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510(k) Data Aggregation
(248 days)
RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
RFMagik Lite is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch. There are two handpieces. RO handpiece and AGNES RF handpiece that delivers RF energy through the disposable electrode in the handpiece.
The provided FDA 510(k) clearance letter for RFMagik Lite does not contain information about specific acceptance criteria or a study that directly proves the device meets such criteria in terms of clinical performance or effectiveness. The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing (electrical, EMC, biocompatibility, sterility, shelf life, and performance bench testing) and an ex vivo study.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria in terms of clinical performance metrics (e.g., success rates, complication rates, or comparative outcomes) are mentioned in the document for the RFMagik Lite. The "performance testing" referenced is primarily bench testing to ensure the device operates safely within design specifications. The acceptance criteria for the non-clinical tests are implicit in the adherence to recognized standards.
| Acceptance Criteria Category | Specific Criteria (Implicit from standards) | Reported Device Performance (Implicit from successful testing) |
|---|---|---|
| Electrical Safety | Compliance with AAMI ES60601-1, IEC60601-2-2 | Passed (stated that testing shows the device is safe) |
| EMC | Compliance with IEC 60601-1-2, TR IEC 60601-4-2 | Passed (stated that testing shows the device is safe) |
| Biocompatibility | Compliance with ISO 10993 series | Passed (stated that non-clinical data shows the device should perform as intended) |
| Sterility | Compliance with ISO 11135, ISO 11138 series, ISO 10993-7 | Verified and validated (EO gas sterilization) |
| Shelf Life | Compliance with ISO 11607 series, ASTM F1929, ASTM F88M | Passed (stated that non-clinical data shows the device should perform as intended) |
| Performance Testing | Operates safely and within predefined design specifications | Passed (stated that AGNES MEDICAL conducted bench testing to assure this) |
| Ex Vivo Study | Thermal testing consistent with FDA guidance | Conducted on liver, skin, and muscle under GLP conditions (no specific performance metrics given) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical or human subject data. The testing mentioned is non-clinical (bench, ex vivo). For the ex vivo study, the number of tissue types used was three (liver, skin, and muscle), but the specific number of samples or specimens within each tissue type is not provided.
The provenance of this ex vivo data would be laboratory-based, focusing on tissue samples rather than human subjects. The country of origin for the ex vivo study is not explicitly stated, but the submission is from a South Korean company.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since there is no mention of a clinical "test set" or human subject data, there is no information about experts establishing ground truth for such a set. The ex vivo study would likely involve experts in histology or pathology for evaluating thermal effects, but their number and qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable, as there is no described clinical "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. The RFMagik Lite is an electrosurgical device for cutting and coagulation, not an AI-assisted diagnostic or imaging device that would typically undergo an MRMC study comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The RFMagik Lite is a physical electrosurgical device, not a standalone algorithm.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" is defined by the adherence to and successful completion of recognized consensus standards (e.g., AAMI ES60601-1, IEC60601-2-2 for electrical safety, ISO 10993 for biocompatibility). For the ex vivo study, the "ground truth" would likely be the observed thermal effects on the tested tissues, assessed against predetermined safety or efficacy thresholds (though these thresholds are not explicitly stated in the document).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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(254 days)
The RF cannula is intended for use in RF heat lesion procedures for the relief of pain.
The RF Cannula is composed of Cannula, Cannula hub, Stylet, Stylet hub, Insulating layer, Depth stop and Protection tube.
Materials being used include SUS 304 stainless steel, K-Resin, polyethylene, polyethylene terephthalate.
RF Cannula is supplied sterile and is only for single-use. It is used in conjunction with a RF Generator and RF Electrode and other accessories to create Radiofrequency (RF) Lesions of nerve tissue or for use in percutaneous nerve blocks. During the RF heat lesion procedure, the RF cannula bare tip is placed into the target tissue; preloaded stylet is withdrawn and replaced by the RF Electrode. The radio frequency is produced by the RF Generator and released by the cannula bare tip.
