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XNY Disposable Gastric Calibration Tube is indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch.

The XNY Disposable Gastric Calibration Tubes are indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid and size the gastric pouch. The device has the advantages of accurately determining residual gastric capacity and easy positioning, and it can be connected to a suction device to extract the gas or liquid in the patient's stomach.

The XNY Disposable Gastric Calibration Tube is a Class II medical device used in gastric and bariatric surgical procedures. The 510(k) summary provides information on the device's acceptance criteria and performance through various bench tests.

1. Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify the exact sample size used for each individual test or the overall test set. The tests performed are bench studies ("non-clinical assessments") which are typically conducted in a laboratory setting. There is no information provided about the country of origin or whether the data is retrospective or prospective, as these are not relevant for bench testing of this type of device.

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 to the provided data. The listed tests are objective, performance-based bench tests that do not involve expert interpretation or subjective ground truth establishment like in clinical image analysis or diagnostic studies. The acceptance criteria are based on measurable physical properties and functional performance, not expert consensus.

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

This information is not applicable. Adjudication methods are typically used in clinical studies where subjective interpretations or disagreements among experts need to be resolved to establish a ground truth. The tests performed for this device are objective bench tests with pass/fail criteria.

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 a "Disposable Gastric Calibration Tube," which is a physical surgical tool and not an AI-powered diagnostic or assistive technology that would involve human readers or image interpretation.

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

This information is not applicable. The device is a passive physical medical instrument, not an algorithm or software-based system.

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

The "ground truth" for the performance tests of this device is based on objective, measurable physical and functional properties as defined by the acceptance criteria. For example, the firmness is measured in Newtons, aspiration function by volume and time, and dimensions by standard measurements. Biocompatibility relies on established ISO standards.

8. The sample size for the training set:

This information is not applicable. This device is a physical medical instrument, not a machine learning model, and therefore does not have a "training set" in the context of AI development. The "training" for a manufacturing process would involve quality control and process validation, which is distinct from an AI training set.

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

This information is not applicable, as there is no "training set" for this type of medical device as described in the context of AI.

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Flexi-Seal AIR™ (with ENFit™ Connector) is an indwelling fecal management catheter intended to manage fecal incontinence through the collection of liquid stool and to provide access to administer medications. The device is intended for use in adult patients.

The Flexi-Seal Air™ (supplied non-sterile) is comprised of a low pressure foam-filled 100% silicone rectal retention balloon fixed to the distal end of a soft collapsible silicone catheter tube with a labelled white inflation port and an auto Inflate valve, Luer lock inflation syringe, an ENFit connector for irrigation/medication port with an ENFit compatible syringe, cinch clamp, date formatted labels, a sub-assembled self-closing quick connector to the catheter end, a matching collection bag, and "Diamonds" gelling and odor control sachets (4 sachets per kit). The components are contained in a rigid thermoformed plastic clamshell.

I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text.

The provided text is an FDA 510(k) clearance letter and a 510(k) summary for the Flexi-Seal AIR (with ENFit Connector). While it details the device, its intended use, technological comparisons, and the rationale for substantial equivalence to a predicate device, it does not contain information about specific "acceptance criteria" for a study that proves the device meets these criteria in the way you've outlined.

Specifically, the document states:

• "Performance testing for Flexi-Seal Air™ was conducted for functional and structural parameters. In this testing, the device's performance has been found to be substantially equivalent to the predicate device both functionally and structurally (balloon, auto inflate valve, joint strength, mechanical properties, odor barrier, etc)."
• "The device has also been evaluated for biocompatibility in accordance with the US Food and Drug Administration's guidance entitled Use of International Standard ISO 10993-1:2018, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process’, issued September 8, 2023, and has been found safe in such respect for its intended use."

