Search Results

The fecal incontinence insert is indicated for the management of accidental bowel leakage (ABL) due to bowel incontinence. The rectal insert is designed for self insertion to seal and help prevent the involuntary leakage of stool from the rectum.

The device is a simple rectal insert which is used to control accidental bowel leakage in adult patients. The single use device is inserted via the anus into the anal canal and rectum. The device engages with and conforms to the anorectal junction and the anal canal to control the accidental leakage of fecal matter.

The device consists of two components: a soft, pre-lubricated, liquid-filled silicone Insert device, and a plastic applicator. The Insert device is soft and flexible which allows engagement with the anorectal junction and the anal canal. The applicator is preassembled inside the Insert device to facilitate insertion of the device and is removed and discarded after the device is in place. The device is available in two sizes, Standard and Large. The device is provided preassembled and non-sterile in individual single-use packages.

The provided text is a 510(k) clearance letter and summary for a medical device, the Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle). It does not describe an AI/ML-driven device or study. Therefore, several sections of your request regarding AI/ML-specific details (like multi-reader multi-case studies, effect size of AI assistance, standalone algorithm performance, training set details, and ground truth for the training set) are not applicable to this document.

However, I can extract information related to the acceptance criteria, the study details, and ground truth as it pertains to the clinical performance of this medical device.

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

The document defines "effectiveness" based on a primary endpoint. While it doesn't explicitly state a pre-defined "acceptance criterion" as a specific threshold that had to be met for clearance, it presents the study's primary effectiveness endpoint and the result. We can infer the "acceptance criterion" was that the device demonstrate a statistically significant reduction in ABL episodes.

Ask a specific question about this device

The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.

Profoject™ Enteral Feeding Syringe provided in a variety of sizes from 0.5mL to 60mL. It consists of plunger, plunger stopper, barrel, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector.

The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10⁻⁶ and supplied sterility maintenance package. The shelf life of both sterile and non-sterile proposed devices has been validated as 5 years.

This looks like a 510(k) clearance letter for a medical device that is NOT an AI/ML device. Therefore, the questions related to AI/ML device evaluations (such as test set, ground truth, expert qualifications, MRMC studies, and training set) are not applicable.

The document describes the non-clinical test conclusions for the Profoject™ Enteral Feeding Syringe.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was evaluated against several ISO and ASTM standards, as well as USP-NF monographs. The acceptance criteria are implicitly those defined by these standards, and the reported performance is that the device "Complied with" these standards.

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

The document indicates that non-clinical verification was performed. This typically involves laboratory testing on device prototypes or production samples. The specific sample sizes for each test are not provided in this summary. Data provenance would be from laboratory testing conducted by or for CMT Health PTE. Ltd. (Singapore), likely in a controlled, prospective manner as part of the device development and validation process.

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

This question is not applicable as the device is a physical medical device (enteral feeding syringe), not an AI/ML device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for non-clinical performance and safety relates to adherence to recognized standards and specifications, which are typically evaluated by engineers and quality assurance professionals, not clinical experts for ground truth establishment.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies for AI/ML algorithms. This document describes non-clinical performance and biocompatibility 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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is relevant.

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

Not applicable. This is not an AI/ML device.

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

For non-clinical testing of a physical device, the "ground truth" is defined by the technical specifications, performance limits, and safety requirements outlined in the referenced ISO, ASTM, and USP standards. For example, for dose accuracy, the ground truth is the specified ±10% accuracy. For sterility, it's the SAL of 10⁻⁶. For biocompatibility, it's the absence of cytotoxicity, irritation, or sensitization as defined by the ISO 10993 series. These are objective, measurable criteria, not subjective expert consensus or clinical outcomes data in the usual sense.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The Enteral Drainage System is intended to allow the evacuation of excess gas and drainage of gastrointestinal fluids from patients utilizing an enteral device.
The Enteral Medicine Straw is intended for drawing and delivery of medicine to patients through an ENFit syringe.

The Enteral Drainage System and the Enteral Medicine straw are intended to be used during enteral nutrition treatments in combination with enteral feeding tubes, syringes and other compatible enteral medical devices.

The Enteral Drainage System is intended to allow the evacuation of excess gas and drainage of gastrointestinal fluids from patients utilizing an enteral device.
The device consists of:

• a bag in DEHP FREE PVC, equipped with a hydrophobic 3μm filter to allow gas escape;
• two short PVC tubes (5-6 cm) on top and bottom of the bag; the bottom one is equipped with a male enteral connector, and the top one with a female enteral connector that is capped off with an ENFit-compatible cap;
• a clamp to regulate the fluid flow, placed over the bottom tube.

It is available in five sizes, depending on the volume of the bag included in the device:

• MED50LU, Enteral drainage bag 50 ml;
• MED100LU, Enteral drainage bag 100 ml;
• MED250LU, Enteral drainage bag 250 ml;
• MED500LU, Enteral drainage bag 500;
• MED1000LU, Enteral drainage bag 1000 ml.

