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510(k) Data Aggregation
(42 days)
Genicon, Inc.
The GENICON Aquas Probes are instruments insulated for optional monopolar coagulation which enable a surgeon to manipulate, cut, or coagulate internal tissue or organs while performing laparoscopic procedures.
The GENICON Aquas Probes product line are multiple-use provided nor-sterile. The probes are insulated for optional monopolar coagulation which enables a surgeon to manipulate, cut, or coagulate soft tissue or organs while performing laparoscopic procedures. The GENICON Aquas Probes have an outside diameter of 5 mm and are provided in varying lengths and tip configurations. Working lengths range from 20 to up to 45 cm. Common tip configurations include L-Hook (Right Angle), J-Hook, Spatula, 45 Deg, Knife, Ball, Needle, and Spoon. Devices may also include a channel for suction and irrigation of sterile irrigant solution when attached to a compatible lavage device. Devices may also include retractable insulation and insulation at the digression of the user. Device are intended to be reused up to 50 times, and may be sterilized by high-pressure steam autoclave.
The provided text is a 510(k) Summary for the GENICON Aquas Probes. It focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and non-clinical performance data. Since this is a submission for an electrosurgical device for general surgery, it does not involve AI/ML technology or studies typically associated with AI device performance such as those listed in your prompt.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance cannot be extracted from this document as these types of studies were not conducted or described.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document mentions that "Non-clinical tests were conducted to verify that the GENICON Reusable Electrosurgical Probe product line met all acceptance criteria and specifications as the substantially equivalent predicate device and any additional test that were required." The specific acceptance criteria are not explicitly detailed as numerical targets but are implied through equivalence to predicate devices and compliance with international standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent overall use/performance to predicate devices (Stryker Stiletto Electrosurgical Probe K052141 and Pajunks HF Electrodes K062047) | "Performance of the GENICON Reusable Electrosurgical Probe product showed that the device performed equivalent or better and is therefore substantially equivalent in performance to the predicate devices." |
| Electrical safety and effectiveness compliant with standards | "Electrical safety complies with IEC 60601." (Referring to predicate, and then implies the same for GENICON)"Electrical performance of the device was completed following FDA guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery' issued August 15, 2016. This requires testing on three different tissue types. The spread is then measured under magnification, and TCO (thermal coagulation) is compared using different tissue types and maximum generator power in order to simulate thermal spread with the predicate product. Results showed an equivalent." |
| Mechanical performance, ergonomic forces | The GENICON Aquas Probes product line was also compared to the predicate device through bench testing which included visual & operational use, ergonomic forces, and electrical safety. Testing demonstrated that the devices met the same requirements as the predicate product. |
| Autoclave sterilization validation (for reusability) | "Autoclave Sterilization Validation" (Listed as a non-clinical test conducted). Device is intended to be reused up to 50 times and sterilized by high-pressure steam autoclave. |
| Biocompatibility | "Conforms to ISO 10993" |
| Cycle Count Testing | "Cycle Count Testing" (Listed as a non-clinical test conducted) |
| Compliance with specific IEC standards | IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007), IEC 60601-2-2:2009, IEC 60601-2-18:2009, ISO 17655-1:2006 (Are listed as standards applied in testing) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes non-clinical bench testing, not human subject testing with a "test set" in the context of an AI/ML algorithm. The testing involved "three different tissue types" for electrical performance evaluation, but no further details on sample size or provenance for this non-human tissue testing are provided.
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 information pertains to studies with human expert interpretation (e.g., for medical imaging or diagnostics), which is not relevant to this electrosurgical probe submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is relevant for studies involving human expert assessment, not for the technical bench testing described.
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 type of study is for evaluating AI-assisted human performance, which is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. The "performance" described refers to the physical and electrical characteristics of the electrosurgical probe.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance would be the experimentally measured physical and electrical characteristics as compared to predefined specifications and predicate device performance. It doesn't involve clinical "ground truth" derived from patient data.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this information is not relevant.