This indicates that various performance tests (functional, structural, biocompatibility) were done to demonstrate substantial equivalence to a predicate device, which is the primary requirement for 510(k) clearance. However, it does not specify:

• A table of explicit "acceptance criteria" and "reported device performance" in a quantitative manner as you've requested.
• Sample sizes for a test set proving a specific performance goal.
• Data provenance, number of experts, adjudication methods, or ground truth establishment as would be present in a clinical performance study for an AI/ML device or a device requiring specific clinical performance metrics to be proven.
• MRMC studies or standalone algorithm performance.

The document is a regulatory submission for a medical device that appears to be a physical product (fecal management catheter), not an AI/ML software device. Thus, the questions regarding "AI vs. without AI assistance," "standalone (algorithm only) performance," and ground truth establishment for a training set are not applicable here.

Therefore, I cannot extract the information you've requested as it is not present in the provided text.

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The hygh-tec drainage II is a fecal management system that is intended for continuous, trans-anal drainage and collection of liquid or semi-liquid stools and to provide access for the administrations. The device is not intended for use on pediatric patients.

The hygh-tec drainage II is a fecal drainage system that is comprised of a stool collection bag, and an inflating syringe. The device is used by healthcare professional heatthcare environment for continuous trans-anal drainage and collection of stools. The stool drainage tool is the patient while a liquid is infused within a specialized port to irigate the rectum. The organic matter then progresses through the drainage tube where it is eventually stored in the collection bag for evaluation or disposal. Along with stool drainage, the hygh-tec drainage II system can be used for the administration that would be prescribed by physicians.

This is a device for fecal management and thus does not include performance studies that would require the information requested for AI/ML devices. As such, most of the fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
Not applicable, as this device does not contain algorithm/AI.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable, as this device does not contain algorithm/AI.

4. Adjudication Method for the Test Set
Not applicable, as this device does not contain algorithm/AI.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable, as this device does not contain algorithm/AI.

6. Standalone (Algorithm Only) Performance Study
Not applicable, as this device does not contain algorithm/AI.

7. Type of Ground Truth Used
Not applicable, as this device does not contain algorithm/AI.

8. Sample Size for the Training Set
Not applicable, as this device does not contain algorithm/AI.

9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not contain algorithm/AI.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The device, hygh-tec drainage II, underwent non-clinical testing to demonstrate substantial equivalence to its predicate device. The following tests were performed and all passed:

• ISO 10993-5:2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.
• ISO 10993-10:2021: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
• ISO 10993-23:2021: Biological evaluation of medical devices – Part 23: Tests for irritation.
• Tensile Strength Testing: This test assessed the material strength of the device.

These tests indicate that the device is biocompatible and structurally sound for its intended use. The 510(k) summary explicitly states that "all tests passed," leading to the conclusion that the device is substantially equivalent and meets the necessary performance and safety requirements. The primary difference between the subject device and the predicate is the material of the drainage tube, changing from PVC to a three-layer extruded tube made of TPU-EVOH-TPU, which was presumably evaluated through these tests.

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The ZZIREN™ Orogastric Tube is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, to serve as a size guide, and to test for leaks.

The ZZIREN™ Orogastric Tube is a non-sterile, single use device comprising a 37-inch-long insertion tube, a Y extension containing a suction regulating valve, and a pinch clamp. An accessory straight connector is included. The insertion is made of flexible polyvinylchloride (PVC). The suction requlating valve limits negative pressure applied to the stomach or intestine to less than 175 mmHg, produces an audible signal when the suction pressure exceeds ~160 mmHg, and is identical in all models. All six models have multiple apertures in proximity to a rounded distal tip. Three of the models, ZZ-SGT-36, ZZ-SGT-40 have side-holes extending 13 cm from the tip, and three models, ZZ-GBT-36, and ZZ-GBT-40, have side-holes extending 6 cm from the tip. The insertion tubes have diameters of 32, 36, and 40 Fr and humeric markings to indicate depth of insertion.

The provided text is a 510(k) summary for the ZZIREN™ Orogastric Tube. It describes a medical device and its substantial equivalence to predicate devices. However, it does not contain any information about a study proving the device meets specific acceptance criteria in the context of device performance related to a diagnostic AI/ML algorithm or similar technology.

