(105 days)
LapBag® is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.
Sterile Specimen Retrieval Pouch, LapBag®, is a single use specimen container. It is designed for use in retrieving specimens during laparoscopic surgery. The LapBag® single use specimen retrieval pouch is supplied sterile in a dispensing tube for ease of insertion through a standard 5, 10, 11,12mm trocar cannula (sleeve). There are 4 types: metal type, non-metal type, metal locking type, and non-metal locking type.
The provided document is a 510(k) summary for the LapBag®, a sterile specimen retrieval pouch. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria for a novel device or AI algorithm.
Therefore, many of the requested fields related to AI performance, expert ground truth, adjudication, and clinical study details cannot be filled directly from this document. The document describes engineering and biocompatibility tests to ensure the device itself is safe and performs as intended compared to a predicate, not clinical accuracy or AI performance.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table for performance similar to how an AI algorithm would be evaluated. Instead, it lists the types of tests performed and states that the "test results support that the subject device is substantially equivalent to the predicate devices."
| Test Category | Specific Test | Reported Performance / Outcome (Implicit Acceptance) |
|---|---|---|
| Sterilization Validation | In accordance with ISO 11737-1 | Results support substantial equivalence. |
| Shelf Life Validation | Not specified (assumed to be per standard) | Results support substantial equivalence. |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Results support substantial equivalence. |
| Ethylene Oxide Sterilization Residuals (ISO 10993-7) | Results support substantial equivalence. | |
| Skin Sensitization (ISO 10993-10) | Results support substantial equivalence. | |
| Systemic Toxicity (ISO 10993-11) | Results support substantial equivalence. | |
| Irritation (ISO 10993-10) | Results support substantial equivalence. | |
| Performance Tests | Appearance | Results support substantial equivalence. |
| Measurement | Results support substantial equivalence. | |
| Extraction Test | Results support substantial equivalence. | |
| Puncture Resistance | Results support substantial equivalence. | |
| Tensile Strength | Results support substantial equivalence. | |
| Bag Leak Test | Results support substantial equivalence. | |
| Ring Pull Test | Results support substantial equivalence. |
Study Proving Device Meets Acceptance Criteria:
The study described is a series of laboratory and bench tests comparing the LapBag® to a predicate device (MGB Disposable Retrieval Bag/LAPBAG, K093194). The objective was to demonstrate substantial equivalence, not to meet specific performance acceptance criteria for a novel medical AI algorithm. The tests show the LapBag® is comparable in physical, mechanical properties, and biocompatibility. The main difference highlighted is that LapBag® has a wider range of pouch sizes, and comparison tests (Puncture Resistance, Tensile Strength, Bag Leak Test, and Ring Pull Test) were performed to confirm equivalence despite this difference.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical data or AI evaluation. The "tests" mentioned are engineering and material verification tests.
- Sample Size: Not explicitly stated for each test, but standard statistical sampling would be used for material and product testing.
- Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based and conducted by the manufacturer, Sejong Medical Co., Ltd. (Republic of Korea).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. "Ground truth" in the context of expert consensus for imaging or clinical diagnosis is not relevant to this type of device (a surgical retrieval bag). The "ground truth" for the material and performance tests would be the established scientific and engineering principles and standards (e.g., ISO standards).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in clinical studies, typically for diagnostic or screening devices. This is a material and performance validation for a surgical device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this device. This is a surgical accessory, not a diagnostic imaging device or AI algorithm intended to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the engineering and biocompatibility tests, the "ground truth" is defined by:
- International standards (e.g., ISO 11737-1, ISO 10993 series).
- Established scientific and engineering principles for material strength, leak integrity, and biocompatibility.
- Comparison to the performance characteristics of the legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning 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.