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510(k) Data Aggregation
(266 days)
Creo Medical Ltd
The SpydrBlade Flex Instrument is indicated for use in the cutting (incision, dissection, avulsion) of soft tissue using radiofrequency energy and the coagulation (hemostasis, cauterization, arrest of bleeding) of soft tissue using microwave energy in the gastrointestinal tract as required or encountered in endoscopic procedures.
The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories.
The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.
The Creo Medical electrosurgical system comprises of the CROMA electrosurgical generator, an interface cable accessory and a footswitch accessory, and a compatible electrosurgical instrument.
The CROMA electrosurgical generator comprises two distinct energy sources for the independent generation of bipolar radiofrequency (RF) current at 400 kHz and microwave (MW) current at 5.8 GHz.
Both energy sources are delivered through the same output coaxial connector. These generator outputs are controlled in terms of voltage, power, current, duty cycle, and duration by means of widely used and long-established design and engineering techniques. Via these controls and system design, only one energy source can be delivered to the output coaxial connector at any one time.
The compatible electrosurgical instrument that is subject of this submission is SpydrBlade Flex. The subject and predicate devices use the same electrosurgical generator, footswitch, and interface cable.
SpydrBlade Flex is a single-use, sterile endoscopic electrosurgical instrument used for procedures in the gastrointestinal (GI) tract. The product is sterilized using Ethylene Oxide.
SpydrBlade Flex is intended for use in endoscopes with a minimum working channel of 3.2 mm and maximum working length of 1.35 m.
SpydrBlade Flex incorporates a distal tip, a shaft, and a handle. The distal tip includes a jaws assembly that consists of two gold-plated ceramic bipolar antennas, each soldered to a stainless-steel base. The stainless-steel bases are joined in a manner to provide a mechanical opening and closing function. The bipolar antennas deliver RF energy for cutting and MW energy for coagulation, in the same manner as the predicate Speedboat SB1. The cutting and coagulation functions are performed regardless of the jaw mechanism and can be provided with the jaws open or closed. The jaw mechanism provides a grasping function for easier tissue manipulation between and during energy applications.
The subject and predicate devices are composed of the same technological components with the same principles of operation related to the energy function:
- Cutting of mucosa, sub-mucosa, muscle using bipolar RF energy,
- Thermal coagulation of mucosa and/or sub-mucosa, muscle, vascular and arterial structures using MW energy.
The provided FDA 510(k) clearance letter pertains to the SpydrBlade Flex Instrument (PRD-RG1-001), an endoscopic electrosurgical unit and accessories. However, the document does not contain information related to software-based AI performance, multi-reader multi-case (MRMC) studies, or the establishment of ground truth by expert consensus for diagnostic purposes.
The information requested in the prompt, such as acceptance criteria based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC), sample size for test sets, number and qualifications of experts for ground truth, adjudication methods, and training set details, are typically associated with the clearance of AI-powered diagnostic devices.
The SpydrBlade Flex Instrument, as described in this 510(k) summary, is a surgical instrument that uses RF and MW energy for cutting and coagulation of soft tissue. The "Software Verification and Validation" section likely refers to the embedded software controlling the electrosurgical generator and instrument functions, ensuring its proper operation and safety, rather than an AI analyzing medical images or data for diagnostic purposes.
Therefore, I cannot provide a table of acceptance criteria and reported device performance for AI, nor can I elaborate on sample sizes, ground truth establishment, or human-in-the-loop performance studies, as this information is not present in the provided document for this specific device.
The document primarily focuses on:
- Substantial Equivalence: Comparing the SpydrBlade Flex Instrument to a predicate device (Speedboat Flush SB1 Instrument) based on indications for use, technological characteristics (design, materials, principles of operation), and safety/performance testing.
- Non-Clinical Testing: Sterilization, biocompatibility, electrical safety, microwave safety, electromagnetic compatibility, and software verification/validation.
- Bench Tests: Confirming that the device meets design verification and validation criteria and performs equivalently to the predicate device.
Key takeaway for your request: This document describes the clearance of a medical device (an electrosurgical instrument) that does not appear to involve AI for diagnostic purposes, hence the absence of the detailed AI-related study information you are seeking.
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Creo Medical Ltd
The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories.
The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.
The Reusable Interface Cable is for connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave (MW) energy for the cutting, coagulation and ablation of tissue via endoscopic access.
The CROMA Electrosurgical Generator is an Electrosurgical unit (ESU) to be used with compatible electrosurgical instruments and accessories.
The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered ESU. It comprises two distinct energy sources for the independent generation of bipolar radiofrequency (RF) and microwave (MW) energies, intended to supply electrosurgical power for cutting, and ablation of soft tissues, when connected to compatible instruments via the interface cable.
The CROMA Electrosurgical Generator incorporates proprietary software developed by Creo Medical Ltd.
The CROMA Electrosurgical Generator subject of this submission incorporates a new front panel, which has been updated from a Vacuum Fluorescent Display (VFD) in the predicate device to a Liquid Crystal Display (LCD) screen in the subject device.
The provided text describes a 510(k) premarket notification for the CROMA Electrosurgical Generator. This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific acceptance criteria in the context of an AI-powered diagnostic. Therefore, many of the requested sections are not applicable.