The document primarily focuses on:

• Device Description: Physical characteristics and components of the ZZIREN™ Orogastric Tube.
• Intended Use/Indications for Use: What the device is used for (gastric aspiration and lavage, size guide, leak testing in gastric/bariatric surgery).
• Technological Comparison: How the ZZIREN™ Orogastric Tube is similar to and differs from its predicate devices in terms of materials, design features (Y extension, FR sizes, number of apertures), and suction regulating mechanisms.
• Non-Clinical Tests Summary & Conclusions: Results from bench tests (e.g., kink test, stiffness test, compression test, pinch clamp test, connector tests, air syringe compatibility test, dimensional analysis). These tests aim to demonstrate that the new device performs similarly and safely compared to the predicate, and meets its design specifications.

Therefore, I cannot fulfill your request for information about acceptance criteria and a study proving device performance in the context you've provided (which implies a diagnostic or AI-driven device with performance metrics like sensitivity, specificity, or AUC). The document is about a mechanical, single-use surgical accessory, and its "performance" is assessed through physical and functional bench tests, not clinical performance or diagnostic accuracy.

To directly answer your numbered points based on the provided text, where applicable, and noting where the information is absent:

1. A table of acceptance criteria and the reported device performance:
   The document describes non-clinical tests and their conclusions, which implicitly serve as performance demonstrations against internal acceptance criteria (e.g., "equally or less stiff," "substantially equivalent," "fit and function well"). However, a formal table of acceptance criteria with quantitative thresholds is not explicitly provided. The conclusions are qualitative comparisons to the predicate devices.

   Acceptance Criteria (Inferred from Test Goals)	Reported Device Performance (Summary)
   Propensity to kink	Substantially equivalent to predicate SIREN SGT™
   Stiffness	Equally or less stiff than corresponding predicate device
   Inadvertent stapling likelihood	Equally or less likely to be inadvertently stapled than corresponding predicate device
   Pinch Clamp performance	Substantially equivalent to predicate SIREN SGT™
   Accessory tubing connector fit and function	Attach easily, reversibly, securely; provide reliable connection
   Compatibility with leak testing device (Air Syringe)	Compatible and may be safely used together for leak testing
   Adherence to design specifications	All models made to design specifications

2. Sample size used for the test set and the data provenance:
   This information is not provided in the document. The tests described are bench tests on the device itself, not clinical studies on patient 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 document describes bench testing of a physical device, not an AI/ML or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable for the same reason as point 3.

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 as the document describes a physical medical device, not an AI/ML or imaging interpretation device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is not applicable as the document describes a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The "ground truth" for the bench tests would be the established physical properties and functional requirements of the predicate devices or engineering specifications. For example, the "truth" for the kink test is whether the tube kinks or not under certain conditions, compared to the predicate. There is no biological or diagnostic ground truth mentioned.

8. The sample size for the training set:
   This information is not applicable as the document describes a physical medical device, not an AI/ML device that requires a training set.

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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Entarik NI Feeding Tubes (FTs) are intended for the administration, fluids and medications by the nasoenteric or orogastric route for neonatal patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

The Entarik NI Feeding Tube System (Entarik NI System) is designed to aid, in conjunction with institutional protocols, qualified operators in the placement of the Entarik NI Feeding Tube (FT) into the stomach of neonatal patients requiring enteral feeding. The Entarik FTs are equipped with sensors designed to provide information about the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik NI FTs are provided sterile.

The Entarik NI System also monitors the feeding tube position continuously during the course of feeding and automatically and in real time alerts of tube migration.

The Entarik NI System provides continuous monitoring of gastric and esophageal temperature. The Entarik device can be used solely for the purpose of monitoring gastric and esophageal temperature in situations where invasive monitoring is indicated.

The Entarik NI system is intended to record, store, view and analyze impedance in the pharynx and stomach.

