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510(k) Data Aggregation
(217 days)
FCX
The MedicCO2LON device is intended to be used for colonic distension with CO2 gas for CT Colonography and conventional Colonoscopy procedures.
MedicCO2LON is designed to function with specific colonic insufflation administration sets that allow passage of gas from the device to the colorectal cavity. MedicCO2LON should only be used with administration sets specifically designed for this purpose.
The device should only be used by personnel trained in the practice of undertaking CT Colonography and conventional Colonoscopy examinations and the use of an automatic insufflation device.
The device should only be used for CT Colonography or conventional Colonoscopy procedures and should not be used for any other patient examination procedure.
MedicCO2LON is an automated insufflation device designed for administering and requlating colonic distension by insufflation with carbon dioxide qas, in preparation for and during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.
Construction:
The MedicCO2LON colonic insufflator is constructed using a plastic (PC/ABS) external shell covering a metal internal frame, internal components are low voltage (3.3V, 12V and 24V DC) powered from an internal mains connected power supply.
None of the parts of the MedicCO2LON contact the patient directly and the user only has transient contact with the unit, with it being table or trolley mounted.
Use period:
The units are for short term use (normally no more than 30 min) and provides. to the patient, CO2 via an external pressure regulator to the device to insufflate the patient using a standard administration set at up to 30mmHg
The provided document is a 510(k) summary for a medical device called MedicCO2LON, a colonic insufflator. This document focuses on demonstrating substantial equivalence to a predicate device, the BRACCO PROTOCOX2L TOUCH Colon Insufflator (K132192), rather than providing detailed acceptance criteria and a comprehensive study report for a novel AI/software-based medical device.
Therefore, many of the requested details regarding acceptance criteria for AI models, sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance are not present in this type of submission. This document primarily focuses on the physical and functional comparison of a new device with an existing predicate, and engineering testing, not clinical performance studies with AI components.
However, I can extract the acceptance criteria as presented for this specific device's performance validation based on its physical/functional characteristics, and the reported performance.
Here's an attempt to answer the questions based only on the provided text, while acknowledging the limitations for an AI/software-centric request:
Acceptance Criteria and Device Performance for MedicCO2LON (Physical/Functional Device)
The provided document describes the functional performance and safety characteristics of the MedicCO2LON device, comparing it to a predicate device. The "acceptance criteria" can be inferred from the performance targets and comparisons made. The study described is primarily bench testing and engineering validation to demonstrate equivalence, not a clinical trial involving human readers or AI.
1. A table of acceptance criteria and the reported device performance
| Function/Parameter | Acceptance Criteria (Implied/Predicate Performance) | Reported MedicCO2LON Performance | Test Report Document Identification |
|---|---|---|---|
| Displayed Data (Input Pressure) | Current output pressure (Predicate) | Current Input Pressure | MCODOC121-102 Appendix Image |
| Displayed Data (Gas Flow Rate) | Not defined (Predicate) | Gas Flow Rate | MCODOC121-102 Appendix Image |
| Displayed Data (Delivered Gas Volume) | Delivered Gas Volume (Predicate) | Delivered Gas Volume | MCODOC121-102 Appendix Image |
| Displayed Data (Gas Supply Level) | Gas Supply level (Predicate) | Gas Supply level | MCODOC121-102 Appendix Image |
| Control Data (Start/Stop/Resume Flow) | Start / Stop flow (Predicate) | Start / Stop / Resume flow | MCODOC121-102 Appendix Image |
| Control Data (Reset Delivered Volume) | Reset Delivered Volume (Predicate) | Reset Delivered Volume | MCODOC121-102 Appendix Image |
| Control Data (Set Target Pressure) | Set Target Pressure (Predicate) | Set Target Pressure | MCODOC121-102 Appendix Image |
| Control Data (Set Maximum Flow) | Not defined (Predicate) | Set Maximum Flow | MCODOC121-102 Appendix Image |
| Maximum total gas volume | No maximum limit (Predicate) | 12.0 L | MCODOC166-101 Page 7 section 3.3 |
| Gas Volume Profile | Flow stops at 3L to 10L (Predicate) | Stops at 4,6,8,10,12L | MCODOC121-102 Volume Accuracy test |
| Default target flow rate | 3.0LPM (Predicate) | 3.0LPM | Power up default on screen |
| Gas Flow Start Profile | Various steps for 0-1.0L delivered volume (Predicate) | 0.5LPM per 0.5L Volume. | MCODOC121-102 Flow rate Accuracy test |
| Target Pressure | 0 to 35mmHg (Predicate) | 0 to 30mmHg | MCODOC121-102 Pressure Accuracy test |
| Volume Accuracy | Unknown (Predicate) | +/- 20% at current reading. | MCODOC121-102 Volume Accuracy test |
| Flow Adjustment | 1.0LPM (Predicate) | 0.5LPM | MCODOC121-102 Flow rate Accuracy test |
| Flow Accuracy | +20% @ 3LPM (Predicate) | +/- 10% at 3LPM | MCODOC121-102 Flow rate Accuracy test |
| Pressure Accuracy | +/- 10% (Predicate) | +/- 1mmHg of current reading | MCODOC121-102 Pressure Accuracy test |
| Safety overpressure relief | Independent Redundant Mechanical Relief (Predicate) | Independent redundant mechanical relief | MCODOC166-101 Page 6 section 3.2 |
