(139 days)
Planmed Nuance DigiGuide is an optional system for Stereotactic Biopsy. It consists of a needle guidance unit attached to Planned Nuance or Planmed Nuance Excel digital mammography X-ray units and DigiGuide software module for Nuance Manager 3 acquisition software.
The system is used for needle sampling of women's breast tissues for examination. The use of Planmed Nuance DigiGuide is allowed only under supervision of a health care professional.
Planmed Nuance DigiGuide is a digital biopsy imaging system. This system is compatible with Planmed Nuance and Planmed Nuance Excel FFDM X-ray units. .
The Planmed Nuance DigiGuide system consists of the FFDM X-ray unit (Planmed Nuance or Planmed Nuance Excel) that is equipped with the needle guidance unit and the acquisition workstation (AWS), including a personal computer with the Nuance Manager 3 software, which is used for acquiring mammographic images, determining the lesion coordinates, and taking the biopsy.
This document describes the Planmed Nuance DigiGuide, a stereotactic biopsy system for Full Field Digital Mammography (FFDM). The submission is a 510(k) premarket notification (K121963) to the FDA.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA submission for the Planmed Nuance DigiGuide does not explicitly define quantitative acceptance criteria for its performance. Instead, it relies on a comparison to a predicate device and qualitative assessments.
| Criteria | Acceptance | Reported Device Performance |
|---|---|---|
| Substantial Equivalence to Predicate Device | Device functions similarly, has similar design and composition. | Considered similar in design, composition, and function to K021945 Planmed Sophie & Sophie Classic (with Digispot and Cytoguide) = Planmed DigiGuide. The biopsy procedure, needle guidance unit, and control are the same. |
| Image Quality (Clinical Test) | At least equal to the old system (predicate device). | The image quality scored was at least equal to the old system. |
| Accuracy and Reliability (Clinical Test) | Accurate and reliable in clinical use. | The new Planmed Nuance DigiGuide system was accurate and reliable in clinical use. |
| Compliance with Set Specifications (Nonclinical) | Compliance with set specifications. | Nonclinical verification tests at the factory and accuracy tests by a 3rd party show compliance with set specifications. |
| Workflow Improvement (Implicit) | Faster and more accurate procedure due to technical differences. | Removes the need to move the detector between stereo exposures and mark the reference in images, "making the procedure faster and more accurate." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 20 stereotactic biopsies.
- Data Provenance: Conducted at a mammography screening facility. The information does not explicitly state the country of origin, but the manufacturer is based in Finland. It is a prospective clinical test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish ground truth for the 20 stereotactic biopsies. It mentions "a mammography screening facility, which already had long experience in using the previous Planmed DigiGuide system," implying experienced healthcare professionals were involved in the clinical evaluation.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) used for the clinical test set. It describes the "end result" of the comparison study, suggesting a consensus or evaluation process by the clinical site's staff.
5. 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 versus without AI assistance?
No MRMC comparative effectiveness study was mentioned. This device is a hardware system for biopsy guidance, not an AI-assisted diagnostic tool for human readers. The clinical test was a comparison of the new hardware system to its predicate, focusing on image quality, accuracy, and reliability during the biopsy procedure.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done?
This is not applicable as the Planmed Nuance DigiGuide is a hardware system for biopsy guidance, requiring human operation. It is not an algorithm with standalone performance.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" was likely defined by the success and accuracy of the biopsy procedure itself, including successful tissue acquisition and the clinical assessment of the system's performance (image quality, accuracy, reliability) by experienced users at the mammography screening facility. It is implied to be expert clinical assessment rather than pathology or outcomes data specifically. The statement "The new Planmed Nuance DigiGuide system was accurate and reliable in clinical use" suggests a clinical consensus on performance.
8. The Sample Size for the Training Set
No training set is mentioned as this device is a hardware system, not a machine learning algorithm requiring a separate training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.