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The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.

The Self-Righting Needle Holder is a single-use, disposable, ETO sterilized instrument for use with the HandX™ device. The Self-Righting Needle Holder is connected to the HandX™ and transmits the motors' rotations to articulate the movement of the Self-Righting Needle Holder's end effector. Self-Righting Needle Holder orients the suturing needle vertically to 90° mounting. It is designed to address the surgeons' needs relating to suturing for various surgical purposes.

Here's an analysis of the acceptance criteria and study information provided, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for each specific bench test. It mentions "The Self-Righting Needle Holder was subjected to bench testing," but does not provide details on the number of units tested.

• Data Provenance: The data is generated from bench testing conducted by the device manufacturer, Human Xtensions Ltd., to demonstrate that the design outputs meet the design input requirements. The country of origin of the testing is not explicitly stated, but the company is based in Israel. This is prospective testing for the purpose of the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This evaluation involves bench testing against predetermined engineering and performance specifications, not a clinical study requiring expert assessment of ground truth.

4. Adjudication Method for the Test Set

Not applicable. As described above, the tests are objective bench tests, not assessments 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 is a medical device (surgical instrument), not an AI/imaging diagnostic device. Therefore, an MRMC study is not relevant.

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

Not applicable. This is a physical surgical instrument, not an algorithm. The device itself (the needle holder) performs the self-righting function, but its operation is "Electromechanically operated, software controlled" by the HandX™ device. The bench tests evaluate the performance of this physical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the bench tests is the "predefined acceptance criteria" derived from engineering specifications and comparisons to the predicate and reference devices. These criteria relate to physical properties and functional performance (e.g., specific angles, force thresholds, dimensional tolerances, and the ability to achieve a "right position").

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an algorithm that requires a training set. The "software controlled" aspect refers to the HandX™ device controlling the mechanical movement, not an AI/ML algorithm that is "trained."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

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The Disposable Polyp Snare is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract. The snare can be used with or without high-frequency current.

The subject device is intended to be used in combination with endoscope for cutting polyps or other redundant tissues in digestive tract.

The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section.

The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current.

The shape of the loop includes oval, crescent, hexagonal, rhombus, dual-width oval, and polygonal. Users can choose the shape of the snare according to their preference and the characteristic of the lesion.

The provided text is a 510(k) summary for a medical device (Disposable Polyp Snare) and does not contain information about software as a medical device (SaMD) or an AI/ML device. Therefore, it does not describe acceptance criteria, the study that proves a device meets those criteria, or the other specific details requested in the prompt related to AI/ML or SaMD performance.

The document pertains to a physical medical device and its substantial equivalence to a predicate device based on non-clinical performance testing. The "510(k) Summary," specifically section 8 "Summary of non-clinical testing," outlines the tests conducted to support its marketing claims and confirm safety and effectiveness.

Based on the provided text, I cannot provide the requested information for the following reasons:

• Device Type: The device is a "Disposable Polyp Snare," which is a physical endoscopic accessory, not an AI/ML or software device.
• Study Type: The document explicitly states "No clinical tests were performed" (Section 9). The "non-clinical testing" summarized in Section 8 refers to physical performance tests (e.g., strength, maneuverability, cutting ability), sterilization, shelf-life, biocompatibility, and electrical safety, not the performance of an AI algorithm.
• Ground Truth/Experts/Sample Size (for AI): Since this is not an AI/ML device, there is no mention of training sets, test sets for AI performance, expert consensus for ground truth, or adjudication methods for AI performance evaluation.

In summary, the provided document does not contain the type of information needed to answer your detailed questions about acceptance criteria and study data for an AI/ML or SaMD product.

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The BAROnova Insufflation System is designed to use air as a distention media in the gastrointestinal tract when used in conjunction with the BAROnova TPS Delivery Device.

The BAROnova Accessory Kit, consisting of the BAROnova Insufflation System, TPS Stand, and Hook Tool is designed to facilitate use of the BAROnova TPS Delivery Device.