N/A
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(174 days)
The RFG-01 is intended to:
- provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
- provide, with a massage device, a temporary reduction in the appearance of cellulite.
The RFG-01 is a mobile standalone equipment with four wheels and consists of a console (main unit), a color display with touch operation and three handpieces (small, medium, and large). The device develops localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. The purpose of the treatment based on the radiofrequency system is to raise the temperature inside the tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated. The devices use RF electrodes of the resistive (or bipolar) types. Resistive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator (through the electrode connectors). Handpieces of different shapes are available to facilitate use by the operator on different body parts. The use of different sizes allows efficient and effective treatment of various parts of the body. Two of the three handpieces can be used with or without vacuum, allowing an even deeper application of heat. The handpieces are to be used with a small amount of contact lotion, the purpose of which is to assist in heat transfer. The LEDs on every handpiece indicate the coupling and the correct temperature range during the treatment. The color touchscreen displays all treatment-related parameters.
The provided text is a 510(k) Summary for the Zimmer MedizinSysteme GmbH RFG-01 device. It details the device's characteristics and its substantial equivalence to predicate devices, but it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.
The document states that "Performance data" and "The following testing has been conducted with satisfactory results:" followed by a list of tests and standards. However, it does not provide specific numerical acceptance criteria or the measured performance results from these tests. It only lists the types of tests performed and the standards met.
Therefore, I cannot populate the table with specific acceptance criteria and reported device performance, nor can I provide details on sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information. The document focuses on demonstrating substantial equivalence through compliance with recognized standards and comparison of technological characteristics, not through clinical performance metrics against defined acceptance criteria.
The information regarding acceptance criteria and reported device performance would typically be found in detailed test reports for the validation tests (e.g., RF Power Accuracy, Vacuum Pressure Accuracy, Thermal Effect on Skin testing), which are not included in this 510(k) Summary.
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(90 days)
The intended use of the RFP-100A Connector Cable (Single Use) is to connect the RFP-100A Generator to separately cleared compatible RF devices.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "RFP-100A Connector Cable (Single Use)". It indicates that the device has been found substantially equivalent to a legally marketed predicate device.
Crucially, this document does not include information about acceptance criteria, performance studies, or ground truth establishment for an AI/ML device.
The device described, a connector cable, is a passive component used to connect two other cleared medical devices (a generator and RF devices). Its function is likely to transmit electrical signals, and its acceptance criteria would focus on electrical safety, biocompatibility, mechanical integrity, and compatibility with the specified devices, rather than the kind of performance metrics (sensitivity, specificity, AUC) typically associated with AI/ML-driven diagnostic or prognostic tools.
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because it is not relevant to the type of device being discussed.
To provide the information you've requested, I would need a 510(k) summary or a similar document for an AI/ML-enabled medical device that performs a diagnostic, prognostic, or therapeutic function.
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(30 days)
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.
The Aqua RF Vapor System uses a catheter to deliver heated water vapor to the tissue surface undergoing treatment. The Aqua RF Vapor System is a catheter-based system for heating and coagulating tissue. The heat is delivered to the target tissue in the form of water vapor that is generated within the catheter tip using radiofrequency (RF) energy. Application of heat to the tissue results in coagulation of the tissues being treated. This technique avoids the need for direct RF energy application to heat the tissue. The Aqua Medical RF Vapor System consists of the following components: Aqua RF Vapor Generator: A software-controlled RF generator is operated i through a graphical user interface (GUI) and incorporates a svringe pump that delivers saline to the catheter. Delivery of bipolar RF energy to the catheter is controlled either by an accessory foot pedal or a button incorporated in the disposable catheter. Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7 F (2.3 mm) and a lengths between145 cm and 210 cm. There are 4 types of RF Vapor catheters available. Saline Delivery Tubing and Syringe: Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.
