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510(k) Data Aggregation
(28 days)
USGI MEDICAL
The USGI g-Prox EZ Endoscopic Grasper is intended for use in minimally Invasive procedures to facilitate tissue grasping and manipulation.
The g-Prox EZ Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is available in two jaw lengths. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments. It is comprised of a polycarbonate proximal handle, flexible shaft made of medical grade polymers and distal stainless steel jaws. It has a nominal working length and outer diameter of 111 cm and 5.5 mm, respectively.
This 510(k) summary (K103688) describes the g-Prox EZ Endoscopic Grasper, a sterile, single-patient-use device intended for tissue grasping and mobilization in minimally invasive procedures.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device Integrity | Non-clinical performance testing, including bond joint strength testing, was conducted. Test data confirmed that the modified g-Prox EZ device demonstrated equivalent safety and performance to the predicate device. |
| Functionality | Non-clinical performance testing was conducted. Test data confirmed that the modified g-Prox EZ device demonstrated equivalent safety and performance to the predicate device. This likely includes the ability to grasp and mobilize tissue, and for the g-Prox EZ, specifically the ability to cut G-Cath anchor suture tails. |
| In Vivo Simulated Use | Non-clinical performance testing, including in vivo simulated use testing, was conducted. Test data confirmed that the modified g-Prox EZ device demonstrated equivalent safety and performance to the predicate device. |
| Equivalence to Predicate Device (g-Prox Endoscopic Grasper - K093018) | The g-Prox EZ Endoscopic Grasper demonstrated equivalent safety and performance to the predicate device in terms of intended use, technology, materials, and overall function. Specific comparisons include: |
- Identical shaft and distal jaw materials and sizes.
- Identical intended use and principles of operation.
- Identical lumen for accepting other instruments.
- New suture cutting component in g-Prox EZ jaw. |
2. Sample Size Used for the Test Set and Data Provenance
The submission states that "Non-clinical performance testing was conducted." While it details the types of tests performed (device integrity, functionality, in vivo simulated use), it does not explicitly state the sample size for these tests or the data provenance (e.g., country of origin, retrospective or prospective). This information is typically found in the detailed test reports which are part of the full 510(k) submission but not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe the use of human experts to establish ground truth for the non-clinical performance testing. The evaluation focused on engineering and performance characteristics of the device itself rather than human interpretation of medical images or conditions.
4. Adjudication Method for the Test Set
Not applicable. This device's performance was evaluated through non-clinical engineering and functional testing, not through a process requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not performed. This device is a surgical instrument (grasper), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of improving human readers with AI assistance does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical instrument and does not involve an algorithm or AI component in its operation. Its performance is entirely mechanical/physical, used by a human operator.
7. The Type of Ground Truth Used
The "ground truth" for this device's testing was based on engineering specifications, material properties, and functional requirements. For example:
- Device Integrity: "Ground truth" would be the predetermined acceptable limits for bond joint strength or other integrity measures.
- Functionality: "Ground truth" would be the successful demonstration of tissue grasping, mobilization, and suture cutting (for the EZ model) according to design specifications.
- In Vivo Simulated Use: "Ground truth" would involve successful and safe operation within a simulated biological environment, meeting predetermined performance criteria.
8. The Sample Size for the Training Set
Not applicable. As described in point 6, this device is a physical surgical instrument and does not involve any AI algorithms or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As described in point 8, there is no training set for this device.
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(87 days)
USGI MEDICAL
The g-Cinch is intended for use with the g-Cath Tissue Anchor Delivery Catheter for suture grasping and cinching of g-Cath Tissue Anchors
The g-Cinch Suture Grasper is a sterile, single patient use device used as an accessory to the g-Cath Tissue Anchor Delivery Catheter for grasping and cinching g-Cath Tissue Anchors. It is comprised of a proximal polycarbonate/ABS handle, flexible shaft made of medical grade polymers and a distal metal snare. It has a nominal working length of 159 cm and can be introduced through either an endoscopic access device or endoscope with a > 2.8 mm nominal channel diameter and working length of
Here's an analysis of the provided text regarding the g-Cinch Suture Grasper, focusing on acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device Integrity (Bond joint strength) | "Test data showed that the device performs as intended when used according to its instructions for use." |
| Performance (as intended) | "Test data showed that the device performs as intended when used according to its instructions for use." |
| Biocompatibility | Met ISO 10993-1 requirements. |
| User Ergonomics | "Test data showed that the device performs as intended when used according to its instructions for use." |
| Equivalence to Predicate Device (g-Cath) | "Test data also showed that the g-Cinch met the same acceptance criteria as the g-Cath predicate device, and thereby demonstrated equivalent safety and performance to the predicate device." |
Study Information:
The provided document describes a non-clinical performance testing study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size used for the non-clinical performance testing. It refers generally to "Test data."