| Safety pressure relief (mechanical) | 1.5psi (78mmHg) nominal (Predicate) | 1.5psi (78mmHg) | MCODOC166-101 Page 6 section 3.2 |
| Safety pressure relief accuracy (mechanical) | Unknown (Predicate) | +/- 20mmHg of trip pressure | MCODOC166-101 Page 6 section 3.2 |
| Safety pressure relief accuracy (electronic) | 50mmHg for 5 seconds (Predicate) | 50mmHg for 5 seconds | MCODOC166-101 Page 6 section 3.2 |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in terms of patient cases or imaging data. The testing described is engineering and performance testing of the device's physical functions (e.g., flow rate, pressure accuracy, volume delivery). These are physical measurements, not statistical analyses of clinical data from patients. Therefore, data provenance (country, retrospective/prospective) is not applicable in the context of this type of device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The "ground truth" for this device's performance is typically established by calibrated measurement equipment and engineering standards, not by human expert assessment of clinical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as the "test set" refers to engineering measurements, not clinical case reviews.
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 a colonic insufflator, a physical medical device for gas delivery, not an AI software supporting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance metrics (e.g., pressure, flow, volume) would be derived from:
- Calibrated measurement equipment: e.g., precise pressure gauges, flow meters, volume displacement methods.
- Engineering specifications and standards: Adherence to established safety and performance norms for medical devices.
- Comparison to predicate device's established performance.
8. The sample size for the training set
Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning device.
In summary, the provided FDA 510(k) summary is for a Class II medical device (colonic insufflator) that is a physical apparatus, not an AI/software device. Consequently, the performance validation outlined focuses on engineering specifications, safety features, and functional equivalence to a predicate device, rather than the types of data-driven performance studies typically associated with AI/ML-based medical devices (e.g., diagnostic imaging aids).
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(30 days)
FCX
The EVA5 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas.
The EVA5 insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. It is indicated to facilitate the introduction of various endoscopic instruments by filling the alimentary canal with gas to distend it. The EVA5 Insufflator is used in an operating room or endoscopic suite. It consists of the following major component (1) a micro-processor-controlled insufflation flow control system.
The EVA5 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate the alimentary canal via an endoscope. The EVA5 is powered by AC and uses a compressed 50 psi CO2 gas supply to supply the pneumatic circuitry for insufflation.
The EVA5 Insufflator is a medical device intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas. The document provides information regarding its non-clinical testing to demonstrate substantial equivalence to its predicate devices.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (EVA5) | Predicate Device (EVA15) Specification (K193520) |
|---|---|---|
| Flow accuracy | ±0.3 SLPM | ±1 SLPM |
| Switch-off time accuracy | Met acceptance criteria | Not explicitly stated (N/A in table) |
2. Sample Size and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is non-clinical, focusing on the device's technical specifications.
3. Number of Experts and Qualifications
This information is not provided as the described testing is non-clinical performance testing of the device's mechanical and electronic functions, not human interpretation of medical images or data.
4. Adjudication Method
This information is not applicable as the testing described is non-clinical performance testing, not involving human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The EVA5 Insufflator is a mechanical device, and its performance is evaluated based on technical specifications rather than human reader accuracy.
6. Standalone Performance Study
Yes, a standalone performance study was done for the algorithm (the insufflator's flow control system). The "Non-clinical Testing" section states: "Performance testing of the insufflator demonstrated that the subject device met its acceptance criteria..." This refers to the device's intrinsic mechanical/electronic performance.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance testing would be the precise, calibrated measurements of flow rate and timing. These would be established using validated testing equipment and methodologies.
8. Sample Size for the Training Set
This information is not applicable. The EVA5 Insufflator is a hardware device with a micro-processor-controlled insufflation flow control system. It is not an AI/ML algorithm that is "trained" on a large dataset in the conventional sense. Its "training" or calibration would occur during its manufacturing and quality control processes based on engineering specifications.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" and "ground truth" for a training set is not directly applicable to a hardware device like an insufflator. The device's operational parameters are designed and calibrated based on engineering principles and established medical device standards. The "ground truth" for its performance would be defined by these engineering specifications and validated through rigorous testing against calibrated measuring instruments.
