Search Results

The Boehringer Laboratories Liver Retractor is indicated for use in laparoscopic surgical procedures to elevate the liver, improve access to surgical sites, and provide visualization of target anatomy.

The Boehringer Laboratories Liver Retractor is comprised of three components: a Suction Delivery Assembly, a Positioning Clip, and an Integral Suction Regulator. The suction delivery assembly is composed of a Flexible Tube with a proximal Suction Cup and a distal Grasping Suture.

The suction delivery assembly is introduced into the abdomen via a standard laparoscopic trocar. A standard suture passer is then used to grip the grasping suture and pull the upper portion of the flexible tube percutaneously through the abdominal wall. The now externalized tip of the flexible tube is cut off and the open end is connected to the integral suction regulator. The conformable suction cup can then be applied laparoscopically to the liver and the external portion of the flexible tube manipulated to adjust liver position. Once at the desired height, the positioning clip is placed around the external portion of the flexible tube and against the skin to lock the device in place. The suction cup can be efficiently repositioned via laparoscopic technique to accommodate the evolving requirements of a procedure. The device is inserted, manipulated, and removed by or under the direct supervision of a surgeon.

The provided FDA 510(k) clearance letter and summary for the Boehringer Laboratories Liver Retractor (K243399) does not describe an AI device. It's a physical medical device (a liver retractor) and the clearance is based on substantial equivalence to a predicate device, supported by non-clinical testing (bench testing, animal studies, biocompatibility, sterilization, packaging, shelf-life).

Therefore, the information requested in your prompt (AI-specific acceptance criteria, test sets, ground truth establishment, MRMC studies, etc.) is not applicable to this specific medical device clearance. The document does not contain any reference to AI, machine learning, or software performance studies that would require the details you've asked for.

To reiterate:

• No AI device: This is a physical liver retractor.
• No AI acceptance criteria: The device's performance is demonstrated through physical properties and functionality (retraction times, regulator functionality, integrity) and safety (biocompatibility, animal safety).
• No test sets, ground truth, or MRMC studies for AI: These concepts are relevant for AI/ML-driven medical devices, which this device is not.

If you have a document for an AI/ML-driven medical device, I would be happy to analyze it against your criteria.

Ask a specific question about this device

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.

Ask a specific question about this device

The Tissue Removal System is indicated for the contained removal of tissue, including contained manual tissue sectioning, during minimally invasive surgical procedures.

The Tissue Removal System is comprised of the Tissue Removal Pouch cleared under K150781 and an additional accessory Sectioning Device. It is provided sterile, and is for single patient use.

The Tissue Removal Pouch of the Tissue Removal System includes a bag with a single large opening held open by a thin, opening ring. During laparoscopic surgery, the bag is placed within the peritoneal space via an existing port site. Tissue that has been resected is placed within the bag for isolation, containment and removal from the patient. The bag opening is exteriorized. Two halves of the Tissue Removal Pouch flip ring are attached to each other and to the bag is rolled around the flip ring by inverting the flip ring, in order to draw the resected tissue toward the port site.

The resected tissue is then removed en bloc (for smaller specimens), or by first dividing the specimen using the accessory Sectioning Device. The Sectioning Device is comprised of a blunt wire, a flexible passer and a handle with a blunt hook. The passer is used to encircle the specimen with the wire. The handle includes a blunt hook that can be used to aid in the advancement of the passer. The specimen is divided by the manual application of a back and forth motion to the wire. Use of the accessory Sectioning Device permits division of the specimen while maintaining the containment effectiveness of the Tissue Removal Pouch

Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured according to your request:

Unfortunately, the provided document does not contain information related to an AI/ML device. The document is a 510(k) premarket notification for a medical device called "Tissue Removal System," which is a physical device used in surgery to contain and remove tissue.

Therefore, many of your requested points, such as AI-related performance metrics, sample sizes for training or test sets for an algorithm, expert adjudication, or MRMC studies, are not applicable to this document.

However, I can extract the information that is present regarding the non-clinical testing performed for this physical device.

Description of Acceptance Criteria and Supporting Study for the Tissue Removal System

The document describes non-clinical testing performed to demonstrate the safety and effectiveness of the "Tissue Removal System," particularly focusing on the integrity and containment capabilities of the Tissue Removal Pouch when used with its accessory Sectioning Device.

