Search Results

The Lap Bag with fabric pouch system is applied in minimally invasive abdominal procedures for the safe and convenient removal of the tissue, organ or specimen during surgery.

The Lap Bag with fabric pouch is applied in minimally invasive abdominal procedures for the safe and convenient removal of tissue, organ or specimens during surgery.

The device is a TPU and nylon bonded fabric pouch that minimizes spillage and intraoperative contamination by isolating and containing tissue specimens. It is designed for introduction and use through 11/12 and 15mm cannula.

The product is a single-use, sterile, and biocompatible laparoscopic accessory device. It is packaged by the Tyvek® 1073B sterile pouch and its shelf life is 3 years.

The provided document is a 510(k) Summary for a medical device called "Lap Bag with Fabric Pouch". It describes the device, its intended use, and substantial equivalence to a predicate device, supported by performance data. However, it does not include specific quantitative acceptance criteria or a detailed study directly proving the device meets those criteria in the way typically found in clinical trials or software validation studies.

This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Laparoscopic Tissue Retrieval Bag, Model 24003-MF, K123728) through various engineering and scientific tests, rather than clinical performance metrics with specific acceptance thresholds.

Therefore, many of the requested details about acceptance criteria, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies are not present in this type of regulatory submission for this particular device.

Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations:

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

The document does not present a single table of "acceptance criteria" alongside specific "reported device performance" in a quantitative manner as one might expect for diagnostic accuracy or clinical outcomes. Instead, it lists various tests performed and states whether the device "Pass"ed them. The implicit acceptance criteria are typically compliance with the referenced standards or internal protocols, and the reported performance is simply passing these tests.

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

The document does not explicitly state sample sizes for individual tests. The tests are bench tests and laboratory validations, not human clinical trials. Data provenance in terms of country of origin or retrospective/prospective is not applicable or stated for these types of engineering and biocompatibility tests. The manufacturer, Advanced Medical Design Co., Ltd., is based in Taiwan.

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)

This information is not applicable to the types of tests reported. The "ground truth" for these tests are the objective results of standard laboratory procedures (e.g., measuring cytotoxicity, sterile barrier integrity, or leak resistance) against predefined ISO or ASTM standards or internal protocols. No human experts are described as establishing "ground truth" in the context of these evaluations.

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

Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method.

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 document describes a physical medical device (a laparoscopic retrieval bag), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and "human readers improve with AI" metrics are irrelevant.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the various tests are based on:

• Biocompatibility: Standardized biological assays and in vivo tests as per ISO 10993 series and USP standards, which have objective endpoints.
• Sterilization Validation: Microbiological testing and physical indicators to verify a Sterility Assurance Level (SAL) of 10-6, according to ISO 11135 and ISO 11737.
• Shelf Life Study: Physical testing of packaging integrity (dye penetration, seal peel strength) and product sterility after accelerated or real-time aging, per ASTM F1929, ASTM F88/F88M, and ISO 11737.
• Product Performance Tests (Loading Capacity, Leak-resistant): Verification against internal testing protocols, implying objective measurement against predefined specifications.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a training set.

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

Not applicable, as there is no training set.

Ask a specific question about this device

AMD Anti-Fog Solution is a sterile and single-use laparoscopic accessory device for use prior to and during endoscopic and laparoscopic procedures. The product is intended to prevent condensation of the distal lenses of the endoscopic/ laparoscopic instruments during the surgery. The product is intended for prescription use only.

The AMD Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is packaged by the Tyvek" Pouch which includes one clear plastic screw top dispenser bottle with the volume of 6 mL and one polyurethane (PU) foam pad with x-ray detectable radiopaque ribbon. The solution is a clear/colorless, odorless, and aqueous solution which comprises of surfactant (≤2%), isopropyl alcohol (≤2%), and water (≥96%). The polyurethane (PU) foam pad is an adhesivebacked sponge with radiopaque ribbon that can be used to introduce the solution into the surface of the lenses.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining explicit performance acceptance criteria with numerical targets for the AMD Anti-Fog Solution itself (beyond biocompatibility, sterility, and shelf life). However, the "Performance" row in Table 5.1 and the "Product Performance Test" section provide the core performance claim.

Ask a specific question about this device