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(282 days)
FCX
The END-200 Tubeset is intended to be used with the EVA15 insufflator, to supply CO2 to an endoscope during gastrointestinal endoscopic procedures.
The END-200 Tubeset is a dual lumen tube with clips that attach to the outside of an endoscope. It connects to a CO2 gas source and is used to insufflate the cavity during an endoscopic procedure, and to provide a line to monitor pressure. It is single use, disposable and provided non-sterile similar to the predicate. The ENDO-200 Tubeset is offered in Small and Medium sizes.
The document provided is a 510(k) summary for the END-200 Tubeset, a medical device. It does not describe a study involving an AI algorithm or its performance criteria, but rather focuses on demonstrating substantial equivalence to a predicate device. Therefore, most of the requested information about AI study design and performance criteria is not applicable to this document.
However, I can extract the non-clinical testing performed and the general acceptance of the device based on that testing.
1. A table of acceptance criteria and the reported device performance
Based on the provided document, specific numerical acceptance criteria are not explicitly stated. Instead, the document mentions that the device "met its performance acceptance criteria" after testing.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Does not affect delivery pressure accuracy of the insufflator. | "met its performance acceptance criteria." (Implying it did not affect accuracy.) |
| Compatible with the endoscope system. | Demonstrated to be compatible. |
| Tubeset remained attached to the endoscope during use. | Remained attached. |
| Device could be maneuvered as intended. | Could be maneuvered as intended. |
| Did not cause any tissue injury during use. | Did not cause any tissue injury. |
| Biocompatibility (Cytotoxicity, Sensitization, and Irritation) for mucosal, limited duration contact according to ISO 10993 standards. | Passed ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation). |
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 for Test Set: This information is not specified in the document for any of the non-clinical or animal testing.
- Data Provenance: Not specified. The document only mentions "Bench Testing" and "Animal Testing."
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 information is not applicable as the document describes non-clinical and animal testing for a physical medical device, not an AI algorithm requiring expert ground truth for image interpretation or similar.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes non-clinical and animal testing for a physical 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
This information is not applicable as no AI algorithm is mentioned or studied in the provided document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as no AI algorithm is mentioned or studied in the provided document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing:
- Bench Testing: The ground truth would be established by the engineering specifications and measurement standards for pressure accuracy.
- Animal Testing: The ground truth would be based on direct observation of the device's function, attachment, maneuverability, and assessment of tissue for injury by qualified animal study personnel (e.g., veterinarians, pathologists).
- Biocompatibility Testing: The ground truth is laboratory testing results conforming to ISO 10993 standards.
8. The sample size for the training set
This information is not applicable as no AI algorithm is mentioned or studied in the provided document.
9. How the ground truth for the training set was established
This information is not applicable as no AI algorithm is mentioned or studied in the provided document.
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(60 days)
FCX
The CO2mbi LED SCB is a combination of an LED light source, intended to provide illumination, and an insufflation/ irrigation pump, intended to insufflate CO2 or air as a distention media in the gastronitestional tract or water irrigation for lens cleaning when used in conjunction with flexible endoscopes for GI endoscopic procedures.
CO2mbi LED SCB is a portable and compact all-in-one LED Light source and insufflation unit that includes a touchscreen control display, an insufflation pump and internal LED light source, intended to be connected to a compatible GI Videoendoscope and CCU for illumination and insufflation purposes. It is also equipped with a water bottle and lid with tube to provide irrigation for lens cleaning.
The provided text describes a medical device, the CO2mbiLED SCB, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of clinical performance. The document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical data.
Therefore, many of the requested details cannot be extracted from this document, as the document explicitly states: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence."
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria for clinical performance because it did not conduct a clinical study. Instead, it refers to:
- Compliance with FDA recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, IEC 62471).
- Software Verification and Validation Testing guided by "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device" with a "Level of concern: Moderate."
- Additional bench testing "to ensure the device met its design specifications."
The reported device performance, in terms of its functions, is stated as having:
- Different flow rates and flow rate settings compared to predicates.
- Slightly different operating pressures and pressure to activate the pressure relief valve (CO2) compared to predicates.
The summary then concludes that these differences "do not raise different questions of safety and effectiveness because the intended use, operating principles, technological characteristics, and features are significantly similar, if not identical. Both systems also comply with identical standards and safety testing, where applicable. Substantial equivalence on the effectiveness of the subject device is supported by the comparison of the flow rate, flow rate settings operating pressure and pressure to activate pressure relief valve (Table F) and bench testing to show that the subject device function as intended (Section 21 – Performance Testing)."
