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Found 17 results
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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(317 days)
GENICON
The GENICON Single-Use Specimen Retrieval Bag is indicated for use in laparoscopic procedures to capture organs or tissue to be removed from the body cavity.
The GENICON Single-Use Specimen Retrieval Bag is comprised of a flexible plastic bag with a large, easily accessible opening, a push-pull rod with thumb ring handle, finger rings, string and an introducer shaft. In the fully deployed condition, the bag opening is maintained in a fully-open position by a metallic rim. A string with a closure suture facilitates closure of the specimen bag after the specimen has been collected. This device is packaged and sterlized for single use only. Do not re-use, reprocess, or re-sterilize. Discard after use.
The provided document is a 510(k) summary for the GENICON Specimen Retrieval Bag. It details the device's description, indications for use, and a statement about nonclinical tests supporting substantial equivalence to predicate devices. However, it does not contain the specific acceptance criteria or a detailed study report that proves the device meets those criteria, as typically found in a clinical trial or performance study report. The document mentions "Bench Testing and Clinical Evaluation performed (ref. TR-12022-A and CLEV-032-A)," but the details of these tests are not provided in this regulatory submission.
Therefore, for aspects requiring detailed study information, the answer will reflect that the information is "Not Available in the provided text."
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly list quantitative acceptance criteria or detailed device performance metrics from a study. It only states that "Successful results support a determination of substantial equivalence" for general operation, seal strength peel, and puncture resistance. Without access to TR-12022-A and CLEV-032-A, specific criteria and performance values cannot be extracted.
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not available in the provided text. The document states "Successful results support a determination of substantial equivalence" for bench testing related to seal strength, puncture resistance, and general operation. | Not available in the provided text. The document refers to internal reports (TR-12022-A and CLEV-032-A) for specifics, which are not included here. |
2. Sample Size for the Test Set and Data Provenance
- Sample size used for the test set: Not available in the provided text. The document mentions "Bench Testing and Clinical Evaluation," but no sample sizes are given for either.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not available in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of experts: Not available in the provided text.
- Qualifications of those experts: Not available in the provided text.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Adjudication method: Not available in the provided text.
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
- MRMC comparative effectiveness study: Not applicable. This device is a physical specimen retrieval bag, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone performance study: Not applicable. This device is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not available in the provided text. For bench testing, ground truth would likely be established by objective physical measurements according to specified test methods. For clinical evaluation, it would typically relate to the device's ability to safely and effectively retrieve specimens in a surgical setting, which could involve surgical observations, successful specimen retrieval without complications, and potentially pathology results of retrieved specimens. However, the document does not specify.
8. The Sample Size for the Training Set
- Sample size for the training set: Not applicable/Not available. This device is a physical specimen retrieval bag, and the concept of a "training set" is usually associated with machine learning algorithms, which is not applicable here. Even if a design verification/validation process involved iterative testing, the term "training set" as used in AI contexts does not apply.
9. How the Ground Truth for the Training Set Was Established
- How the ground truth for the training set was established: Not applicable/Not available, as the concept of a "training set" for a physical device is not relevant in the context of this summary.
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(21 days)
GENICON
The GENICON implantable clips are intended for use during procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
The ligation clips are composed exclusively of titanium, and are supplied as sterile products in various sizes (mini-micro, micro, smallmedium, medium, medium-large, large and extra large) with six clips per disposable holder. The titiaum used meets all requirements for A.S.T.M. specifications F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and ISO 5832-2-93 and 10993 "Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium".
The provided text is a 510(k) summary for the GENICON Titanium Ligation Clip. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain information about a study that proves the device meets specific acceptance criteria in the way a diagnostic AI/ML device would.
Instead, the summary focuses on:
- Material Composition: Stating the device is made of titanium meeting specific ASTM and ISO standards.
- Substantial Equivalence: Claiming the device is substantially equivalent in material and function to a predicate device (Ethicon K830503).
- Safety and Efficacy: Asserting that titanium is "well recognized as being safe and effective for long term implantation" and that millions of titanium clips applied yearly "attest to the wide acceptance of this method of hemostatic and ligation control."
- Compliance with Standards: Stating that devices are manufactured according to GMP, AAMI, ASTM, and ISO 13485 requirements.