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(47 days)
Genicon, Inc
THE GENICON SIMPLE SPECIMEN RETRIEVAL IS INDICATED FOR USE IN LAPAROSCOPIC PROCEDURES TO CAPTURE ORGANS OR TISSUE TO BE REMOVED FROM THE BODY CAVITY.
The Genicon Simple Specimen Retrieval Bags are comprised of a flexible plastic bag with and without a deployment mechanism. The deployment mechanism consists of a push rod and handle. The deployment mechanism allows for easy insertion through the cannula to deploy the bag within the body cavity. Bags without a deployment mechanism may be introduced using a standard atraumatic grasper or dissector. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
This is a medical device submission for the GENICON Simple Specimen Retrieval Bag (SimplyStrong and SimplyEZee) and therefore does not include information about AI/ML algorithm performance. The document describes the substantial equivalence of the device to a predicate device based on non-clinical testing.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test/Characteristic | Acceptance Criteria (Bench Test Outcome) | Reported Device Performance (GENICON Simple Specimen Retrieval Bag) |
|---|---|---|
| Introduction Forces | Not explicitly stated as a numerical criterion, but implied to be "appropriate" and equivalent to the predicate device. | Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for introduction forces. |
| Seam Strengths | Not explicitly stated as a numerical criterion, but implied to be "appropriate" and equivalent to the predicate device. | Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for seam strengths. |
| Puncture Forces | Not explicitly stated as a numerical criterion, but implied to be "appropriate" and equivalent to the predicate device. | Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for puncture forces. |
| Fluid Permeability | Not explicitly stated as a numerical criterion, but implied to be "appropriate" (likely non-permeable for fluid containment) and equivalent to the predicate device. | Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for fluid permeability. |
| Transparency | Not explicitly stated as a numerical criterion, but implied to be "appropriate" (likely transparent enough for visualization) and equivalent to the predicate device. | Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for transparency. |
| Open/Closure Forces | Not explicitly stated as a numerical criterion, but implied to be "appropriate" for ease of use and secure closure, and equivalent to the predicate device. | Testing showed the device performed equivalently or better, meeting the "same requirements as the predicate device" for open/closure forces. |
| Packaging Validation | Not explicitly stated, but implies meeting established standards for medical device packaging integrity. | Validation was conducted. (Assumed to meet acceptance criteria as it's listed as a conducted test contributing to substantial equivalence). |
| Visual Inspection | Not explicitly stated, but implies conforming to manufacturing specifications and absence of defects. | Inspection was conducted. (Assumed to meet acceptance criteria as it's listed as a conducted test contributing to substantial equivalence). |
| Biocompatibility | Conforms to ISO 10993. | Conforms to ISO 10993. |
| Sterilization Validation | Not explicitly stated, but implies meeting established standards for medical device sterilization. | Validation was conducted. (Assumed to meet acceptance criteria as it's listed as a conducted test contributing to substantial equivalence). |
| Radiopaque Markers | The predicate device (Espiner Tissue Retrieval System) is X-ray opaque, implying the ability for detection. For the GENICON device, it's the incorporation of radiopaque markers allowing for x-ray detection in case the bag is left inside the patient after the surgical procedure. | Bags incorporate radiopaque markers allowing for x-ray detection in case the bag is left inside the patient after the surgical procedure. (This isn't a direct performance-based "acceptance criterion" in the same way as forces, but a design feature that meets a safety requirement). |
| Intended Use | Endoscope and Accessories (GCJ) for capturing organs or tissue to be removed from the body cavity during laparoscopic surgery. | SAME – Indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity. |
| Volume | 50 to 6000 mL (Predicate) | 50 to 3000 mL (GENICON) - Note: Reduced volume range compared to predicate, but still deemed substantially equivalent for its intended use. |
| Cannula Diameter | 5 to 15 mm (Predicate) | SAME – 5 to 15 mm. |
| Sterilization | Sterile/Single-Use. | SAME – Sterile/Single-Use. |
| Prescription Only | Yes. | SAME – Yes. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document primarily discusses "bench testing" and "performance studies" for non-clinical evaluation. It does not specify sample sizes for these tests, nor does it explicitly mention data provenance (country of origin, retrospective/prospective). These are typically internal corporate tests supporting substantial equivalence claims.
