(182 days)
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.
| Test Name | Applicable Standards/Protocol | Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility Testing | |||
| Cytotoxicity Test | ISO 10993-5:2009 | No significant cytotoxic effects | Pass |
| Sensitization Test | ISO 10993-10:2010 | No significant sensitization | Pass |
| Intracutaneous Reactivity Test | ISO 10993-10:2010 | No significant irritation/reactivity | Pass |
| Acute Systemic Toxicity Test | ISO 10993-11:2017 | No significant systemic toxic effects | Pass |
| Material-Mediated Pyrogenicity Test | USP | Non-pyrogenic | Pass |
| Sterilization Validation & Shelf Life Study | |||
| Ethylene oxide Sterilization Validation Study | ISO 11135:2014, ISO 11737-1:2018, ISO 11737-2:2019 | Achieve Sterility Assurance Level (SAL) of 10-6 | Meets requirements |
| Package Integrity Test (Dye penetration Test) | ASTM F1929-15:2015 | Maintain sterile barrier integrity | Pass |
| Seal Peel Strength Test | ASTM F88/F88M-15:2015 | Maintain seal strength | Pass |
| Product Sterility Test | ISO 11737-2:2019 | Sterile | Pass |
| Product Performance Test | |||
| Loading capacity test | N/A (followed by the internal testing protocol) | Meet specified internal capacity requirements (e.g., hold a certain weight/volume without tearing) | Pass |
| Leak-resistant test | N/A (followed by the internal testing protocol) | Maintain leak resistance (e.g., no fluid leakage under specified conditions) | Pass |
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.