- Data Provenance: The study was a non-clinical performance testing and therefore did not involve human subjects or patient data. It describes internal testing conducted by USGI Medical.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This was a non-clinical engineering/performance study, not a study evaluating diagnostic accuracy or requiring expert-established ground truth in the traditional sense of clinical or image-based studies. The "ground truth" would be the engineering specifications and performance standards.
4. Adjudication Method for the Test Set
- Not applicable. As a non-clinical engineering performance study, there was no need for expert adjudication of results. Performance was measured against predefined engineering and material specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study was not conducted as this was a non-clinical device performance study, not a clinical study involving human readers or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not applicable. This device is a mechanical medical instrument, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
- The "ground truth" for this non-clinical study was based on engineering specifications, material properties, and predefined performance standards for the device itself and its predicate (g-Cath Tissue Anchor Delivery Catheter). For example, bond joint strength would have objective measurement criteria.
8. The Sample Size for the Training Set
- Not applicable. This was a physical device performance study, not an AI/algorithm study that involves "training sets."
9. How the Ground Truth for the Training Set was Established
- Not applicable. As this was not an AI/algorithm study, there was no training set or ground truth established for a training set.
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(19 days)
USGI MEDICAL
The g-Cath Tissue Anchor Deliver Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures, e.g. fistula closure, perforation/leak closure and repair of dilated gastric tissue.
The g-Cath Tissue Anchor Delivery Catheter is a sterile, single patient use device that contains a nitinol/polyester/titanium tissue anchor pair within the catheter lumen. The anchor pair is deployed through the catheter lumen to compress and approximate tissue.
The provided text describes a 510(k) summary for the g-Cath Tissue Anchor Delivery Catheter. It focuses on the device's substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or a specific study proving device performance in the manner requested by the prompt (e.g., in a clinical setting with human readers, AI assistance, ground truth establishment, or training set details). Instead, it refers to "bench testing" to ensure the modified device performs as intended.
Based on the information provided, here's an attempt to answer the questions, highlighting where specific details are missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Bench testing confirmed that the device met its performance specifications." However, the specific acceptance criteria (e.g., tensile strength, deployment force, tissue approximation efficacy) and the quantitative reported device performance values are not provided in this summary.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | Met performance specifications (Specifics not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench testing" but does not specify the sample size used for these tests. There is no information regarding the data provenance (e.g., country of origin) or whether the data was retrospective or prospective, as this was laboratory bench testing, not clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since the testing was bench testing of a device's physical properties, there would not be "experts" establishing ground truth in the clinical sense (e.g., radiologists interpreting images). The "ground truth" would be established by the engineering specifications and measurement of physical properties. The document does not specify the number or qualifications of engineers or technicians involved in establishing the testing protocols or verifying results.
4. Adjudication Method for the Test Set
Not applicable. As the testing was bench testing of device performance against specifications, an adjudication method for a test set (like 2+1 or 3+1 for expert consensus) is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. An MRMC comparative effectiveness study is not mentioned. This type of study relates to the performance of human readers, potentially with AI assistance, in interpreting clinical cases. The document describes bench testing of a physical medical device (tissue anchor delivery catheter) and does not involve AI or human "readers" in this context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This question is relevant to AI algorithms. The document describes a physical medical device (g-Cath Tissue Anchor Delivery Catheter) and its bench testing, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the bench testing would be the predefined engineering specifications and measurable physical properties of the device (e.g., material strength, deployment accuracy, tissue compression characteristics). The document states, "Bench testing confirmed that the device met its performance specifications," indicating that the "ground truth" was these specifications.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The term "training set" is typically used for data that an AI model learns from.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a physical device.
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(20 days)
USGI MEDICAL
The USGI g- Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures, e.g., fistula closure, perforation/leak closure and repair of dilated gastric tissue.
