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510(k) Data Aggregation
(154 days)
The Giltech Plus Connecting Tube Sets will consist of: (a) Insufflation Tubing Sets (b) Suction / Irrigation Sets (c) Urinary Extension Tubing (d) Tubing Sets necessary to connect two devices, however never to be used to transmit a gas or a liquid for intravenous or intramuscular transmission.
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I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance, or a study conducted to prove the device meets any criteria.
The document is an FDA 510(k) clearance letter for the "Giltech Plus Connecting Tube Set." This letter primarily:
- Confirms that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976.
- Outlines general regulatory obligations for the manufacturer.
- Lists the "Indications For Use" for the device, which describes its intended functions and types of tubing sets included.
The document does not contain details about:
- Acceptance criteria or reported device performance.
- Sample size or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size or ground truth establishment for a training set.
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(72 days)
The irrigation tubing sets will be used to flush and instill fluids into sites so that visibility is maintained for the operating team. The sets will be attached to standard irrigation systems such as either gravity bag systems attached to I.V. standard neiganian a pump systems that use pressurized bottles instead of the gravity fed bags as the source of the irrigant. The handle or accessory for irrigation would be attached to the end opposite the irrigant source.
The aspiration tubing sets will be used for the removal of fluids, air or debris left I fie aspiration the surgery. These sets could be used just to remove the flushing irrigant that is used to keep the surgical arena visible. One ond would be attached to the suction source and the other end would be attached to the suction tip handle.
The irrigation sets will be offered in different sizes with spikes and luer locks for attachments to the gravity bag feed systems. There would be four different size attaching to the grate to allow the customer to chose the most economical set according to what their requirements are. There would be one dual set with a wye and two pinch clamps to allow for the use of two supply bags. There would w one set offered with valves for the use of the bottle type supply systems so that clamps would not have to be activated for operation.
The aspiration tubing sets will be offered in different sizes with suction I no aspreaten and luer locks for those smaller sizes that require them for hooking them to the suction system. The larger sizes may be used by just pushing the tubing over the barbed connectors on the suction supply systems.
This document is a 510(k) Pre-Market Notification for the SuperFlow Irrigation and Aspiration Tubing Sets. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a clinical study would for a diagnostic or therapeutic device.
The document discusses the device's substantial equivalence to a predicate device (EndoSI Suction/Irrigator), focusing on design, composition, function, and biocompatibility. The "study" mentioned is primarily related to the validation of the sterilization process and biocompatibility testing, not a performance study against acceptance criteria from a clinical or diagnostic perspective.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert involvement, and comparative effectiveness studies is not applicable or cannot be extracted from this particular document.
Here's what can be extracted based on the document's content:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Substantial Equivalence | "The safety and effectiveness of this device is substantially equivalent to that of the predicate device (The EndoSI Suction Irrigators) because the components are identical to those that have been used in the EndoSI Suction Irrigations." |
| Biocompatibility | "The tubing sets have been tested to be biocompatible." (Referenced Addendum IX for information) |
| Sterility Assurance Level (SAL) | "The sterility assurance level will be 10(-6)." |
| Sterilization Method Validation | "The sterilization process for the EndoSI Suction/Irrigator has been validated utilizing the guidelines issued by AAMI for Method I Radiation Sterilization. This validation will apply to the irrigation and aspiration tubing sets." |
| Radiation Dose | "Both of the irrigation and aspiration tubing sets will be processed on a production basis at 25 to 35 kGs." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document is a pre-market notification (510(k)) asserting substantial equivalence, not a report on a clinical or performance study that would have a test set for diagnostic accuracy or efficacy. The "testing" mentioned refers to biocompatibility and sterilization validation, not clinical performance. Specific sample sizes for these tests are not provided in the summary.
- Data Provenance: Not specified for any underlying biocompatibility or sterilization validation data within this summary.
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. This document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no "test set" or adjudication process described in this document.
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 (tubing sets) for irrigation and aspiration, not an AI-powered diagnostic or therapeutic device. 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 a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for clinical performance. The "ground truth" equivalent for this device is compliance with material safety (biocompatibility), manufacturing standards (sterilization validation), and demonstrating physical equivalence and functionality to the predicate device.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical medical device.
