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PhantomMSK Hip is an image-processing software indicated to assist in the positioning of Total Hip Replacement and Hip Preservation components. It is intended to assist in precisely positioning Total Hip Replacement and Hip Preservation components intraoperatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images. Clinical judgement and experience are required to properly use the device. The device is not for primary image interpretation. The software is not for use on mobile phones.

The PhantomMSK Hip is a non-invasive software system that provides image analysis tools for Total Hip Replacement and Hip Preservation procedures that use fluoroscopic imaging to assist with implant and anatomic alignment. PhantomMSK Hip provides templating, measurement, and distortion adaptation (correction) tools for intraoperative fluoroscopic image assessment. PhantomMSK Hip does not include any custom computer hardware and is a software-based device that can be run on a "commercial off-the-shelf" system (i.e. PC, keyboard, mouse, touchscreen monitor etc.) that meet minimum performance requirements. Furthermore, PhantomMSK Hip operates on image principles that are not vendor specific. To operate PhantomMSK Hip, a fluoroscopic image is acquired from a C-arm and displayed outside the sterile field, where the image analysis tools can be used at the surgeon's discretion.

Fluoroscopic distortion is attributed to external electromagnetic interference and the mapping of the planar image on a curved input phosphor. The PhantomMSK Hip uses software features in conjunction with its radiopaque calibration array, which attaches to the C-arm image intensifier, to calculate and adapt for fluoroscopic distortion.

The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria with quantitative results, sample sizes, expert qualifications, or ground truth establishment methods typical for AI performance testing.

Instead, the document is an FDA 510(k) clearance letter and a 510(k) summary for the OrthoGrid Systems, Inc. PhantomMSK Hip. It focuses on demonstrating substantial equivalence to a predicate device (PhantomMSK K182332) rather than providing a performance study report against specific acceptance metrics for AI functionality.

The key points regarding testing are:

• Verification and validation testing: Performed at code and system level according to written test protocols.
• Purpose of testing: To ensure that all templating overlay, measurement, and distortion correction tools performed as expected.
• Specific equipment used: Philips Zenition 50 Digital Video Signal.
• Calibration array compatibility: Designed for C-arms with specific image intensifier outer diameters (34.5 to 38.5 cm and 28.6 to 33 cm).
• Review of results: Reviewed by "designated technical professionals" to ensure "acceptability criteria were satisfied."
• Conclusion of testing: "Verification strategies and test procedures used are appropriate," "System test procedures trace to requirements," "All requirements are tested or otherwise verified," and "Test results meet the required pass/fail criteria."

Below is a table showing the lack of specific acceptance criteria and performance data in the provided document, along with explanations.

Table of Acceptance Criteria and Reported Device Performance

Study Details (Based on provided text)

The document does not provide a detailed study report with the specific information requested. Here's what can be inferred or explicitly stated:

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

   • Sample Size: Not specified. The document only mentions "testing was conducted" and "test results were reviewed." It does not provide the number of images, cases, or patients used in the validation.
   • Data Provenance: Not specified. There is no mention of the country of origin of the data, nor whether it 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: Not specified. The document states "The test results were reviewed by designated technical professionals." It does not specify the number of professionals or whether they were medical experts (e.g., radiologists, surgeons) or engineering professionals.
   • Qualifications of Experts: Only "designated technical professionals" are mentioned. Their specific qualifications (e.g., medical degrees, years of experience, board certification) are not detailed.

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

   • Adjudication Method: Not specified. The document only states results were "reviewed by designated technical professionals." There's no mention of consensus methods or conflict resolution for ground truth establishment.

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. This type of study is not mentioned or described. The device is indicated to "assist in the positioning" and "is intended to assist in precisely positioning," implying an assistive role, but no human-in-the-loop performance study is reported. The document explicitly states, "The device is not for primary image interpretation."

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

   • Standalone Performance: While the software has automated functions (e.g., distortion correction, templating, measurement), the document does not detail specific standalone performance metrics (e.g., sensitivity, specificity, F1-score for automated detections/measurements) against a ground truth. The testing described is more about functional verification ("performed as expected").

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

   • Type of Ground Truth: Not explicitly stated. Given the nature of the device (image processing for surgical assistance and measurements), the "ground truth" for the tests would likely involve known geometric properties, simulated distortions, or measurements from calibrated phantoms or expert-annotated images. However, the document does not specify how the ground truth was established for the "test results" that "meet the required pass/fail criteria."

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable/Not specified. The document does not describe the PhantomMSK Hip as an AI/ML device that requires a distinct "training set" in the context of deep learning or similar algorithms. It is described as "image-processing software" with "software features" to perform templating, measurement, and distortion adaptation. While some algorithms might be used, the typical AI/ML paradigm with training and test sets is not detailed. The focus is on substantial equivalence and functional testing.

