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The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures and monitor patient progress in a digital environment. As an add-on component to the IMPAX client, the OT3000 orthopedic application provides digital planning to the PACS system. These images can be aimed at images helping the surgeon plan the actual prosthetic implant. These plans can also be shown to surgical placement of the implant. They will undergo and to help them understand the pathology present. The application consists of an Impax Diagnostic Workstation and templates. The application consists of guides intended for selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

Concentrating within the specialty of joint replacement, the IMPAX® OT3000 will provide an orthopedic surgeon with the ability to produce presurgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and and operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons surgiour ownershow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.

The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper pre-surgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.

The provided text does not contain any information about acceptance criteria, study details, or performance metrics for the Agfa IMPAX® OT3000 Orthopedic Workstation.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study. It states that "Technological and functional characteristics of the Agfa's IMPAX® OT3000 software are identical to those of the predicate device."

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or MRMC studies.

Summary of what is missing from the provided text:

• Acceptance Criteria and Reported Performance: No specific performance metrics or thresholds are mentioned.
• Study Details: No study is described that evaluates the device's accuracy or effectiveness. The 510(k) submission relies on substantial equivalence to a predicate device (Siemens' EndoMap).
• Sample Sizes: No information on test sets or training sets.
• Data Provenance: No details on where any data (if used for testing) originated.
• Experts and Ground Truth: No mention of experts, how ground truth was established, or adjudication methods.
• MRMC Study: No information about a comparative effectiveness study with human readers.
• Standalone Performance: No standalone performance study is described.
• Type of Ground Truth: Not applicable since no performance study is detailed.
• Training Set Sample Size and Ground Truth: Not applicable since no training or performance study is detailed.

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The Agfa IMPAX OT3000 Orthopedic Workstation is designed as an x-ray imaging system software option, which allows the planning of orthopedic surgeries on a workstation. Along with basic diagnostic display station functionality the software is intended to read in diagnostic images (c.g. digitized x-rays) for use with a database of orthopedic implant geometries and dimensions. This provides a constructed image of this data, to use in conjunction with the Agfa Impax OT3000 software to overlay the constructed images to aid surgeons in their planning of orthopedic surgeries.

The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures, educate patients and monitor patient progress in a digital environment.

As an add-on component to the IMPAX client, the OT3000 orthopedic application provides digital planning to images acquired through the PACS system. These images can be utilized to place digital templates that reflect actual prosthetic implants on patients' images helping the surgeon plan the surgical placement of the implant. These plans can be shown to patients to explain the procedure they will undergo and to help them understand the pathology present.

The application consists of the following components:

• Hip Prosthetic Planning .
• Knee Prosthetic Planning ●
• Biometry Planning takes into account patient motion and metrics .
• Coxometry tracking of known measurement values in pediatrics to determine surgical . intervention
• Osteotomy determines optimum osteotomy locations .
• Impax Diagnostic Workstation ●

Concentrating within the specialty of joint replacement, the IMPAX® OT3000 will provide an orthopedic surgeon with the ability to produce presurgical plans and distribute those plans for intra operative guidelines. It will also support the proper workflow necessary to effectively compare pre and post operative radiograph studies for a unique understanding of the patient's surgical outcome. Integrating this workflow with the orthopedic surgeons existing workflow and combining it with the data produced from the patient physical exam, provides a comprehensive data set for the continued prescription of a patient's relevant treatment and therapy.

The proper choice of prosthesis implant, size and placement is critical to postoperative success and minimizing intra operative complications. Proper pre-surgical planning is key for identifying the correct choices and decisions an orthopedic surgeon makes.

Here's an analysis of the provided text regarding the Agfa IMPAX® OT3000 Orthopedic Workstation, focusing on the acceptance criteria and study information:

Based on the provided 510(k) summary, there is no detailed information regarding specific acceptance criteria or an explicit study proving the device meets them. The document primarily focuses on establishing substantial equivalence to a predicate device.

Here's a breakdown of the requested information based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria: Not explicitly stated in the document. The submission is based on substantial equivalence, implying that the device's performance aligns with that of the predicate device (Siemens' EndoMap).
   • Reported Device Performance: Not explicitly enumerated in performance metrics. The document states that the "Technological and functional characteristics of the Agfa's IMPAX® OT3000 software are identical to those of the predicate devices."

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

   • This information is not provided in the document. No specific test set or study data is mentioned.

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

   • This information is not provided in the document. No information on ground truth establishment for a test set is present.

4. Adjudication Method for the Test Set:

   • This information is not provided in the document. No test set or related adjudication method is mentioned.

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

   • No MRMC study is mentioned or referenced. The document does not discuss human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

   • No standalone performance study for the algorithm is described. The focus is on the software's functionality and its substantial equivalence to a predicate device, not on specific performance metrics of the algorithm itself.

7. Type of Ground Truth Used:

   • This information is not provided. As no specific study or test set is detailed, the type of ground truth used is not mentioned.

8. Sample Size for the Training Set:

   • This information is not provided. There is no mention of a training set or its size.

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

   • This information is not provided. As no training set is mentioned, the method for establishing its ground truth is also absent.

Summary of what the document does provide:

• Intended Use: The workstation is designed for orthopedic surgical planning, accessing images, educating patients, and monitoring progress. It allows for placing digital templates of orthopedic implants on patient images to aid in surgical planning.
• Predicate Device: The Agfa IMPAX® OT3000 is deemed substantially equivalent to the Siemens' EndoMap (K014113).
• Technological Identity: The document explicitly states, "Technological and functional characteristics of the Agfa's IMPAX® OT3000 software are identical to those of the predicate devices." This is the primary "proof" of its suitability for market, based on the 510(k) pathway for substantial equivalence.

Conclusion:

The provided 510(k) summary is typical for a substantial equivalence submission, where detailed performance studies with acceptance criteria, sample sizes, and ground truth establishment are often not included if the device is found to be sufficiently similar to an already cleared predicate device. The "proof" the device meets acceptance criteria essentially relies on its "identical" technological and functional characteristics to a legally marketed predicate. It does not contain the granular study details typically found for novel devices or those undergoing more rigorous performance testing.

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