(118 days)
The LumenR Tissue Retractor System is indicated for use in conjunction with an endoscope for tissue or foreign body manipulation and/or where multiple removal and reinsertions of the endoscope are required.
The LumenR Tissue Retractor System (LRS) is an intra-luminal surgical device facilitating tissue manipulations inside the lumen.. It is a non-powered, handmanipulated device. The LumenR Tissue Retractor System includes a LumenR Instrument Guide (LIG) and LumenR Cannula Retractor (LCR). The LIG and LCR are single use devices that are provided non-sterile. LumenR Cannula Retractor (LCR) is provided in various Lengths and Diameters in order to accommodate individually variable natural body lumens. The LumenR Cannula Retractor (LCR) comprises of (1) Handle (proximal end located outside of a patient), (2) Retractor (chamber-like expandable retractor located at the device's distal end), and (3) flexible Shaft (located in between the handle and a Retractor). LumenR Instrument Guide (LIG) is an instrument guide or a hollow conduit for existing flexible endoscopic instruments, for example, tissue forceps, which helps guide the instrument towards the target tissue, but doesn't directly interact with the tissues.
This document is a 510(k) premarket notification for the LumenR Tissue Retractor System, a medical device. It does not contain the structured information about acceptance criteria and a study proving device performance as typically expected for an AI/ML-based medical device.
The document focuses on demonstrating substantial equivalence to a predicate device (Megachannel Endoscopic Overtube - K080550) rather than proving performance against specific acceptance criteria with detailed statistical analysis.
However, I can extract information related to performance testing that was conducted to support the claim of substantial equivalence.
Here's an analysis based on the provided text, outlining why a complete answer to your request regarding acceptance criteria and a "study that proves the device meets the acceptance criteria" cannot be fully provided from this document:
Missing Information & Why it's Not Present:
- Acceptance Criteria for Performance: The document does not explicitly state quantitative acceptance criteria (e.g., "Device must achieve a minimum seal strength of X N/mm"). Instead, it lists standards followed (e.g., ASTM F088/ASTM F088M-09 Standard Test Method for Seal Strength of Flexible Materials) and types of tests performed. The results are used to show similarity to the predicate or compliance with general safety/performance aspects, not to meet pre-defined "acceptance criteria" in the context of device accuracy or specific performance metrics in clinical use.
- Reported Device Performance against Criteria: Since specific acceptance criteria are not detailed in a quantitative manner, direct "reported device performance" against such criteria is also not present in the format you requested.
- AI/ML Specifics: This device, the LumenR Tissue Retractor System, is a mechanical surgical instrument. It is not an AI/ML-based device. Therefore, questions 2, 3, 4, 5, 8, and 9 from your prompt (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, training set GT) are not applicable to this document.
- "Study that proves the device meets the acceptance criteria": The document describes "Performance Testing / Shelf Life Study" and "Comparison Testing to Predicate Device." These are studies conducted, but they are aimed at demonstrating substantial equivalence and general safety/efficacy per regulations for this type of mechanical device, rather than a specific validation study against an AI/ML model's performance criteria.
Based on the available information, here's an attempt to answer your request, focusing on the types of performance testing and standards used, as actual acceptance criteria and corresponding quantitative performance metrics are not explicitly detailed:
The provided document describes the LumenR Tissue Retractor System, a mechanical intra-luminal surgical device used in conjunction with an endoscope for tissue or foreign body manipulation. It is not an AI/ML-based device, therefore many sections of your request regarding AI/ML performance metrics are not applicable.
The "study" referenced in this document is a series of performance tests and comparison testing to a predicate device conducted to demonstrate substantial equivalence, safety, and efficacy for its intended use.
1. Table of "Acceptance Criteria" and Reported Device Performance
As mentioned, explicit quantitative acceptance criteria for device performance (e.g., "Seal Strength > X N/mm") are not provided in this 510(k) summary. Instead, the document lists standards and types of tests performed. The "reported performance" is implicitly that the device met the requirements of these standards and performed comparably to the predicate where applicable, supporting the claim of substantial equivalence.
| Performance Aspect / Test Type | Governed by Standard(s) / Test Objective | Implied Acceptance Criteria (based on standards/objectives) | Reported Device Performance |
|---|---|---|---|
| Seal Strength | ASTM F088/ASTM F088M-09 | Compliance with ASTM F088 for flexible materials seal strength. | Testing performed, results implicitly met standard / acceptable for intended use. |
| Bag Leak Test | ASTM D3078-02 | Compliance with ASTM D3078 for determination of leaks in flexible packaging. | Testing performed, results implicitly met standard / acceptable for intended use. |
| Biocompatibility | ISO 10993-5: 2009, ISO 10993-10 | Absence of in vitro cytotoxicity, irritation, and skin sensitization. | Testing performed, device found biocompatible (implicitly met ISO standards). |
| Shipping & Packaging Integrity | ASTM D4169-09 | Packaging integrity maintained after simulated distribution; box integrity maintained. | Testing performed (simulated distribution, box integrity study), results implicitly met standard / acceptable for shipping and storage. |
| Predesignate Device Comparability | (Direct comparison) | Performance comparable to predicate (Megachannel Endoscopic Overtube K080550) regarding insertion/removal force, dimensions, and material. | Similar insertion and removal force profiles during testing. Dimensional similarities (OD, length, endoscope size compatibility). Similar material composition (wire reinforced PVC, smooth thermoplastic). |
| Microbial Limits | (Microbial Enumeration, Specified Microorganisms) | Acceptable levels of microbial contamination. | Testing performed, results implicitly met acceptable limits. |
| Tensile Strength | (Shelf Life Study) | Device components (e.g., shaft, retractor) maintain structural integrity over shelf life. | Testing performed as part of shelf life study, results implicitly acceptable. |
| Reliability (Cyclic, Bending, Stress) | (Shelf Life Study) | Device functions reliably through expected use cycles and bending; tip withstands stress. | Testing performed as part of shelf life study, results implicitly acceptable for intended use and shelf life. |
| Break Strength | (Shelf Life Study) | Device components withstand specified forces without breaking. | Testing performed as part of shelf life study, results implicitly acceptable. |
| Leak Testing (seal around endoscope) | (Performance Testing) | Seal around endoscope prevents significant gas leakage from the lumen. | Testing performed, results implicitly acceptable. |
Regarding your specific numbered points:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the summary. For mechanical devices, testing typically involves a statistically relevant number of manufactured units, but the specific quantity is not disclosed here. As it's a mechanical device verification, "data provenance" like country of origin or retrospective/prospective is not applicable in the same way it would be for clinical data or AI model training data.
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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 mechanical device, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or diagnosis.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for a mechanical device.
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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 is a mechanical device, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable as this is a mechanical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical tests, the "ground truth" is adherence to engineering specifications, national/international standards (e.g., ASTM, ISO), and performance comparable to a legally marketed predicate device. There isn't a "ground truth" derived from clinical experts or patient outcomes in the way you'd apply it to a diagnostic AI.
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The sample size for the training set:
- Not applicable as this is a mechanical device, not an AI/ML model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable as this is a mechanical device.
§ 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.