Here's the information that can be extracted or derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a diagnostic device's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate electrosurgical generator by comparing technological characteristics and compliance with electrical safety and software standards.
| Characteristic / Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 Ed. 3.2, IEC 60601-2-2 Ed. 6.0, IEC 60601-2-6 Ed. 2.1 | Device complies with standards |
| EMC | Compliance with IEC 60601-1-2:2014 | Device complies with standards |
| Software V&V | Compliance with IEC 62304 Ed. 1.1 | Software developed, verified, and validated with IEC 62304 Ed. 1.1 |
| Mechanical & Usability Testing | Satisfactory performance in power on/off, initialization, standby, timeout, settings, language, accessory selection, connection/reconnection | Tests performed, usability assessment of UI changes |
| Indications for Use | Same as predicate (with rewording for clarity) | Stated Indications for Use are substantially equivalent to predicate |
| Technological Characteristics | Substantially equivalent to predicate in terms of energy inputs/outputs, principles of operation, control console functionalities | Device has same energy inputs/outputs, principles of operation, and functionalities with minor differences in display (LCD vs VFD) and associated software |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This device is an electrosurgical generator, not an AI-powered diagnostic or a device that uses a "test set" of patient data in the way implied by the question. The testing described is primarily engineering and software verification/validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. As noted above, this device is not an AI-powered diagnostic, and therefore, the concept of "ground truth" established by experts for a test set of data does not apply in this context.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "Animal & Clinical Studies: Not Applicable." An MRMC study would fall under clinical studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, an electrosurgical generator does not have a "standalone algorithm" in the context of AI performance. The software mentioned is for controlling the device's functions and user interface.
7. The Type of Ground Truth Used
Not applicable. The ground truth concept, as it pertains to diagnostic accuracy, is not relevant here. The "truth" for this device relates to its adherence to engineering specifications, safety standards, and functional performance.
8. The Sample Size for the Training Set
Not applicable. This device does not employ machine learning or AI that would require a "training set" of data in the common sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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(31 days)
Creo Medical Ltd
The Interface Cable is for connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation of gastrointestinal tissue.
The Reusable Interface Cable comprises a flexible, low-loss coaxial cable intended for high-power microwave operation and has latching connectors at each end for connection to the CROMA Electrosurgical Generator and compatible Creo Medical Instruments (Surgical Accessories). The established lifetime of the Reusable Interface Cable is for 20 uses in total.
The provided text is related to a 510(k) premarket notification for a medical device (Reusable Interface Cable 1.5 m), which is an electrosurgical accessory. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to provide detailed acceptance criteria and study results for clinical efficacy or sophisticated AI performance.
Therefore, the document does not contain information relevant to:
- A table of acceptance criteria and reported device performance related to a diagnostic or AI-driven outcome.
- Sample size used for a test set in the context of an accuracy study or provenance of data.
- Number of experts for ground truth establishment or their qualifications.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes of AI assistance.
- Standalone algorithm performance.
- Type of ground truth (expert consensus, pathology, outcomes data).
- Sample size for training set.
- How ground truth for the training set was established.
Instead, the document focuses on:
- Device Description: A flexible, low-loss coaxial cable connecting a Creo Medical Instrument to a CROMA Electrosurgical Generator for delivering RF and/or Microwave energy. It specifies a lifetime of 20 uses.
- Intended Use/Indications for Use: Connection of compatible Creo Medical Instrument to the CROMA Electrosurgical Generator to deliver RF/Microwave energy for cutting, coagulation, and ablation of gastrointestinal tissue. This indication is stated to be the same as the predicate device, with reworded readability.
- Technological Comparison: The subject device is a reusable version of the predicate device. The conductor cable was modified for durability while maintaining identical electrical properties. Principles of operation, electrical properties, energy source, materials, dimensions, and cleaning methods are identical to the predicate.
- Non-Clinical Tests:
- Electrical safety testing: Conducted in compliance with FDA-recognized versions of IEC 60601-2-2 and IEC 60601-2-6 standards.
- Performance bench testing: Conducted to establish device durability over its established lifetime for:
- Cleaning between uses (reprocessing)
- Rotation load
- Cyclic load
- Connector connection and disconnection forces.
Conclusion:
This submission is for an accessory device (cable) that facilitates the use of an electrosurgical unit. The "acceptance criteria" and "study" described are primarily related to electrical safety and physical durability/reusability of the cable, ensuring it functions as intended for its specified lifespan and remains substantially equivalent to the predicate device. It does not involve complex performance metrics or clinical studies in the context of diagnostic accuracy or AI-driven decision support.
Since the provided text does not contain the requested information about diagnostic performance, AI, or specific clinical study details as implied by the questions, I cannot populate the table or answer those specific points. The information available is about engineering and regulatory compliance testing for a reusable medical cable.
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(267 days)
Creo Medical Ltd
Intended for use in the cutting of soft tissue using radiofrequency current, the coagulation (hemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.
The Creo Medical Electrosurgical System with Speedboat surgical instrument comprises:
- Electrosurgical Generator (7-EMR-050)
- Footswitch (2-EMR-032)
- Interface Cable Procedure Pack (cable with sterile sheath) (7-RS2-210)
- Speedboat RS2 instrument (7-RS2-001)
- Speedboat RS2 8 Fr instrument (7-RS2-003)
- Speedboat SB1 instrument (7-RS2-001)
The Electrosurgical Generator is deliver bipolar radiofrequency (RF) energy and microwave energy for the purpose of cutting and coagulating tissue. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cut; the other pedal activates the microwave energy output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable.