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

   • Training Set Ground Truth Establishment: Not applicable/Not specified, for the same reasons as #7.

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PhantomMSK Trauma is an image-processing software indicated to assist in the positioning of Orthopedic Trauma components. It is intended to assist in precisely positioning Orthopedic Trauma components intraoperatively by measuring their positions relative to the bone structures of interest, provided that the points of interest can be identified from radiology images. Clinical judgement and experience are required to properly use the device is not for primary image interpretation. The software is not for use on mobile phones.

The PhantomMSK Trauma is a non-invasive software system that provides image analysis tools for Orthopedic Trauma procedures that use fluoroscopic imaging to assist with implant, instrument and anatomic alignment. PhantomMSK Trauma provides templating, measurement, and distortion correction tools for intraoperative fluoroscopic image assessment. PhantomMSK Trauma does not include any custom computer hardware and is a software-based device that can be run on a "commercial off-the-shelf" system (i.e. PC, keyboard, mouse, touchscreen monitor etc.) that meet minimum performance requirements. Furthermore, PhantomMSK Trauma operates on image principles that are not vendor specific. To operate PhantomMSK Trauma, a fluoroscopic image is acquired from a C-arm and displayed outside the sterile field, where the image analysis tools can be used at the surgeon's discretion.

Fluoroscopic distortion is attributed to external electromagnetic interference and the mapping of the planar image on a curved input phosphor. The PhantomMSK Trauma uses software features in conjunction with its radiopaque calibration array, which attaches to the C-arm image intensifier, to calculate and correct for fluoroscopic distortion.

This document, K192279, is an FDA 510(k) Premarket Notification for the device "PhantomMSK Trauma." Based on the provided text, the device itself is an image-processing software intended to assist in the positioning of Orthopedic Trauma components. It offers templating, measurement, and distortion correction tools for intraoperative fluoroscopic image assessment.

However, the provided text does not contain specific acceptance criteria, reported device performance metrics (e.g., accuracy, sensitivity, specificity), details about test set sample sizes and provenance, the number and qualifications of experts for ground truth establishment, adjudication methods, details of any multi-reader multi-case (MRMC) studies, or information about the training set (size, ground truth establishment).

The document states that "Verification and validation testing were done at the code and system level according to written test protocols established before testing was conducted to ensure that all templating overlay, measurement, and distortion correction tools performed as expected." It also mentions that "The test results were reviewed by designated technical professionals to ensure acceptability criteria were satisfied prior to the release of the software," and that "Test results meet the required pass/fail criteria."

While these statements confirm that testing was performed against pre-defined criteria, the specific details of those criteria and the quantitative results are not included in this FDA 510(k) summary. The summary focuses on demonstrating substantial equivalence to a predicate device, PhantomMSK (K182332), rather than providing a detailed performance study report.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance metrics, or specific details about sample sizes, expert qualifications, adjudication methods, or MRMC studies for a performance study based solely on the provided text. The document indicates that such testing was performed internally by the manufacturer, but the results and methodologies are not publicly detailed here beyond general statements.

In summary, based on the provided document, I can report the following:

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

• Acceptance Criteria: Not explicitly stated in quantitative terms. The document vaguely refers to "written test protocols established before testing was conducted to ensure that all templating overlay, measurement, and distortion correction tools performed as expected" and "acceptable criteria were satisfied."
• Reported Device Performance: Not explicitly stated in quantitative metrics (e.g., accuracy, precision). The conclusion broadly states, "performance data demonstrate that the PhantomMSK Trauma does not raise different questions of safety or effectiveness."

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not specified. The document only mentions that "The test results were reviewed by designated technical professionals."

4. Adjudication method for the test set:

• Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• Not indicated or described in the provided text. The document focuses on demonstrating substantial equivalence based on technical characteristics and intended use.

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

• The document implies that testing was done on the software's functionality, but does not provide details on whether this was a standalone algorithmic performance study or part of a human-in-the-loop workflow. The device itself is described as "image-processing software indicated to assist in the positioning...Clinical judgement and experience are required to properly use the device."

7. The type of ground truth used:

• Not explicitly defined. The testing mentioned refers to ensuring "templating overlay, measurement, and distortion correction tools performed as expected," implying comparisons against expected or reference values for these functions.

8. The sample size for the training set:

• No information about a training set is provided in this 510(k) summary, as it is primarily focused on post-development verification and validation.

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

• No information about a training set is provided.

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PhantomMSK is an image-processing software indicated to assist in the positioning of Total Hip Replacement components. It is intended to assist in precisely positioning Total Hip Replacements intraoperatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images. Clinical judgement and experience are required to properly use the device. The device is not for primary image interpretation. The software is not for use on mobile phones.