Therefore, many of the requested items related to an AI/ML device performance study cannot be answered from this document.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material meets specified biocompatibility/strength standards. | Titanium used meets ASTM F-67 95, Grade I, and ISO 5832-2-93 and 10993. |
| Substantially equivalent to predicate device (Ethicon K830503) | Material composition and disposable holder material are "substantially equivalent." Functionally, clips are "substantially equivalent." |
| Safe and effective for its intended use (ligation, hemostasis). | "Titanium is well recognized as being safe and effective for long term implantation. Millions of titanium clips are applied yearly and since inception in the 1960's attest to the wide acceptance of this method of hemostatic and ligation control." |
| Manufacturing quality | Devices are manufactured according to Good Manufacturing Practices (G.M.P.), Association for Advancement of Medical Instrumentation (A.A.M.I.) and American Society for Testing and Materials (A.S.T.M.) requirements and applicable Harmonized Standards ISO 13485 (This refers to the manufacturing process, not clinical performance data from a specific study). |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes a medical device (titanium ligation clip), not an AI/ML diagnostic or predictive model that would use a "test set" in this context. The "safety and efficacy information" refers to general acceptance of titanium clips over time, not a specific clinical study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device's performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device's performance study.
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, nor is an MRMC study described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implicitly relies on:
- Material Standards: ASTM and ISO specifications for titanium.
- Historical Clinical Use/Outcomes: "Millions of titanium clips are applied yearly...attest to the wide acceptance of this method of hemostatic and ligation control."
- Substantial Equivalence: Ground truth for equivalence is based on comparison to a legally marketed predicate device, likely involving material properties, design, and intended use.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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(141 days)
GENICON
Endoscopic surgical procedures. It is a family of instruments which includes graspers, Linsectors, and scissors, which are intended to be used to grasp, manipulate, cut, and cauterize soft tissue.
The GENICON disposable electrosurgical instruments are single use sterile instruments made from biocompatible plastic and stainless steel with a working length of 33cm. Current may be supplied by an approved electrosurgical generator which provides the ability for the coagulation of tissue when used with an appropriate ground electrode.
The provided text describes the Genicon Disposable Electrosurgical Instrumentation device, its intended use, and its substantial equivalence to a predicate device. However, it does not include specific acceptance criteria for performance metrics in the way one would expect for an AI/ML device, nor does it detail a study proving the device meets such criteria through quantitative performance measures.
Instead, the document states that Genicon electrosurgical instruments were "designed to meet the following voluntary standards." These standards are related to electrical safety, surgical instrument materials, and sterilization, rather than performance metrics like sensitivity, specificity, or reader improvement.
Therefore, many of the requested information points (e.g., acceptance criteria for specific performance, sample sizes for test/training sets, ground truth establishment, MRMC study details) are not applicable or cannot be extracted from this document, as it pertains to a traditional medical device (electrosurgical instruments) and not an AI/ML device.
Here's a breakdown of what can be extracted based on the provided text, and where information is missing or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Voluntary Standards Met) | Reported Device Performance (Implied by meeting standards) |
|---|---|
| AAMI/ANSI HF18:2001, Electrosurgical Devices | Implies electrical safety and performance as per standard. |
| IEC 60601-2-2:2000, Medical electrical equipment - Particular requirements for the safety of high frequency surgical equipment | Implies electrical safety for high-frequency surgical equipment. |
| EN 12011:1998, Instrumentation to be used in association with non-active surgical implants - General requirements | Implies suitability for use with non-active surgical implants. |
| ISO 7153-1:1991, Surgical Instruments -- Metallic Materials -- Part 1: Stainless Steel | Implies use of appropriate stainless steel for surgical instruments. |
| ISO 4957:1999, Tool Steels | Implies use of appropriate tool steels. |
| EN 868-1:1997, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods | Implies appropriate packaging for sterilization. |
| EN 552:1994, Sterilization of medical devices - Validation and routine control of sterilization by irradiation | Implies validated sterilization process for irradiation. |
Device Performance: The document states, "The technological characteristics of the new device are the same as the predicate device." The conclusion further states, "Based on the indications for use and technological characteristics, we conclude that the new device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act." This implies that the device performs equivalently to the predicate device (Ethicon Endopath K984240) in its intended use, based on the adherence to the listed voluntary standards. No specific quantitative performance metrics (e.g., cutting force, coagulation time, tissue dissection efficiency) are provided in this summary.
2. Sample size used for the test set and the data provenance
- Not Applicable. This document does not describe a clinical study with a "test set" in the context of an AI/ML device. The "performance" section refers to adherence to voluntary engineering and safety standards, not a clinical data-driven performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method for the test set
- Not Applicable. No adjudication method is mentioned as there is no "test set" in the context of an AI/ML performance study.