The Interface Cable connects electrosurgical instruments to the Electrosurgical Generator and is for single-use and is supplied with a sterile sheath that is fitted over its distal end during connection to the surgical accessory.
Speedboat is an electrosurgical instrument for use with the Creo Medical Electrosurgical Generator only. Speedboat instrument is for endoscopic use and provides cutting, coagulation and injection of fluids incorporated in a single device. Speedboat Instrument is for single-use only and is provided sterile via EO sterilization.
Speedboat SB1 instrument is a line addition to the system, designed to be used in endoscopes with a minimum working channel of 2.8 mm.
The provided document is a 510(k) summary for the Creo Medical Speedboat Flush SB1 Instrument. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of its performance against specific acceptance criteria in a clinical setting with human subjects.
Therefore, the requested information, particularly regarding specific performance metrics with acceptance criteria, sample sizes for test sets (including data provenance, expert involvement, and adjudication methods), MRMC studies, standalone algorithm performance, and training set details, is not available in the provided text.
The document primarily covers bench testing to demonstrate that design changes (fluid injection, shaft diameter, distal tip dimensions, handle design) do not negatively impact device performance compared to the predicate device.
However, I can extract the general "acceptance criteria" through the lens of device validation and the types of performance testing mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) summary, the acceptance criteria are implicitly met by "passing" the various bench tests and demonstrating substantial equivalence. Explicit numerical targets are not provided within this document.
| Acceptance Criteria Category | Reported Device Performance (as per bench tests) |
|---|---|
| Fluid Injection Functionality | Ability to produce a jet (constant stream) of saline from the device tip at minimum pressure, determined to be equivalent to the needle injection of the predicate. |
| Shaft Diameter/Compatibility | Performances evaluated via bench tests and determined to be substantially equivalent to the predicate device, despite smaller diameter. |
| Distal Tip Dimensions/Performance | Lifetime cut and coagulation performance evaluated and demonstrated to be substantially equivalent to the predicate device. |
| Handle Design Functionality | Function of the handle unchanged; incorporates same connections (QMA, luer lock). Evaluated via bench tests and determined to be substantially equivalent. |
| Overall Design Specifications | Meets all design specifications, risk mitigation requirements, and applicable medical device standard requirements. |
| Sterilization Assurance Level (SAL) | 10⁻⁶ (as per ISO 11135:2014 and AAMI TIR28:2016). |
| Shelf-life | 1 year (12 months). |
| Biocompatibility | Meets all required biological endpoints (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute systemic toxicity, Hemocompatibility) as per ISO 10993-1. |
| Electrical Safety, Microwave Safety, EMC | Complies with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-6 (safety) and IEC 60601-1-2 (EMC). |
| Software Verification & Validation | Conducted and documented as per FDA guidance; "major" level of concern addressed. |
| Lifetime Cut & Coagulation | Passed acceptance criteria (implicitly, by demonstrating substantial equivalence). |
| Connection Latch & Retention | Passed acceptance criteria. |
| Minimum Bend Radius | Passed acceptance criteria. |
| Connector Rotation | Passed acceptance criteria. |
| Device Rotation | Passed acceptance criteria. |
| Device & Injection Fluid Temperature | Passed acceptance criteria. |
| Endoscope Insertion & Withdrawals | Passed acceptance criteria. |
| Vector Network Analysis (VNA) | Passed acceptance criteria. |
| Hot Tissue Damage | Passed acceptance criteria. |
| Cutting Speed & Thermal Margin | Passed acceptance criteria. |
| Distal Tip Shear Force | Passed acceptance criteria. |
| Components & Sub-assemblies Strength | Passed acceptance criteria. |
2. Sample size used for the test set and the data provenance
Not specified in the document. The document describes various bench tests (e.g., Lifetime Cut & coagulation, Fluid injection, Hot tissue damage) but does not provide details on the number of samples tested for each or the specific "data provenance" as one would expect for clinical data. These are likely performed in a lab setting rather than with human or animal data for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. For bench testing of physical device characteristics, human expert "ground truth" setting in the context of interpretation (like radiology) is not relevant. The "ground truth" is typically defined by engineering specifications, physical measurements, and performance benchmarks.
4. Adjudication method for the test set
Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessments. This document describes bench testing, where outcomes are typically objective measurements against engineering specifications.
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 instrument, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical electrosurgical device; it does not have a standalone "algorithm-only" performance that would be evaluated in this manner. Software verification and validation were conducted for the generator's control software, which is part of the integrated system.
7. The type of ground truth used
For the bench tests, the "ground truth" would be engineering specifications, physical and electrical standards, and predetermined performance benchmarks established during device design and validated against the predicate device. For biocompatibility, the ground truth is established by the relevant ISO standards and FDA guidance.
8. The sample size for the training set
Not applicable. This document describes a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI model. For the software verification and validation, the "ground truth" would be the software requirements specifications and expected functional behavior.
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(265 days)
Creo Medical Ltd.
The AB1 Instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
The AB1 Instrument is not intended for use in cardiac procedures.
The Creo Electrosurgical System is intended to provide microwave energy for coagulation (ablation) of soft tissue and is for use only with compatible Creo Medical instruments and accessories.
The System is not intended for use in cardiac procedures.