The Aqua Medical RF Vapor System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract in adults. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in a quantitative manner (e.g., minimum percentage of coagulation, specific temperature achieved). However, it does describe the types of tests performed to demonstrate substantial equivalence to the predicate device. The performance data is presented as verification that the new catheter design performs as intended and is as safe and effective as the predicate.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use Equivalence | The Aqua Medical RF Vapor System has identical indications for use as the previously cleared Aqua RF Vapor System (predicate device). |
| Technological Equivalence | The new Aqua Medical Circumferential RF Vapor Ablation Catheter design was tested to ensure it performs as intended via hardware verification testing. Comparative simulated use bench model testing was conducted to support substantial equivalency and demonstrate that the new design functions in an equivalent manner as the previously cleared Aqua Medical Focal RF Vapor Catheters. |
| Safety and Effectiveness | Comparative validation testing and verification testing demonstrated that the additional catheter design is substantially equivalent to the previously cleared Aqua RF Focal Vapor Catheter. The device is considered as safe and effective as its predicate without raising any new safety and/or effectiveness concerns. This was supported by: Hardware Verification TestingSimulated tissue model testingBiocompatibility Testing (cytotoxicity, sensitization, and irritation)Packaging and shelf-life testingSterilization Validation |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for the simulated use bench model testing or other performance tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective, beyond stating "simulated tissue model" which implies a prospective, controlled lab setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for the test set.
4. Adjudication Method
The document does not describe any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or indicated in the provided text. The evaluation focuses on the device's technical performance and equivalence to a predicate, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
The Aqua Medical RF Vapor System is a physical medical device (catheter-based system using RF energy for tissue coagulation), not an algorithm or AI-driven system. Therefore, a standalone (algorithm only) performance study is not applicable and was not mentioned.
7. Type of Ground Truth Used
Based on the description of "simulated tissue model" and various verification and validation tests, the ground truth for the performance evaluations likely involved established scientific and engineering standards for tissue coagulation, material properties, biocompatibility, and sterilization effectiveness. The "ground truth" would be objective measurements and observations against these standards, rather than expert consensus on medical images or patient outcomes.
8. Sample Size for the Training Set
Since this is a physical medical device and not an AI or machine learning algorithm, the concept of a "training set" in the context of data for model development is not applicable.
9. How the Ground Truth for the Training Set Was Established
As noted above, a training set is not applicable for this type of device.
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(56 days)
The RFA-1717DI detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.
The RFA-1717DI detector is a digital X-ray flat panel detector which has 43cm x 43cm imaging area and communicates with a wired communication feature. Giga-bit Ethernet communication method through connection of tether cable. The RFA-1717 detector is available in two types of scintillator: Csl: Tl type for RFA-1717DIC model and Gadox:Tb type for RFA-1717DIG model. The device accepts x-ray photons and the scintillator and emits visible spectrum photons that illuminate an array of photo (IGZO)-detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis and imaging data management on network.
This document describes a 510(k) submission for the RFA-1717DI digital flat panel X-ray detector, seeking substantial equivalence to existing predicate devices. As such, the acceptance criteria and study described are for a non-clinical performance evaluation comparing the new device to established predicates, rather than a clinical study evaluating the impact of an AI algorithm on human reader performance.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating comparability to the predicate devices. The "performance" here refers to the technical specifications and measurements of the device itself, rather than diagnostic accuracy.
