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The SimpleSnip Suture Cutter is intended to cut sutures during all flexible endoscopic procedures.

The SimpleSnip Endoscopic Suture Cutter is sterile, single patient-use device intended to cut sutures during flexible endoscopic procedures. The cutting device goes through the working channel of the endoscope and is compatible with flexible endoscopes with a minimum channel diameter of 2.8mm. The device is available in two working lengths: 160cm working length for gastroscopes and 230 cm working length for colonoscopes. The device consists principally of a proximal handle assembly, a catheter with core wire, and a blade to cut the suture. Once the SimpleSnip device is inserted in the working channel of the endoscope, the blade is advanced from the catheter, the suture is captured within the blade such that when the blade is pulled back toward the catheter the suture is cut. The blade is rotatable to allow easy suture capturing and cutting.

I am sorry, but the provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. The document is an FDA 510(k) clearance letter for the SimpleSnip Endoscopic Suture Cutter, detailing its substantial equivalence to a predicate device. It includes information about the device description, indications for use, comparison with a predicate device, and performance/biocompatibility/sterilization testing conducted.

Specifically, it states:

• "No clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device." This means there isn't a clinical study with acceptance criteria and reported performance in the context of human data.
• The performance data mentioned is primarily bench testing and functional testing, as well as comparative testing against the predicate device for certain mechanical aspects (rotation, actuation, bending stiffness). These tests are designed to verify specifications and show equivalence, not necessarily to meet pre-defined clinical performance acceptance criteria against human outcomes.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance for a clinical study.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth for a clinical study.
8. Sample size for a training set.
9. How ground truth for the training set was established.

This document focuses on demonstrating substantial equivalence through non-clinical data and comparison to a predicate device, which is common for 510(k) submissions where clinical studies are not deemed necessary.

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Single Use Grasping Forceps are indicated for use in gastrointestinal tract of the patient to grasp, clip, drag, and remove tissue or foreign particle during endoscopic procedures.

The proposed device Single Use Grasping Forceps is a sterile, single-use device, designed to pass through a 2.0mm and 2.8mm or greater working channel of an endoscope. The main components of Single Use Grasping Forceps are jaws, spring sheath and handle. This device can be used to grasping tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close. The Single Use Grasping Forceps has three models, the differences of these models are type of jaws, OD of the device and working length. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10^-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

The provided document describes the acceptance criteria and the study that proves the performance of the Single Use Grasping Forceps (K191900).

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

The document mentions "performance test bench" and "Non clinical tests were conducted," indicating laboratory-based testing rather than clinical data from human subjects. As such, the concept of a "test set" in the context of clinical data provenance (country, retrospective/prospective) and sample size of human subjects doesn't directly apply here. The tests were performed on the device itself.

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. The study involves non-clinical bench testing and compliance with established standards for device performance, sterilization, and biocompatibility. There is no "ground truth" established by human experts in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable, as the study is not based on expert adjudication of clinical findings.

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. This is a 510(k) submission for a medical device (grasping forceps), not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this context is the fulfillment of established engineering specifications, performance standards (e.g., tensile strength, clamping strength, jaws opening/closing), and regulatory compliance as defined by international standards (ISO, ASTM, EN, USP) and FDA guidance for medical devices.

8. The sample size for the training set:

This information is not applicable. There is no concept of a "training set" as this is not an AI/machine learning model. The devices are manufactured and tested against predefined specifications.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as point 8.

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Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.

The proposed device Grasping Forceps is a sterile, single-use device, designed to pass through a 2.8 mm or greater working channel of an endoscope.

The main components of Grasping forceps are jaws, spring sheath and handle. Grasping forceps can be used to grasp tissue and/or retrieve foreign bodies, and excised tissue through jaws open and close.

The Grasping Forceps has six (6) specifications, the differences of these specifications are jaws open width, shape configuration of jaws and working length.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10t and placed in a sterility maintenance package to ensure a shelf life of 5 years.

