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510(k) Data Aggregation
(32 days)
STARmed Co., Ltd.
The VIVA combo RF System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation and ablation of tissue. VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This system monitors the power, resistance, current and temperature. The active electrodes are a sterile, single-use, hand-held electrosurgical instrument designed for use with VIVA combo RF System. Cooling of the electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient. VIVA combo RF System consists of S_VCS_F, MRFALogger and STAR Logger. The S VCS F software continuously monitors impedance, current, power and temperature. The unit automatically monitors rises in impedance and adjust RF output accordingly. MRFALogger software can be stored and monitored on PC or tablet the RF output parameter (power, impedance, current, temperature and energy). STAR Logger can be stored and monitored on a tablet PC the RF output parameter (power, impedance, current, temperature and energy).
The provided text describes a 510(k) premarket notification for the "VIVA combo RF System". This submission is for an electrosurgical cutting and coagulation device, and the specific change for which this 510(k) is submitted is the replacement of the "VIVA Logger" software with "STAR Logger" for using a tablet with the device.
Based on the document, here's what we can extract regarding acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria with reported device performance. It states that "Software verification and validation was conducted on the changed to VIVA combo RF System software to validate it for its intended use per the design documentation in line with recommendations outlined in General Principles of Software Validation, Guidance for Industry and FDA staff." It further states, "The VIVA combo RF System demonstrated passing results on all applicable testing."
This indicates that internal acceptance criteria were met, but the specific metrics and their corresponding performance values are not detailed in this summary. The assessment appears to be focused on functional equivalence and safety rather than a comparative performance study against specific, quantified acceptance thresholds for clinical efficacy using data.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a "test set" in the context of clinical data. The "testing" mentioned refers to software verification and validation, which is typically conducted on the software itself and the integrated system, not a data set of patient cases.
- Data Provenance: Not applicable, as no clinical data or test sets derived from patient data are mentioned for the software validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment for a test set of clinical data is mentioned, as the study is a software verification and validation, not a clinical performance study.
4. Adjudication method for the test set:
Not applicable. There's no mention of a test set requiring adjudication in the context of clinical interpretation or diagnosis.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were considered necessary and performed." This means there's no comparison of human readers with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The software's function is to "display certain data that is also shown on the VIVA combo RF Generator" and to "store and monitor... RF output parameter (power, impedance, current, temperature and energy)." It continuously monitors these parameters and adjusts RF output. While this is algorithmic behavior, the document does not describe a standalone "performance" study in the sense of a diagnostic algorithm's accuracy as it is an operational control and monitoring software. The "performance" assessment was for its functional correctness and safety, ensuring it behaves as intended and doesn't introduce new risks.
7. The type of ground truth used:
Not applicable in the conventional sense of clinical ground truth (e.g., pathology, expert consensus). The "ground truth" for this software validation would be the functional requirements and design specifications. The software was validated against these specifications to ensure it accurately monitors and displays the intended parameters and maintains safety.
8. The sample size for the training set:
Not applicable. This is not an AI/ML product developed with a training set of data. It's software for controlling and monitoring an electrosurgical device.
9. How the ground truth for the training set was established:
Not applicable, as no training set was used.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria was a software verification and validation process. This process was conducted on the changed software (STAR Logger) to ensure it performs its intended function safely and effectively within the VIVA combo RF System.
- Acceptance Criteria (Implicit): The implicit acceptance criteria were that the "STAR Logger" software would accurately display and store the RF output parameters (power, impedance, current, temperature, energy) and communicate correctly with the VIVA combo RF generator without introducing new safety or effectiveness concerns. These criteria were derived from the device's design documentation and aligned with general software validation guidance from the FDA.
- Reported Device Performance: The document states, "The VIVA combo RF System demonstrated passing results on all applicable testing." This implies that the software met all pre-defined functional and safety requirements during verification and validation.
- Safety and Risk Assessment: A risk assessment was conducted, evaluating compliance with FDA-recognized consensus standards for medical device software (ANSI AAMI ISO 14971, IEC 62304, IEC TIR80002-1). This confirms that the altered software does not pose new or increased risks.
- Nature of the Change: The change was specifically replacing the "VIVA Logger" software with "STAR Logger" to enable tablet use with a new UI. The core technological characteristics and indications for use of the VIVA combo RF system itself remained unchanged.