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (RFA-1717DI) | Remark |
|---|---|---|---|
| Intended Use | Same as predicate | For digital imaging solution designed for general radiographic system for human anatomy. Intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. Not to be used for mammography. | Same. This is a critical point for demonstrating substantial equivalence. |
| Detector Type | Amorphous Silicon, TFT | IGZO, TFT | Similar. The change in material (IGZO vs Amorphous Silicon) for the Thin Film Transistor array is noted, but deemed "similar" in the context of overall performance equivalence. |
| Scintillator | LTX240AA01: CsI; LLX240AB01: GdOS | RFA-1717DIC: Cesium Iodide: TI; RFA-1717DIG: Gadox : Tb | Same. While the specific chemical variations are slightly different (e.g., CsI vs CsI:Tl), the fundamental scintillator types used are the same as those present in the predicate devices. |
| Imaging Area | 17 x 17 inches | 17 x 17 inches | Same. |
| Pixel matrix | 3072 x 3072 (9.4 million) | 3072 x 3072 (9.4 million) | Same. |
| Pixel pitch | 143μm | 140μm | Similar. A slight difference, but within acceptable limits for a "similar" claim. |
| Resolution | 3.5 lp/mm | 3.4 lp/mm | Similar. A minor difference, still considered similar. |
| MTF (0.5 lp/mm) | GdOS: 76%; CsI: 81% | GdOS: 79%; CsI: 83% | Similar. The RFA-1717DI actually demonstrates slightly higher MTF (Modulation Transfer Function) values, which is generally a positive indicator of image quality. This supports the claim of equivalence. |
| DQE (1 lp/mm) | GdOS: 32%; CsI: 50% | GdOS: 34%; CsI: 60% | Similar. The RFA-1717DI demonstrates higher DQE (Detective Quantum Efficiency) values, which indicates better dose efficiency and image quality. This also supports the claim of equivalence. |
| A/D Conversion | 14 bit | 16 bit | Similar. The RFA-1717DI has a higher bit depth, allowing for more grayscale levels, which is an improvement but still within the scope of "similar" for its intended use. |
| Grayscale | 16384 (14bit) | 65350 (16bit) | Same. This reflects the higher A/D conversion, demonstrating improved grayscale capability while remaining within the expected performance of such devices. The document says "Same" despite the numerical difference, indicating it fulfills the "same" functional purpose. |
| Data output | RAW, convertible to DICOM 3.0 | RAW, convertible to DICOM 3.0 | Same. |
| Dimensions | 500 x 496.6 x 45 mm | 460 x 460 x 15 mm | Similar. Differences in physical dimensions are noted but do not impact the core functional equivalence for intended use. |
| Application | General Radiology system, various stands | General Radiology system, various stands | Same. |
| Electrical Safety | Conformance to IEC 60601-1 | Conformance to IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) | Demonstrated compliance with updated standards. |
| EMC Compliance | Conformance to IEC 60601-1-2 | Conformance to IEC 60601-1-2: 2014, CISPR 11: 2015 Group 1, Class A, IEC61000-3-2: 2014, IEC 61000-3-3: 2013, EN 55011: 2009 +A1: 2010, EN 60601-1-2:2015. EN 61000-3-2:2014. EN 61000-3-3:2013. | Demonstrated compliance with updated standards. |
| Software Validation | Yes, predicate was validated | Software validation and verification testing performed. | Demonstrated compliance. |
| Risk Management | ISO 14971 compliance | ISO 14971: Risk management file A | Demonstrated compliance. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial with patient cases. The evaluation is primarily based on bench testing and technical performance measurements of the device itself (e.g., MTF, DQE, NPS).
- Data Provenance: The testing was conducted by ASTEL Inc. (the manufacturer) and a 3rd party testing lab A (for electrical safety and EMC). The country of origin for the data (and manufacturing) is explicitly stated as Korea (26-79, Gajeongbuk-ro, Yuseong-gu, Daejeon, 34113, Korea). This was a prospective evaluation of the new device's performance against established standards, not a retrospective analysis of patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. For this type of device (a digital X-ray detector, not an AI diagnostic algorithm), "ground truth" is established via physical measurements and adherence to engineering standards, not clinical expert consensus on image interpretation.