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 submission is for a physical medical device (specimen retrieval bag) and relies on technical bench testing and comparison to a predicate, not clinical "ground truth" established by experts in the context of diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the predicate device's established performance and the generally accepted engineering and material standards for medical devices (e.g., ISO 10993 for biocompatibility, sterility standards). The new device's performance is compared against these established benchmarks through non-clinical bench testing.
8. The sample size for the training set
Not applicable. There is no AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML algorithm requiring a training set.
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(19 days)
Genicon, Inc
The GENICON Specimen Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
The Genicon Specimen Retrieval Bag System is comprised of a flexible plastic bag and deployment mechanism. The deployment mechanism consists of a push-pull rod and an introducer assembly. The deployment mechanism allows for easy insertion through the cannula and full deployment the bag with the use of the biasing arms. The bag consists of a large, easily accessible opening and a closure suture that facilitates closure of the specimen bag after the specimen(s) have been collected. This device is packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
I am sorry, but the provided text from the FDA 510(k) document for the GENICON Specimen Retrieval Bag (GeniStrong) does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets those criteria in the format requested.
The document is a general FDA clearance letter and a 510(k) Summary. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a performance study with quantitative acceptance criteria and results.
Specifically, the document states:
- "There were no clinical trials performed on the GENICON Specimen Retrieval Bag (GeniStrong)." This immediately tells us there's no clinical performance data to report in the context of human reader studies, ground truth establishment, or multi-reader multi-case studies.
- The "Nonclinical Tests" section describes bench testing for various mechanical properties (introduction forces, seam strengths, puncture forces, fluid permeability, transparency, open and closure forces, re-deployment tests). However, it does not provide specific acceptance criteria values (e.g., "seam strength must be >X Newtons") or the precise numerical results obtained for each test. It generally states that "The tests show that after multiple deployments there are no concerns of safety or effectiveness of the device after multiple uses" and that "The critical performance features of the device passed all minimum acceptance currently applied to the product." This is a qualitative summary, not quantitative data.
Therefore, I cannot populate the table or answer the specific questions regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training data, as this information is simply not present in the provided text.
The document indicates "Bench Testing and Clinical Evaluation performed" for the predicate device, but for the GENICON Specimen Retrieval Bag (GeniStrong), it explicitly states "There were no clinical trials performed." The focus is on demonstrating equivalence through material composition, design, and non-clinical bench testing.
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(14 days)
Genicon, Inc
The GENICON EZee Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
The GENICON EZee Retrieval is comprised of a flexible plastic bag with a large, easily accessible opening, an actuation rod with thumb ring handle, finger rings, string and closure suture, and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim, and the size of the specimen bag is 4" x 5" with a volume of 230ml. A string with a closure suture facilitates closure of the specimen bag after the specimen had been collected. This device is disposable device packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical trial or a performance study with specific metrics and statistical analysis. Instead, it describes a substantial equivalence determination based on non-clinical bench testing.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the GENICON EZee Retrieval (K180579) indicates that there are "no FDA performance standards for these products." Therefore, the acceptance criteria are based on internal performance studies and bench testing to demonstrate the device performs as intended and is substantially equivalent to a predicate device (GENICON EZEE Retrieval [K162059]).
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Deployment Force | Evaluated and deemed acceptable |
| Seam Strength | Evaluated and deemed acceptable |
| Puncture Force | Evaluated and deemed acceptable |
| Performance after multiple specimen captures (simulated) | No concerns of safety or effectiveness after multiple uses |
| Leak inspection after multiple specimen captures | No bursts or tears observed; no water on the exterior of the bag |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The text mentions "the sample pouch" in reference to the leak inspection, suggesting a small number of units were tested, but no specific count is given.
- Data Provenance: The testing was conducted internally by Genicon. The text does not specify the country of origin of data or whether it was retrospective or prospective, but it implies prospective bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Two, "our Chief Technical Officer and Design Engineers."
- Qualifications: "Chief Technical Officer and Design Engineers." Specific years of experience or specialized certifications are not provided, but their titles suggest expertise in medical device design and engineering.