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 available because no clinical test set was used for a substantial equivalence determination in this document. The evaluation was based on non-clinical bench testing and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available because no clinical test set requiring expert-established ground truth was part of this submission for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available because no clinical test set requiring adjudication was part of this submission.
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
An MRMC comparative effectiveness study was not done. The device is an endoscope accessory (light source and insufflation/irrigation pump), not an AI-powered diagnostic tool for human reader improvement.
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 not an algorithm, but a hardware device (light source and pump).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance, the "ground truth" was established by design specifications for the device, and compliance with recognized consensus standards.
8. The sample size for the training set
This information is not available as the device is not an AI/machine learning algorithm that requires a training set. The evaluation was based on non-clinical bench testing.
9. How the ground truth for the training set was established
This information is not available as the device is not an AI/machine learning algorithm requiring a training set with established ground truth.
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FCX
The BAROnova Insufflation System is designed to use air as a distention media in the gastrointestinal tract when used in conjunction with the BAROnova TPS Delivery Device.
The BAROnova Accessory Kit, consisting of the BAROnova Insufflation System, TPS Stand, and Hook Tool is designed to facilitate use of the BAROnova TPS Delivery Device.
The BAROnova Accessory Kit includes the following products:
- BAROnova Insufflation System
- BAROnova Transpyloric Shuttle (TPS) Stand
- Hook Tool
The BAROnova Insufflation System is designed to provide pressure-controlled air to the stomach for insufflation within the gastric space during endoscopic procedures for placement of the BAROnova Transpyloric Shuttle (TPS) device. The Insufflation System is used in conjunction with the BAROnova TPS Delivery Device to facilitate TPS skin expansion during deployment once the Delivery Device is inserted. Prior to initiating TPS coil advancement with the handle controls, the TPS Delivery Device is connected to the reusable Insufflation System using the disposable tubing set provided within the TPS Delivery Device Kit. The reusable components of the Insufflation System are composed of a portable air Compressor, a Power Adapter, and Pressure Regulator Box. The air Compressor and Power Adapter are the identical components as utilized in the PARI Trek S nebulizer (K060357). The Pressure Regulator Box includes a precision low-pressure regulator and redundant pressure relief valves to limit system output pressure. The Box also includes a calibrated pressure gauge for testing and monitoring the performance of the system. The BAROnova Insufflation System allows the physician to deliver pressure-controlled air to the patient in a manner consistent with that being done currently in a routine endoscopic procedure with room air which is supplied by an air pump in the console of the endoscopic equipment.
The TPS Stand (Class I, regulated under 878.4800 – Manual surgical instrument for general use) and Hook Tool (Class I, regulated under 876.4730 - Manual Gastroenterology-Urology Surgical Instrument and Accessories), are optional accessories included in the Accessory Kit for use with the BAROnova TPS Delivery Device. The TPS Stand is a non-sterile, reusable plastic stand with a weighted aluminum base provided for the convenience of the operator, and can be used to support the TPS Delivery Device handle during TPS deployment. The Hook Tool is a stainless steel reusable tool which may be used to facilitate cutting of tension lines for deployment troubleshooting.
The provided text describes the BAROnova Insufflation System and BAROnova Accessory Kit, and the FDA's 510(k) clearance. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for a medical device (BAROnova Insufflation System and Accessory Kit), which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria, sample sizes, and ground truth information as requested.
Therefore, I cannot provide the requested information based on the input text. The text only states:
- "Non-clinical testing of the subject device for functional and simulated use has been performed, as well as testing to applicable standards. The subject device was found to meet all requirements." This is a general statement and does not provide specific acceptance criteria, reported performance, or details of the study.
- "The results of the testing performed demonstrate that the BAROnova Insufflation System is safe and effective when used in accordance with its intended use and labeling." Again, this is a concluding statement without the underlying data or criteria.
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(67 days)
FCX
This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm's endoscopy system.
FUJIFILM Endoscopic CO2 Regulator GW-100 supplies CO2 gas to insufflate the gastrointestinal tract. The GW-100 supplies water to wash the endoscope lens during an examination.
FUJIFILM Endoscopic CO2 Regulator GW-100 is comprised of the following components: Main Unit, Water Tank, and Gas Tube. The Main Unit utilizes a solenoid/decompression valve mechanism to dispense CO₂ from the Water Tank via the Gas Tube and the air/water channel in the endoscope into the body cavity. The Main Unit also supplies sterile water Tank via the air/water channel in the endoscope.
