(139 days)
The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.
The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, opening support, outer introducer shaft, outer introducer handle, inner introducer handle, string and pull loop. The device is available in a series of models. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use.
The provided text describes a 510(k) premarket notification for a Specimen Retrieval Bag. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria for a novel medical device.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted because such a study was not presented in this document.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison of the proposed device against a predicate device, focusing on technological characteristics and compliance with general standards. It does not explicitly state "acceptance criteria" for a study to prove performance but rather lists the tests performed to demonstrate substantial equivalence to the predicate.
| Test Item | Acceptance Criteria (Implicit - achieved SE to predicate) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Biocompatibility | Conform with ISO 10993 requirements (for predicate) | |
| Cytotoxicity | No cytotoxicity | No cytotoxicity |
| Skin Sensitization | No skin sensitization | |
| Irritation | No irritation | No irritation |
| Physical Performance Tests | Met design specifications and demonstrated SE to predicate | |
| Retracted Bag Peeling Force Test | (Not explicitly stated, but performed) | Test performed (results not detailed, but implied to be sufficient for SE) |
| String Tensile Strength Test | (Not explicitly stated, but performed) | Test performed (results not detailed, but implied to be sufficient for SE) |
| Force to Withdraw Retracted Bag Test | (Not explicitly stated, but performed) | Test performed (results not detailed, but implied to be sufficient for SE) |
| Force to Push out Retracted Bag Test | (Not explicitly stated, but performed) | Test performed (results not detailed, but implied to be sufficient for SE) |
| Penetration Force Test | (Not explicitly stated, but performed) | Test performed (results not detailed, but implied to be sufficient for SE) |
| Leak Test | (Not explicitly stated, but performed) | Test performed (results not detailed, but implied to be sufficient for SE) |
| Standards Compliance | Compliance with relevant ISO and ASTM standards | Complies with ISO 10993-1, -5, -7, -10; ASTM F88/F88M-15; ASTM F 1929-15 |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample sizes used for the non-clinical tests or the data provenance. It only states that "performance tests were performed on both proposed device and predicate device."
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 and not provided. The study is a non-clinical, bench-testing evaluation designed to demonstrate substantial equivalence, not a clinical study involving human readers or expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided, as there was no clinical study or expert adjudication described.
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
No MRMC or clinical study was done. The document explicitly states: "No clinical study is included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a physical specimen retrieval bag, not an AI algorithm. The tests performed are non-clinical, bench tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests, the "ground truth" would be the established scientific and engineering principles and the performance of the predicate device, as well as compliance with recognized standards (e.g., ISO, ASTM). It's not a clinical "ground truth."
8. The sample size for the training set
This information is not applicable as there is no mention of a "training set." The device is a physical medical device, not an AI or machine learning model that requires training data.
9. How the ground truth for the training set was established
Not applicable as there is no training set mentioned.
§ 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.