The PhantomMSK is a non-invasive software system that provides image analysis tools for Total Hip Replacement procedures that use fluoroscopic imaging to assist with implant and anatomic alignment. Total Hip Replacement aims to restore native hip biomechanics, since an unstable or asymmetrical pelvic anatomy may increase the risk of postoperative complications. Several alignment considerations during Total Hip Replacement include leg length, femoral offset, cup inclination, femoral abduction, pelvic tilt and pelvic obliquity. To assist surgeons with these alignments, PhantomMSK provides templating, measurement, and distortion adaptation tools for intraoperative fluoroscopic image assessment. PhantomMSK does not include any custom computer hardware and is a software-based device that can be run on a "commercial off-the-shelf" system (i.e. PC, keyboard, mouse, touchscreen monitor etc.) that meet minimum performance requirements. Furthermore, PhantomMSK operates on image principles that are not vendor specific. To operate PhantomMSK, a fluoroscopic image is acquired from a C-arm and displayed outside the sterile field, where the image analysis tools can be used at the surgeon's discretion.

Fluoroscopic distortion is attributed to external electromagnetic interference and the mapping of the planar image on a curved input phosphor. The PhantomMSK uses software features in conjunction with its radiopaque calibration array, which attaches to the C-arm image intensifier, to calculate and adapt for fluoroscopic distortion.

The provided text describes the 510(k) premarket notification for OrthoGrid Systems, Inc.'s PhantomMSK device. While it mentions that "acceptance criteria were satisfied" and "test results meet the required pass/fail criteria," it does not provide the specific acceptance criteria or the reported device performance in a quantitative manner.

However, based on the general description of verification and validation testing, we can infer some aspects and highlight what information is missing according to your request.

Here's an attempt to answer your questions based on the provided text, and specifying where information is missing:

Device: PhantomMSK
Description: Image-processing software to assist in the positioning of Total Hip Replacement components intraoperatively by measuring their positions relative to bone structures using fluoroscopic images.

1. Acceptance Criteria and Reported Device Performance

The document states: "acceptance criteria were satisfied prior to the release of the software" and "Test results meet the required pass/fail criteria." However, the document does not explicitly list the specific acceptance criteria or quantitative performance results in a table format.

Missing Information: Specific numerical thresholds for accuracy, precision, or other performance metrics.

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

The document states: "Testing verification and validation were done at the code and system level according to written test protocols... Specifically, testing was performed with the GE OEC 9900 and 9800 Elite Composite Video Signal and for Carms having an outer diameter of the image intensifier ranging between 34.5 to 38.5 cm."

• Sample Size for Test Set: Not explicitly stated. The text mentions "testing was performed with the GE OEC 9900 and 9800 Elite Composite Video Signal and for Carms having an outer diameter of the image intensifier ranging between 34.5 to 38.5 cm," implying a range of compatibility tests, but not the number of cases or images used.
• Data Provenance: Not explicitly stated. The location or whether the data was retrospective or prospective is not mentioned. It seems to be related to internal testing data.

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

• Number of Experts: Not explicitly stated. The document mentions: "The test results were reviewed by designated technical professionals to ensure acceptability criteria were satisfied." It does not specify how many, or their role in establishing ground truth (vs. just reviewing test results).
• Qualifications of Experts: "designated technical professionals." No further specific qualifications (e.g., radiologists, years of experience) are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not provided. The document only states that "test results were reviewed by designated technical professionals." It does not describe a method like 2+1, 3+1, or any multi-reader adjudication process for ground truth establishment.

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

• MRMC Study Done: No indications of an MRMC comparative effectiveness study. The focus seems to be on the device's functional performance and compatibility rather than human reader improvement with AI assistance.
• Effect Size of Human Reader Improvement: Not applicable as no MRMC study was described.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done: Yes, implicitly. The "Test results were reviewed by designated technical professionals to ensure acceptability criteria were satisfied." and verifying "all templating, measurement, and distortion adaptation tools performed as expected," refers to the algorithm's performance without a human in the loop, beyond using it as a tool. The device is a "software system that provides image analysis tools," suggesting its primary function is algorithmic processing and measurement.
  • However, specific quantitative results of this standalone performance are not provided.

7. Type of Ground Truth Used

• Type of Ground Truth: The document does not explicitly state how ground truth was established for the performance evaluation. It implies that the "expected" performance of templating, measurement, and distortion adaptation tools against known inputs or standards was confirmed.
  • It is likely based on simulated or phantom data with known measurements/distortions for validation, rather than expert consensus on clinical cases or pathological findings, given the nature of image processing and measurement tools. However, this is an inference; it's not explicitly stated.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not provided. The document focuses on verification and validation testing, which pertains to the performance of the final device, not the training of any underlying models. The description of PhantomMSK doesn't explicitly state it uses machine learning models requiring a "training set" in the modern AI sense, though it's "image-processing software."

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

• How Ground Truth for Training Set Established: Not applicable/Not provided. As the document does not mention a training set, the method for establishing its ground truth is also not mentioned.

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