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(206 days)
FUID LAVAGE DEVICE THE COMBIPORT TO FLUSH FLUID INTO IS INTENDED DURING GASTRIC LAVAGE THE STOMACH PROCEDURES.
The CombiPort is a device intended to fluid into the stomach during gastric lavage procedure.
This document describes a 510(k) submission for the CombiPort Fluid Lavage Device. This is a medical device and not an AI/ML powered device. As such, the typical acceptance criteria and study data points requested (e.g., sample size for test set/training set, ground truth, MRMC studies, standalone performance) are not applicable in the usual sense for software or AI/ML.
The provided text focuses on demonstrating substantial equivalence to a predicate device and ensuring the device's safety and effectiveness through material testing and manufacturing quality control.
Here's an attempt to answer the questions based on the available information, noting where the requested information is not relevant or directly provided for a traditional AI/ML study:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (fluid lavage device), acceptance criteria are primarily related to material biocompatibility, functional performance (e.g., ability to flush fluid, connection integrity), and manufacturing quality. The document does not provide a quantitative table of specific performance metrics with target values.
| Acceptance Criteria Category | Reported Device Performance (Summary from Text) |
|---|---|
| Material Biocompatibility | "...materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product." |
| Functional Performance | Implied: The device is "intended to fluid into the stomach during gastric lavage procedure." The testing described below would confirm this. |
| Manufacturing Quality & Reliability | "All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications." |
| Substantial Equivalence | "The CombiPort Fluid Lavage Device is similar in intended use to the Easi-Lav cleared by Ballard Medical Products. There are no new issues of safety or effectiveness raised by The CombiPort Fluid Lavage Device." |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a physical medical device, not a software or AI/ML product evaluated on a "test set" of data. The "testing" refers to manufacturing quality control and material biocompatibility, which would involve samples of the device and its materials. The document does not specify general sample sizes for these tests, as these are typically defined by internal quality procedures.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in the context of expert consensus is relevant for AI/ML diagnostic or predictive tools. For a fluid lavage device, the "ground truth" for its functional performance is based on engineering specifications and physical testing, not expert interpretation of outputs.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human readers or experts when establishing ground truth for AI/ML validation. This device undergoes physical and material testing, not human-read evaluation in this manner.
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. MRMC studies are specific to evaluating the clinical impact of AI/ML systems on human reader performance, particularly in diagnostic imaging. This device does not involve AI assistance for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on:
- Engineering Specifications: The design parameters and functional requirements for the device (e.g., flow rate, material strength, connection integrity).
- Material Standards: Biocompatibility standards like ISO 10993.
- Quality Control Test Procedures: Established methods to verify that each manufactured unit meets specifications.
8. The Sample Size for the Training Set
Not applicable. There is no training set for a traditional medical device like this, as it's not an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set for an AI/ML model.
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(214 days)
Comparable to single tube Gastric lavage and stomach evacuator tubes.
Disposable, non-sterile tube for gastric lavage.
The lavage tube is used as a two way conduit from a lavage bag set to the stomach.
The tube is made of a flexible PVC that is easy to insert and comfortable for the patient. Water is released from a fluid source and flows into the stomach. The larger the tube, depending on patient age, the quicker the lavage can be completed. Once in the stomach, the water is drawn back up the tube and into a drainage bag. Pill fragments from the overdose are part of the discharged fluid. The extra port in the lavage tube simply allows better "back and forth" flow. This is done by allowing air to quickly replace the fluid drawn out during drainage.
The dual lumen lavage tube is an improvement to Ethox's current tubes to allow a quicker lavage. The extra lumen is a small diameter airway that acts as a vent allowing the lavage fluid in the main tube to pass in and out of the stomach without any "vapor lock" action.
This document is a 510(k) summary for a medical device called a "DUAL LUMEN GASTRIC LAVAGE TUBE". It is not a study demonstrating the performance of an AI/ML powered medical device against acceptance criteria.
Therefore, I cannot provide the requested information as it pertains to AI/ML device studies. The document describes a traditional medical device and its function, comparing it to existing similar devices. It does not involve algorithms, expert reviews, ground truth establishment, or any of the other criteria mentioned in your prompt that are specific to AI/ML powered devices.
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