The provided text describes a 510(k) premarket notification for the FUJIFILM Endoscopic CO2 Regulator GW-100. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that an AI/ML powered device meets specific performance criteria.
Therefore, the information required to answer the prompt (acceptance criteria, study details for an AI/ML device, sample sizes, expert involvement, etc.) is not present in this document. This document is for a medical device (a CO2 regulator for endoscopy) that is an accessory and does not appear to involve AI/ML.
The "Performance Data" section (Page 5) describes engineering and safety tests for the device itself and its accessories, not clinical performance or diagnostic accuracy. It mentions:
- Electrical safety testing: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18.
- Biocompatibility testing: ISO 10993-1, ISO 10993-5, ISO 10993-10 for an optional accessory.
- Software testing: IEC 62304 (for the predicate device, with the proposed device adopted into it).
- Cleaning, high-level disinfection, and sterilization validation testing: Per FDA guidance.
- "Performance testing" on CO2 gas supply and Water supply: Stated that "In all cases, the device met the pre-defined acceptance criteria for the test" but does not specify the criteria or the results.
Since the requested information pertains to AI/ML device performance and clinical validation, and this document describes a hardware medical device's engineering and safety testing for substantial equivalence, a complete answer to your prompt cannot be generated from the given input.
However, if we assume, for the sake of demonstrating the structure of the answer you're looking for, that the "CO2 gas supply" and "Water supply" tests were the "performance tests" for this device, a highly speculative and incomplete answer based on the limited provided text would look like this:
Based on the provided document, the device in question (FUJIFILM Endoscopic CO2 Regulator GW-100) is a hardware medical device, not an AI/ML powered device. As such, the comprehensive details typically required for AI/ML device validation (e.g., ground truth establishment, reader studies, effect sizes) are not applicable or provided in this 510(k) submission.
The document states that "performance testing" was conducted for "CO2 gas supply" and "Water supply," and that "In all cases, the device met the pre-defined acceptance criteria for the test." However, the document does not specify what these criteria were or the actual reported device performance values for these parameters.
Therefore, most of the specific questions regarding AI/ML device validation cannot be answered from this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| CO2 Gas Supply Performance | "Pre-defined acceptance criteria" (not specified in document) | "Met the pre-defined acceptance criteria for the test" (specific values not reported) |
| Water Supply Performance | "Pre-defined acceptance criteria" (not specified in document) | "Met the pre-defined acceptance criteria for the test" (specific values not reported) |
Note: The document only states that the device "met the pre-defined acceptance criteria" but does not explicitly list the criteria or the quantitative results of the performance.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for the "CO2 gas supply" and "Water supply" performance tests. This would typically involve engineering test units rather than patient data.
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are engineering/device performance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically defined for AI/ML (e.g., diagnosis, abnormality detection) is not established for this type of device's performance testing. The "ground truth" for the performance tests would be the accurate measurement of CO2 gas and water supply.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring human adjudication of clinical data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-powered device, and therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI-powered device.
7. The type of ground truth used:
- For the "CO2 gas supply" and "Water supply" tests, the "ground truth" would be the engineering specifications and calibrated measurement of the device's output, rather than clinical outcomes or expert consensus.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
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(41 days)
FCX
The Nexcore GI Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
The Nexcore GI Insufflator allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.
The Nexcore GI Insufflator is a reusable electronic medical device that delivers CO2, via a gastrointestinal (GI) endoscope, to provide improved visualization, increase patient comfort, and increase procedure efficiency during GI endoscopic procedures. The insufflator operates by receiving CO2 from a pressurized cylinder or hospital infrastructure supply and regulating it down in stages to a lower pressure by means of primary and secondary regulators. Each stage of pressure, including the output pressure, has a pressure relief valve as a redundant safety backup for the regulator system. The flow rate is controlled by an electronically controlled proportional valve, which utilizes differential pressure across an in-line orifice to measure flow rate. The output flow rate is user adjustable with four pre-defined settings: high, medium, low and ultra-low.
The device contains software that receives inputs from a touchscreen user interface and controls the operation of the device, including the delivery of CO2 to the endoscope. There are no direct patient-contacting components in this device, other than the delivered CO2 gas. The device is reusable and is not sterile. The Nexcore GI Insufflator is used in hospitals and outpatient endoscopy suites. The device operates from mains power.
There is one model (NX-350) of this device. The accessories sold with the device are the line (power) cord and a pin-indexed high pressure hose for CO2 cylinder connection.
The Nexcore GI Insufflator is used with commercially available, separately cleared devices, including a GI endoscope and tube set. The appropriate compatible tube set is intended to provide CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures and must have a ≤0.2 micron hydrophobic filter, check valve, and luer fittings at both ends. The tubing ID must be sufficient to deliver 4L/min.
