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510(k) Data Aggregation
(61 days)
ORTHOSIZE
Orthosize is indicated for assisting healthcare professionals in preoperative planning of orthopedic surgery. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the templates. Clinical judgments and experience are required to properly use the software.
Orthosize software uses digital templates, template overlays provided by orthopedic manufacturers, to estimate the size of joints. Orthosize software allows the user to place a template over a radiographic image. The user may then select an overlay that best approximates the size of the joint in the image. The user may also translate and rotate the overlay such that it substantially matches the shape and outline of the ioint in the image. In this way, Orthosize software enables the user to estimate the size and shape of implant that most closely approximates the joint presented in the image. Orthosize also allows the user to make simple measurements.
This document describes the Orthosize software, a medical device for preoperative planning in orthopedic surgery. The information provided focuses on the software's functional and safety requirements testing, rather than a clinical study evaluating its performance in terms of surgical outcomes or accuracy against a ground truth.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Requirements | All functional requirements as defined by the Orthosize Software Requirements Specification (SRS) | "The Orthosize software passed all tests." "Final evaluation showed that testing of all software requirements was completed with passing results." |
| Safety Requirements | All safety requirements identified by a safety risk analysis performed in accordance with ISO 14971:2007 | "Safety requirements were tested as identified by a safety risk analysis ... The Orthosize software passed all tests." |
| Software Validation | Traceability performed and documented as defined by FDA's General Principles of Software Validation (January 2002) guidance document | "traceability was performed and documented as defined by FDA's General Principles of Software Validation" |
| Stress/Boundary Testing | Boundary values and stress testing as defined by the FDA's Guidance for the Content of Premarket Submission for Software Contained in Medical Devices (May 2005) guidance document | "Validation included boundary values and stress testing as defined by the FDA's Guidance..." |
| Overall Software Quality | No test faults, no test variances, all software requirements addressed, performs as intended, and meets product specifications | "No test faults were found. Additionally, no test variances were found during testing. Final assessment using a requirements coverage matrix showed that all software requirements were addressed by the tests." "Evaluation of the test results demonstrates that the software performs as intended and meets product specifications." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not describe a test set in terms of patient data or images. The testing described is intrinsic to the software itself (functional, safety, and validation testing). Therefore, there is no information on sample size for a test set or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as the document describes software validation and verification, not a clinical study involving expert interpretation of medical images.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as there was no test set of medical images requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A MRMC comparative effectiveness study was not performed or described in the provided text. The document focuses on the software's internal validation, not its clinical impact on human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document describes the standalone performance of the software in meeting its functional and safety requirements. The performance report confirms that the software, as an algorithm, passed all its defined tests. However, this is in the context of software engineering validation, not in the context of a standalone diagnostic or predictive performance against a ground truth from patient data. The device's indication for use explicitly states it is for "assisting healthcare professionals," implying human-in-the-loop operation.
7. The Type of Ground Truth Used
The "ground truth" for the tests performed was against the Software Requirements Specification (SRS) and safety risk analysis. This is an internal ground truth for software development, not a clinical ground truth like pathology, expert consensus on images, or patient outcomes data.
8. The Sample Size for the Training Set
The document does not mention a training set. This type of software, which involves overlaying digital templates, translating, and rotating overlays by a user, is likely rule-based or template-driven, rather than a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or implied, this information is not applicable/not provided.
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