The provided document is a 510(k) summary for the Micro-Tech Grasping Forceps. It details the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it explicitly states:

"8. Clinical Test Conclusion: No clinical study is included in this submission."

Therefore, a detailed description of acceptance criteria for a clinical study and the study proving the device meets those criteria, as requested, cannot be provided because no clinical study was conducted or presented in this document.

The document does include a "Non-Clinical Test Conclusion" which states: "Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device."

Here's the relevant information about the acceptance criteria and non-clinical testing from the document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with explicit acceptance criteria for performance in a clinical setting. Instead, it relies on non-clinical tests to demonstrate that the device complies with various standards, thereby showing it meets design specifications and is substantially equivalent to a predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for each non-clinical test. The provenance of the data is implicitly from Micro-Tech (Nanjing) Co., Ltd. in Jiangsu Province, PRC, as they are the submitter of the 510(k). The tests are non-clinical (laboratory/bench tests), not human clinical data, so the retrospective/prospective and country of origin for patients are not applicable.

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. The "ground truth" for non-clinical tests is compliance with published international and national standards, not expert consensus interpreting clinical data. Therefore, no experts for establishing ground truth in the context of clinical performance are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this refers to clinical data adjudication, which was not performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. No clinical studies, MRMC studies, or AI components are mentioned in the document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. No algorithm or AI component is mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is adherence to the specified technical standards (e.g., ASTM, ISO, USP). For the claim of Substantial Equivalence, the "ground truth" is that the device's technical characteristics, intended use, and performance (as shown through non-clinical testing) are sufficiently similar to the predicate device, and it raises no new questions of safety and effectiveness.

8. The sample size for the training set

Not applicable. No training set is mentioned as there is no AI or machine learning component.

9. How the ground truth for the training set was established

Not applicable. No training set or ground truth for a training set is mentioned.

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Slater Endoscopy Ensizor™ Endoscopic Scissors are designed to cut and dissect tissue and sutures during all flexible endoscopic procedures.

The above referenced Endoscopic Scissors are sterile, single use, non-electrocautery devices for soft tissue dissection and the cutting of sutures during flexible endoscopic procedures. The devices are compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The device cuts and dissects tissue and suture materials during all flexible endoscopic procedures. The device consists principally of an actuation handle and a flexible shaft body terminating in a pair of cutting scissors. The scissor blades function as standard scissors for mechanical cutting of sutures and tissue.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and study proving device performance as it relates to AI/ML devices. The document describes a 510(k) submission for "Ensizor Endoscopic Scissors," which are mechanical, non-AI medical devices.

Therefore, I cannot extract:

1. A table of acceptance criteria and reported device performance related to an AI/ML device.
2. Sample size used for the test set or data provenance for an AI/ML study.
3. Number of experts or their qualifications for establishing ground truth in an AI/ML context.
4. Adjudication method for an AI/ML test set.
5. MRMC comparative effectiveness study results (effect size of human readers with/without AI assistance).
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used (e.g., pathology, outcomes data) for an AI/ML model.
8. Sample size for the training set of an AI/ML model.
9. How ground truth for the training set was established for an AI/ML model.

The document discusses non-clinical performance data for the endoscopic scissors, including:

• Operation in Tortuosity: Ensuring the device can open and close when the distal shaft is formed into a 20 cm diameter circle.
• Sample Cutting: Cutting various suture and polyethylene materials at least 10 times.
• Comparative Testing to US Endoscopy Suture Cutter: Functional testing in straight and tortuous pathways, and simulation testing to grasp and cut various sutures.

The table provided in the document summarizes acceptance criteria and performance for these mechanical tests, not AI/ML performance.

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Slater Endoscopy Ensizor Endoscopic Scissors are designed to cut and dissect tissue during flexible endoscopic procedures.

The above referenced Endoscopic Scissors are sterile, single use, non-electrocautery devices for soft tissue dissection during flexible endoscopic procedures. The devices are compatible with flexible endoscopes with a minimum channel diameter of 2.8 mm. The device cuts and dissects tissue during flexible endoscopic procedures. The device consists principally of an actuation handle and a flexible shaft body terminating in a pair of cutting scissors. The scissor blades function as standard scissors for mechanical cutting of sutures and tissue.