- No Clinical Studies: No clinical studies were deemed necessary because the software change was considered minor and did not impact the fundamental safety or effectiveness of the device's therapeutic action. The change was related to user interface and data display/storage for operational parameters.
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(28 days)
STARmed Co., Ltd.
The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and billiary tracts.
The ELRA Electrode is a bipolar electrode. ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators.
The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides.
The lengths of the flexible tube available for the ELRA Electrode length are 400 mm and 1,750 mm. The tip exposures available for the ELRA Electrode length are 11 mm, 18 mm, 22mm and 33 mm. The diameter available for the ELRA Electrode diameters is 7 French.
The model with longer length(1,750 mm) are used with endoscopes. This electrode is inserted into the body through the oral rout, and are used at the application site. The shorter length(400 mm) models are performed by percutaneous resection directly at the site of application. Both methods have to be used with fluoroscopy during the procedure.
This document is a 510(k) summary for a medical device (ELRA Electrode) and focuses on expanding its shelf-life. As such, it does not contain information related to an AI/ML powered device, and therefore cannot provide data on acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies for AI/ML performance.
The content primarily addresses technical aspects of the ELRA Electrode and its equivalence to a predicate device, specifically for extending its shelf-life through performance testing.
Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about an AI/ML powered device and its performance evaluation against acceptance criteria.
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(392 days)
Starmed Co., Ltd.
VVR Generator system is intended for endovascular coagulation of Saphenous Veins in patients with superficial vein reflux.
VVR Generator System consists of Generator (VVR Generator), Active electrode (VENISTAR) and accessory such as foot switch and cooling pump.
The generator generates, controls and monitors RF energy and delivers energy to the active electrode.
The active electrode has an active coil and a receiver coil that allow the RF energy to flow through the tissue. The RF energy raises the temperature in the tissue, causing coagulation and occlusion of blood vessels.
The single footswitch works as an on/off switch and the double footswitch works to increase the power output.
A cooling pump circulates water around the electrodes to reduce the temperature of the electrodes and prevent tissue sticking to the electrodes.
The provided text does not contain information about acceptance criteria and a study proving a device meets acceptance criteria in the usual sense of a diagnostic or AI device that relies on performance metrics like sensitivity, specificity, or accuracy.
Instead, the document is a 510(k) Premarket Notification for a medical device called the "VVR Generator System," which is an electrosurgical cutting and coagulation device. The purpose of this notification is to demonstrate that the new device is "substantially equivalent" to legally marketed predicate devices.
The "study" described is a compilation of non-clinical data, animal studies, and referenced clinical studies to support this claim of substantial equivalence, not to meet specific performance acceptance criteria for a diagnostic output.
Therefore, many of the requested categories in your prompt will not be directly applicable, as they relate to the performance evaluation of a diagnostic or AI algorithm, which is not the nature of this submission.
However, I can extract information related to the closest concepts in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't define "acceptance criteria" in terms of specific performance metrics (like accuracy, sensitivity, specificity) for an AI or diagnostic device output. Instead, the "acceptance" is demonstrated through substantial equivalence to predicate devices. The "reported device performance" is framed in terms of similar technical characteristics, thermal effects, and clinical outcomes compared to the predicate devices.