- Qualifications of Experts: The experts would be qualified engineers and physicists specializing in medical imaging device testing and regulatory compliance. The document mentions "3rd party testing lab A," implying accredited professionals conducted the safety and performance tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no human interpretation or diagnostic "ground truth" adjudicated for this type of device submission. The device's performance is objectively measured against physical and engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This type of study (MRMC) is typically performed for AI-powered diagnostic aids, where the impact of the AI on human reader performance is being evaluated. This submission is for a basic imaging acquisition device, not an AI diagnostic tool.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? Yes, in essence. The "non-clinical tests" and "performance testing/data" section describe the standalone performance of the RFA-1717DI detector. This includes measurements of MTF, DQE, and NPS, which are intrinsic performance metrics of the device itself, independent of human interpretation or any AI algorithm. The device's ability to produce images comparable to the predicate devices is the core of this "standalone" assessment.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device is based on objective physical and engineering standards and measurements. This includes:
- International Standards: IEC 62220-1 (for DQE, MTF, NPS performance), IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility).
- Predicate Device Specifications: The performance values of the legally marketed predicate devices (LLX240AB01 and LTX240AA01) serve as the benchmark for "substantial equivalence."
- Risk Management Standards: ISO 14971.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is a 510(k) for a hardware device (X-ray detector). It does not involve AI algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- How Established: Not applicable, as there is no training set for this type of device.
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(182 days)
Heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation
The Thermal RF System is a Class II Medical Device that utilizes monopolar RF energy for the purpose of elevating tissue temperature for selected medical conditions. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics and the user interface. It then has a handpiece that is attached to the console, and through the user interface can be selected for administering the treatment.
The provided text describes a 510(k) premarket notification for a medical device called the "RF Thermal System" and includes information about its performance data and substantial equivalence to a predicate device. However, it does not describe:
- Acceptance criteria expressed as specific quantitative metrics (e.g., sensitivity, specificity, accuracy thresholds).
- A study using a test set with expert-established ground truth for performance evaluation of a diagnostic or AI-based device.
- Sample sizes for test sets in the context of diagnostic accuracy.
- Data provenance (country of origin, retrospective/prospective) for a test set.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used in the context of diagnostic accuracy (e.g., pathology, outcomes data).
- Sample size for a training set or how ground truth for a training set was established.
This document focuses on the safety and basic performance of a therapeutic device (RF Thermal System) which uses heat to relieve pain, muscle spasms, and increase local circulation. The "performance data" refers to technical safety standards (IEC, ISO) and the device's ability to raise and maintain tissue temperature within a therapeutic range, not diagnostic accuracy metrics.
Therefore, based solely on the provided text, it is not possible to answer the detailed questions about acceptance criteria, test sets, ground truth, experts, or AI-specific study designs as they relate to a diagnostic or AI-driven device. The device in question is a therapeutic RF system, and its "performance" is assessed through engineering and biocompatibility tests, and its ability to achieve a therapeutic temperature, not through diagnostic accuracy metrics.
The only "performance data" provided relates to:
- IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: Standards for general safety, electromagnetic compatibility, and high-frequency surgical equipment.
- ISO 10993-1, -12, -5, -10: Biocompatibility evaluation for medical devices.
- ASTM D 4169: Package validation testing.
- Thermal Testing: "Results showed that the Thermal RF system is capable of raising the temperature to 40°C and then maintain the temperate between 40°C – 44°C for 10 minutes, which meets the requirements for a therapeutic treatment."
- Mechanical performance: "output accuracy of the TRF TIP, all results demonstrate accuracy within ±20%."
- Temperature sensor testing: "tested successfully to demonstrate the device meets design specifications and performance requirements."
There are no details on "acceptance criteria" in the sense of accuracy metrics for a diagnostic device, nor any study design related to AI or human interpretation of images/data. The "study" mentioned is primarily engineering and bio-compatibility testing, along with a small-scale in vivo thermal test.
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(231 days)
RF Surgical Generator FW-120A is an electrosurgical generator containing monopolar and bipolar technology. It is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating.
RF Surgical Generator FW-120A, is a compact source of high power RF energy, enhanced capability of radiosurgery generator, which can be employed for a variety of radiosurgery procedures, such as cut and coagulate living human tissue.