The Entarik NI Feeding Tube System (Entarik NI System) consists of the Entarik NI Feeding Tube (disposable) and the Entarik NI Monitor (reusable) with Power Supply. The Entarik NI System is designed for enteral feeding and to aid in the placement of the Entarik NI Enteral Feeding Tube into the stomach of neonatal patients requiring enteral feeding. The Entarik NI System also continuously monitors feeding tube position, gastric and esophageal temperature, and gastrointestinal impedance and reflux. The feeding tubes are single use devices intended for prolonged use (less than 30 days). The Entarik NI Feeding Tubes are provided sterile.

The provided text describes the acceptance criteria and study proving the device meets those criteria for the Entarik NI Feeding Tube System.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various tests performed and states that the device was found to be "safe and effective". We can infer the "acceptance criteria" from the fact that no issues were raised during these tests, indicating successful outcomes for all mentioned evaluations.

2. Sample Sizes and Data Provenance

• Training Set Sample Size: 16 subjects.
• Test Set Sample Size: 11 subjects for the validation study.
• Data Provenance: The document does not explicitly state the country of origin. The studies appear to be prospective clinical studies, as they involved the placement and monitoring of the device in new participates for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth. It mentions that the validation study's placement confirmation was "per institutional standard of care," which implies reliance on qualified medical professionals within the clinical setting.

4. Adjudication Method

The document does not describe a specific adjudication method (e.g., 2+1, 3+1, none) for the test set. It mentions "placement was confirmed per institutional standard of care," suggesting that the medical institution's standard procedures were followed for verifying tube placement.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of how much human readers improve with AI vs. without AI assistance. The study focuses on the device's ability to aid operators and monitor position, not on comparing human reader performance with and without AI.

6. Standalone (Algorithm Only) Performance

The document describes two clinical studies. The first (observational study) collected data silently for algorithm training and optimization without providing placement guidance. This suggests an initial phase where the algorithm was developed and refined, but standalone performance against a ground truth is not explicitly reported in terms of metrics like sensitivity/specificity for tube placement. The second (validation study) involved the device aiding qualified operators, indicating a human-in-the-loop scenario rather than a purely standalone algorithm evaluation of performance directly supporting a diagnostic claim.

7. Type of Ground Truth Used

• For the validation study's tube placement: "placement was confirmed per institutional standard of care." This likely refers to methods such as X-ray confirmation, pH testing of aspirate, or visual confirmation, as standard practice in clinical settings for feeding tube placement. While not explicitly stated, this would be a clinical ground truth established by medical professionals following established protocols.
• For continuous monitoring of tip location: The device itself automatically and in real time alerts of tube migration. The validation study confirmed this functionality was "safe and effective," implying these alerts were indeed accurate relative to actual tube migration conditions (though the specific ground truth for judging "tube migration" during continuous monitoring is not detailed).

8. Sample Size for the Training Set

The training set for the algorithm involved 16 subjects.

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

In the observational study for algorithm training and optimization, the Entarik NI Monitor "did not provide any placement guidance or verification. It collected impedance and temperature data silently that was used to train and optimize the placement and monitoring algorithm." This implies that while the device collected its data, the true tube position (ground truth) during this training phase was independently established by standard clinical methods (e.g., X-ray) by the clinicians or institution, and this independent ground truth was then used to train the algorithm. The document doesn't explicitly state the method for ground truth establishment during the training phase, but it must have been an independent reference standard.

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The CORGRIP* SR Nasogastric/Nasointestinal (NG/N) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal of displacement of the tubes for adult patients.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes used for testing/training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or the type of ground truth used.

The document is an FDA clearance letter for a medical device (CORGRIP* SR NG/NI Tube Retention System). It confirms the device's substantial equivalence to legally marketed predicate devices and outlines regulatory requirements for the manufacturer. It specifies the indications for use but does not delve into the studies or data used to establish that equivalence or any performance metrics.

