(112 days)
Panther OIS is an information management system used to manage medical data and clinical workflow in a hospital or clinic. To support radiation oncology users, it allows the user to:
- · Enter or import, modify, store and archive treatment plans and images from treatment planning systems.
- · Import, view, manipulate, enhance, annotate, store, and archive radiological images.
- · Select and provide radiation treatment plans to a radiation treatment delivery system for atment.
- · Store and view treatment records provided by the radiation treatment delivery system.
Panther OIS is an information management system used to organize medical data and facilitate the clinic workflow in a hospital or clinic. It is built on the Windows system as standard thin client-server system with a centralized database.
Panther OlS has incorporated and enhanced the previously cleared Prowess Panther OIS|R&V (K122616) into its framework so the user is able to:
- Record patient related information, especially radiation treatment planning and records. ●
- Schedule patients, medical resources and any type of activity.
- Capture procedure codes that will be used for billing.
- Generate reports for statistics purpose.
- Complete their tasks easily using the new ribbon Ul that supports their workflow.
- Import treatment plans
- Record patient treatment histories
- . Deliver treatment plans on radiation treatment delivery systems that have a DICOM interface for both external and stereotactic plans.
- Import, access, store and archive radiological images and review images to verify delivered treatment.
- The client is updated to a thin client so that it can be installed on more supported devices.
- Support for stereotactic treatment workflow which is similar to the external beam workflow but using a shot concept instead of a beam/arc concept.
Changes within the scope of this 510(k):
- Addition of support for stereotactic planning ●
- Addition of thin-client support, running resources stored on a central server instead of its localized hard drive
- R&V-related functionalities have been removed
Here's a breakdown of the acceptance criteria and study information for the Panther OIS device, based on the provided FDA 510(k) summary:
The Panther OIS is an information management system for radiation oncology. It is not an AI-powered diagnostic device, and therefore, many of the typical AI-related study components (like expert ground truth, MRMC studies, or specific performance metrics like sensitivity/specificity) are not directly applicable or reported in this type of submission.
The acceptance criteria primarily revolve around the system's functionality, safety, and adherence to established software development and quality standards, demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is an Oncology Information System (OIS) focusing on data management and workflow, the "acceptance criteria" are primarily related to its ability to perform its defined functions reliably and safely, matching or exceeding the predicate devices. Performance is demonstrated through successful verification and validation (V&V) testing.
| Acceptance Criteria (Implied from Summary) | Reported Device Performance (Summary of V&V Results) |
|---|---|
| Functional Equivalence to Predicate Devices: | |
| - Patient Chart/Record Management | Yes (performs as intended) |
| - DICOM Import/Export (including plans with beams/arcs/shots) | Yes (performs as intended) |
| - Treatment Plans (Import, Store, Access, Modify, Archive) | Yes (performs as intended) |
| - Images (Import, Store, Access, Modify, Archive) | Yes (performs as intended - an enhancement over the primary predicate which did not have this feature for images) |
| - Image Review | Yes (performs as intended - an enhancement over the primary predicate) |
| - Treatment Machine Characterization | Yes (performs as intended) |
| - Scheduling | Yes (performs as intended) |
| - Activity Capture | Yes (performs as intended - an enhancement over the primary predicate) |
| - Support for Stereotactic Planning | Yes (performs as intended - new addition in the subject device) |
| Software Quality and Safety: | |
| - Adherence to Predetermined Specifications | Demonstrated by verification and validation (V&V) testing. |
| - Substantially Equivalent Performance to Predicate Devices | Demonstrated by V&V testing and comparison of features. |
| - Operation as Intended | Demonstrated by V&V testing. |
| - Safety and Effectiveness for Specified Use | Demonstrated by hazard analysis, V&V testing (in-house and external), and user site testing, confirming that the benefits outweigh risks. |
| - Compliance with Software Development Standards (ISO 14971, IEC 62304) | Stated compliance. |
| - No Unanticipated Negative Impact from Changes (Thin-Client, Stereotactic) | Relevant regression testing was conducted. |
| User Experience and Clinical Integration: | |
| - Performance in Clinical Environment (safety & feedback) | Verified through external testing by "OUR United" and user site (beta-site) testing using clinical cases. This testing confirmed the software is safe and effective in a clinical environment. |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical "sample size" in terms of cases or patients for the software testing. Instead, it refers to:
- "Established test plans and protocol" for in-house V&V.