The provided text describes the Nexcore GI Insufflator, a device designed to use CO2 as a distention medium in the gastrointestinal tract during endoscopic procedures. The document is a 510(k) premarket notification approval, establishing substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might see in a detailed performance study for an AI algorithm. Instead, it describes compliance with various standards and functional equivalence to a predicate device. The "acceptance criteria" are implied by the standards and the comparison to the predicate.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | The proposed device and predicate device (Bracco CO2MPACT Endoscopic Insufflator) have identical intended uses and identical principles of operation. Fundamental technological characteristics are the same. Specifications are substantially equivalent, with only minor differences not raising different safety/effectiveness questions. Performance data demonstrate safety and effectiveness. |
| Output Pressure Control / Max Delivered Pressure | Nexcore GI Insufflator limits output pressure to 5psi (by controlling flow rate). Maximum delivered pressure does not exceed average anatomical maximum pressure for the GI tract. |
| Overpressure Safety | Staged/redundant overpressure method: audible alarm/on-screen alert at 7.5psi; shutdown switch at 8psi; mechanical relief valve opens at 10psi. (Predicate has mechanical relief valve at 7.25psi). |
| Flow Rate Control | User adjustable with four pre-defined settings: high, medium, low, and ultra-low. |
| Timer Functionality | Offers an intermediate 90-minute timer (Addressing market needs; predicate does not have this specific setting). |
| Software Functionality | Software verification and validation testing conducted, complying with FDA Guidance for "moderate" level of concern. |
| Electrical Safety | Complies with IEC 60601-1 standard. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 standard. |
| Biocompatibility | Complies with ISO 10993-1 for biocompatibility (evaluated in comparison to Xylog Insufflator K945970). |
| General Safety and Essential Performance | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8 (alarm systems). |
| Medical Device Software Life Cycle Processes | Complies with AAMI/ANSI/IEC 62304. |
| Application of Risk Management | Complies with ISO 14971. |
| Application of Usability Engineering | Complies with IEC 62366-1. |
| CO2 Cylinder Connection (Accessories) | Pin-indexed high-pressure hose for CO2 cylinder connection (accessory). |
| Compatible Tube Set Requirements | Used with commercially available, separately cleared tube sets intended to provide CO2/air to an endoscope, which must have a ≤0.2 micron hydrophobic filter, check valve, luer fittings, and sufficient tubing ID to deliver 4L/min. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "non-clinical testing" and "performance (bench) testing." It states: "The purpose of the testing was to compare the output the predicate device against the Nexcore GI Insufflator. Follow up non-clinical testing was performed to further focus and define the software's control algorithms. This testing also included a distal pressure test."
- Sample Size: The document does not specify a "sample size" in terms of number of patients or cases, as this is a non-clinical, benchtop device. The testing likely involved multiple repetitions of measurements or simulations, but the exact number of test runs or devices tested is not provided.
- Data Provenance: The data is from non-clinical bench testing. There is no mention of human or animal data, retrospective or prospective studies, or country of origin for such data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The device is an insufflator, a mechanical/electronic medical device. Its performance is evaluated against technical specifications and safety standards, not against human expert diagnoses or interpretations. Therefore, there is no "ground truth" established by experts in the context of diagnostic performance.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for diagnostic studies involving human readers and AI where there might be disagreements in interpretation. This device's performance is measured against objective physical parameters and engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., imaging AI) assessing how AI assistance impacts human reader performance. The Nexcore GI Insufflator is a therapeutic/procedural accessory device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes "non-clinical testing," "software verification and validation testing," and "electrical safety and EMC testing." These are essentially standalone performance evaluations of the device and its embedded software. The device itself operates autonomously to deliver CO2 based on user settings. While it interacts with an endoscope and is controlled by a physician, the performance tests described (e.g., pressure control, flow rate, safety mechanisms, software algorithms) are evaluating the device's intrinsic function without a human-in-the-loop performance measurement.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering specifications, recognized national and international safety standards (e.g., IEC, ISO), and the functional parameters of the predicate device. For example:
- Pressure: Measured pressure output against desired settings and safety limits.
- Flow Rate: Measured flow rate against desired settings.
- Software: Code analysis and functional testing against design requirements.
- Electrical Safety/EMC: Compliance with specific limits defined in the IEC standards.
- Biocompatibility: Results of tests against ISO 10993-1 guidelines.