The Creo Medical (Creo) AB1 soft tissue microwave ablation instrument (electrosurgical instrument, accessory or instrument, also referred to as AB1) is designed for use with the Creo electrosurgical system, previously cleared under K200298. No changes have been made to the Creo generator, footswitch, or interface cable with sterile sheaths that comprise the electrosurgical system, nor are any changes proposed to the AB1 instrument in this 510k.
AB1 is provided as a sterile, single-use instrument that is 0.95 m long with a 4.3 mm diameter shaft that terminates in a distal antenna that is 38 mm long and less than 2.00 mm in diameter (nominally, 1.9 mm) with a conical tip. The AB1 instrument is provided with a flexible, removable (distal) handle. The outer sheath of the flexible shaft may be removed.
This 510k provides instructions to the end user on how to remove the outer extrusion and distal handle to create a configuration that has an outer diameter less than 2.00 mm. The instrument may be used to access target tissue directly, e.q. in open surgical procedures, or, with the handle and outer sheath removed, through a compatible trocar in minimally invasive procedures. The antenna couples microwave energy to target tissue when AB1 is powered by the Creo Electrosurqical System. AB1 is only compatible for use with the Creo Electrosurgical System, and the Creo Electrosurgical System is only intended for use with compatible Creo instruments and accessories.
The provided text is a 510(k) summary for a medical device (Creo Electrosurgical System with AB1 Instrument). It describes a change to the Indications For Use (IFU) of an already cleared device, specifically allowing the removal of an outer sheath and distal handle to enable use with a compatible trocar in minimally invasive procedures.
This document does not describe an AI/ML-based device or a study involving human readers and AI assistance for diagnostic purposes. Therefore, most of the requested information (such as acceptance criteria for AI performance, sample size for AI test sets, expert ground truth establishment, MRMC studies, standalone AI performance, etc.) is not applicable to this submission.
The document focuses on demonstrating the safety and effectiveness of a modified configuration of an electrosurgical instrument for soft tissue ablation, predominantly through bench testing and preclinical evaluation, ensuring it is equivalent to the predicate device.
However, I can extract the information related to the device performance data based on the context of the document, even though it's not an AI/ML study.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted to address the change in labeling. It doesn't present a formal table of acceptance criteria with corresponding performance data, but rather a list of tests and a general conclusion.
| Test Conducted | Purpose/Criterion (Inferred) | Reported Performance |
|---|---|---|
| Pull (tensile) test | To ensure the mechanical integrity and strength of the instrument in the modified configuration. | "meets all design specifications" (general statement) |
| Removal of outer extrusion test (effects on underlying cable, cosmetics, electrical performance) | To verify that the process of removing the outer sheath does not damage the instrument, affect its appearance, or compromise its electrical function. | "meets all design specifications" (general statement) |
| Insertion and retraction into and from an introducer test | To ensure the instrument can be safely and effectively inserted into and retracted from an introducer, as implied by the revised IFU. | "meets all design specifications" (general statement) |
| Shaft bending test | To assess the flexibility and durability of the instrument shaft in the modified configuration under potential bending stress. | "meets all design specifications" (general statement) |
| VNA (vector network analyzer) return loss test | To evaluate the electrical performance and impedance matching of the microwave antenna in the modified configuration, ensuring efficient energy delivery. | "meets all design specifications" (general statement) |
| Thermal profile with introducer test | To assess the thermal characteristics of the device when used with an introducer, ensuring safe operating temperatures and effective energy delivery. | "meets all design specifications" (general statement) |
| Comparison of dimensions of ablations created by new and predicate device in ex-vivo tissue | To demonstrate that the modified configuration produces comparable ablation zones (size and shape) to the original predicate device, ensuring equivalent therapeutic effect. | "meets all design specifications" (general statement) |
| Preclinical evaluation of safety and performance in a pig model | To assess the safety and efficacy of the device in a living biological system, simulating clinical use conditions. | "meets all design specifications" (general statement), also "results... demonstrate that the potential risks associated... have been reduced to low and acceptable levels." |
| Simulated use testing of deployment through introducers | To simulate the clinical use case of deploying the device through compatible introducers, verifying ease of use and functionality. | "meets all design specifications" (general statement) |
| Electrical safety testing | To ensure the device meets applicable electrical safety standards. | "meets all design specifications and applicable medical device standard requirements" |
| Usability engineering validation | To ensure the device (with the modified IFU) can be safely and effectively used by intended users, and to identify potential use errors. This is particularly relevant for instructions on modifying the device configuration. | "meets all design specifications" (general statement), and "no new or different questions of safety or effectiveness raised by the modification to the IFU" |
Overall Conclusion on Performance: "The results of the tests conducted and leveraged demonstrate that the AB1 instrument in the proposed configuration with outer sheath and distal handle removed meets all design specifications and applicable medical device standard requirements, and that it is substantially equivalent to the predicate AB1 instrument with the handle and outer sheath in place."
2. Sample size 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 individual bench or preclinical tests. The document generically refers to "tests conducted". For the "Preclinical evaluation of safety and performance in a pig model", the sample size (number of pigs) is not provided.
- Data Provenance: Not explicitly stated for each test. The sponsor, Creo Medical Ltd., is based in the United Kingdom, so some testing might have occurred there. The preclinical study type would be prospective.
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. This summary is for an electrosurgical instrument, not an AI/ML-based diagnostic device where expert ground truth for interpretation would be established. The "ground truth" for this device's performance would be engineering specifications, material properties, and biological effects (ablation size/shape, safety in animal models).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to a process typically used in AI/ML performance evaluation where multiple human readers contribute to a consensus ground truth. The tests performed here are primarily objective engineering and preclinical evaluations.