4. Adjudication Method for the Test Set
Not applicable. The "experts" (CTO and Design Engineers) appear to have directly conducted and/or reviewed the performance studies and bench testing results. There is no mention of a separate adjudication process for subjective assessments, as the tests described (force, strength, leaks) are objective measurements.
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 is a physical retrieval bag for laparoscopic procedures, not an AI or imaging diagnostic tool that would typically undergo such a study.
6. If a Standalone Performance Study Was Done
Yes, a "standalone" performance evaluation in the form of bench testing was done. This testing assessed the device's physical properties and performance characteristics (Deployment Force, Seam Strength, Puncture Force, and performance after simulating multiple specimen captures) independent of human interaction beyond operating the test equipment.
7. Type of Ground Truth Used
The "ground truth" for the bench testing was based on engineering specifications and direct observation of physical properties. For example, seam strength would be compared against a defined engineering requirement or industry standard for adequate strength, and leak inspection relied on visual confirmation of no water egress.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/machine learning model, so there is no concept of a "training set" for the algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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(126 days)
Genicon, Inc
The GENICON X-Surge instrumentation line is intended for use in endoscopic surgical procedures. It is a family of instruments which includes graspers, dissectors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
The GENICON X-Surge monopolar laparoscopic instruments are sterile packaged Single Use Mono-Polar attachments intended for use in combination with a compatible reposable handle. It is designed to include graspers, dissectors, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue. The device diameter has a range of 3 - 5mm, and connects to a handle with the appropriate configuration. The handle has a male cautery connector that will be utilized for cauterizing soft tissue when attached to standard monopolar cautery cables and their generators.
The disposable shaft and tips are composed of an aluminum outer shaft, and a stainless steel drive rod which connects to the scissor blades and interacts with the handle activation rod. The outer insulation consists of fluorinated ethylene which is an insulation with functional material properties that are improved over Polytetrafluoroethylene PTFE, and is less rigid than Radel insulation. The disposable shafts and tips are to be supplied sterile in single unit trays with Tyvek lid, similar to the current GENICON electrosurgical instrumentation line. The Reposable handle is sterilized by the user using an autoclave process and is then connected to the sterile disposable shaft or tip. Once the procedure is completed, the instrument ends are disassembled from the handle, and are disposed of appropriately, and the handle is cleaned and sterilized for the next procedure.
The provided text describes the 510(k) submission for the GENICON X-Surge Electrosurgical Instrument, comparing it to a predicate device (GENICON Electrosurgical Instrumentation, K061417). The submission focuses on demonstrating substantial equivalence rather than proving the device meets specific acceptance criteria related to AI or diagnostic performance. Therefore, many of the requested elements for an AI/diagnostic study (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth types) are not applicable or detailed in this document.
However, I can interpret "acceptance criteria" based on the provided performance testing for a medical device and highlight what information is available. The study described focuses on non-clinical performance and safety testing to show equivalence to a predicate device.
Here's an attempt to answer the questions based only on the provided document, noting where information is not available due to the nature of the device and submission:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list specific quantitative "acceptance criteria" in a table format for performance beyond "equivalent or better" compared to the predicate. Instead, it describes performance studies conducted to demonstrate equivalence.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cut Performance | Equivalent or better than the predicate device. | "Testing showed the X-Surge device performed equivalent or better than the predicate Genicon product." (Regarding instances of slipping, overall cut length, scissor geometry) |
| Electrical Performance (Thermal Spread) | Equivalent or less thermal spread than the predicate device under same conditions. | "Results showed an equivalent or less area of thermal spread under the same conditions across the different tissue types and power settings." |
| Bench Testing (Visual & Operational Use, Ergonomic Forces) | Met the same requirements as the predicate product. | "Testing on performance and general ergonomic use showed that the X-Surge device met the same requirements as the predicate product in terms of closure force, opening angle, finger spacing, and rotation knob interaction." |
| Biocompatibility | Conforms to ISO10993 | "Conforms to ISO10993" |
| Sterilization | Equivalent to predicate (Irradiation or Ethylene Oxide) | "SAME" as predicate (Irradiation or Ethylene Oxide) |
| Materials | Equivalent or comparable to predicate (specific list provided). | Patient Contact: AISI Stainless Steel, FEP; Non-Patient Contact: Aluminum, Polycarbonate, Nylon, ABS, HDPE/LDPE, TPE. (Predicate used Radel instead of FEP for patient contact) |
| Diameter | SAME as predicate (3mm to 5mm) | "SAME" as predicate |
| Intended Use | SAME as predicate (General & Plastic Surgery, GEI) | "SAME" as predicate |
| Prescription Only | YES | "SAME" as predicate |
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: The document mentions "three tissue samples of different origin" for cut performance testing and "three different tissue types" for electrical performance testing. Specific quantities beyond "three" for these tissue samples are not provided. For bench testing, no specific sample size is mentioned.
