(58 days)
OPSInsight™ is intended for use as preoperative surgical planning software to aid orthopaedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.
OPSInsight™ is an interactive software for preoperative planning of Total Hip Arthroplasty. It enables 3D sizing and placement of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on landmarks and anatomical models derived from patient-specific radiographic imaging and the templated implants. The biomechanical measurements include measurements relating to leg length, offset and femoral version, and the functional analysis includes determination of pelvic parameters, cup orientation calculation during flexion and extension, and impingement detection.
The software uses 2D and 3D patient-specific radiographic data. The implant data required by the software is contained within a controlled database. OPSInsight™ is a closed platform. Please refer to the Instructions for Use for compatible implant systems.
The provided text describes the 510(k) submission for the Optimized Positioning System (OPS) Insight™, a preoperative surgical planning software for total hip arthroplasty. However, the document does not contain the specific details about the acceptance criteria and the study that proves the device meets those criteria.
The 510(k) summary (sections 13 and 14) states:
- "Non-clinical testing was performed, assessing the usability and performance testing that was conducted on the predicate device. In addition to this, nonclinical testing was performed to assess the performance of the bony impingement feature in OPSInsight to demonstrate that the feature functions as intended."
- "Software verification and validation testing was conducted according to IEC 62304 and documentation provided as recommended by FDA's Guidance for the Industry: 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"
- "Clinical testing was not necessary for this Traditional 510(k)."
This indicates that while performance testing was done on the bony impingement feature, the document does not provide the specific acceptance criteria, the methodology of that testing (e.g., sample size, ground truth, experts), nor details typical of a comparative effectiveness study or standalone performance study as requested in the prompt. The statement that "clinical testing was not necessary" further confirms the absence of a large-scale human-in-the-loop study as would be described in point 5 or 6 of your request.
Therefore, based solely on the provided text, I cannot complete the table or answer most of the questions as the information is not present.
Based on the provided text, here's what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document (Only general statement that "the feature functions as intended.") |
| Performance of bony impingement feature | "demonstrate that the feature functions as intended." (No quantitative metrics provided) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the performance testing of the bony impingement feature.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "patient-specific radiographic imaging," but not the source of the test set data.
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 the "end user" as being orthopedic surgeons but doesn't detail their role in establishing ground truth for testing.
4. Adjudication method for the test set:
- Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The document explicitly states: "Clinical testing was not necessary for this Traditional 510(k)." This implies no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The text mentions "nonclinical testing was performed to assess the performance of the bony impingement feature... to demonstrate that the feature functions as intended." While this is a standalone performance assessment of the feature, the specific metrics and methodology (e.g., how "functions as intended" was quantified) are not detailed. It's implied, but the specifics are absent.
7. The type of ground truth used:
- Not specified. For the "bony impingement feature," it might have involved simulated data or expert review against CAD models, but the document does not elaborate.
8. The sample size for the training set:
- Not specified. The device uses "anatomical models derived from patient-specific radiographic imaging" and "implant data required by the software is contained within a controlled database." This alludes to data used for development, but no specific training set size is mentioned.
9. How the ground truth for the training set was established:
- Not specified. It's broadly stated as "landmarks and anatomical models derived from patient-specific radiographic imaging." Details on the establishment of ground truth for these models (e.g., expert annotation, consensus, pathological confirmation) are not provided.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).