The g-Cath Tissue Anchor Delivery Catheter is a sterile, single patient use device that contains a nitinol/polyester tissue anchor pair within the catheter lumen. The anchor pair is deployed through the catheter lumen to compress and approximate tissue.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and related FDA correspondence for a medical device (g-Cath Tissue Anchor Delivery Catheter), primarily focusing on its description, intended use, and substantial equivalence to a predicate device for market clearance.
The text does not contain any details regarding:
- Acceptance criteria for device performance.
- A study design, sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided input.
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(29 days)
USGI MEDICAL
The USGI g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and manipulation.
The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It includes a lumen that can accept the g-Cath Tissue Anchor Delivery Catheter and other small diameter instruments.
The provided document is a 510(k) summary for a medical device (USGI g-Prox Endoscopic Grasper) and primarily focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a detailed study proving performance against acceptance criteria in the context of AI or advanced analytical devices. As such, most of the requested information (related to AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not available or applicable to this type of submission.
The relevant information from the document is summarized below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | Device performs as intended for tissue grasping and mobilization in minimally invasive procedures. |
| Technology | Comparable to predicate devices. |
| Materials | Comparable to predicate devices. |
| Safety & Effectiveness | Deemed substantially equivalent to predicate devices, implying similar safety and effectiveness profiles. |
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 mentions "Bench testing was conducted to ensure that the modified device performs as intended." However, it does not specify the sample size, type of data (e.g., in vitro, ex vivo, in vivo), country of origin, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a surgical instrument, and its performance is evaluated through bench testing and comparison to predicate devices, not typically through expert-established ground truth in the context of diagnostic or analytical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document refers to "Bench testing," but provides no details on adjudication methods.
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 a surgical instrument, not an AI-assisted diagnostic or analytical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For bench testing, the "ground truth" would likely be engineering specifications, material properties, and functional performance benchmarks (e.g., grasping force, durability, tissue damage assessment), rather than clinical ground truth like pathology or expert consensus. No specific type is mentioned.
8. The sample size for the training set
Not applicable. The device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. The device is not an AI algorithm requiring a training set.
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(17 days)
USGI MEDICAL
The USGI TransPort Endoscopic Guide is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
The TransPort Endoscopic Access Device is comprised of a flexible shaft that can be rigidized and locked into position, a steerable tip and multiple lumens that allow insertion and exchange of flexible instruments. It is supplied as two separately packaged components, i.e., a reusable, metal body and a strerile, single use disposable sheath.
The provided text describes a 510(k) summary for the USGI TransPort™ Endoscopic Access Device. This device is an "Endoscopic Overtube" and its submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria and performance studies is not directly available in this document.
Here's a breakdown of what can be extracted and what is not applicable:
1. Table of acceptance criteria and the reported device performance
This information is not present in the provided 510(k) summary. The summary states: "Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use." However, it does not detail specific acceptance criteria or the reported performance metrics from this bench testing.
2. Sample size used for the test set and the data provenance
No test set data for performance evaluation (e.g., in a clinical study) is described in this 510(k) submission. The "bench testing" mentioned suggests in-vitro or simulated use, not a human-based test set from a specific country or retrospective/prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the summary does not describe a clinical study requiring ground truth establishment by experts.
4. Adjudication method for the test set
This information is not applicable as the summary does not describe a clinical study 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
This information is not applicable. The device is an endoscopic access device, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm or AI-powered.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable as the summary describes functional "bench testing" for a physical device, not a diagnostic or AI algorithm requiring ground truth.
8. The sample size for the training set
This information is not applicable as the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI algorithm requiring a training set and ground truth establishment.
Summary of available information from the K072405 document:
- Device Name: USGI TransPort™ Endoscopic Access Device
- Intended Use: To be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
- Comparison Basis: Substantially equivalent to predicate devices (USGI Medical TransPort™ Endoscopic Access Device K061216 and ShapeLock™ Endoscopic Access Device K033954) in terms of intended use, technology, and materials.
- Performance Claim: "Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use." (No specific criteria or results provided in this summary).
In conclusion, the provided 510(k) summary for K072405 focuses on demonstrating substantial equivalence through comparison and general bench testing, not on providing detailed acceptance criteria and performance data from a clinical or AI-centric study. Therefore, most of the requested fields are not applicable to the content of this specific document.
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(212 days)
USGI MEDICAL
The g-Cath Tissue Anchor Delivery Catheter is intended for approximation of soft tissue in minimally invasive gastroenterology procedures.
The g-Prox Endoscopic Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization.