- External testing by "OUR United" to verify safety and performance under conditions equivalent to an actual clinical environment.
- "Our beta-site using clinical cases" for additional in-field testing.
- Data Provenance:
- External testing by "OUR United": The specific country of origin is not mentioned.
- Beta-site testing: Not specified.
- Retrospective or Prospective: Not explicitly stated, but the use of "clinical cases" during beta-site testing implies retrospective data or data collected prospectively during the test period. The functionality of an OIS would typically be tested with existing clinical data or simulated patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Ground Truth for OIS Functionality: The concept of "ground truth" for an OIS is different from that for an AI diagnostic algorithm. For an OIS, ground truth relates to the accuracy of data handling, workflow execution, and proper interfacing. This is typically established through:
- Defined specifications: The software correctly implements its intended functions.
- Comparison to predicate devices: The functionality matches or improves upon what is already cleared.
- Clinical expert review: In this case, "clinical physicists contracted by Prowess" were involved in verifying the adequacy of risk mitigation. This implies their expertise was used to validate the safety and functional integrity of the system in a clinical context.
- Number of Experts & Qualifications:
- The document mentions "clinical physicists contracted by Prowess" were involved in verifying the adequacy of risk mitigation. The specific number of these physicists is not provided.
- Their qualification is stated as "clinical physicists," implying expertise in the practical application and safety aspects of radiation oncology systems.
4. Adjudication Method for the Test Set
The document does not describe a traditional adjudication method (like 2+1 or 3+1) because the study is not focused on evaluating human-level diagnostic performance or AI algorithm output agreement. Instead, verification and validation involved:
- In-house testing: By "in-house test engineers."
- External testing: By "OUR United" for performance in equivalent clinical conditions.
- Beta-site testing: By "our beta-site using clinical cases" to confirm safety and effectiveness in a clinical environment.
The "adjudication" is implicitly done by confirming that the software meets its predetermined specifications and functions as intended without errors, as evaluated by these different testing groups.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done.
- This type of study is typically conducted for AI-powered diagnostic devices to assess how the AI assists human readers (e.g., radiologists) in their diagnostic tasks.
- The Panther OIS is an information management system, not an AI diagnostic algorithm, so an MRMC study is not relevant to its clearance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in essence, standalone performance testing was done for the software's functional adherence to specifications.
- The "verification and validation of the software was performed in-house according to established test plans and protocol." This represents the core "standalone" performance testing of the software's functionalities (e.g., can it import a DICOM plan correctly, can it store a patient record, can it generate a report?).
- The "functional testing was conducted both in-house and by OUR United."
- It's important to distinguish that "standalone performance" for an OIS means proving the software itself works as intended according to its functional and safety requirements, not demonstrating a diagnostic accuracy metric.
7. The Type of Ground Truth Used
For an OIS, the "ground truth" is primarily based on:
- Predetermined Specifications: The software is designed to perform specific functions according to a set of requirements. The "ground truth" is that the software correctly executes these requirements.
- Predicate Device Functionality: The Panther OIS demonstrated "substantial equivalence" to predicate devices, meaning its functional behavior aligns with or improves upon established, legally marketed systems.
- Clinical Expert Verification: "Clinical physicists contracted by Prowess" validated risk mitigation, indirectly confirming the system's safe and effective operation within clinical workflows.
There isn't a "pathology" or "outcomes data" type of ground truth in the diagnostic sense, as this device doesn't make diagnostic calls.
8. The Sample Size for the Training Set
- Not applicable / not provided: The Panther OIS is an information management system, not an AI algorithm that undergoes a "training" phase with a dataset. Therefore, there is no "training set sample size" as would be seen for a machine learning model. Its development follows traditional software engineering principles.
9. How the Ground Truth for the Training Set Was Established
- Not applicable: As explained above, this device does not utilize a "training set" in the context of machine learning. The "ground truth" for its development is its functional specifications, compliance with regulatory standards, and established best practices in oncology information systems and software engineering.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.