The provided text is a 510(k) Summary for the Slater Endoscopy Ensizor Endoscopic Scissors, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with all the specific elements requested for acceptance criteria and device performance evaluation.

Therefore, much of the requested information, particularly regarding the methodology of a detailed clinical or comparative effectiveness study (like MRMC studies, details on ground truth establishment for large datasets, or specific expert qualifications for adjudication), is not present in this type of regulatory submission. The document primarily details non-clinical bench testing.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

2. Sample sizes used for the test set and the data provenance

• Sample Size for Test Set (Ensizor™ Endoscopic Scissors):
  • 15 units of 235 cm length
  • 15 units of 165 cm length
• Sample Size for Predicate Device (Apollo Endosurgery Endoscopic Monopolar Scissors):
  • 1 unit of 235 cm length
• Data Provenance: The data appears to be from in-house bench testing conducted by the manufacturer, Slater Endoscopy, LLC. The document does not specify country of origin for the data or if it's retrospective/prospective, but given it's a 510(k) submission for a new device, it's inherently prospective testing for regulatory approval.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This document describes non-clinical bench testing, not a study requiring expert-established ground truth. The "ground truth" here is the objective performance of cutting and operation in tortuosity as measured by the testing protocols.

4. Adjudication method for the test set

Not applicable. There was no clinical study involving human assessment or adjudication described. The tests were objective performance evaluations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is for a mechanical surgical device (endoscopic scissors), not an AI/imaging device. Therefore, no MRMC study or AI-related effectiveness assessment was included.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/algorithm device. The "standalone" performance here refers to the device's mechanical function, which was indeed tested independently.

7. The type of ground truth used

For the non-clinical testing described, the "ground truth" was established by the objective physical performance criteria for cutting and operation in tortuosity (e.g., successful cutting of LDPE sheet 10 times, successful opening and closing in a tortuous path).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

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The US Endoscopy Endoscopic Suture Cutter Device is intended to be used in conjunction with an endoscope to grasp and cut suture in the GI tract.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called "The US Endoscopy Endoscopic Suture Cutter Device." This type of document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for market.

Crucially, 510(k) notifications do not typically include detailed studies or acceptance criteria for device performance in the way that a PMA (Pre-Market Approval) or clinical trial report would. The 510(k) process focuses on demonstrating substantial equivalence, often through bench testing, materials characterization, and comparisons to predicate devices, rather than extensive clinical efficacy studies with specific performance metrics and acceptance criteria.

Therefore, based solely on the provided text, it is not possible to provide the requested information about acceptance criteria and the study proving the device meets them. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. MRMC comparative effectiveness study details or effect sizes.
6. Standalone algorithm performance (as this is a physical medical device, not an AI algorithm).
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the clearance was based on substantial equivalence, not on meeting specific, pre-defined performance acceptance criteria from a comprehensive study detailed in this document.

To find the kind of information requested, one would typically need to refer to the full 510(k) submission itself (which is often voluminous and not publicly released in its entirety), or any associated clinical trial publications if they were part of the submission (though for 510(k)s, clinical data is often not required or is limited).

In summary, the provided text does not contain the information needed to answer the prompt.

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The US Endoscopy Endoscopic Retrieval Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for "The US Endoscopy Endoscopic Retrieval Device." This letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This type of FDA clearance does not typically involve the rigorous multi-reader multi-case (MRMC) comparative effectiveness studies, standalone algorithm performance studies, or detailed statistical evaluations of acceptance criteria that would be conducted for novel AI/ML medical devices.

Instead, substantial equivalence is determined by demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this type of regulatory document.