The g-Prox Endoscopic Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is also used as an accessory to the g-Cath Tissue Anchor Delivery Catheter for placement of tissue anchors for soft tissue approximation in minimally invasive gastroenterology procedures. A nitinol/polyester tissue anchor pair is deployed through the g-Cath Tissue Anchor Delivery Catheter lumen and compressed to approximate soft tissue. Anchor tensile strength meets USP for a size 4-0 nonabsorbable suture. The anchor does not meet USP for diameter and is oversized by 100% compared to a 4-0 nonabsorbable suture.
The provided text describes a 510(k) submission for the g-Cath Tissue Anchor Delivery Catheter and g-Prox Endoscopic Grasper, focusing on their substantial equivalence to predicate devices. It does not present acceptance criteria or a study proving that the device meets specific acceptance criteria in the way a clinical performance study would for an AI/ML device.
Instead, the submission focuses on:
- Comparison with Predicate Devices: Demonstrating that the new devices are comparable to existing legally marketed devices in terms of intended use, technology, design, and materials.
- Preclinical Testing: Stating that "Bench and animal testing demonstrated satisfactory performance of the g-Prox Endoscopic Grasper and g-Cath Tissue Anchor Delivery Catheter." This is a general statement of satisfactory performance, not a detailed report against specific, quantified acceptance criteria.
- Compliance with Industry Standards: The g-Cath Tissue Anchor's tensile strength is stated to meet USP for a size 4-0 nonabsorbable suture, although its diameter is oversized. This is the closest thing to a specific performance metric mentioned.
Given this context, I cannot extract the information requested as it pertains to AI/ML device performance studies. The provided document is for a medical device clearance (510(k)) that relies on preclinical testing and substantial equivalence to predicate devices, not a human-in-the-loop or standalone AI/ML performance study.
Therefore, most of your requested table and points regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies for AI performance cannot be answered from the provided text.
Here's a breakdown of what information can be extracted or inferred based on the document's nature:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| g-Cath Anchor tensile strength (similar to predicate sutures) | Meets USP for a size 4-0 nonabsorbable suture. |
| General satisfactory performance during preclinical testing | Bench and animal testing demonstrated satisfactory performance. |
| Material and design compatibility with intended use | Comparable to predicate devices in materials and design. |
| Functionality (grasping, mobilization, tissue approximation) | Performs grasping, mobilization, and tissue approximation as intended. |
| Sterility, single-patient use (implied from description) | Described as sterile, single-patient use. |
| Anchor diameter consistency with USP (implied, though not met) | Oversized by 100% compared to a 4-0 nonabsorbable suture (for diameter). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for bench or animal testing. The text only states "Preclinical testing was performed..."
- Data Provenance: The testing was "Bench and animal testing," indicating lab-based and in-vivo animal studies. Country of origin is not specified but implicitly US-based given the FDA submission. These are prospective tests for device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The "ground truth" here would relate to the physical and functional properties of the device, likely assessed by engineers and veterinarians/pathologists in animal studies, not human experts establishing ground truth for diagnostic AI.
4. Adjudication method for the test set
- Not applicable/Not provided. Adjudication methods are typically relevant for human reader studies or expert consensus, not for mechanical or animal performance testing.
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/ML device, and no MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device. The "standalone performance" was the physical device independent of human assistance in a diagnostic context.
7. The type of ground truth used
- Bench Testing: Ground truth would be based on established engineering standards, physical measurements (e.g., tensile strength testing against USP standards), and functional tests.
- Animal Testing: Ground truth would be based on physiological observations, histological assessment of tissue approximation, and veterinary pathology.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device where a "training set" would be used in the same context.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
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(87 days)
USGI MEDICAL
The g-Lix Tissue Grasper is intended for use in minimally invasive procedures to facilitate tissue grasping and mobilization, especially for tissue which will be removed, such as the gall bladder.
The g-Lix Tissue Grasper is a sterile, single patient use device used for tissue grasping and mobilization. It is comprised of a proximal rotation knob, flexible or rigid shaft and distal helix tip.
The g-Lix Tissue Grasper is a manual surgical instrument for general use. The provided text is a 510(k) summary for the device, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance metrics or conducting extensive clinical efficacy studies with specific acceptance criteria as would be done for AI/ML devices or more complex medical devices.
Therefore, the requested information elements (1-9) which are typically associated with AI/ML device evaluations or detailed clinical studies for performance validation are not fully applicable or derivable from this submission for a simple manual grasper.
