(169 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 proposed RFID Localization System 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/Tag Applicator S, LOCalizer Reader) and LOCalizer Surgical Probe (Surgical Probe). The Tag, when used in conjunction with the Reader and Surgical Probe, can be used as a guide for the surgeon to refer to in the excision of tissue. The RFLS is a prescription device meant only for use by trained professionals.
Since the provided text is a 510(k) summary for a medical device (RFID Localization System), and not a study report for a diagnostic AI/ML device, much of the requested information regarding acceptance criteria for AI/ML performance, sample sizes for AI test/training sets, expert ground truth establishment, and MRMC studies is not directly applicable or present in this document.
The document discusses performance data related to the physical device's function, safety, and compatibility, rather than the performance of an AI model in a diagnostic context. The "RFID Localization System" is a marker-with-detector device, not an AI-powered diagnostic system.
However, I can extract the acceptance criteria and performance data as described for this physical device, along with other relevant information that is present.
Here's the closest possible interpretation of your request based on the provided text, focusing on the device validation rather than AI performance:
Device: RFID Localization System (RFLS)
Intended Use: Percutaneous placement in the breast to mark a lesion intended for surgical removal. Aids in non-imaging detection and localization of the implanted Tag for surgical removal.
1. Table of Acceptance Criteria and Reported Device Performance
For a physical device like the RFLS, "acceptance criteria" relate more to meeting design specifications and safety/performance standards. The document states that the RFLS met the applicable design and performance requirements. The "performance" is demonstrated by passing the various tests listed, affirming its functionality and safety.
| Feature/Test Type | Acceptance Criteria (Implied: Met applicable design/performance requirements & standards) | Reported Device Performance |
|---|---|---|
| RFLS System Design Verification | Device meets product specifications defined in design requirement documentation. | "RFID Localization System verification testing was conducted to demonstrate that the RFID Localization System (RFLS) meets product specifications as defined in the design requirement documentation." |
| "Testing was conducted to measure the effect of multiple tags on tag-to-probe distance readings." (Implied successful demonstration, as it supports substantial equivalence). | ||
| Tissue Marker Migration Eval | RFID Tag does not migrate due to MRI-induced forces or simple body movement beyond acceptable limits. | "A migration evaluation was performed to assess migration of the RFID Tag due to MRI-induced forces as well as simple migration resultant from body movement." |
| "Migration has previously been established through evaluation for the RFID Localization System (K163667 and K181692)." (Implied successful demonstration, relying on previous clearances). | ||
| Usability Verification & Validation | Device design meets usability requirements. | "Usability testing was conducted to demonstrate that the RFID Localization System (RFLS) design meets Usability requirements." |
| "Usability has previously been established through evaluation for the RFID Localization System (K181692 and K190932)." (Implied successful demonstration, relying on previous clearances). | ||
| Electrosurgery & MRI Compatibility | RFID Tag function is not adversely affected by electrosurgery. Device is safe and compatible in the MR environment. | "Testing was conducted to assess electromagnetic interference and RFID Tag functionality after direct exposure to electrical current from an electrosurgery instrument." |
| "Electrosurgical compatibility has previously been established through testing for the RFID Localization System (K163667)." | ||
| "Testing was conducted to evaluate the interaction (safety and compatibility) of the RFID Tag in the magnetic resonance (MR) environment." | ||
| "MRI compatibility has previously been established through testing for the RFID Localization System (K163667 and K190932)." (Implied successful demonstration, relying on previous clearances). | ||
| Packaging Validation | Sterile components meet standards for packaging integrity and sterility. | "Package Qualification Testing for sterile components was completed in accordance with the following standards: ISO 11607-1, ASTM D4169-09, ASTM F1886/F1886M-16, ASTM F2096-11, ASTM F88/F88M-15, ASTM F1929-98 (2004)." |
| "Ship testing was completed in accordance with ASTM D4149 and ISTA 2A." | ||
| "Packaging qualification has previously been established through testing for the RFID Localization System (K163667)." | ||
| "Shipping evaluations has previously been established through testing for the RFID Localization System (K190932)." (Implied successful demonstration, relying on previous clearances). | ||