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, and no MRMC study is mentioned.
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
- Not Applicable. For this traditional device, "ground truth" as pertaining to a performance study with data is not detailed. The "ground truth" for demonstrating safety and efficacy is essentially adherence to the listed engineering and safety standards, and demonstrating substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, and no training set is mentioned.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device, and no training set is mentioned.
Summary of what the document primarily focuses on:
The 510(k) summary for the Genicon Disposable Electrosurgical Instrumentation focuses on demonstrating substantial equivalence to a predicate device (Ethicon ENDOPATH K984240). This is achieved by:
- Stating that the technological characteristics of the new device are the same as the predicate device.
- Listing adherence to a series of voluntary industry standards related to electrical safety, materials, and sterilization, which are relevant to electrosurgical devices.
The "study" in this context is the comparison against technical specifications and adherence to standards, rather than a clinical performance study with defined performance metrics and a patient dataset.
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(114 days)
GENICON
The GeniCon Laparoscopic Suction/Irrigation System is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
The Genicon Laparoscopic Suction Irrigator system is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, surgical sites and smoke from the surgical site.
The system consists of a hand piece equipped with two trumpet style valves, a probe, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.
The hand piece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigator probe to reach the surgical site. The probes are available in a variety of instruments and diameters.
It is a single use, disposable device and is sold sterile, and the probes may be available as single use or reusable depending on the purpose.
This looks like a 510(k) premarket notification for a medical device called the "Genicon Laparoscopic Suction Irrigation System." Based on the provided text, it's clear that this is not a study to prove a device meets acceptance criteria involving AI or advanced performance metrics.
This document is a regulatory submission for a Class II medical device, seeking clearance based on substantial equivalence to a predicate device. Therefore, many of your specific questions regarding AI-related studies and detailed performance metrics are not applicable to this type of submission.
Here's a breakdown of what can be extracted and why other questions are not relevant:
1. A table of acceptance criteria and the reported device performance
- Not applicable in the context of this document. This 510(k) submission states, "Performance – There are no performance standards for this product." This means there aren't specific quantitative acceptance criteria or a formal performance study in this document that measures the device against such criteria. The "performance" described is in the context of its intended use and functional capabilities, not a statistical demonstration of efficacy or accuracy.
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. There is no "test set" in the sense of a clinical trial or performance evaluation data provided in this regulatory submission. This is a submission for a mechanical surgical device based on substantial equivalence.
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 ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method for a test set is mentioned.
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 laparoscopic suction/irrigation system, a mechanical tool, not an AI-powered diagnostic or assistive technology for "human readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth in the context of performance metrics or AI is not part of this submission. The "ground truth" for this device's effectiveness relies on established surgical practices and the functional demonstration that it can perform its stated mechanical tasks (suction and irrigation).
8. The sample size for the training set
- Not applicable. No training set for an algorithm is applicable here.
9. How the ground truth for the training set was established
- Not applicable. No training set for an algorithm is applicable here.
Summary based on the document:
The Genicon Laparoscopic Suction Irrigation System is a Class II device seeking 510(k) clearance. The basis for its acceptance (clearance) is its substantial equivalence to a legally marketed predicate device (Stryker K963646).
- Acceptance Criteria Implied by 510(k): The primary "acceptance criterion" for a 510(k) submission is demonstrating that the new device is as safe and effective as a predicate device and does not raise new questions of safety or effectiveness. This is typically achieved by comparing the new device's indications for use, technological characteristics, and performance data (if applicable and available) to the predicate device.
- Study Proving Acceptance: The "study" isn't a traditional clinical trial or performance study with quantified metrics against acceptance criteria. Instead, the submission itself is the "proof," asserting:
- Indications for Use: They are aligned with existing laparoscopic procedures (gynecologic, general, thoracic, urology) to provide suction and irrigation.
- Technological Characteristics: It consists of a handpiece with valves, a probe, and tubing for irrigation fluid and aspiration pump attachment. It's single-use, disposable. These characteristics are compared to the predicate device to show similarity.
- Conclusion: "Based on the indications for use and technological characteristics, the Genicon Suction Irrigation system is shown to be safe and effective for its intended use and substantially equivalent to the predicate devices."
Therefore, the document describes a regulatory pathway for a conventional medical device, not a performance study as typically understood for AI or novel technologies requiring extensive clinical data or performance metrics.
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