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

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

• Sample Size for Test Set: The document does not specify the sample sizes (e.g., number of pouches, sectioning devices, or test repetitions) used for any of the non-clinical tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, though non-clinical tests are inherently prospective laboratory studies.

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

• Not Applicable. This document describes non-clinical engineering and material integrity tests on a physical device, not an AI/ML diagnostic system requiring expert interpretation or ground truth establishment in the traditional sense. The "ground truth" here is the physical performance of the device against predefined engineering standards (e.g., no leaks, no punctures, no tears).

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

• Not Applicable. As above, this is not an interpretive diagnostic study requiring adjudication. The outcomes are objective measurements of physical integrity (e.g., presence/absence of bubbles, dye penetration, tears, punctures).

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 a study involving human readers or AI assistance.

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

• Not Applicable. This document pertains to a physical medical device, not an algorithm.

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

• The "ground truth" in this context refers to the objective performance of the physical device as measured by specific non-clinical test methods. For example, for "Bubble Leak" testing, the ground truth for failure would be the observation of bubbles, and for "Dye Penetration," it would be the observation of dye. These are direct physical observations, not interpretive diagnoses.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML model.

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

• Not Applicable. There is no "training set."

Summary of Device and Testing Context:

The Tissue Removal System is a physical device for containing and removing tissue during minimally invasive surgery. Its key innovation over a predicate device is the inclusion of an accessory Sectioning Device that uses a blunt wire for dividing specimens, in contrast to predicate devices that might require sharp instruments.

The non-clinical tests aim to prove that this new Sectioning Device does not compromise the primary function of the Tissue Removal Pouch, which is to maintain containment and integrity. The tests specifically assessed physical characteristics such as leak prevention, puncture resistance, and tear resistance under various conditions, including simulated and extreme use. The "conclusions" state that the device is "as safe and effective as, and performs as well as, or better than, the legally marketed predicate device" based on these non-clinical tests.

Ask a specific question about this device

The Tissue Removal Pouch is indicated for the removal of tissue during surgical procedures and for the containment of tissue during extracorporeal manual morcellation.

The Tissue Removal Pouch is contraindicated for laparoscopic power morcellation during gynecologic procedures.

The Tissue Removal Pouch is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.

The Tissue Removal Pouch includes a polymer film bag, a flip ring packaged in two halves, and a guard. It is provided sterile and is for single patient use.

The bag has a single large opening held open by a thin, opening ring. During laparoscopic surgery, the bag is placed within the peritoneal space via an existing port site. Tissue that has been resected is placed within the bag for isolation and removal from the patient. The bag opening is then exteriorized. The two halves of the flip ring are attached to each other and to the bag opening.

The bag is rolled around the flip ring by inverting the flip ring in order to draw the resected tissue toward the port site. The resected tissue is then removed en bloc (for smaller specimens) or by extracorporeal manual morcellation (for larger specimens). The guard may be used to protect the bag during manual morcellation. The bag is removed following the removal of sufficient tissue to be pulled out through the port site.

I am sorry, but the provided text does not contain a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) summary for a "Tissue Removal Pouch," which outlines the device's description, intended use, comparison to predicate devices, and a list of non-clinical tests performed.

While the document lists various non-clinical tests conducted (e.g., film impermeability, burst strength, simulated use), it does not provide the acceptance criteria for these tests nor does it report specific performance results in a quantitative manner that would allow for a direct comparison against such criteria. It merely states what each test "verifies" or "demonstrates" (e.g., "Verifies film impermeability," "Demonstrates adequate burst strength").

Therefore, I cannot populate the requested table or provide information about:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or specific performance values are listed.
2. Sample sizes used for the test set and the data provenance: No sample sizes for any tests are provided, nor is the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This type of information is usually relevant for studies involving diagnostic or AI devices with human interpretation, not for mechanical device testing as described here.
4. Adjudication method: Not applicable given the nature of the listed tests.
5. Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned or applicable.
6. Standalone performance (algorithm only without human-in-the-loop performance): Not mentioned or applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not explicitly stated; the "ground truth" for mechanical tests would typically be the physical properties measured against engineering specifications, but these specifics are not provided.
8. The sample size for the training set: Not applicable; this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The document concludes with a statement that the device is "as safe and effective as, and performs as well as, or better than, the legally marketed predicate devices," based on the provided information, but the detailed data to back this claim against specific acceptance criteria is not present in this summary.