| Sterilization Validation | Sterile components meet sterilization requirements. | "Sterilization Validation for the sterile components was completed in accordance with the following standards, as appropriate: AAMI ANSI ISO 11137-1, AAMI ANSI ISO 11137-2, AAMI ANSI ISO 10993-7." |
| "Sterilization parameters have previously been validated through testing for the RFID Localization System (K163667, K181692 and K190932)." (Implied successful demonstration, relying on previous clearances). | ||
| Stability Testing | Device maintains performance and safety over its intended shelf-life. | "Shelf-life evaluations were conducted in accordance the Food & Drug Administrations; "Shelf Life of Medical Devices" and the ASTM Standard "F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices"." |
| "Device shelf-life has previously been established through testing for the RFID Localization System (K163667, K181692 and K190932)." (Implied successful demonstration, relying on previous clearances). | ||
| Biocompatibility | Patient-contacting materials are biocompatible per ISO 10993-1 for the expected contact category, type, and duration. | "Testing completed met the requirements of the respective test methods per the International Standard ISO 10993-1 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process' as appropriate for the expected contact category, type and duration." |
| "Biocompatibility has previously been established through biocompatibility testing for the RFID Localization System patient contacting materials (K190932 and DEN040007/K033440)." (Implied successful demonstration, relying on previous clearances). | ||
| Electrical Safety & EMC | Device meets electrical safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2). | "Electrical safety and EMC safety testing was performed to, and passed, the following standards: IEC 60601-1, IEC 60601-1-2." (Explicitly states "passed the following standards"). |
| Software V&V Testing | Software meets FDA guidance for medical device software and cybersecurity. | "Software verification and validation testing for the proposed RFID Localization System (RFLS) was conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and 'Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices'." (Implies successful completion and adherence to guidance, relying on previous clearances K181692 and K190922). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set sample size" in the context of an AI/ML model. Instead, it refers to various engineering and biological validation tests. For many tests, it explicitly states that the performance was "previously established" through prior 510(k) clearances (e.g., K190932, K181692, K163667, DEN040007/K033440). This indicates that the current submission relies on historical test data and validations, with some additional testing (e.g., multiple tags, updated packaging/shipping in K190932, and the explicitly mentioned electrosurgery and MRI compatibility for K163667, and the current submission's specific software and electrical safety/EMC testing).
- Data Provenance: The document doesn't specify the country of origin for the underlying test data, but it refers to FDA-cleared predicate and reference devices, implying compliance with US regulatory standards. All validations appear to be retrospective or performed as part of device development and previous submissions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable. This is a physical medical device, not an AI/ML diagnostic algorithm requiring expert "ground truth" for interpretations of medical images or data. The "ground truth" for the device's performance would be established by objective measurements against engineering specifications and validated medical standards.
4. Adjudication Method for the Test Set:
Not applicable. This concept applies to human reader studies often used for AI/ML validation, not the direct performance testing of a physical medical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study is for evaluating observer performance with or without AI assistance, which is not the subject of this 510(k). The device is a physical marker and localization system, not a diagnostic AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
Not applicable. This device is not an algorithm; it's a marker-with-detector system that a human surgeon uses. Its performance is inherent in its physical properties and functionality.
7. Type of Ground Truth Used:
The "ground truth" for this device's validation is based on:
- Engineering specifications and design requirements.
- Objective measurements (e.g., distance readings, physical stability, electrical safety parameters).
- Compliance with established international and ASTM standards (e.g., ISO 11607-1, ASTM D4169-09, ISO 10993-1, IEC 60601-1).
- Biocompatibility assessments of materials.
- Validation of sterilization processes.
8. Sample Size for the Training Set:
Not applicable. This device does not use an AI/ML model that requires training data in the conventional sense.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no AI/ML training set. The "ground truth" for the device's design and manufacturing is established through scientific principles, engineering validated methods, and adherence to medical device regulatory standards and best practices.
§ 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.