The BAROnova Accessory Kit includes the following products:

• BAROnova Insufflation System
• BAROnova Transpyloric Shuttle (TPS) Stand
• Hook Tool

The BAROnova Insufflation System is designed to provide pressure-controlled air to the stomach for insufflation within the gastric space during endoscopic procedures for placement of the BAROnova Transpyloric Shuttle (TPS) device. The Insufflation System is used in conjunction with the BAROnova TPS Delivery Device to facilitate TPS skin expansion during deployment once the Delivery Device is inserted. Prior to initiating TPS coil advancement with the handle controls, the TPS Delivery Device is connected to the reusable Insufflation System using the disposable tubing set provided within the TPS Delivery Device Kit. The reusable components of the Insufflation System are composed of a portable air Compressor, a Power Adapter, and Pressure Regulator Box. The air Compressor and Power Adapter are the identical components as utilized in the PARI Trek S nebulizer (K060357). The Pressure Regulator Box includes a precision low-pressure regulator and redundant pressure relief valves to limit system output pressure. The Box also includes a calibrated pressure gauge for testing and monitoring the performance of the system. The BAROnova Insufflation System allows the physician to deliver pressure-controlled air to the patient in a manner consistent with that being done currently in a routine endoscopic procedure with room air which is supplied by an air pump in the console of the endoscopic equipment.

The TPS Stand (Class I, regulated under 878.4800 – Manual surgical instrument for general use) and Hook Tool (Class I, regulated under 876.4730 - Manual Gastroenterology-Urology Surgical Instrument and Accessories), are optional accessories included in the Accessory Kit for use with the BAROnova TPS Delivery Device. The TPS Stand is a non-sterile, reusable plastic stand with a weighted aluminum base provided for the convenience of the operator, and can be used to support the TPS Delivery Device handle during TPS deployment. The Hook Tool is a stainless steel reusable tool which may be used to facilitate cutting of tension lines for deployment troubleshooting.

The provided text describes the BAROnova Insufflation System and BAROnova Accessory Kit, and the FDA's 510(k) clearance. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a medical device (BAROnova Insufflation System and Accessory Kit), which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria, sample sizes, and ground truth information as requested.

Therefore, I cannot provide the requested information based on the input text. The text only states:

• "Non-clinical testing of the subject device for functional and simulated use has been performed, as well as testing to applicable standards. The subject device was found to meet all requirements." This is a general statement and does not provide specific acceptance criteria, reported performance, or details of the study.
• "The results of the testing performed demonstrate that the BAROnova Insufflation System is safe and effective when used in accordance with its intended use and labeling." Again, this is a concluding statement without the underlying data or criteria.

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The A.M.I. FiXcision device is intended to be used by qualified physicians to provide access of internal structures and for manipulating soft tissue (cutting) for treatment of simple anal fistulae.

FiXcision is an EO-sterilized, single use, multi-part, manual cutting instrument for use during anal fistula surgery in coloproctology. FiXcision enables circumferential tissue removal for the treatment of simple anal fistulae. The four components include the following:

• Probe: Component made of stainless steel that passes through the fistula tract.
• Guide: Component made of stainless steel that compresses tissue within the fistula tract.
• Base Plate: Component made of stainless steel that acts as a stop for the Circular Cutter.
• Circular Cutter: Component made of stainless steel and polyvinyl chloride (PVC-U). The Circular Cutter cuts tissue from fistula tract. The distal end of the Circular Cutter has a protective cap made of silicone that is removed prior to use.

The provided text describes a medical device called FiXcision, a manual cutting instrument for use during anal fistula surgery. However, the text does not contain information about acceptance criteria for device performance, nor does it describe a study that proves the device meets such criteria.

The document discusses:

• Indications for Use: The A.M.I. FiXcision device is intended to be used by qualified physicians to provide access to internal structures and for manipulating soft tissue (cutting) for the treatment of simple anal fistulae.
• Device Description: It's an EO-sterilized, single-use, multi-part, manual cutting instrument consisting of a Probe, Guide, Base Plate, and Circular Cutter.
• Predicate Device: K760715, Flexible Cutting Scissors / V. Mueller O.V. Baxter Healthcare Corp.
• Summary of Non-Clinical Testing:
  • Sterilization and shelf life validation
  • Biocompatibility testing (Cytotoxicity, Sensitization, Irritation per ISO 10993-5 and 10993-10)
  • Performance testing (bench):
    • Design validation: Wear of the cutting edge, Tensile force of the Circular Cutter, Bending test for the Probe, Strength of screwed end of the Guide.
    • Usability per IEC 62366-1

The text explicitly states: "No FDA performance standards have been established for FiXcision." Therefore, there are no acceptance criteria, and consequently, no study described to prove the device meets them, in the typical sense of clinical performance metrics like sensitivity, specificity, or accuracy.

The non-clinical testing performed is to demonstrate equivalence to the predicate device and ensure safety and basic functionality, not to establish performance against specific acceptance criteria for diagnostic or treatment effectiveness.

Therefore, I cannot populate the requested table or answer the specific questions regarding acceptance criteria and performance studies because that information is not present in the provided document. The document focuses on regulatory clearance based on substantial equivalence to a predicate device through non-clinical testing.

