(122 days)
The Tag of the RFLS is intended for percutaneous placement in the breast to temporarily (
The RFID Localization System (RFLS) 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. The RFLS is comprised of a Tag, Tag Applicator, Reader, and Surgical Probe. 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.
The provided text details the 510(k) summary for the RFID Localization System (RFLS). While it outlines various performance tests conducted, it does not provide a specific table of acceptance criteria with corresponding reported device performance, nor does it detail a comparative effectiveness study involving human readers (MRMC). The information focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Based on the provided text, here's an attempt to answer the questions, highlighting what information is available and what is not:
Acceptance Criteria and Study for RFID Localization System (RFLS)
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table with specific numerical acceptance criteria and corresponding reported performance for each criterion. It broadly states that "performance testing was conducted to evaluate and characterize the performance of the RFLS."
However, one specific performance metric is mentioned under "Localization Accuracy" in the comparison table:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Localization Accuracy | ±7 mm |
Other performance aspects mentioned (without specific numerical criteria or reported values):
- RFLS System Verification
- Reader/Probe Design Verification
- Localizer System and Component Accuracy, Repeatability Evaluation
- Test Media Evaluation
- Reader and Surgical Probe Operating Environment Evaluation
- Tissue Marker Migration Evaluation
- Usability Verification and Validation
- Electrosurgical tool compatibility
- EMC/Safety Testing
- Biocompatibility
- Magnetic Resonance Testing
- Packaging Validation
- Sterilization Validation
The document states that these tests "demonstrates the safety of the system for its intended use and confirms the performance of the system for use in intra-operative surgical guidance. Specifically, the performance testing demonstrates the safe use of the system to facilitate intra-operative guided surgical procedures by detecting the presence of the Tag by providing an audible tone which increases pitch and volume with decreased distance, a visible bar indicator, and a measurement readout."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the various performance tests (e.g., number of RFLS tags tested, number of measurement repetitions for accuracy, etc.).
It also does not detail the data provenance in terms of country of origin or whether the studies were retrospective or prospective. Given that this is a 510(k) summary for a medical device cleared by the FDA (USA), it's highly probable the testing was conducted in the USA, but this is not explicitly stated. The tests are described as "non-clinical testing," implying they were not conducted on human patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts or the establishment of ground truth by experts for the described performance tests. The tests appear to be primarily engineering and bench-top evaluations (e.g., accuracy, repeatability, EMC, sterilization validation) rather than studies requiring expert clinical judgment for ground truth.
4. Adjudication Method for the Test Set
Not applicable, as expert involvement and clinical ground truth establishment are not described for the non-clinical performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed to assess how human readers improve with AI vs. without AI assistance. The RFLS is a localization device, not an AI-assisted diagnostic tool that would typically involve comparative reader studies for diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The performance testing appears to be primarily focused on the standalone performance of the device's components and system operation (e.g., localization accuracy of ±7mm, detection of the tag, providing audible tone and visible indicators). The device's function is explicit: "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." This implies an "algorithm only" type of measurement in terms of its core function, but it's part of a human-guided surgical procedure.
7. The Type of Ground Truth Used
For "Localization Accuracy (±7 mm)," the ground truth would likely be established by a highly precise physical measurement system (e.g., an optical tracking system, a precisely calibrated measurement jig) during bench testing, rather than expert consensus, pathology, or outcomes data, as it's a direct physical measurement. For other tests like "Sterilization Validation" or "Biocompatibility," the ground truth would be adherence to established standards and test protocols.
8. The Sample Size for the Training Set
The document does not mention a training set. The RFLS is described as a marker-with-detector localization device, relying on RFID technology for detection and distance measurement. This does not suggest the use of machine learning or algorithms that require a distinct "training set" in the conventional sense (e.g., for image classification or prediction). The device's function appears to be based on direct physical principles of radiofrequency wave detection rather than learned patterns from a training dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set is not mentioned.
§ 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.