| Acceptance Concept (as inferred from 510(k)) | Reported Device Performance (VVR Generator System) |
|---|---|
| Similar Design Characteristics | VVR Generator System has similar design characteristics to Predicate Device (A) (K040638) and Predicate Device (B) (K111887). |
| Similar Technical Specifications | Similar to predicate devices in: Regulation Number, Regulation Name, Product Code, Indications for Use, Prescription/OTC, Generator type, Output frequency, Power output, Active Electrode type, Length of Use, Diameters, Insertable Lengths, Heating element lengths, Handle. |
| Equivalent Thermal Effects on Tissue | Comparative evaluation showed similar heat damage area sizes to predicate device on liver, kidney, and muscle tissue. |
| Power Output Varies with Impedance | Power output decreased as impedance increased, as intended in its design. |
| Equivalent Effectiveness (Animal Study) | Similar occlusion rates and degrees of vein wall damage without perivenous side effects compared to control devices. |
| Equivalent Safety (Animal Study) | No significant difference in mean vein injury/thickness. No perivenous side effects. |
| Effectiveness (Clinical Study) | Treatment success rate of 97.7% for varicose veins. |
| Safety (Clinical Study) | Complications included 20 cases of bruising, 3 cases of recanalization, and 1 case of neovascularization, indicating a level of safety. |
2. Sample size used for the test set and the data provenance:
- Animal Study:
- Sample Size: 7 dogs
- Origin: Animal model (dog)
- Clinical Study (referenced):
- Sample Size: 60 patients (41 males, 19 females)
- Origin: Not explicitly stated, but implies real-world data (RWD) from a clinical setting where the device was used. This was a referenced study, not one conducted directly for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For the animal study, evaluation methods (macroscopic, microscopic, ultrasonographic) are mentioned, but not the number or qualifications of experts. For the clinical study, it's a referenced study reporting outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
This device is an electrosurgical system, not an AI or diagnostic imaging device. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not applicable and was not performed/reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is an electrosurgical device, not an algorithm or AI. Performance is assessed through its direct physical and physiological effects, not through an algorithm's standalone diagnostic capabilities. So, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Animal Study:
- Macroscopic: 2,3,5-triphenyltetrazolium chloride stain (TTC) evaluation for tissue viability/injury.
- Microscopic: Hematoxylin and eosin (H&E) stain for histological evaluation.
- Ultrasonographic: For assessment of blood flow and vein status.
- Clinical Study:
- Outcomes Data: Reported "success rate" and "complications" which are clinical outcomes.
8. The sample size for the training set:
This device is an electrosurgical system, not an AI or machine learning model that requires a training set. So, this question is not applicable.
9. How the ground truth for the training set was established:
As this is not an AI/ML device, there is no "training set" or ground truth established for one. So, this question is not applicable.
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(94 days)
STARmed Co., Ltd.
Star/VIVA RF Electrode is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
Not Found
Based on the provided text, the document is an FDA 510(k) clearance letter for the Star RF Electrode and VIVA RF Electrode. It describes the regulatory classification, indications for use, and general controls applicable to these medical devices.
However, the provided text DOES NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed technical study information requested in your prompt.
The document is purely a regulatory clearance letter and does not include the technical study report that would contain the requested information. Therefore, I cannot generate the table or answer the specific questions about the study design and results from this text.
To answer your prompt, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) submission's performance data section.
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(283 days)
STARmed Co., Ltd.
The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.
The ELRA Electrode is a bipolar electrode. ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators.
The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides.
The lengths of the flexible tube available for the ELRA Electrode length are 400 mm and 1,750 mm. The tip exposures available for the ELRA Electrode length are 11 mm, 18 mm, 22mm and 33 mm. The diameter available for the ELRA Electrode diameters is 7 French.
The model with longer length(1,750 mm) are used with endoscopes. This electrode is inserted into the body through the oral rout, and are used at the application site. The shorter length(400 mm) models are performed by percutaneous resection directly at the site of application. Both methods have to be used with fluoroscopy during the procedure.
Here's an analysis of the provided text regarding acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that the non-clinical tests all met the acceptance criteria specified in the standards, and similarly for the clinical trials. However, the specific quantitative acceptance criteria are not detailed in a table format within the provided text. Instead, it refers to compliance with established international and FDA-recognized consensus standards.
Here's an attempt to infer and structure the information:
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing | ||
| Mechanical Failure | Minimized risks associated with mechanical failure (evaluated by drop and bending force tests) | Met acceptance criteria (implied by statement that tests "all met the acceptance criteria specified in the standards"). |
| Temperature Sensing Function | Demonstrated function of temperature sensor | Met acceptance criteria (performance testing conducted to demonstrate this function). |
| Thermal Effects on Tissue | Equivalent ablation performance to predicate device (evaluated by ex vivo testing on width and depth of thermally damaged zones on liver, kidney, and muscle tissue according to FDA Guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery'). | Substantially equivalent ablation performance to predicate device, meeting acceptance criteria. |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-2-2 | Complies with stated standards. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Complies with stated standard. |
| Biocompatibility | Compliance with ISO 10993 (Parts 1, 5, 10, 11) | Complies with stated standards. |
| Clinical Testing | ||
| Stenting Procedure Success | Successful stent placement | 100% success rate in 30 patients. |
| Device-Related Adverse Events | No direct side effects associated with the device | No major complications identified. Three minor inflammatory reactions noted, but not directly associated with the device. |
| Safety and Effectiveness | Deemed "safe and effective" | Concluded as safe and effective. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes two clinical studies:
-
Prospective Clinical Trial:
- Sample Size: 30 patients
- Data Provenance: Not explicitly stated, but clinical trial implies prospective data collection. The manufacturer is based in the Republic of Korea, which might suggest the trial was conducted there, but this is not confirmed.