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. An MRMC study is not relevant to an electrosurgical cutting and coagulation device. This document is not describing an AI-assisted diagnostic or therapeutic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm-based device. The "performance" being evaluated is the physical and functional characteristics of the electrosurgical instrument itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the performance tests, the "ground truth" would be:
- Engineering Specifications: For mechanical tests (tensile, bending, insertion/retraction), and electrical tests (VNA, electrical safety).
- Defined Ablation Characteristics: For ex-vivo tissue comparisons (ablation dimensions).
- Physiological/Histopathological Observation: For the preclinical pig model, assessing safety (e.g., lack of unintended damage) and efficacy (e.g., successful ablation).
- Usability Standards: For usability engineering validation.
8. The sample size for the training set
- Not applicable. This device is an electrosurgical instrument, not an AI/ML model. There is no training set in the AI/ML sense.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no AI/ML training set.
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(250 days)
Creo Medical Ltd.
The NP1 MicroBlate Fine Instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
The NP1 MicroBlate Fine Instrument is not intended for use in cardiac procedures.
The Electrosurgical Generator provides microwave (MW) energy to the compatible Creo Medical AB1 MicroBlate Flex and NP1 MicroBlate Fine instruments, intended for coagulation (ablation) of soft tissue.
The Electrosurgical Generator provides microwave (MW) energy to the compatible Creo Medical HS1 SlypSeal Instrument, intended for coagulation (hemostasis and cauterization) of soft tissue.
The Electrosurgical Generator provides microwave (MW) and radiofrequency (RF) energy to the compatible Creo Medical RS2 Speedboat Instrument, intended for coagulation (hemostasis and cauterization) and cutting soft tissue.
The Electrosurgical System is not intended for use in cardiac procedures.
The Creo Medical Electrosurgical System with NP1 Instrument includes the following:
- . NP1 Instrument
- . Electrosurgical Generator
- . Footswitch
- . Interface Cable with Sterile Sheaths
The Electrosurgical Generator is designed to deliver bipolar radiofrequency (RF) energy and microwave (MW) energy for the purpose of cutting and coagulating tissue. Only the microwave output is used to power the NP1 Instrument. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cutting (not active for use of NP1); the other pedal activates the MW enerqy output for coaqulation. The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable.
The single-use Interface Cable provides a conductive pathway between compatible Creo electrosurgical instruments and the output of the Electrosurgical Generator and is supplied with a sterile sheath that is fitted over the cable's distal end during use to minimize the potential for contamination of the sterile field.
The sterile, single-use NP1 soft tissue ablation instrument consists of a handle, 1.6 m long x 2.7 mm diameter flexible shaft, active nitinol antenna and pointed ceramic tip. Bipolar electrodes separated by dielectric materials couple microwave energy to target tissue when NP1 is activated. NP1 is only compatible for use with the Creo Medical Electrosurgical System, and the System is only intended for use with compatible Creo instruments and accessories.
The provided document does not contain acceptance criteria or a study demonstrating device performance against such criteria in the context of typical AI/ML device evaluations. This document is a 510(k) premarket notification for a medical device (electrosurgical system) and focuses on demonstrating substantial equivalence to a predicate device, primarily through technological characteristics and the removal of a specific contraindication for transluminal use.
Therefore, I cannot provide the requested information for an AI/ML context because the document does not discuss an AI/ML device, its performance metrics, or related studies like sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance.
The "Performance Data" section explicitly states: "No bench or clinical data were required to demonstrate substantial equivalence with the predicate device or to justify the elimination of the contraindication for transluminal use from the NP1 instrument IFU." It does mention a preclinical study in a porcine model to demonstrate transluminal navigation and ablation, but this is not presented as meeting specific, measurable acceptance criteria in the format requested for AI/ML performance.
In summary, the information you requested is not present in the provided document as it pertains to a different type of device clearance rather than an AI/ML device performance evaluation.
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(334 days)
Creo Medical Ltd.
The Creo Electrosurgical System is intended to provide microwave energy for coagulation (ablation) of soft tissue and is for use only with compatible Creo Medical instruments and accessories.
The System is not intended for use in cardiac procedures.
The AB1 Instrument, when used with the Creo Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
The AB1 Instrument is not intended for use in cardiac procedures.
The Creo Medical (Creo) Electrosurgical System with AB1 Accessory includes the following:
- . AB1 Instrument
- . Electrosurqical Generator
- . Footswitch
- . Interface Cable with Sterile Sheaths
The Electrosurgical Generator is designed to deliver bipolar radiofrequency (RF) energy and microwave (MW) energy for the purpose of cutting and coagulating (ablating) tissue. Only the microwave output is used to power the AB1 Instrument. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cutting; the other pedal activates the MW energy output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by Creo for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable.
The single-use Interface Cable connects compatible Creo electrosurgical instruments to the Electrosurgical Generator and is supplied with a sterile sheath that is fitted over its distal end during use to minimize the potential for contamination of the sterile field.
The sterile, single-use AB1 soft tissue ablation accessory (Instrument) consists of a flexible, movable handle and a 0.95 m long x 4.3 mm diameter shaft that terminates in a 38 mm long x 1.9 mm diameter distal antenna with conical tip. Two metallic washers separated by dielectric materials couple microwave energy to target tissue when AB1 is only compatible for use with the Creo Electrosurgical System, and the Creo Electrosurgical System is only intended for use with compatible Creo instruments and accessories.