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The disposable Overtube is a device used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract.

The Endoscope Caps are intended to keep suitable endoscopic view field during endoscopic procedures.

The BAROnova Retrieval Kit includes the following products:

• BAROnova Overtube Set (Overtube with a mated Obturator and • Seal Cap)
• Endoscope Cap Set (Endoscope Caps, Small and Large) ●
• Push Tube ●

The BAROnova Overtube Set (BAROnova Overtube) consists of a non-sterile, polymer extrusion with a metallic coil reinforcement, atraumatic tip and handle, in addition to a mated Obturator made of flexible PVC with a tapered tip, and a flexible polymer seal cap. The BAROnova Endoscope Cap Set (BAROnova Endoscope Caps) consists of two non-sterile, plastic caps for use with standard endoscopes. The Endoscope Caps are provided in two sizes to accommodate a range of standard endoscope sizes. The Push Tube (Class I, regulated under 876.4730 - Manual Gastroenterology-Urology-Urology Surgical Instrument and Accessories) and the Endoscope Cap Sizing Guide (Class I, regulated under 876.1500 - Endoscope and Accessories), are optional accessories included in the Retrieval Kit for use with the BAROnova Overtube and BAROnova Endoscope Caps respectively. The Push Tube is a non-sterile, plastic probe with a handle, which may be used to facilitate removal of foreign objects through the BAROnova Overtube. The Endoscope Sizing Cap Guide is an optional accessory for the BAROnova Endoscope Caps to assist the user in selecting the correct size Cap.

The provided text describes a 510(k) summary for the BAROnova Retrieval Kit, which includes an Overtube and Endoscope Caps. The purpose of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices.

The information provided does not contain any details about an AI/algorithm-based device, nor does it discuss acceptance criteria and a study that proves an AI device meets those criteria. The document focuses entirely on the physical characteristics, intended use, and performance of traditional medical devices (an overtube and endoscope caps) and their comparison to predicate devices for regulatory clearance.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI device.
• Sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for an AI test set.
• Details on MRMC studies or effect sizes for AI assistance.
• Details on standalone algorithm performance.

The document describes non-clinical testing for mechanical, biocompatibility, and simulated use data for the physical devices (BAROnova Overtube and Endoscope Caps), confirming they "perform as intended and that no new issues of safety and effectiveness are introduced" when compared to their predicates. This is a standard regulatory pathway for physical medical devices and does not involve AI performance metrics.

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These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

The subject device consists of a handle section, a tube section and a loop section. The loop section is inserted into the tube section and is extended and retracted by operating the handle section. The tube section and the loop section are inserted into the gastrointestinal tract through the endoscope. The loop is extended from the tube to resect the target tissue. The resection is performed with or without high-frequency current.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Single Use Electrosurgical Snare SD-400, structured to address your specific points:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical trial. As such, information on specific clinical performance metrics (like sensitivity, specificity, accuracy), sample sizes for clinical test sets, expert qualifications for ground truth, and multi-reader multi-case studies are generally not included in this type of submission. The studies described are primarily non-clinical (biocompatibility, electrical safety, etc.) and performance testing aimed at showing the device functions as intended and is safe.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a direct table of specific clinical acceptance criteria and reported device performance in the way one might expect for an AI diagnostic device. Instead, it describes various non-clinical performance tests and their compliance with established standards.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size (Test Set): Not specified in the document. The studies were non-clinical performance and safety tests, likely conducted on a representative sample of manufactured devices rather than a patient-based test set.
• Data Provenance: The studies are laboratory and bench testing, not human patient data. Therefore, the concept of "country of origin" or "retrospective/prospective" doesn't directly apply in the usual clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Given the non-clinical nature of the tests (e.g., measuring dimensions, testing durability, chemical residuals), the concept of "ground truth" derived from medical experts for a "test set" in the context of clinical performance is not applicable. The "ground truth" for these tests would be the established scientific and engineering standards and limits.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human reader interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This is a medical device (electrosurgical snare) and its submission is focused on physical and electrical safety and performance, not on diagnostic image interpretation or AI assistance for human readers.
• Effect size of human readers improvement with AI vs. without AI assistance: Not applicable as no AI component for diagnostic assistance is mentioned or evaluated.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone algorithm-only performance study was not done. The device itself is a physical instrument, not a diagnostic algorithm.

7. Type of Ground Truth Used

The "ground truth" for the various non-clinical tests involved:

• Engineering specifications and design requirements (for dimensions, operation).
• Established international and national standards (ISO, ASTM, AAMI/ANSI, IEC) for sterilization, shelf-life, biocompatibility, and electrical safety.

8. Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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The Rotatable Snare is used endoscopically in the removal and/or and cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the gastrointestinal tract.

The Rotatable Snare consists of a flexible wire cable (core wire) and loop which can be extended and retracted from the Snare's flexible outer sheath using a three-ring handle. The flexible cable and loop can also be rotated 360° using the rotation actuator on the handle. The inner diameter of the sheath is Polyglide™ coated to provide minimal friction during extension, rotation, and retraction of the loop from the sheath. When passed through an endoscope and activated, the Snare delivers a monopolar electrical current to cut and cauterize tissue with the loop.

This document is a 510(k) premarket notification for a medical device called "Rotatable Snares" from Boston Scientific Corporation. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the safety and effectiveness via clinical studies with acceptance criteria in the same way one would for a novel device or a PMA.

Therefore, the specific information requested in the prompt, such as acceptance criteria, reported device performance, sample sizes for test sets (in the context of clinical data), number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not typically found or required in a 510(k) submission for a device like this, especially when the changes are related to ergonomic improvements and not a fundamental change in the intended use or technology.

However, I can extract the information provided regarding performance data from the document:

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

The document states that "In-vitro Testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests." It then lists the tests performed. While specific numerical acceptance criteria and reported values are not provided in the summary, the conclusion is that the device met all specifications.

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

This document describes in-vitro testing, not clinical studies with patients. Therefore, the concept of sample size for a "test set" in the context of clinical data, country of origin, or retrospective/prospective data is not applicable here. The testing was performed on components, subassemblies, and/or full devices in a laboratory setting.

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. The tests performed are engineering/performance specification tests (e.g., electrical safety, tensile strength), not diagnostic or interpretative tasks requiring expert consensus.

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

Not applicable. The tests are objective measurements against predefined engineering specifications.

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 for an endoscopic snare, not an imaging or AI-assisted diagnostic device.

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

Not applicable. This is for an endoscopic snare, not an algorithm.

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

For the in-vitro testing, the "ground truth" would be the defined engineering specifications or performance standards for each test category (e.g., a specific tensile strength value, acceptable electrical resistance range, proper actuation of the snare).

8. The sample size for the training set

Not applicable. This document refers to in-vitro testing for an existing device with an ergonomic modification, not a machine learning model requiring a training set.

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

Not applicable. As above, this is not a machine learning context.

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The Polypectomy Snares are used endoscopically in the removal and /or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

The Polypectomy Snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope the snare can be activated to deliver a monopolar electrical current to cut and cauterize tissue with the loop.

This document focuses on the Boston Scientific Polypectomy Snares and describes the in-vitro testing performed to demonstrate substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria related to a specific clinical outcome or a multi-reader multi-case study with human readers and AI. The performance data presented is limited to technical specifications of the device itself.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for individual tests. The document states "all components, subassemblies, and/or full devices met the required specifications," implying that an appropriate number of samples were tested for each characteristic, but the exact count is not given.
• Data Provenance: The testing was "in-vitro," meaning it was conducted in a laboratory setting, not on human subjects. There is no information about country of origin, retrospective or prospective nature as it's not a clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

• Not applicable. This device's performance was evaluated through engineering and functional testing (in-vitro), not requiring expert-established ground truth related to medical diagnoses or interpretations.

4. Adjudication Method

• Not applicable. As noted above, this was a technical performance study, not a clinical trial requiring adjudication of patient cases.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes in-vitro engineering tests for device functionality, not a clinical study involving human readers or AI assistance.

6. Standalone Performance Study (Algorithm Only)

• No, a standalone study (algorithm only without human-in-the-loop performance) was not done. This device is a physical medical instrument (polypectomy snare), not an AI algorithm.

7. Type of Ground Truth Used

• The "ground truth" for the in-vitro performance tests was based on established engineering specifications and requirements for mechanical, electrical, and functional performance of the polypectomy snare.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth establishment method.

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The Polypectomy Snares and Rotatable Snares are used endoscopically in the removal and /or cauterization of diminutive polyps, sessile polyps, pedunculated polyps and tissue from within the GI tract.

Both the rotatable and non-rotatable snares consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop. For the rotatable snares, the snare can be rotated by using the rotation actuator.