-
Retrospective Study:
- Sample Size: 10 patients
- Data Provenance: Retrospective study. The patients had malignant biliary hilar duct obstruction. Country of origin not specified, but again, likely related to the manufacturer's location.
For non-clinical tests (e.g., thermal effects): The sample size isn't specified in terms of "cases," but it mentions testing on "liver, kidney, and muscle tissue."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their qualifications for either the clinical trials or the non-clinical tests.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in either the clinical or non-clinical studies. The clinical outcomes (stent success, complications) appear to be directly observed or reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted. This device is an electrosurgical electrode and does not involve AI for interpretation or assistance with human readers. The comparative effectiveness assessment was against a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical electrosurgical electrode, not an AI algorithm. Its performance is intrinsic to its design and how it affects tissue, not based on an algorithm's output. The performance studies detailed are for the device's physical and functional characteristics.
7. The Type of Ground Truth used
- Clinical Trials: The ground truth appears to be based on direct clinical outcomes (successful stent placement, incidence of complications, absence of direct device-related side effects). This aligns with outcomes data.
- Non-Clinical (Thermal Effects): The ground truth was based on objective measurements of "width and depth of thermally damaged zone" in tissue samples. This is a form of objective measurement/pathology-like assessment on ex vivo tissue samples.
- Non-Clinical (Safety & Biocompatibility): Ground truth is established by adherence to and successful completion of tests outlined in international consensus standards (e.g., IEC 60601-1, ISO 10993 series).
8. The Sample Size for the Training Set
This information is not applicable as the ELRA Electrode is a hardware medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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(29 days)
STARmed Co., Ltd.
The VIVA combo RF System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation of tissue. The VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This system monitors the power, resistance, current and temperature.
The active electrodes are a sterile, single-use, hand-held electrosurgical instrument designed for use with VIVA combo RF System. Cooling of the electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.
The VIVA combo RF system consists of S VCS F, MRFALogger and VIVALogger software.
The S_VCS_F software continuously monitors impedance, current, power and temperature. The unit automatically monitors rises in impedance and adjust RF output accordingly.
MRFALogger software can be stored and monitored on PC the RF output parameter (power, impedance, current, temperature and energy).
VIVALogger software can be stored and monitored on a tablet PC the RF output parameter (power, impedance, current, temperature and energy).
The VIVA combo RF System is an electrosurgical device intended for percutaneous and intraoperative coagulation and ablation of tissue. This submission describes modifications to a previously cleared predicate device (K163450).
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" in a quantitative table for device performance. Instead, it details that the modified device was tested to ensure compliance with relevant medical device standards, and that these tests demonstrated the device meets design specifications and is safe and effective.
| Acceptance Criteria (Implied by Compliance) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Electrical Safety | Complies with AAMI ANSI ES60601-1 and IEC 60601-2-2. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2. |
| Software Functionality | Software verification and validation conducted, including performance test for automatic cut-off at 15 ohms in temperature mode. Results show no new safety/effectiveness issues. |
| Peristaltic Pump Functionality | Electrical safety and EMC testing conducted for changed SMPS board, motor, and addition of new pump (VP01-1). Device qualified. |
| Fuse Performance | Electrical safety testing conducted for changed fuse. Device qualified. |
| Design Specifications | Bench tests conducted to verify compliance. |
2. Sample sized used for the test set and the data provenance
The document does not specify a "test set" in terms of patient data or specific samples for clinical performance. The studies performed were non-clinical bench tests and engineering validations on the device itself. Therefore, concepts like sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in the context of this device's evaluation, as no human or animal subject data was generated for the safety and effectiveness testing described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth was established by experts in the context of clinical or diagnostic performance for this electrosurgical device as no clinical studies were performed. The "ground truth" for the non-clinical tests was defined by the requirements of the international and FDA-recognized consensus standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method was used as there was no test set involving human interpretation or clinical outcomes to adjudicate.