The provided text describes the Creo Electrosurgical System with AB1 Accessory, which is intended for soft tissue coagulation (ablation) using microwave energy. The 510(k) summary (K200298) primarily focuses on demonstrating substantial equivalence to a predicate device (K163105 Emprint Ablation System) through various performance data, rather than outlining specific clinical acceptance criteria for diagnostic performance.
Therefore, the requested information categories related to diagnostic performance (e.g., effect size of human readers with AI, standalone performance, MRMC study, expert qualifications for ground truth) are not applicable to this submission, as it is for an electrosurgical device and not an AI/diagnostic software.
However, the document does contain information about performance testing and acceptance criteria related to its operational safety and effectiveness as a medical device.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria (as implied by testing) and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization Assurance Level: Maintain required sterility for single-use instruments. (Implied: SAL of 10^-6) | The AB1 Sterility Assurance Level is 10^-6, per ISO 11135 and AAMI TIR28 standard evaluation. |
| Shelf-life: Maintain device integrity and functionality over time. | The shelf-life for the AB1 Instrument is 6 months. The shelf life for the Interface Sheath is 3 years. |
| Biocompatibility: Acceptable biological risk for patient-contacting materials. (Implied compliance with ISO 10993-1 and FDA guidance) | Biocompatibility evaluation conducted in accordance with ISO 10993-1:2009 and FDA guidance. The antenna assembly of AB1 and distal portion of its shaft are categorized as externally communicating with limited ( |
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(300 days)
Creo Medical Ltd.
The Creo Electrosurgical System is intended to provide microwave energy for coagulation (ablation) of soft tissue and is for use only with compatible Creo Medical instruments and accessories.
The System is not intended for use in cardiac procedures.
The NP1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.
The NP1 Instrument is not intended for use in cardiac procedures.
The Creo Medical Electrosurgical System with NP1 Accessory includes the following:
- . NP1 Instrument
- . Electrosurgical Generator
- . Footswitch
- Interface Cable with Sterile Sheaths
The Electrosurgical Generator is designed to deliver bipolar radiofrequency (RF) energy and microwave (MW) energy for the purpose of cutting and coagulating tissue. Only the microwave output is used to power the NP1 Instrument. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cutting; the other pedal activates the MW energy output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable.
The single-use Interface Cable connects compatible Creo electrosurgical instruments to the Electrosurgical Generator and is supplied with a sterile sheath that is fitted over its distal end during use to minimize the potential for contamination of the sterile field.
The sterile, single-use NP1 soft tissue ablation accessory (Instrument) consists of a handle, 1.4 m long x 2.7 mm diameter shaft, active nitinol antenna and pointed ceramic tip. Stainless-steel bipolar electrodes separated by dielectric materials couple microwave energy to target tissue when NP1 is in use. NP1 is only compatible for use with the Creo Medical Electrosurgical System, and the System is only intended for use with compatible Creo instruments and accessories.
I am sorry, but the provided text from the FDA 510(k) Pre-Market Notification for the Creo Medical Electrosurgical System with NP1 Accessory does not contain the specific information required to answer your request.
The document is a notification of substantial equivalence for a medical device, and while it mentions performance testing, it does not include:
- A table of acceptance criteria and reported device performance related to a specific study. It broadly states, "The system meets all design specifications, risk mitigation requirements, and applicable medical device standard requirements." and references "Results of mechanical and ablation performance tests, including bench tests and simulated use studies conducted in ex-vivo tissue, demonstrate that the NP1 Electrosurgical System meets design specifications and performs as intended." but no specifics.
- Sample sizes used for a test set or data provenance for specific performance studies. It mentions "simulated use studies conducted in ex-vivo muscle, liver, and kidney tissue" but does not give sample sizes or specific data provenance beyond being ex-vivo tissue.
- Number of experts used or their qualifications for establishing ground truth. This information is entirely absent for any performance claims.
- Adjudication method for a test set. Not mentioned.
- Details about a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size. This type of study is not described or referenced.
- Details about a standalone (algorithm only) performance study. The device is an electrosurgical system, not an AI algorithm, so this concept does not apply in the typical sense of AI/ML software. Its performance is tied to its physical operation and effect on tissue.
- The type of ground truth used (e.g., pathology, outcomes data). For the ablation studies, it implies the "ablation volumes created" as a measure of performance, but it doesn't describe who established this ground truth or how precisely it was measured in terms of a clinical "ground truth."
- The sample size for a training set. As this is a hardware device with embedded software for control, not a machine learning model, the concept of a "training set" for an AI algorithm is not applicable here. The software verification and validation are mentioned but not in the context of a machine learning training set.
- How the ground truth for the training set was established. Not applicable for the reasons above.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of technological characteristics.
- Compliance with electrical safety, EMC, and biocompatibility standards.
- Software verification and validation (for control software, not AI/ML).
- Bench testing and simulated use testing to show the system meets design specifications and performs as intended.
Therefore, I cannot extract the requested information from the provided text.
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(156 days)
Creo Medical Ltd.
The Creo Electrosurgical Generator is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, and is for use only with compatible Creo Medical instruments and accessories.