The provided text describes Boston Scientific Corporation's Polypectomy Snares and Rotatable Snares, which are medical devices used endoscopically for the removal and cauterization of polyps and tissue within the GI tract. The 510(k) submission (K131700) is for a change to the device indication only, and the devices are stated to be identical in design, materials, and manufacturing processes to previously cleared predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided documentation does not explicitly state quantitative acceptance criteria or detailed results for each performance metric. It generally states that the devices met required specifications.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size for the comparative or in-vitro testing. It refers to "all components, subassemblies, and/or full devices" and "Comparative testing."
• Data Provenance: The testing was "In-vitro testing" and "Comparative testing" performed by Boston Scientific Corporation. The country of origin is not explicitly stated but implied to be the US given the submission to the FDA. The testing is assumed to be prospective for the purpose of this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts or human assessment in establishing ground truth for the performance testing. The study focuses on physical and mechanical specifications of the device itself.

4. Adjudication Method for the Test Set

Not applicable. The testing described is primarily in-vitro and comparative, not involving human judgment or adjudication of results in the clinical sense.

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 document describes a medical device (polypectomy snares) and its physical characteristics and indications for use, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or applicable here.

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

Not applicable. This device is a physical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance study was based on predetermined engineering specifications and measurements (e.g., length, OD, loop width and shape, loop plane deflection, tensile strength), and comparison to predicate devices. There is no biological or clinical ground truth described, as the study is focused on device attributes.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

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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The devices are used for temporary grasping and clamping of soft tissue and small tubular structures during minimally invasive procedures.

The MINI-TONG instruments are minimally invasive devices. Prior to insertion, the physician must depress the safety button and retract the instrument into the needle is inserted through the soft tissue under visualization. Once the needle has penetrated the soft tissue, the physician will advance the instrument into the body cavity using the handle. As the instrument advances, the instrument will open. The device includes a self-activating safety that prohibits the jaws from returning to their fully retracted position while in use. The devices are sterile disposable, single patient only. The devices were designed to hold pneumoperitoneum during use.

The provided FDA 510(k) summary for the "MINI-TONG" device primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. It does not present a detailed study with acceptance criteria and reported device performance metrics in the way that would typically be seen for a new, complex diagnostic or therapeutic device requiring extensive performance testing.

The document states: "We believe the addition of this new jaw configuration is a minor expansion to a product family that already has 510(k) clearance. The subject device is composed of biocompatible materials and the sterilization process has been validated." This suggests that the primary "study" or justification for equivalence relied on the established performance of existing predicate devices and basic material/sterilization validation.

Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this submission.

Here's a breakdown of what can be extracted and what is explicitly not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative acceptance criteria (e.g., minimum grasping force, maximum tissue damage, durability under specific loads) and detailed performance data (e.g., actual measured grasping force, results of biocompatibility tests, sterilization validation reports) are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• No specific "test set" sample size for functional performance is mentioned in the provided text.
• No details on data provenance (e.g., country of origin, retrospective/prospective) related to a performance study are provided. The justification for equivalence relies on the known performance of predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable as no specific test set requiring expert-established ground truth is described in this submission. The "ground truth" for substantial equivalence appears to be based on the established safety and effectiveness of the predicate devices and the technological similarity.

4. Adjudication Method for the Test Set

• Not applicable as no specific test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was mentioned or implied. This type of study is typically for diagnostic devices or devices where human-AI interaction is central to the performance. The MINI-TONG is an instrument, not a diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. The MINI-TONG is a manual surgical instrument, not an algorithm, so independent algorithmic performance is not relevant. Its performance is always human-in-the-loop.

7. Type of Ground Truth Used

• For the purpose of substantial equivalence, the "ground truth" implicitly relies on:
  • Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices (Mini Lap Instruments - K070686, U.S. Surgical Modified Hand Instrument Devices K960748, Solos Endoscopy 10mm Atraumatic Grasping Forcep and 5mm Grasping Forcep K900948 / K900958).
  • Design & Material Standards: Compliance with biocompatibility standards and validated sterilization processes.
  • Functional Description: The device's described ability to perform its intended function of grasping and clamping.

8. Sample Size for the Training Set

• Not applicable. As a physical instrument, there is no "training set" in the context of an AI/ML algorithm. The design and validation are based on engineering principles and testing appropriate for a mechanical device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set." The performance characteristics are derived from engineering design, material selection, manufacturing processes, and comparison to predicate devices, rather than machine learning training.

Summary Caveat: This analysis is strictly based on the provided text, which is an FDA 510(k) summary. Such summaries are often high-level and refer to more detailed internal documentation (e.g., test reports for biocompatibility, sterilization validation, mechanical testing) that would contain the specific acceptance criteria and detailed performance data. This document's primary purpose is to articulate the basis for claiming substantial equivalence, not to fully detail all underlying engineering and performance tests.

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