Here's why and what can be inferred:

Reasons for Absence of Requested Information:

• Device Type: This is for an "Endoscopic Retrieval Device," which is a physical instrument (likely a forceps or snare) used to grasp and retrieve objects during endoscopy. It is not an AI/ML diagnostic or prognostic device.
• Regulatory Pathway (510(k)): The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device. This typically involves bench testing, biocompatibility testing, and sometimes limited clinical testing, but not the extensive multi-reader performance studies or detailed statistical analyses of acceptance criteria for diagnostic accuracy characteristic of AI/ML devices.
• Focus of the Document: The provided text is an FDA clearance letter and an "Indications for Use" statement. These documents confirm clearance and define intended use, but do not contain detailed study reports.

Information that CAN be inferred or stated based on the document:

• Acceptance Criteria and Reported Device Performance: This information is not provided in a quantified manner. The letter establishes "substantial equivalence" as the primary acceptance criterion, meaning the device performs similarly to existing predicate devices.
• Sample Size for Test Set and Data Provenance: Not applicable for this type of device and regulatory submission as detailed in the document. Performance would typically be assessed through bench testing (e.g., strength, durability, material compatibility) rather than a clinical "test set" in the context of diagnostic accuracy.
• Number of Experts and Qualifications for Ground Truth: Not applicable. For physical medical devices, "ground truth" might relate to physical properties or performance in a simulated environment, not expert consensus on diagnostic images.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is typically for evaluating the impact of AI on human diagnostic performance, which is not relevant for a physical endoscopic retrieval device.
• Standalone (algorithm-only) Performance: No. This is not an algorithm.
• Type of Ground Truth Used: Not applicable in the context of diagnostic accuracy. "Ground truth" for this device would relate to its mechanical function and safety (e.g., ability to grasp, material integrity, biocompatibility).
• Sample Size for Training Set: Not applicable. This device is not an AI/ML model that undergoes "training."
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is for a physical medical device cleared via the 510(k) pathway based on substantial equivalence. It does not contain the information requested, which is typically associated with the evaluation and clearance of AI/ML diagnostic or prognostic devices.

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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

• 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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Grasping forceps are intended to be used to grasp tissue and / or retrieve foreign bodies, excised tissue, and stents from within the gastrointestinal tract.

The EndoChoice grasping forceps are designed for grasping tissue and / or retrieving foreign body, and excised tissue under endoscopic visualization. These forceps consist of a flexible shaft and a proximal control handle. Operation of the proximal control handle actuates the distal tip grasping jaws.

The provided text describes a 510(k) premarket notification for the EndoChoice Grasping Forceps. Crucially, the document states: "No performance standards exist for this device." and "No performance data or studies were required to establish substantial equivalence for the EndoChoice Grasping Forceps."

Therefore, a detailed table of acceptance criteria and reported device performance, and information about specific studies, training/test sets, ground truth, and expert involvement, as requested, cannot be provided from the given text.

The submission focuses on establishing substantial equivalence to a predicate device (Olympus FG – 4/14/20/21/22/26/32/38/40/##-1) based on technological characteristics and intended use, rather than formal performance testing against defined acceptance criteria.

The conclusion of the 510(k) summary explicitly states: "Based on the technological characteristics and overall performance of the devices, EndoChoice, Inc. believes that the grasping forceps and the predicate device selected are substantially equivalent and that the differences between the devices are minor which do not raise new issues of safety or effectiveness."

In summary, none of the requested information (performance data, specific acceptance criteria, study details, sample sizes, ground truth methodology, or expert involvement) is present in the provided K101298 submission. The device was cleared based on its similarity to existing devices.

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The intended use of the Mondeal Endoscopic Tissue Recession and Release System is to endoscopically recess the gastrocnemius tendon or the plantar fascia ligament and to release the transverse carpal tunnel ligament.

Indications for use:

The Mondeal Endoscopic Tissue Release Recession and Release System is indicated for the following:

Endoscopic Gastrocnemius Tenotomy (EGT) - as a tool for tissue recession in patients with heel cord contracture (equinus) who fail to respond to a full course of non-surigcal treatment.