The device is connected to the nasogastric or naso-jejunal feeding tube between feeding sessions to allow the drainage of stomach or intestinal fluids and gasses in excess. The transparency of the materials allows for constant monitoring and visualization of drained fluids. The bag must be placed at a lower level than the patient's stomach and also acts as a venting device.

The Enteral Medicine straw, coded C005LU, is intended for drawing and delivery of medicine to patients through an ENFit enteral syringe. It consists of a male enteral connector (that allows the connection to a compatible enteral syringe) and a tubing in thermoplastic polyurethane.
Once the fluid is drawn up from the container into the syringe, the cannula must be disconnected, and the syringe can then be connected to another medical device (normally, a feeding tube or a gastrostomy tube) to administer its content to the patient.

All enteral connections of the subject devices are designed to avoid for inadvertent delivery of enteral feedings through the intravenous route. i.e., the devices cannot be connected to devices endowed with a luer connector.

The devices are sterilized with Ethylene Oxide (EtO).

These devices are targeted to neonatal, pediatric and adult patients, with compromised or limited gastric motility; they are for single patient use and can be reused multiple times within a twenty-four-hour period, after which they are to be replaced.

The provided text is a 510(k) clearance letter and an associated 510(k) Summary for the HMC Premedical S.p.a. Enteral Drainage System and Enteral Medicine Straw. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance and biocompatibility testing. It does not include information about human factor studies, clinical trials, or studies involving human readers or expert panels for ground truth determination.

Therefore, many of the requested criteria cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

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

The document broadly states that the device "met the pre-determined acceptance criteria" for performance tests and "comply with the applicable sections of the standards cited below." However, it does not explicitly list specific numerical acceptance criteria or the exact reported performance values for the tests mentioned (Misconnection testing, leak testing, tensile strength testing, dimensional requirements, integrity of device packaging).

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

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: Not specified. These are laboratory tests, not clinical data from specific countries.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No expert-based ground truth was established as these were non-clinical performance and biocompatibility tests, not clinical efficacy studies involving human interpretation.

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

Not applicable. No adjudication method was used as these were non-clinical performance and biocompatibility tests.

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

Not applicable. This device is a medical accessory (drainage system, medicine straw), not an AI-powered diagnostic or assistive technology. No MRMC study was mentioned or would be relevant for this type of device.

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

Not applicable. This device is a medical accessory, not an algorithm or AI system.

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

For the non-clinical tests, the "ground truth" was defined by the requirements and specifications outlined in the referenced international standards (e.g., ISO 80369-3, ISO 80369-20, ISO 20695, ISO 10993 series, USP , ISO 11607-1, ASTM standards). Successful adherence to these standards constituted the "truth" for device performance and safety in a non-clinical setting.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/ML model.

Ask a specific question about this device

The CoapTech PUMA-G Pediatric System is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube. The PUMA-G Pediatric System is intended to be utilized in pediatric patients that meet criteria for minimum weight (15 kg) and appropriate abdominal wall thickness (between 0.6 cm and 3.0 cm), as stated in the instructions for use.
To Aid in Percutaneous Access to the Stomach During Gastrostomy Tube Placement.

The PUMA-G Pediatric System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G Pediatric System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G Pediatric System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using either the Sachs-Vine PUSH technique or the Ponsky PULL technique.

The provided FDA 510(k) clearance letter and summary for the PUMA-G Pediatric System describe a medical device designed to aid in the initial placement of gastrostomy feeding tubes. The summary outlines some performance testing, including a small safety clinical study. However, the document does not contain the detailed acceptance criteria or the specific study design elements (beyond a "small safety clinical study" and "single-center study") that would typically be reported for an AI/software device that needs to meet performance criteria for metrics like sensitivity, specificity, or accuracy based on a test set.

The PUMA-G Pediatric System appears to be a mechanical device with an ultrasound visualization component, not an AI/software-driven diagnostic or assistive device that would rely on a test set with ground truth established by experts and MRMC studies. The "performance data" mentioned focuses on mechanical, biocompatibility, and sterilization aspects, along with a safety study.

Therefore, many of the requested information points (e.g., sample size for the test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not present in the provided document, as they pertain to the rigorous evaluation of AI/software algorithm performance against established ground truth, which is not the primary focus of this device's clearance.

Based on the provided information, here's an attempt to answer the questions, highlighting where information is absent or non-applicable:

Device Description

The PUMA-G Pediatric System is a medical device designed to aid in the initial percutaneous placement of a gastrostomy feeding tube. It utilizes a balloon catheter with an internal magnet and an external magnet to coapt the stomach to the anterior abdominal wall. Users then employ their existing ultrasound for visualization and guided needle placement. The system also includes a guidewire.

Acceptance Criteria and Performance Study Analysis (Based on Provided Document)

Given the nature of the device as a mechanical aid with ultrasound visualization (rather than an AI/software algorithm for diagnosis or image analysis), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on safety, functional performance, and effectiveness in facilitating the procedure, rather than typical AI performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics in the way one would see for an AI algorithm (e.g., sensitivity, specificity thresholds). Instead, the performance is described qualitatively and through the outcomes of a safety study.