- Data Provenance: Not specified (e.g., country of origin).
- Retrospective or Prospective: The testing described appears to be prospective lab/bench testing conducted for the purpose of this submission rather than analysis of existing data.
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 is not a study requiring expert ground truth for diagnostic performance like an AI algorithm. The performance evaluation is based on objective measurements (e.g., thermal spread under magnification, force measurements, visual inspection of cuts) directly from the device's function.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Not a diagnostic study with human interpretation requiring adjudication.
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-assisted diagnostic tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical electrosurgical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth, in the sense of a diagnostic benchmark, is not relevant here. The "ground truth" for performance is the objective measurement of the device's physical and electrical properties against its intended function and comparison to the predicate device. For example:
- Cut performance: measured cut length, observation of slipping, geometry measurements.
- Electrical performance: measured area of thermal spread.
- Ergonomic forces: objective force measurements, angle measurements, finger spacing measurements.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device, not an AI model.
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(65 days)
GENICON, INC
The GENICON EZEE Retrieval is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
The GENICON EZEE Retrieval is comprised of a flexible plastic bag with a large, easily accessible opening, an actuation rod with thumb ring handle, finger rings, string and closure suture, and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim, and the size of the specimen bag is 4" x 5" with a volume of 230ml. A string with a closure suture facilitates closure of the specimen bag after the specimen had been collected. This device is disposable device packaged and sterilized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
This document describes the regulatory submission for the "GENICON EZEE Retrieval" device, a specimen retrieval bag for laparoscopic procedures. The provided text outlines the device's technical specifications and a summary of testing conducted to demonstrate substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria in the context of AI/ML performance.
Therefore, many of the requested categories related to AI/ML device evaluation (like sample size, ground truth, experts, MRMC studies, standalone performance, and training set details) are not applicable to this document.
Here's the information that can be extracted or inferred from the provided text regarding the GENICON EZEE Retrieval device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in the typical sense of AI/ML performance metrics (e.g., sensitivity, specificity). Instead, it refers to "performance studies and bench testing" for specific physical attributes. The "reported device performance" is broadly stated as showing substantial equivalence to predicate devices based on these tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Deployment Force | Evaluated through bench testing |
| Seam Strength | Evaluated through bench testing |
| Puncture Force | Evaluated through bench testing |
| Biocompatibility | Compliant with FDA Class II requirements for ISO 10993 |
| Sterilization | Ethylene Oxide per ISO 11135-1:2014 |
2. Sample sized used for the test set and the data provenance
The document does not specify sample sizes for the "performance studies and bench testing." Data provenance information (country of origin, retrospective/prospective) is not provided as these are not a clinical study involving patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of an AI/ML device. For the physical performance tests, the evaluation was conducted by the device manufacturer's internal team: "our Chief Technical Officer, Design Engineers, and Chief Medical Officer." Their specific qualifications beyond their titles are not detailed.
4. Adjudication method for the test set
Not applicable as this is not a study requiring adjudication of expert interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done, as this is a medical device (a specimen retrieval bag) and not an AI/ML product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used
For the specific performance characteristics (Deployment Force, Seam Strength, Puncture Force), the "ground truth" would be the measured physical properties of the device under test conditions. Biocompatibility and sterilization compliance are based on adherence to ISO standards.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
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