The device which is consisted of a generator, an IEC Neutral Plate, and a Two Pedal Footswitch, provides 5 modes and corresponding output power ranges that is user/operator selectable based on the surgical procedure undertaken. The action is achieved by front panel selection of waveforms and power level. All selection is affected through push buttons and indicators which give the operator feedback of status. Power level for each mode is indicated by front panel digital displays
The device is provided with safety features of automatically system initialize self-check after power on and continuously monitored during the device running. The device will provide error information and/ or alerts when detect following faults, such as a) Accessary fail connection, b) Overheating of Main Unit, c) Neutral plates Contact resistance exceed the limit, d) System initialize error. The error monitoring is interlocked with the controls to prevent operation when fault condition happened in the unit.
The generator is configured for Monopolar and Biopolar output and the final output power could be controlled by pedal foot switch and/or hand switches. Recommended Monopolar Handpieces 510(k) No.: K092634. Recommended IEC Neutral Plate 510(k) No.: K102372.
This document is a 510(k) premarket notification for an RF Surgical Generator (Model: FW-120A) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing details on a study to meet specific acceptance criteria for a new device.
Therefore, many of the requested categories about acceptance criteria, detailed study design, ground truth, and expert involvement are not applicable or not provided in this type of submission. This document primarily reports on verification testing against established standards and a comparison to a predicate device.
Here's a breakdown based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not outline specific numerical "acceptance criteria" in the way one might see for a diagnostic device (e.g., sensitivity/specificity targets). Instead, it relies on demonstrating compliance with recognized safety and performance standards and showing equivalence to a predicate device.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with ANSI AAMI ES60601-1 | Device evaluated and found in compliance with ANSI AAMI ES60601-1:2005/(R)2012 and associated amendments. |
| EMC Performance | Compliance with IEC 60601-1-2 | Device evaluated and found in compliance with IEC 60601-1-2 (2014). |
| HF Surgical Equipment Specific Safety | Compliance with IEC 60601-2-2 | Device evaluated and found in compliance with IEC 60601-2-2 (Edition 6.0 2017-03). |
| Thermal Effects | Performance comparable to predicate device for cutting/coagulating tissue with acceptable thermal damage. | Thermal damage (length, width, depth of thermal zone) measured in porcine muscle, liver, and kidney in all applicable modes. Performance supports substantial equivalence. |
| System Performance/Waveform Output | Performance comparable to predicate device. | System performance and waveform outputs tested. Results support substantial equivalence. |
| Software Verification | Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for moderate concern level. | Software verifications performed to ensure appropriate operation as a moderated concern level software. |
| Monopolar Neutral Electrode Monitor Resistance | MAX 1000Ω | MAX 1000Ω |
| Rated Duty Cycle | 10s on, 30s off | 10s on, 30s off |
| Output Power | Comparable to predicate device (specific values provided in table) | Cutting: 120W@500Ω; Blend cutting and coagulation: 80W@500Ω; Hemostasis: 60W@500Ω; Fulguration: 40W@500Ω; Bipolar: 120W@200Ω |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of number of human subjects or distinct test cases. The testing involved "lab bench testing" and "porcine muscle, liver, and kidney" tissue. The number of samples/tests for each tissue type is not detailed.
- Data Provenance: The testing was "lab bench testing" using "porcine" tissue. The country of origin for the data is not explicitly stated beyond the applicant being based in China. The data is from prospective testing conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Provided: This type of submission (510(k)) for an electrosurgical generator typically relies on objective physical measurements and engineering evaluations against standards, rather than expert-established ground truth like in diagnostic imaging. There is no mention of experts establishing a ground truth for a test set in this context.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided: As there's no mention of expert ground truth establishment, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: An MRMC comparative effectiveness study is not mentioned as this device is an electrosurgical generator, not an interpretative diagnostic imaging device that involves human readers.
