The core database is Microsoft SQL 2000.

Encompass. Net is intended to acquire medical images for storage, archiving, and routing to medical professionals. In addition, Encompass.Net allows medical professionals to retrieve medical images on demand using Internet communication protocols according to various user options and lossy and/or lossless compression techniques for subsequent review. A host of image process tools are available for the medical professional.

In addition to Encompass. Net, the fully integrated RIS/PACS device, there are also multiple stand-alone PACS models (subsets of Encompass Net) that will be marketed. Those configurations are: R1.Net, R2.Net, and R3.Net.

The provided text is a 510(k) summary for the Encompass.Net™ device, which is a Picture Archiving Communications System (PACS). It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain any information about specific acceptance criteria or a study proving the device meets them.

The document is primarily a regulatory submission to the FDA for market clearance, focusing on:

• Device Description: Encompass.Net™ is a fully web-based system for acquiring, storing, archiving, routing, and retrieving medical images (CT, MR, CR, DR, US, and other DICOM compliant systems) for viewing and diagnostic interpretation. It supports both lossless and lossy compression.
• Indications for Use: Viewing and diagnostic interpretation of images from various medical imaging systems, with specific caveats for mammographic images (lossy compressed mammograms and digitized film-screen images) which must not be reviewed for primary interpretation, and requiring FDA-approved monitors for mammography.
• Technological Characteristics: It's a software product that handles digital medical images and does not contact the patient or control life-sustaining devices.
• Predicate Device: Amicas Light Beam Workstation (K022970).
• Conclusion: The submission aims to demonstrate substantial equivalence to the predicate device.

Therefore, I cannot provide the requested information about acceptance criteria or a study with performance data because it is not present in the provided text. The document does not describe a clinical performance study using test sets, ground truth, or expert readers. It appears to be a review of technical and functional equivalency rather than clinical efficacy or accuracy.

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Using the software listed to post-process images, various analysis and reconstruction can be initiated by the user to obtain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are:

• URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. .

• URFR-001A: Three-dimensional image reconstruction from the ultrasound . diagnostic images for abdominal, small organs and peripheral vascular.

• URTQ-001A : Following analysis from the TDI (Tissue Doppler Image) from the . ultrasound diagnostic images.

• Gray scale (display of only black-and-white images)

• Velocity display (display of the velocity after angle correction and smoothing)

• Display of the velocity gradient based on the velocity image

• Display of the degree of myocardial strain based on the velocity image

• Display of the displacement based on the velocity image

• Display of the dyssynchrony imaging based on the above imaging methods

These software packages are to be applied to the imaging processing system Encompass from Agfa Corp. Using the software listed to post-process images, various analysis and reconstruction can be initiated by the user to obtain clinically relevant information pertaining to cardiac and radiology. Additionally this information can be used in the detection of cardiovascular disease and radiology diagnosis and risk management. Support functions are:

• URSE-001A: Stress Echo analysis of the ultrasound diagnostic images. .

• URFR-001A: Three-dimensional image reconstruction from the ultrasound . diagnostic images for abdominal, small organs and peripheral vascular.

• URTQ-001A : Following analysis from the TDI (Tissue Doppler Image) from the . ultrasound diagnostic images.

• Gray scale (display of only black-and-white images)

• Velocity display (display of the velocity after angle correction and smoothing)

• Display of the velocity gradient based on the velocity image

• Display of the degree of myocardial strain based on the velocity image

• Display of the displacement based on the velocity image

• Display of the dyssynchrony imaging based on the above imaging methods

The provided text is a 510(k) summary for the Toshiba America Medical Systems, Inc. Encompass Software Package (K053043). This document details the software's intended use, technological characteristics, and substantial equivalence to predicate devices. However, this specific document does not contain information about acceptance criteria, detailed study designs, performance metrics, sample sizes, or ground truth establishment that would typically be found in a performance study report.

The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance based on rigorous clinical trials and statistical acceptance criteria. The document explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth, or MRMC studies, as this information is not present in the provided 510(k) summary. The summary focuses on comparing the new device's features and intended use to existing devices.

Below is a summary of what can be extracted from the provided text, while also noting the absence of the requested performance study details:

Summary of Device: Encompass Software Package (K053043)

1. Table of Acceptance Criteria and Reported Device Performance:

• No specific acceptance criteria or quantified performance metrics are reported in this 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than performance against defined criteria.

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

• Not applicable / Not provided. The 510(k) summary does not describe any specific test set or data used for a performance study.
• The comparison is made against predicate devices' known functionalities.

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

• Not applicable / Not provided. No ground truth establishment process involving experts for a test set is described.

4. Adjudication method for the test set:

• Not applicable / Not provided. No 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 performed / Not described. This 510(k) summary does not mention an MRMC comparative effectiveness study. The device is software for post-processing images, not an AI for assisting human readers in diagnosis in the context of an MRMC study.

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

• Not applicable / Not described as a standalone study. The software itself performs analysis and reconstruction, but its "performance" is assessed in terms of its functions being similar to predicate devices, not through a standalone quantitative performance study described here.

7. The type of ground truth used:

• Not applicable / Not provided. No ground truth for a performance study is mentioned in this document. The basis for approval is substantial equivalence to legally marketed predicate devices and compliance with general controls.

8. The sample size for the training set:

• Not applicable / Not provided. No training set for an algorithm is mentioned in this document.

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

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

Explanation of Device and Substantial Equivalence (from the document):

This 510(k) submission is for software packages (URSE-001A, URFR-001A, URTQ-001A) designed to be applied to the Agfa Corp. Encompass imaging processing system. These software packages enable:

• URSE-001A: Stress Echo analysis of ultrasound diagnostic images.
• URFR-001A: Three-dimensional image reconstruction from ultrasound diagnostic images for abdominal, small organs, and peripheral vascular.
• URTQ-001A: Analysis from Tissue Doppler Imaging (TDI) from ultrasound diagnostic images, including display of velocity, velocity gradient, myocardial strain, displacement, and dyssynchrony imaging.

The device's substantial equivalence is claimed based on its similarity in uses and applications to the predicate devices:

• Agfa Corp. Encompass [K040896]
• Toshiba SSA-770A [K041499]
• General Electric Vivid 7 with TSI [K031663]

The FDA's determination of substantial equivalence (K053043) means the device can be legally marketed, as it has similar indications for use and technological characteristics to devices already on the market prior to May 28, 1976, or reclassified devices. This implies that the device is considered as safe and effective as the predicate devices, without requiring new clinical performance studies to prove novel performance or meet specific, quantifiable acceptance criteria.

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The device is intended for cemented use only. The device is intended for use in hip arthroplasty applications whose indications include:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, post traumatic acetabuli and painful hip dysplasia.
2. Previously failed surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Not Found

This looks like a 510(k) clearance letter for a hip implant, not a study report for an AI/ML medical device. Therefore, I cannot extract the information requested as it is not present in the provided document.

The document discusses:

• Device Name: Encompass™ Cemented Hip System
• Regulation Number: 21 CFR 888.3350
• Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis
• Regulatory Class: II
• Product Code: JDI
• Indications for Use: Conditions like osteoarthritis, rheumatoid arthritis, fractures, avascular necrosis, etc., where a hip arthroplasty is indicated.

This document confirms the FDA's clearance of the device based on its substantial equivalence to a legally marketed predicate device, as per Section 510(k) of the Federal Food, Drug, and Cosmetic Act. It does not contain any information about performance studies, acceptance criteria, sample sizes for AI training or testing, expert ground truth adjudication, or any AI-related metrics.

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