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 device is an electrosurgical system, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrosurgical system, not a standalone algorithm. The software components are integral to the device's operation and are not standalone "algorithms" in the sense of AI or diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests performed, the "ground truth" was based on the requirements and specifications mandated by recognized international and FDA consensus standards:
- IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
- IEC 60601-2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment.
- IEC 60601-1-2: Collateral standard for electromagnetic compatibility.
- AAMI ANSI ES60601-1: Harmonized standard for electrical safety.
- FDA guidance "The content of premarket submissions for software contained in medical devices": For software validation.
8. The sample size for the training set
Not applicable. As a medical device that performs electrosurgical procedures, there is no "training set" in the context of machine learning or AI algorithm development. The device design and safety/performance are based on engineering principles and compliance with standards.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device in the context of machine learning.
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(117 days)
STARmed Co., Ltd.
The EUSRA RF Electrode is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.
The EUSRA RF Electrode is a monopolar electrode. The EUSRA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The EUSRA RF Electrode consists of the tubing set and grounding pad. The grounding pad is FDA cleared (K163450).
The EUSRA RF Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of EUSRA RF Electrode are stainless steel 304, polyimide, polyether block polyamide copolymer and PTFE. Cooling of the EUSRA RF Electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.
This document describes the EUSRA RF Electrode, a device indicated for the coagulation of soft tissue when used with a compatible radio frequency generator. The provided text outlines the performance criteria and studies for this device, but it is important to note that this is a medical device (hardware) and not an AI/software device. Therefore, many of the typical acceptance criteria and study descriptions for AI/software (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) do not apply in this context.
The document focuses on demonstrating substantial equivalence to a predicate device (Habib EUS RFA 6700) through non-clinical testing and adherence to international safety and performance standards.
Here's an adaptation of your requested information based on the provided hardware device context:
1. A table of acceptance criteria and the reported device performance
Since this is a hardware device submission, the "acceptance criteria" are primarily based on meeting established safety and performance standards and demonstrating equivalence to a predicate device, rather than specific performance metrics like sensitivity/specificity for an AI algorithm. The "reported device performance" refers to the successful completion of various non-clinical tests.
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 | Complies |
| IEC 60601-2-2 | Complies | |
| IEC 60601-2-18 | Complies | |
| Electromagnetic Compatibility | IEC 60601-1-2 (implied for both electrical safety and EMC) | Complies |
| Biocompatibility | ISO 10993-1 | Complies |
| ISO 10993-5 (In vitro cytotoxicity) | Complies | |
| ISO 10993-10 (Irritation & skin sensitization) | Complies | |
| ISO 10993-11 (Systemic toxicity) | Complies | |
| Mechanical Integrity | Drop test | Met acceptance criteria |
| Bending force test | Met acceptance criteria | |
| Length control test | Met acceptance criteria | |
| Thermal Effects (Efficacy) | FDA Guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' | Demonstrated effectiveness comparable to predicate; results showed efficacy not affected by tip diameter/length differences. |
| Substantial Equivalence | Comparison to predicate device K150029 | Demonstrated substantial equivalence in intended use, technological characteristics, energy used, operation principle, sterile nature, and single-use design. Differences (physical specifications, patient contacting materials, neutral electrodes, extensible tip length) do not raise new safety or effectiveness concerns. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this 510(k) submission for a hardware medical device. There are no "test sets" of patient data in the context of an AI algorithm evaluation. The testing involved various non-clinical (bench, ex vivo) studies as described below.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is a hardware medical device, not an AI/software device requiring ground truth establishment by experts for specific diagnostic or prognostic tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a hardware medical device.
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. MRMC studies are relevant for evaluating AI-assisted diagnostic tools, not a hardware electrosurgical electrode.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable as this is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the thermal effects test, the "ground truth" would be the direct measurement of thermal damage in tissue samples, determined experimentally.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of hardware medical device.
9. How the ground truth for the training set was established
Not applicable.