6. Standalone (Algorithm Only) Performance
- Yes, implicitly: The "performance data" section (Section 6) describes "System Performance and waveform outputs test," "Thermal effects testing," and "software verifications" which represent the standalone performance of the device itself and its integrated software. These tests involve direct measurement of the device's output and effects, independently of human interpretation of a diagnostic output.
7. Type of Ground Truth Used
- Objective Measurements and Physical Science Principles: The "ground truth" for this device's performance is established through objective measurements of electrical output parameters (waveform, power), physical effects on tissue (thermal damage size), and compliance with internationally recognized safety and performance standards (e.g., IEC 60601 series). For software, it's verification against design specifications and guidance documents.
8. Sample Size for the Training Set
- Not Applicable / Not Provided: This device, an RF Surgical Generator, does not utilize machine learning or AI models that require a "training set" in the conventional sense. Its functionality is based on established engineering principles and not on learning from a large dataset.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable / Not Provided: As there is no training set for a machine learning model, this question is not applicable.
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(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.
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(156 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, Tag Applicator S, 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 handheld reader that can measure distance to the Tag. 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 describes the 510(k) summary for the Health Beacons, Inc. RFID Localization System (RFLS). However, based on the provided text, there is no detailed information about acceptance criteria and a specific study proving the device meets those criteria, especially in the context of AI assistance or human reader performance improvement.
The document is a 510(k) summary for a medical device (RFID Localization System) intended to mark and locate lesions in the breast for surgical removal. While it mentions performance testing was conducted to support substantial equivalence, it does not provide the specific acceptance criteria or the results from those tests in a format that would allow filling out the requested table or answering many of the follow-up questions.
The device itself is an RFID localization system, which uses miniature RFID tags as markers and a handheld reader to measure distance to the tag. This is a physical localization device, not an AI/software-based diagnostic tool that would typically involve acceptance criteria related to sensitivity, specificity, or human reader improvement with AI assistance.
Therefore, many of the requested details, particularly those pertaining to AI/ML algorithms (e.g., acceptance criteria for diagnostic accuracy, standalone algorithm performance, MRMC studies, training/test set details, ground truth for AI models), are not applicable or not present in this specific 510(k) summary.
Here's what can be extracted and what cannot, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Not explicitly provided in the document. The document states that "All verification and validation activities identified as necessary were performed... and results demonstrate that predetermined acceptance criteria were met." However, the specific criteria and the numerical performance results are not tabulated or detailed.
- The "performance testing" subsections (VIII) list categories of tests but not acceptance criteria or outcomes. These tests include:
- Magnetic field emission testing per IEC 60601-1-2:2014
- Delivery testing
- Deployment Force testing
- Needle Penetration Force testing
- Usability testing
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document states "performance testing was provided," but offers no details on sample size, study design (retrospective/prospective), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This is relevant for diagnostic AI/ML devices where human expert consensus often establishes ground truth. This device is a physical localization system, not a diagnostic imaging AI.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Same reasoning as point 3.
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:
- No. This device is a physical localization system; it's not an AI assisting human readers with diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The device is a "marker-with-detector localization device" that involves a Tag and a Reader/Probe used by a surgeon. There isn't an "algorithm only" component in the sense of a standalone diagnostic AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated for the listed performance tests. For a physical device, ground truth for performance tests would likely involve physical measurements (e.g., actual vs. measured distance, force applied, magnetic field readings).
8. The sample size for the training set:
- Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. Same reasoning as point 8.
In summary of the provided text:
This FDA 510(k) summary describes a physical medical device (RFID Localization System), not an AI/ML diagnostic software. The document asserts that performance testing was conducted and met predetermined acceptance criteria, which supported the substantial equivalence determination to a predicate device. However, it does not provide the specific numerical acceptance criteria or the detailed results of those performance tests. Information regarding sample sizes, data provenance, expert involvement for ground truth, or MRMC studies (which are highly relevant for AI/ML diagnostic devices) is absent as these concepts are not directly applicable to the type of device described.
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