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this device's performance as an insufflator.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The Nexcore GI Insufflator is not described as an AI/machine learning device that requires a "training set" in the conventional sense. Its "software" controls device operation but is not implied to be a learning algorithm. The software development follows traditional software engineering principles (verification and validation) rather than machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no mention of a traditional "training set" for an AI/machine learning model. The software's operational parameters would have been established through engineering design, requirements specification, and validation against known physical principles and safety limits.
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(257 days)
FCX
This product is intended to supply CO2 gas and feed water to clean lenses in the gastrointestinal tract when used as an accessory with Fujifilm's endoscopy system.
The Fujifilm Endoscopic CO2 Regulator GW-100 supplies CO2 gas to insufflate the gastrointestinal tract and water to wash the endoscope lens during an examination. The GW-100 is similar to Olympus' XECR-2 Endoscopic Insufflation Unit. The scientific fundamental technology and operating principle of the subject and predicate devices are similar. Both devices utilize a solenoid/decompression valve mechanism to dispense CO2. CO2 can either be supplied from a CO2 gas cylinder or from a facility's main CO2 supply.
The GW-100 can be used with any Fujnon/Fujifilm gastrointestinal endoscope, Fujinon/Fuiifilm Video Processor/Light Source system, video monitor, footswitch, cart, endoscopic accessories, electrosurgical unit and other peripheral devices used for endoscopy.
The provided document is a 510(k) summary for the Fujifilm Endoscopic CO2 Regulator GW-100. It details the device's intended use and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria for device performance or a study demonstrating that the device meets those criteria, as typically found for AI/ML-based devices.
This document describes a medical device seeking clearance based on substantial equivalence, which is a different regulatory pathway than proving performance against specific clinical acceptance criteria for new AI/ML-based diagnostic or therapeutic devices. The studies mentioned are primarily related to electrical safety, electromagnetic compatibility (EMC), software validation, and biocompatibility, not clinical performance metrics like sensitivity, specificity, or reader improvement.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be gathered, with notes explaining the absence of other details:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The device's "acceptance" is based on its substantial equivalence to a predicate device and meeting safety/performance standards (electrical safety, EMC, software, biocompatibility).
- Reported Device Performance: Performance is demonstrated through compliance with safety and engineering standards. No clinical performance metrics (e.g., accuracy, sensitivity, specificity) are reported.
| Acceptance Criteria (Implied) | Reported Device Performance (as per non-clinical studies) |
|---|---|
| Compliance with IEC 60601-1 (Medical electrical equipment) | Passed |
| Compliance with IEC 60601-1-1 (Safety for medical systems) | Passed |
| Compliance with IEC 60601-2-18 (Endoscopic equipment) | Passed |
| Compliance with IEC 60601-1-2 (EMC) | Passed |
| Compliance with IEC 60601-1-4 (Safety Standards Series) | Passed |
| Compliance with IEC 62304 (Medical device software) | Software validation performed; "Minor Level of Concern" |
| Compliance with ISO 10993-1, -5, -10 (Biological evaluation) | Passed (for indirect patient contact materials) |
| Validated reprocessing instructions | Validated |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this type of submission. This submission relies on substantial equivalence and non-clinical engineering tests, not a clinical test set with patient data for performance evaluation.
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. No clinical ground truth was established for a test set in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or adjudication was 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. This is a hardware device (CO2 regulator), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a hardware accessory for an endoscopy system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical performance ground truth was established. The "ground truth" here is compliance with established engineering and safety standards.
8. The sample size for the training set
- Not applicable. As this is not an AI/ML device, there is no concept of a training set for an algorithm. Device validation was based on testing against design specifications and international standards.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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(214 days)
FCX
The PROTOCO₂L Touch Colon Insufflator administers and regulates CO₂ as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy).
The Bracco Diagnostics Inc. (BDI) PROTOCO₂L Touch Colon Insufflator (PROTOCO₂L Touch) administers and regulates CO₂ as a distention media to the colon during Computed Tomography Colonography (CTC or Virtual Colonoscopy). Insufflation during CTC is used to distend the colon with uniform pressure in order to properly present the colon during the given diagnostic procedure.
The PROTOCO2L Touch consists of two (2) components:
(1) the Colon Insufflator, and
(2) the disposable, non-sterile Administration Set.
The provided text describes a 510(k) Premarket Notification for the Bracco Diagnostics Inc. PROTOCO₂L Touch Colon Insufflator. This is a submission for a medical device that administers and regulates CO₂ for colon distention during CT Colonography, aiming to demonstrate substantial equivalence to existing predicate devices.
The document does not contain information about:
- Acceptance criteria and device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).
- Any details of a study involving a test set, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- A standalone performance study of an algorithm.
- The type of ground truth used (pathology, outcomes data, etc.) for any clinical performance evaluation.
- The sample size for a training set or how ground truth for a training set was established.