Ask a specific question about this device

The Extension Feeding Set with ENFit™ connectors is intended for use as an extension set for a Low-Profile Gastrostomy Replacement Tube (G. Button). It is intended to provide delivery of Enteral Nutrition from administration media with ENFit™ connector and or medication into a single patient, for a maximum of two weeks.

Feeding via an Extension Feeding Set is advocated when nutrition cannot be provided to the patient by mouth and therefore cannot consume an adequate number of calories because of an underlying condition.

The Extension Feeding Set with ENFit™ connectors (Extension Feeding Set), comprises a hollow tube with two different connectors at each end: an ENFit™ connector connecting to an administration media, the other is a secure lock connector for connecting to a gastric feeding device.

The Extension Feeding Set is sterile, single patient use device, consisting of a polyvinylchloride tube, ABS secure lock connector, Tritan ENFit™ connector. The connectors on the proximal end of the extension sets are ENFit™ ISO 80369-3 compliant. The ENFit™ connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices. Extension Feeding Sets are available in three lengths: 5 cm (2"), 30.5 cm (12") or 61 cm (24"). All Extension Feeding Sets are available with either a right-angle secure lock connector or a straight secure lock connector. Both connectors are compatible with G. Button.

The provided FDA 510(k) clearance letter and summary for the "Extension Feeding Set with ENFit™ connectors" (K250481) pertains to a physical medical device (gastrointestinal tube and accessories). Therefore, it does not include information on acceptance criteria, studies, or ground truth establishment relevant to an AI/ML-based medical device.

The questions you've asked (about acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, training set information) are all highly specific to the evaluation and validation of AI/ML-driven devices, particularly in image analysis or diagnostic support.

Since the provided document describes a physical Class II medical device (a tube with connectors), the clearance process for it focuses on:

• Substantial Equivalence: Comparing its design, materials, and technological characteristics to an existing legally marketed predicate device.
• Non-Clinical Testing: Laboratory tests to ensure physical performance (e.g., tensile strength, leakage, flow rate, biocompatibility) and safety based on relevant industry standards (e.g., ISO 80369-3 for ENFit connectors).
• Shelf Life Validation: Ensuring the device remains functional and sterile over its stated shelf life.

Therefore, I cannot extract the requested information (acceptance criteria, study details for AI/ML device validation) from the provided text because it describes a different type of medical device.

If you have a document describing an AI/ML-based medical device, I would be happy to analyze it for the specific details you've requested.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

For nasogastric oralgastric enteral feeding, incorporating safety connectors which eliminates the risk of IV administration through the feeding tube.

Nutrifit is a combined system of feeding tubes and extension sets. The feeding tubes are available in several configurations: Not made with DEHP PVC and Polyurethane (PUR). The PUR versions are available without stylet. All tubes include centimeter numerical markings from 5 to 35 cm for the 40, 50 and 75 cm feeding tubes and markings from 5 to 70 cm for the 90, 125 and 160 cm feeding tubes.

The Nutrifit devices are single-use, disposable devices intention in adults and children. Nutrifit PVC feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 5 days. Nutrifit PUR feeding tubes are intended for enteral nutrition and for a short-term use, not longer than 29 days.

The Nutrifit accessories for this submission sets, which enable longer connections for the feeding tubes. They allow greater freedom of movement and greater flexibility and are available with or without a pinch clamp.

Nutrift is ENFit compliant, meeting requirements for design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories as detailed in ISO 80369-3.

The provided text is a 510(k) summary for the Vygon USA Nutrifit device, a gastrointestinal tube and accessories. It asserts the device's substantial equivalence to a predicate device (Nutrisafe 2) based on non-clinical performance bench testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set for any of the bench tests mentioned. It states "Adequate non-clinical performance bench testing was conducted" and "The VYGON's Nutrifit device met all predetermined acceptance criteria."
The data provenance is from non-clinical performance bench testing conducted by Vygon; the country of origin is not explicitly stated but implied to be internal testing by the manufacturer. The data is prospective for this device's evaluation.

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

This information is not provided in the document. The tests performed are engineering/performance-based bench tests, not clinical evaluations requiring expert interpretation of ground truth in the traditional sense (e.g., medical image interpretation). The "ground truth" for these tests would be the established specifications and standards (e.g., ISO 80369-3).

4. Adjudication Method for the Test Set

This is not applicable as the tests are objective, performance-based bench tests against defined specifications, not subjective assessments requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Bench Testing was conducted in order to support this submission." There is no mention of human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. The Nutrifit is a medical device (tubing and accessories), not an AI algorithm or software. The testing focuses on its physical performance and safety characteristics.

7. The Type of Ground Truth Used

The ground truth used for the performance testing cited is based on established engineering specifications, international standards (ISO 80369-3), and FDA guidance protocols (e.g., "Gravity Flow Rate Testing in Enteral Tube"). This falls under objective technical standards rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable as the Nutrifit device is a physical medical device, not an AI algorithm 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.

Ask a specific question about this device