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The Avanos* CORTRAK* 2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding the placement of Avanos Medical CORTRAK* 2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

The Avanos* CORTRAK* 2 Enteral Access System (EAS) utilizes tube tracking technology to assist, in conjunction with institution protocols, qualified clinicians in guiding the placement of Avanos Medical CORTRAK* 2 feeding tubes of 8FR or greater into the stomach or small bowel of patients requiring enteral feeding.

The provided text is a letter from the FDA regarding the 510(k) premarket notification for the CORTRAK* 2 Enteral Access System. This letter determines substantial equivalence but does not contain the detailed acceptance criteria and study information requested. It primarily focuses on regulatory compliance, general controls, and classification of the device.

Therefore, I cannot extract the specific information about:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

This type of information would typically be found in the 510(k) summary document or the full submission, which is not provided here.

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The Stylus is intended to assist in the placement of Low-Profile Gastrostomy Feeding Tube or Gastrostomy Button by providing temporary feeding tube stability during insertion through patient stoma tract.

The Stylus (may also be referred as Stylet, Introducer, Obturator or Stiffener) is an Introducer for the Low-Profile Gastrostomy Feeding Tube or Gastrostomy Button (LPGFT/B - K122030) originally cleared in July 2012 which was developed at Degania Silicone Ltd. The Stylus is made of Polycarbonate (Macrolon®) and has various ranges of lengths, colors and weights. The Stylus is inserted all the way into the Feeding Port of the LPGFT/B port of the cleared gastrostomy device. The use of the Stylus is optional, it provides stiffness to the LPGFT/B shaft to guide the LPGFT/B through the stoma. The Stylus should not exceed the buttons distal tip. The Stylus is being sterilized by Ethylene Oxide (EtO) along with a compatible Low Profile Gastrostomy Feeding Tube/ Gastrostomy Button kit, rather than a standalone device.

The provided text describes the "Stylus" device, which assists in placing gastrostomy feeding tubes. The 510(k) summary (K233591) details its regulatory information and a brief overview of testing. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and study specifics.

Based on the available text, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Bench Performance Testing" that included:

• Tensile strength testing
• Stylus stiffness testing
• Dimensional testing
• Gastrostomy compatibility testing

The reported performance conclusion is: "The results show that the device is at least as [effective as] a legally marketed predicate device."

However, the specific numerical acceptance criteria or the quantitative results for these tests are not provided in the given text. A table cannot be generated without these details.

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

The document states, "Bench Performance Testing included tensile strength testing, styls stiffness testing dimensional testing, and gastrostomy corpatibilitytesting." However, no details about the sample size used for these tests or the data provenance (e.g., country of origin, retrospective/prospective) are provided.

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

This information is not mentioned in the provided text. The testing described appears to be bench testing, not involving human interpretation or ground truth established by experts.

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

This information is not mentioned in the provided text. Adjudication methods are typically relevant for studies involving human assessment or interpretation, which is not described for this bench 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

An MRMC study is not mentioned in the provided text. The device described, the Stylus, is a physical introducer for feeding tubes, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable as the Stylus is a physical medical device, not an algorithm or software. The testing mentioned is device performance testing, not algorithm performance testing.

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

For the bench performance tests mentioned (tensile strength, stiffness, dimensions, compatibility), the "ground truth" would be the engineering specifications and established physical measurement standards relevant to the device's function and comparison to the predicate. The document doesn't explicitly state "ground truth" in this context but implies a comparison to predicate device performance.

8. The sample size for the training set

The Stylus is a physical device and not an AI/ML model, so there is no training set in the context of machine learning. The testing described is physical performance testing.

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

As there is no training set for this type of device, this question is not applicable.

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ReShape Calibration Tubes™ are indicated for use in gastric and bariatric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.

The Gastric Balloon Suction Catheter is indicated for use in gastric surgical procedures to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.