Instead, the performance testing described focuses on:
- Sterilization and Shelf-Life: Not applicable as the device is not shipped sterile and has no shelf life.
- Biocompatibility: Verification of patient contact materials within the tubing set against ISO 10993-1: 2009.
- Software Testing: Design and development based on a robust software development process, with verification and validation against internal requirements and FDA guidance documents ("The content of premarket submissions for software contained in medical devices," "General principles of software validation").
- Electrical Safety Testing: Compliance with IEC 60601-1: 2005 and UL 60601-1: 2006.
- Electromagnetic Compatibility (EMC) Testing: Compliance with IEC 60601-1-2: 2007.
- Performance Testing – Bench: Compliance with internal requirements, IEC 62366: 2007 (usability engineering), and ISTA Procedure 3A – 2008 (packaged-products for parcel delivery).
The conclusion states that these verification and validation activities demonstrate that the device is safe and effective and substantially equivalent to the predicate device.
Therefore, I cannot provide a table of acceptance criteria for diagnostic performance or details about a study evaluating such performance, as the provided text does not contain that information. The "acceptance criteria" and "device performance" in this context refer to engineering, safety, and software validation rather than diagnostic accuracy.
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(312 days)
FCX
The CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET is intended to connect a CO2 source (insufflator), and a sterile water source (water bottle), to an endoscope to supply CO2 during gastrointestinal endoscopic procedures.
The Bracco Diagnostics Inc. (BDI) CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET (ILTS) is intended for use with BDI CO2 Endoscopic Insufflators and OEM endoscope systems, in this specific case the Olympus® 140, 160, 180, and 190 series endoscopes. The ILTS is supplied sterilized using Gamma radiation to a Sterility Assurance Level (SAL) of 10-6. The ILTS is individually packaged At the time of this submission, accelerated aging tests confirmed a one (1) year shelf life.
The provided text describes the acceptance criteria and the studies conducted for the "Bracco Diagnostics, Inc. CO2 Endoscopic Insufflator In Line Tubing Set (ILTS)."
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11137-1:2006 and ISO 11137-2:2006. | Verified to a sterility assurance level of 10^-6. Complies with ISO 11137-1:2006 and ISO 11137-2:2006. |
| Packaging | Packaging validated in accordance with ISO 11607-1:2006 (requirements for materials, sterile barrier systems, and packaging systems) and ISO 11607-2:2006 (validation requirements for forming, sealing, and assembly processes). | Verification results indicate that the ILTS packaging complies with the standards. |
| Shelf-Life | Initially, a shelf life of at least one (1) year. (Based on accelerated aging tests). | Accelerated aging tests confirmed a one (1) year shelf life. |
| Biocompatibility | Patient contact materials verified in accordance with ISO 10993-1:2009 (Biological evaluation of medical devices - Part I: Evaluation and testing within a risk management process). | Verification results indicated that the ILTS patient contact materials comply with the standard. |
| Performance Testing | Predetermined specifications for: |
- Device compatibility
- Usability
- Environmental
- Delivery flow rate
- Delivery pressure
- Leakage
- Mechanical integrity
- Shipping and transportation
- Labeling | Test results indicate that the ILTS complies with its predetermined specification for all listed performance parameters (device compatibility, usability, environmental, delivery flow rate, delivery pressure, leakage, mechanical integrity, shipping and transportation, and labeling). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., sterilization validation, biocompatibility, performance testing). Instead, it refers to "verification results" and "test results" indicating compliance with standards.
The data provenance is not specified regarding country of origin or whether studies were retrospective or prospective. Given the nature of a 510(k) submission for a medical device accessory, these would typically be internal laboratory tests and validations rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device and study. The "ground truth" for a medical tubing set's performance is established by objective engineering and scientific standards (e.g., sterility, biocompatibility, flow rates) rather than expert clinical consensus or interpretation of subjective data.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert interpretation, such as image reading or clinical assessments, to resolve discrepancies. This is not relevant for the objective performance testing described for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) with and without AI assistance. The "LINE TUBING SET" is a hardware accessory, not a diagnostic AI tool.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable. The device is a physical tubing set, not an algorithm. The performance testing described (sterilization, shelf-life, biocompatibility, device compatibility, flow rate, etc.) constitutes its standalone performance assessment.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- International Standards: e.g., ISO 11137 for sterilization, ISO 11607 for packaging, ISO 10993-1 for biocompatibility.
- Predetermined Specifications: Internal engineering specifications for performance parameters like delivery flow rate, delivery pressure, leakage, and mechanical integrity.
8. The Sample Size for the Training Set
This is not applicable. The ILTS is a passive medical device accessory, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this device.
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