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(254 days)
STARmed Co., Ltd.
star/VIVA RF Electrode is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
The star/VIVA RF Electrodes are a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators. The star/VIVA RF Electrodes consists of the tubing set, PC pipe, PC plug and grounding pad. The grounding pad is FDA cleared (K163450).
The star/VIVA RF Electrodes consist of an electrode tip, insulation part, handle and tubing. Patient contacting materials of star RF Electrode are stainless steel 304 and polyester, and patient contacting materials of VIVA RF Electrode are stainless steel 304 and polyimide. Cooling of the electrode is provided by chilled water which is pumped the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.
The star/VIVA RF Electrodes are available in different lengths, different tip exposures and different thicknesses. The lengths that are available for the star RF Electrode range from 7 cm to 20 cm and VIVA RF Electrode range from 15 cm to 20 cm. The tip exposures available for the star RF Electrode range from 5 mm to 20 mm and VIVA RF Electrode range from 5 mm to 30 mm. The exposed length of the VIVA RF Electrode can be adjusted by the control button on the handle. The diameters available for the star RF Electrode diameters are 17 Gauge. The diameters available for the VIVA RF Electrode diameters are 15 Gauge and 17 Gauge.
Here's an analysis of the provided text regarding the acceptance criteria and study for the STARmed Co., Ltd. RF Electrodes:
It's important to note that this document is a 510(k) summary for a medical device (RF Electrodes), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study on its performance against specific clinical acceptance criteria. Therefore, the information provided below reflects this context.
Acceptance Criteria and Reported Device Performance
The document doesn't present a table of specific numerical acceptance criteria (e.g., a specific percentage of sensitivity or specificity) for clinical performance. Instead, it demonstrates acceptance primarily through comparative testing against a predicate device and compliance with established international and FDA-recognized consensus standards for safety and biocompatibility.
The "reported device performance" is implicitly that the device performs as safely and effectively as the predicate device and meets the requirements of the listed standards.
Table of Acceptance Criteria (as inferred from the document) and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (as inferred) | Reported Device Performance |
|---|---|---|
| Safety - Mechanical | - No mechanical failure after drop test | Met criteria; drop test performed. |
| - Withstand bending forces without failure | Met criteria; bending force test performed. | |
| Safety - Electrical | - Proper electric conduction | Met criteria; electric conduction test performed. |
| - No short-circuiting | Met criteria; electric conduction test performed. | |
| - Compliance with IEC 60601-2-2 (sections 101.3) | Met full compliance; standard applied. | |
| - Compliance with AAMI HF 18 (sections 5.2 and 5.5) | Met full compliance; standard applied. | |
| Safety - Temperature | - Accurate temperature sensing/monitoring | Met criteria; temperature monitoring test performed. |
| Effectiveness / Thermal Effects | - Demonstrate appropriate width and depth of thermally damaged zone | Met criteria; ex vivo testing performed. |
| - Performance comparable to predicate device in tissue ablation | Deemed substantially equivalent to predicate. | |
| Biocompatibility | - No cytotoxicity (ISO 10993-5) | Met full compliance; standard applied. |
| - No irritation/skin sensitization (ISO 10993-10) | Met full compliance; standard applied. | |
| - No systemic toxicity (ISO 10993-11) | Met full compliance; standard applied. | |
| - Compliance with ISO 10993-1 (risk management process) | Met full compliance; standard applied. | |
| Substantial Equivalence | - Equivalent intended use, technological characteristics, energy, operation principle, sterility, single-use, connector type to predicate. | Achieved; stated to be substantially equivalent. |
| - Differences in physical specs/materials do not adversely affect safety/effectiveness. | Demonstrated through testing; stated not to adversely affect use. |
Study Details:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in numerical terms for each non-clinical test (e.g., how many electrodes were drop-tested, or how many tissue samples were used for ex vivo testing). The tests are described as types of tests performed (e.g., drop test, bending force test, thermal effects test).
- Data Provenance: The tests are "non-clinical performance tests" and "ex vivo testing." The thermal effects test was performed on liver, kidney, and muscle tissue. The country of origin for the data is implicitly the Republic of Korea, where STARmed Co., Ltd. is based. These are described as retrospective in the sense that they are conducted on manufactured devices/materials in a lab setting, not as part of a prospective clinical trial.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For non-clinical, ex vivo, and bench testing, "ground truth" is typically established by objective measurements and standardized protocols rather than expert consensus on individual cases. For example, for thermal effects, the ground truth would be the objectively measured width and depth of tissue damage.