The ReShape Calibration Tubes™ (Model B-2032, B-2040, and B-2017) and the Gastric Balloon Suction Catheter (Model B-2020) are manufactured by our company, ReShape Lifesciences. These catheters are flexible gastric tubes designed to be used in gastric and bariatic surgical procedures. The catheters provide visible and tactie delineation of the gastroesophageal (GE) junction and its location relative to the esophageal hiatus and antrum of the stomach. These devices provide the ability to decompress the stomach, drain and remove gastric fluid, irrigate, and act as a sizing guide.

This document is a 510(k) Premarket Notification from the FDA regarding ReShape Lifesciences' Calibration Tubes and Gastric Balloon Suction Catheter. It is a clearance letter, not a study report. Therefore, it does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets those criteria as requested in the prompt.

The document states:

• "There are no changes to the principle of operation or technological characteristics of the devices."
• "The minor differences between the predicate devices include the material change to the black length marking ink/paste printed on the outer shaft of the catheters. Other minor labeling updates include product name change, the addition of a general contraindication, and labeled shelf life, which have no impact on the substantial equivalence."
• "The final finished subject devices with the proposed design modification have been tested in accordance with applicable ISO 10993 standards and in compliance with 21 CFR Part 58, and concluded non-cytotoxic, non-sensitizing, and non-irritant."
• "The labeled shelf life of 7 years is supported by leveraging the shelf life data of Model B-2017 previously cleared under K220455 with appropriate rationale."
• "No bench testing, packaging study, usability study, or sterility are deemed applicable or necessary for these with proposed modifications."

This indicates that the modifications were minor and largely related to material changes and labeling, not a fundamental change requiring a new, extensive performance study as one might expect for a novel AI/software device. The 510(k) process often relies on demonstrating substantial equivalence to a predicate device rather than conducting new, large-scale clinical trials.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert involvement, MRMC studies, or training sets because the provided text does not contain this information. The document is a regulatory approval, not a detailed scientific study report.

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ViSiGi® LUX is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing quide.

VISIGi® LUX is a non-sterile, single patient use device for use in gastric and bariatric surgery. It is used to apply suction, decompress the stomach, drain gastric fluids, irrigate and to serve as a sizing guide. The design is derived from the predicate by addition of battery-powered LED lights. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end includes a slide valve, integral suction regulator and a battery case. The non-rechargeable batteries power up an array of LEDs enclosed within the distal end of the tube. The purpose of the LED lights is to aid visualization of the tube by tissue transillumination during insertion and surgery under laparoscopic vision. The device is inserted by an anesthesiologist under supervision of the surgeon. The added lights do not change the intended use and are not required for the surgery to proceed safely.

The provided text describes the 510(k) premarket notification for the ViSiGi LUX device. However, it does not contain information about acceptance criteria, device performance against specific metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/algorithm-driven device.

The document focuses on demonstrating substantial equivalence of a physical medical device (a gastrointestinal tube with added LED lights) to a predicate device. The tests mentioned are for physical and electrical safety, biocompatibility, and functional performance (suction, drainage, irrigation) of the tube itself.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as it relates to AI or algorithmic performance against specific metrics, as this information is not present in the provided text.

Specifically:

• 1. A table of acceptance criteria and the reported device performance: Not available for an AI/algorithm. The document lists general tests like "Suction Testing," "Drainage Testing," etc., and states "Passing these tests demonstrates substantial equivalence." It doesn't define quantitative acceptance criteria or specific performance numbers for these tests.
• 2. Sample sized used for the test set and the data provenance: Not applicable in the context of an AI/algorithm for this device. The tests mentioned are laboratory bench tests on physical 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, as this is a physical device submission, not an AI/imaging algorithm.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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, as this device does not involve human readers or AI assistance in image interpretation.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for an AI/algorithm. Ground truth for a physical device typically refers to engineering specifications and performance benchmarks.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The device, ViSiGi LUX, is a gastrointestinal tube with an added LED light subassembly. Its primary function is mechanical (suction, drainage, irrigation, sizing guide). The LED lights are for visualization, not for generating or processing diagnostic data that would typically involve AI or complex algorithmic performance evaluation metrics as requested in the prompt.

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