The HS1 Hemostasis Accessory is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following:
- · Peptic Ulcers
- · Dieulafoy Lesions
- · Mallory-Weiss Tears
- · Bleeding Polyp Stalks
- · Arteriovenous Malformations (AVMs)
- · Angiomata
The HS1 also has irrigation capability. Any other use is not recommended.
The Creo Medical Electrosurgical System with HS1 hemostasis accessory comprises of the following:
- . HS1 hemostasis surgical accessory
- . Electrosurgical Generator
- Footswitch
- Interface Cable
The Electrosurgical Generator is designed to deliver bipolar radiofrequency (RF) energy and microwave (MW) energy for the purpose of cutting and coagulating tissue. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cut: the other pedal activates the MW energy output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable.
The Interface Cable connects electrosurgical instruments to the Electrosurgical Generator and is for single-use and is supplied with a sterile sheath that is fitted over its distal end during connection to the surgical accessory.
HS1 is an electrosurgical hemostasis accessory for use with the Creo Medical Electrosurgical Generator only. HS1 is for endoscopic use and provides coagulation and injection of fluids incorporated in a single device. HS1 is for single-use only and provided sterile.
This submission describes the Creo Electrosurgical System with HS1 Hemostasis Accessory. The device is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, primarily for endoscopic electrohemostasis in the gastrointestinal tract.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail format typical for AI/ML device submissions. Instead, it details performance testing to demonstrate substantial equivalence to predicate devices. The performance aspects tested are related to the device's functional characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Coagulation Energy Equivalence (penetration and spread of thermal effects) | Bench testing showed substantial equivalence with the predicate device (Boston Scientific Injection Gold Probe) regarding the penetration and spread of thermal effects in gastrointestinal tissue, despite using different energy types (MW vs. bipolar RF). |
| Distal Tip Design Equivalence (penetration and spread of thermal effects) | Bench testing showed substantial equivalence with the predicate device concerning the penetration and spread of thermal effects in gastrointestinal tissue, despite differences in distal tip design (blade vs. dome-shaped). |
| Shaft and Distal Tip Materials Biocompatibility | Meets all relevant requirements of FDA guidance and ISO 10993 (biocompatibility). Bench testing showed substantial equivalence with the predicate devices regarding penetration and spread of thermal effects. |
| Needle and Injection Performance (flowrate, durability, sharpness, tensile strength) | Bench testing showed acceptable levels of performance for injection flowrate, insertion and retraction durability (throughout lifetime use and in worst-case endoscope positions), needle point sharpness (throughout lifetime use), and needle to hypotube and ferrule tensile strength. |
| Needle and Injection Materials Biocompatibility | Meets all relevant requirements of FDA guidance and ISO 10993 (biocompatibility). |
| General Design Specifications & Standards Compliance | The system meets all design specifications, design-risk analysis, and medical device standards for electrical safety and FDA recognized versions of EMC (IEC 60601), electrical safety (IEC 60601), biocompatibility (ISO 10993), and sterility (ISO 11135). |
| Mechanical, Coagulation, and Injection Performance (in ex-vivo/in-vivo) | Meets the design specification and shows substantial equivalence to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each type of bench, ex-vivo, or in-vivo test.
- Data Provenance: The studies include "bench testing," "ex-vivo," and "in-vivo" tests. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though in-vivo studies are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a electrosurgical device, "ground truth" might refer to histological analysis of tissue effects or clinical outcomes. The document does not mention the use of experts for establishing ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method, such as 2+1 or 3+1, which is typically relevant for studies involving human interpretation or subjective assessments. For objective performance metrics like thermal spread or mechanical durability, such methods are not usually applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is an electrosurgical system, not an AI-assisted diagnostic or interpretive tool that would typically involve human readers. Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device incorporates "proprietary software developed by Creo Medical for generating and controlling the two energies delivered," the submission focuses on the performance of the integrated electrosurgical system (hardware + software). There is no mention of a standalone algorithm performance study independent of the physical device or a human operator. The system itself is the "standalone" entity whose performance is being evaluated.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for evaluation involved:
- Physical Measurements/Observations: For bench testing of coagulation (penetration and spread of thermal effects), injection flowrate, durability, sharpness, and tensile strength.
- Standard Compliance: Adherence to electrical safety (IEC 60601), EMC (IEC 60601), biocompatibility (ISO 10993), and sterility (ISO 11135) standards.
- Clinical/Biological Equivalence: Demonstrated through ex-vivo and in-vivo tests (though specific metrics for "ground truth" here are not detailed, they would likely involve histological analysis or observable clinical effects in tissue).
8. The Sample Size for the Training Set
This information is not applicable/not provided in the context of this device submission. This is a medical device (electrosurgical system), not an AI/ML diagnostic or predictive algorithm that typically undergoes a training phase with a distinct training set of data. The "proprietary software" controls energy delivery but isn't described as a machine learning model trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a specific "training set" for an AI/ML algorithm in this submission, this information is not applicable. The "ground truth" for the device's design and engineering would have been established through established physics, electrical engineering principles, surgical practice, and regulatory standards.
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(48 days)
Creo Medical Ltd
Intended for use in the cutting of soft tissue using radiofrequency current, the coagulation (hemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.