Ask a specific question about this device

The Boehringer Laboratories Gastric Sizing Tube 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 guide.

The Boehringer Laboratories Gastric Sizing Tube is a single patient use, non-sterile device which consists of a 76 cm long, thermoplastic elastomer (Styrene-Ethylene-Styrene) tube of either 32 French, 36 French, or 40 French diameter, with a low density polyethylene (LDPE) slide valve-connector at the proximal end of the tube. The tube has multiple holes and a rounded end, distal from the slide valve, and contains a stainless steel support spring inside the lumen of the tube at the distal end. The device is used to decompress the stomach contents, and allow for irrigation via the distal holes. The slide valve is used to switch between open for suction/irrigation and closed/vent. The tube serves as a sizing guide.

Here's an analysis of the provided 510(k) summary regarding the Boehringer Laboratories Gastric Sizing Tube, focusing on the acceptance criteria and the study (or lack thereof) that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are primarily focused on equivalence to predicate devices and adherence to established standards for medical devices and biocompatibility. The performance reported is that the device meets or exceeds these criteria, primarily through non-clinical bench testing.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test. The tests are described as performance testing and primarily involve bench testing of the device itself (e.g., dimensional analysis, strength tests).
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory or engineering setting, not on patients. Therefore, there is no patient data provenance (e.g., country of origin, retrospective/prospective). The studies are inherent to the device's design and manufacturing process.

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

• This section is not applicable to this 510(k) submission. The "ground truth" for the non-clinical performance tests is based on engineering specifications, recognized international standards (like ISO 80369-1, ISO 10993-5, ISO 10993-10), and comparisons to predicate device characteristics. There's no mention of expert consensus required to establish the truth for, for example, a tube's burst strength or material biocompatibility, as these are objectively measurable against defined standards.

4. Adjudication Method for the Test Set

• This section is not applicable. Adjudication typically refers to expert review in clinical studies to resolve disagreements in interpretations or diagnoses. Here, the testing is objective and based on engineering and biocompatibility standards.

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

• No, an MRMC comparative effectiveness study was not done. This type of study evaluates how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance, which is not relevant for a gastric sizing tube. The submission is for a physical medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• No, a standalone (algorithm only) study was not done. This device is a physical, non-AI medical instrument. The concept of an "algorithm only" performance study is not applicable here.

7. The Type of Ground Truth Used

• The "ground truth" for the performance criteria is derived from:
  • Engineering Specifications: Designed physical boundaries and performance targets for the device.
  • International Standards: Compliance with recognized standards such as ISO 80369-1 for connectors and ISO 10993 series for biocompatibility.
  • Predicate Device Characteristics: The characteristics of the legally marketed predicate devices serve as a benchmark for equivalence in terms of function and safety profile.

8. The Sample Size for the Training Set

• This section is not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.

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

• This section is not applicable, as there is no training set for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The “study” that proves the device meets the acceptance criteria is a compilation of non-clinical performance testing and biocompatibility testing. This testing demonstrates that the Boehringer Laboratories Gastric Sizing Tube's physical and material properties meet established engineering standards, regulatory requirements, and are comparable to (or better than) the predicate devices it claims substantial equivalence to.

The non-clinical tests included:

• Dimensional Analysis
• Valve-Connector to Tube Joint Strength Test
• Tube Distal End Kink Test
• Support Spring to Tube Stability Test
• Age Test
• ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General Requirements Compliance
• Suction Tubing Fitting Connector Test

Additionally, biocompatibility studies were conducted:

• Cytotoxicity study per AAMI/ANSI/ISO 10993-5: 2009
• Intracutaneous study per AAMI/ANSI/ISO 10993-10: 2010
• Maximization Sensitization study per AAMI/ANSI/ISO 10993-10: 2010

The conclusion states that based on the intended use, technological characteristics, and performance testing, the device is "as safe, as effective, and performs as well as the predicate devices," thereby meeting the criteria for substantial equivalence.

Ask a specific question about this device