Endoscopic Plantar Fasciotomy (EPF) – as a tool for tissue recession in patients with plantar fasciitis who fail to respond to a full course of non-surgical treatment.

Carpal Tunnel Release (ECTR) - as a tool for tissue release in patients who fail to respond to non-surgical treatment of carpal tunnel syndrome.

The Mondeal Endoscopic Tissue Recession and Release System is a minimally invasive device for gaining exposure to perform Gastrocnemius Tenotomy, Plantar Fasciitis Recession, and Carpal Tunnel Release.

The system is comprised of the instruments required to perform the above mentioned maladies in conjunction with commercially available endoscopes. The instruments include an obturator, cannula, cannula locking mechanism, elevator, rasp, suction handle, and knife(s).

The system requires bi-portal incisions to pass the cannula from one side of the intended recession/resection to the other, allowing the knife to perform a complete and verified recession/release.

The cannula locking mechanism aids the surgeon in ensuring the cannula does not move while performing the procedure.

The knife is offered in two different designs. One design is for forward cutting (away from the surgeon), the other is for reverse cutting (towards the surgeon). The benefits of each design are dependent upon which procedure the device is used for and surgeon preference.

The provided text is a 510(k) summary for a medical device called the "Mondeal Endoscopic Tissue Recession and Release System." This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a clinical study with detailed acceptance criteria, performance metrics, and a study design to prove those criteria.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in the provided text. The document is a regulatory submission, not a clinical trial report.

Here's what can be extracted and what is explicitly not available based on your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The document implies the acceptance criterion is substantial equivalence to predicate devices. It doesn't define specific numerical performance targets (e.g., sensitivity, specificity, accuracy) that a study would measure against. The criteria are related to design, materials, and intended use being similar to already cleared devices.
• Reported Device Performance: The document states: "The Mondeal Endoscopic Tissue Recession and Release System is shown to be safe and effective for the indications described in this submission." This is a general statement required for a 510(k) submission, based on comparison to predicate devices, but not performance data from a specific study against predefined numerical acceptance criteria.

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 / Not Provided: As this is a 510(k) summary focused on substantial equivalence to existing devices, there is no mention of a clinical "test set" in the context of performance metrics like sensitivity or specificity. This document does not describe a clinical study that would involve such a test set. The "data provenance" would refer to the technical specifications and design comparisons made with predicate devices.

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 / Not Provided: This information pertains to a study involving human readers and ground truth, which is not described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided: This information pertains to a study involving human readers and adjudication, which is not described in this 510(k) summary.

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: The device is a surgical instrument (Endoscopic Tissue Recession and Release System), not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI assistance improvement effect size are not relevant or discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: This device is a manual surgical instrument. It is not an algorithm that would have standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable / Not Provided: Ground truth in the context of device performance (like sensitivity/specificity) is not discussed because such a performance study is not described. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices to which it is compared.

8. The sample size for the training set

• Not Applicable / Not Provided: This implies machine learning or AI training, which is not relevant to this mechanical surgical instrument.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided: As above, this is unrelated to the device described.

Summary of what the document does provide:

• Device Name: Mondeal Endoscopic Tissue Recession and Release System
• Intended Use: To endoscopically recess the gastrocnemius tendon or the plantar fascia ligament and to release the transverse carpal tunnel ligament.
• Indications for Use: Endoscopic Gastrocnemius Tenotomy (EGT), Endoscopic Plantar Fasciotomy (EPF), Carpal Tunnel Release (ECTR) for specific conditions after non-surgical treatment failure.
• Predicate Devices: Instratek EndoTrack System (K925083), Instratek Endoscopic Carpal Tunnel Instrument (K922391), A.M. Surgical Mountable Endoscopic Knife (K982142).
• Basis of Substantial Equivalence: Comparison to the listed predicate devices regarding intended use, design, materials, energy used, and performance characteristics (implied to be similar or identical, thus leading to similar safety and effectiveness). The document does not provide details of how this comparison was done (e.g., specific tests performed), other than the general statement of substantial equivalence.

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