The Creo Medical Electrosurgical System comprises: Speedboat RS2 surgical instrument (7-RS2-001), Electrosurgical Generator (7-EMR-050), Footswitch (2-EMR-032), Interface Cable (7-RS2-210). The Electrosurgical Generator is designed to deliver bipolar radiofrequency (RF) energy and microwave energy for the purpose of cutting and coagulating tissue. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cut; the other pedal activates the microwave energy output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable. The Interface Cable connects electrosurgical instruments to the Electrosurgical Generator and is for single-use and is supplied with a sterile sheath that is fitted over its distal end during connection to the surgical accessory. Speedboat RS2 is an electrosurgical instrument for use with the Creo Medical Electrosurgical Generator only. Speedboat RS2 is for endoscopic use and provides cutting, coagulation and injection of fluids incorporated in a single device. Speedboat RS2 is for single-use only and provided sterile.
This document describes the premarket notification (510(k)) for the Creo Medical Electrosurgical System, including the Speedboat RS2 surgical accessory. This device is intended for electrosurgical procedures within the gastrointestinal tract, specifically for cutting soft tissue using radiofrequency (RF) current, coagulating soft tissue using microwave energy, and delivering/injecting solutions.
Based on the provided text, the submission relies heavily on bench testing and compliance with existing medical device standards rather than clinical studies with human participants or a detailed AI model evaluation. Therefore, many of the requested elements for an AI-based device acceptance criteria and study cannot be fully addressed.
Here's the information that can be extracted or inferred:
Acceptance Criteria and Device Performance
The document states that the system "meets all design specifications, design-risk analysis, and medical device standards." When discussing differences between the subject device and predicate devices, the "Performance Testing" column serves as an implicit acceptance criterion, with the reported device performance being "substantial equivalence with the predicate device" in relevant areas.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Cutting Performance (Energy) | "Comparison with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The bench testing showed substantial equivalence with the predicate device." |
| Cutting Performance (Distal Tip Design) | "Comparison with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The bench testing showed substantial equivalence with the predicate device." |
| Coagulation Performance (Energy) | "Comparison with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The bench testing showed substantial equivalence with the predicate device." |
| Coagulation Performance (Distal Tip Design) | "Comparison with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The bench testing showed substantial equivalence with the predicate device." |
| Biocompatibility | "Meets all relevant requirements of ISO10993." (Performance data also states, "The mechanical, cut, coagulation and injection performance in ex-vivo and in-vivo meets the design specification and shows substantial equivalence to the predicate devices.") |
| Electrical Safety and EMC | "Meets... medical device standards for electrical safety and EMC (IEC 60601)." |
| Sterility | "Meets... medical device standards for... sterility (ISO 11135)." |
| Mechanical, Cut, Coagulation and Injection Performance (Overall) | "The mechanical, cut, coagulation and injection performance in ex-vivo and in-vivo meets the design specification and shows substantial equivalence to the predicate devices." (This appears to be an overarching summary of the performance.) The statement also notes: "The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered." |
Study Details for Acceptance Criteria Proof
Based on the provided document, the "study" demonstrating the device meets acceptance criteria is primarily a series of bench tests and compliance checks against established standards. The information provided does not indicate a clinical study with human patients for AI performance evaluation.
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for "bench testing" explicitly. It refers to "gastrointestinal tissue" for thermal effects comparisons. It also mentions "ex-vivo and in-vivo" testing, but no specific numbers for samples or cases are provided.
- Data Provenance: The bench testing and "ex-vivo and in-vivo" tests were conducted by Creo Medical Ltd. The country of origin of the data is not explicitly stated beyond Creo Medical's location in the United Kingdom. It is considered prospective for the purpose of this submission, as it was conducted to support the 510(k).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The assessment relies on measurements of physical effects (penetration, thermal spread) and compliance with standards, rather than expert interpretation of images or other subjective data. If experts were involved in interpreting histological samples from the ex-vivo/in-vivo tests, their number and qualifications are not disclosed.
-
Adjudication method for the test set:
- This information is not provided. Given the nature of bench testing and comparing physical effects, a formal adjudication method (like 2+1, 3+1 for expert review) is not typically applicable in the same way it would be for diagnostic AI.
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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 study was conducted. This device is an electrosurgical system, not a diagnostic AI system intended to assist human readers in interpreting medical images or data. The "AI" mentioned is proprietary software controlling energy delivery, not an AI for diagnostic assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "performance" described refers to the physical effects of the electrosurgical device as controlled by its internal software. In essence, the "algorithm only" performance (referring to the control software) is what was tested through the bench and ex-vivo/in-vivo studies to ensure it produced the desired energy outputs and tissue effects. There is no separate "standalone" performance in the context of an AI diagnostic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench testing, the "ground truth" seems to be physical measurements of parameters like penetration depth and spread of thermal effects in tissue, likely compared against established safe and effective ranges or the performance of predicate devices. For biocompatibility, electrical safety, and sterility, the ground truth is adherence to specified international standards (ISO 10993, IEC 60601, ISO 11135).
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The sample size for the training set:
- The document mentions that the Electrosurgical Generator incorporates "proprietary software developed by Creo Medical for generating and controlling the two energies delivered." This is control software, not explicitly described as a machine learning/AI model that undergoes "training" in the conventional sense. Therefore, a "training set" for such a system would not be applicable or described in this type of submission.
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How the ground truth for the training set was established:
- As there is no described training set for an AI model, this question is not applicable. The control software functionality would have been developed and validated through traditional software engineering and testing processes, likely using design specifications as the "ground truth" for its correct operation.
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