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Adjudication method for the test set:
- This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation (e.g., imaging reads) to resolve disagreements among experts. The non-clinical tests described here rely on quantitative measurements and compliance with objective standards.
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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 MRMC comparative effectiveness study was performed. This is a device (RF electrode) for direct tissue ablation, not an AI diagnostic or assistance tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone (algorithm only) performance study was done. This device is an electrosurgical accessory and does not involve an algorithm working independently. It functions in conjunction with an RF generator and is operated by a human.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Measurements and Compliance with Standards: For the non-clinical tests, the "ground truth" is derived from objective measurements (e.g., physical parameters for drop/bending tests, electrical readings for conduction, temperature measurements, measured dimensions of tissue damage in ex vivo models) and comparison against the quantitative limits and qualitative requirements specified in the international and FDA-recognized consensus standards (IEC 60601-2-2, AAMI HF 18, ISO 10993 series). There is no "pathology" or "outcomes data" in the clinical sense for these validation tests.
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The sample size for the training set:
- Not applicable. This document describes a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply here.
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(90 days)
STARmed Co., Ltd.
The VIVA combo RF Ablation System is intended for use in percutaneous and intraoperative coagulation and ablation of tissue.
The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation and ablation of tissue.
The VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This generator monitors the power, resistance, current and temperature.
The active electrodes are a sterile, single-use, hand-held electrosurgical instrument designed for use with VIVA combo RF System. Cooling of the electrode is provided by chilled water which is pumped through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and the water is not to be in contact with the patient.
The provided document is a 510(k) summary for the STARmed VIVA Combo RF System. It details the device's characteristics, intended use, and comparison to a predicate device.
However, it explicitly states:
"No clinical studies were considered necessary and performed."
This means that the document does not contain information on acceptance criteria for device performance based on a clinical study or a study proving that the device meets such criteria. The acceptance criteria and performance data provided are based on non-clinical bench tests and compliance with electrical safety and EMC standards.
Therefore, I cannot provide a response filling in all the requested sections regarding clinical study performance, human expert involvement, ground truth, or MRMC studies, as these types of studies were not conducted for this device's 510(k) submission.
Here is what can be extracted from the document regarding the acceptance criteria and non-clinical performance:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Compliance with safety requirements of standard AAMI ES60601-1 | Test results demonstrated compliance with AAMI ES60601-1 |
| Compliance with EMC requirements of standard IEC 60601-1-2 | Test results demonstrated compliance with IEC 60601-1-2 |
| Compliance with particular requirements of standard IEC 60601-2-2 | Test results demonstrated compliance with IEC 60601-2-2 |
| Software validation (MODERATE level of concern) | Software designed, developed, verified, and validated according to a software development process and FDA guidance |
| Biocompatibility (cytotoxicity, irritation/intracutaneous reactivity, sensitization, acute systemic toxicity) | Performed (tests not detailed, but implied successful for submission) |
| Sterilization and Shelf Life (ethylene oxide sterilization, 3-year shelf life for active electrode) | Confirmed (implies successful validation for submission) |
| Electrical Specifications: Output Frequency | 480 kHz ± 10% (matching predicate) |
| Electrical Specifications: Drive on Time | Up to 30 minutes (matching predicate) |
| Electrical Specifications: Maximum Power Output | Up to 200 watts @ 50 ohm (matching predicate) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for non-clinical bench testing.
- Data Provenance: Non-clinical bench tests, likely performed at the manufacturer's facility in Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no clinical studies with expert-established ground truth were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical studies requiring adjudication were performed.
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 MRMC or human-in-the-loop studies were conducted. The device is not an AI/software as a medical device (SaMD) that typically relies on such studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done in a clinical context. The device is electrosurgical hardware, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For non-clinical tests, "ground truth" would be the established engineering specifications, published standards (e.g., AAMI, IEC), and internal validation protocols for software, biocompatibility, and sterilization.
8. The sample size for the training set
- Not applicable, as there is no indication of machine learning or AI models with training sets being part of this device or its submission.
9. How the ground truth for the training set was established
- Not applicable.
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