(90 days)
The Tag of the RFLS is intended for percutaneous placement in the breast to mark (>30 days) a lesion intended for surgical removal. Using image guidance (such as ultrasound or radiography) or aided by non-imaging guidance (RFLS), the RFID Tag is located and surgically removed with the target tissue. The RFLS is intended only for the non-imaging detection and localization of the Tag that has been implanted in a lesion intended for surgical removal.
The Tag, Tag Applicator, LOCalizer Reader, and LOCalizer Surgical Probe are components of the Health Beacons RFID Localization System (RFLS). The proposed device is a marker-with-detector localization device that employs miniature RFID tags as markers and a hand-held reader that can measure distance to the Tag, when used in conjunction with the Reader and Surgical Probe, can be used as a guide for the surgeon during the excision of tissue. The RFLS is a prescription device meant only for use by trained professionals, specifically breast surgeons and diagnostic radiologists.
This document is a 510(k) Summary for the RFID Localization System (RFLS). It describes a medical device and provides information on its performance data, but it does not contain the results of a clinical study with acceptance criteria and a detailed comparison against it. The document primarily focuses on technical performance testing and equivalence to predicate devices, rather than a clinical effectiveness study measuring human reader improvement or standalone algorithm performance against a clinical ground truth.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
The document lists "Performance Testing" categories, but it does not provide specific acceptance criteria or quantitative performance results for clinical endpoints. Instead, it states that tests were performed to demonstrate that the RFLS "met the applicable design and performance requirements."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in terms of clinical performance or specific thresholds for accuracy, sensitivity, specificity, etc.) | - RFLS System Verification performed. |
- Reader/Probe Design Verification performed.
- Localizer System and Component Accuracy, Repeatability Evaluation performed.
- Test Media Evaluation performed.
- Reader and Surgical Probe Operating Environment Evaluation performed.
- Tissue Marker Migration Evaluation performed.
- Usability Verification and Validation performed.
- Electrosurgical tool compatibility performed.
- Packaging Validation performed.
- Sterilization Validation performed. |
| Biocompatibility requirements per ISO 10993-1 | Met requirements; previously established for reference device (K163667) using identical patient-contacting materials. |
| Electrical Safety and EMC per IEC 60601-1 and IEC 60601-1-2 | Passed testing for both standards. |
| Software Verification and Validation testing per FDA Guidances | Conducted and documentation provided. |
2. Sample size used for the test set and the data provenance: Not mentioned. The performance data refers to device-level technical testing rather than a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this document does not describe a study involving expert-established ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 vs without AI assistance: Not applicable. This document does not describe an MRMC study or AI assistance. The device is a localization system, not an AI diagnostic tool for image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an "algorithm only" performance. The device is a "marker-with-detector localization device" used by trained professionals. The performance tests mentioned are for the physical device system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as this document does not describe a study involving clinical ground truth. The "ground truth" for the device's technical performance would be engineering specifications and measurements.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide:
- Device Name: RFID Localization System (RFLS)
- Intended Use: Percutaneous placement of a Tag in the breast to mark a lesion for surgical removal. The RFLS (hand-held reader and surgical probe) assists in non-imaging detection and localization of the Tag.
- Predicate Device: Cianna Medical SAVI Scout Reflector and SAVI Scout System (K171767)
- Comparison: The RFLS has the "same indications for use, principles of operation and similar fundamental scientific technology and materials" as the predicate.
- Performance Data Types: System verification, design verification, accuracy/repeatability, test media evaluation, operating environment, tissue marker migration, usability, electrosurgical tool compatibility, packaging, sterilization, biocompatibility, electrical safety, and software V&V.
- Biocompatibility: Established based on an identical reference device (K163667) and adherence to ISO 10993-1.
- Electrical Safety & EMC: Passed IEC 60601-1 and IEC 60601-1-2 standards.
- Software V&V: Conducted per FDA guidances.
The document concludes that the RFLS is substantially equivalent to its predicate device based on these performance and technical characteristic comparisons.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.