However, I can extract the relevant information concerning bench testing which serves as the "study" for this type of device and functional equivalence as the implicit "acceptance criteria."
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance for g-Lix Tissue Grasper
1. A table of acceptance criteria and the reported device performance
For a manual surgical instrument like the g-Lix Tissue Grasper, the "acceptance criteria" are primarily established in relation to its intended use and functional equivalence to legally marketed predicate devices. The performance is assessed through bench testing to ensure it functions as designed without specific quantitative metrics provided in this summary.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs as intended for tissue grasping and mobilization, comparable to predicate devices in terms of intended use, technology, and materials. | Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use. |
| Safety: Does not introduce new safety concerns compared to predicate devices. | The 510(k) summary asserts substantial equivalence to predicate devices, inferring comparable safety profiles. |
| Sterility: Device is sterile for single-patient use. | "The g-Lix Tissue Grasper is a sterile, single patient use device..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the 510(k) summary. Bench testing typically involves a number of samples to ensure reproducibility and reliability, but the exact quantity is not disclosed.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by USGI Medical (the manufacturer in San Clemente, CA, USA). The testing would be prospective in nature as it's performed on new devices to validate their design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a manual surgical instrument, "ground truth" in the context of expert review is typically not established for bench testing. The testing would likely involve engineers and technicians evaluating mechanical performance, grasping capabilities, and material integrity against design specifications and functional requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, this type of testing does not typically involve expert adjudication methods commonly seen in clinical or diagnostic studies.
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 manual surgical instrument, not an AI/ML diagnostic tool. Therefore, an MRMC study and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not explicitly defined as "ground truth" in the context of this 510(k) submission. The "ground truth" for bench testing of a manual instrument generally refers to adherence to engineering specifications, functional performance requirements (e.g., grasping strength, material durability, rotation capability), and comparison to the performance of predicate devices. These are typically assessed through objective measurements rather than expert consensus on a diagnostic outcome.
8. The sample size for the training set
Not applicable. There is no training set mentioned or implied for this manual device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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(13 days)
USGI MEDICAL
The USGI TransPort Endoscopic Guide is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
USGI Transport™ Endoscopic Access Device
The provided text is a 510(k) premarket notification letter from the FDA regarding the USGI Transport™ Endoscopic Access Device. This type of document primarily confirms substantial equivalence to a predicate device and outlines regulatory compliance. It does not typically contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as one would find for a novel device requiring extensive clinical trials.
Therefore, many of the requested fields cannot be directly extracted from this document. However, I will fill in what can be inferred or stated based on the nature of a 510(k) submission.
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. In a 510(k) submission, acceptance criteria are generally related to demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness, often through performance testing, material characterization, and sometimes limited clinical data. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. This implies that the device's performance, as evaluated against the predicate(s), met the necessary criteria for equivalence in its intended use. Specific performance metrics are not detailed in this letter. |
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: Not specified in this document. For a 510(k) for an endoscopic access device, testing typically involves mechanical and functional performance tests rather than a "test set" in the context of AI/diagnostic algorithms. If any human-factors or limited animal/human studies were performed for the 510(k), their sample sizes are not detailed here.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable or specified. This device is not an AI/diagnostic device that relies on expert-established ground truth for its performance evaluation in the way a diagnostic algorithm would. Its performance is assessed primarily through engineering and functional testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable or specified. As above, this is not a diagnostic device evaluated with expert adjudication methods.
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 device is not an AI-assisted diagnostic tool, so 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 is a physical medical device (endoscopic access device), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of AI/diagnostic ground truth. The "ground truth" for this device would be its functional performance specifications, material properties, and compatibility with endoscopes and instruments, as demonstrated through engineering tests and potentially limited animal or ex-vivo studies.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
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(11 days)
USGI MEDICAL
The USGI ShapeLock Endoscopic Guide is intended to be used with an endoscope to to facilitate intubation, e.g., colonoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
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I am sorry, but the provided text does not contain information about the acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "USGI ShapeLock Endoscopic Guide," indicating that the device has been found substantially equivalent to a legally marketed predicate device.
The letter mentions:
- Trade/Device Name: USGI ShapeLock™ Endoscopic Guide
- Regulation Number: 21 CFR §876.1500 (Endoscope and accessories)
- Regulation Name: Endoscope and accessories
- Regulatory Class: II
- Indications For Use: To be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, and removal of multiple polyps and/or foreign bodies.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study, including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information based on the given text.
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