(66 days)
ENDOPOUCH PRO Specimen Retrieval Bag is intended for use during general laparoscopic surgical procedures as well as the collection and extraction of tissue specimens such as the appendix, gall bladder, ovaries, fibroid tumors, other tissues and calculi.
ENDOPOUCH PRO Specimen Retrieval Bag is a disposable device used as a receptacle for the collection and extraction of tissue specimens such as the appendix, gall bladder, ovaries, fibroid tumors, other tissues and calculi during laparoscopic surgical procedures.
The ENDOPOUCH PRO device is comprised of a flexible plastic bag with a large, easily accessible opening, a push rod handle and an introducer tube. The push rod and handle allow for single hand deployment.
The provided text describes a 510(k) summary for a medical device called the ENDOPOUCH PRO Specimen Retrieval Bag. It outlines its intended use, technological characteristics, and a brief summary of performance data. However, the document does NOT contain the detailed information required to answer all the questions in your request, particularly those related to specific acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this device is not an AI/ML algorithm.
Here's an analysis of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in terms of specific, quantifiable criteria) | "It was determined that the device has greater bag strength than either predicate device." |
- Explanation: The document states that "Pre-clinical in vivo as well as bench top testing has been performed to verify that the product meets the performance requirements described." However, it does not explicitly list the acceptance criteria (e.g., "bag strength must be X Newtons") nor provides quantitative reported device performance other than the qualitative statement about greater bag strength.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Information Not Provided: The document mentions "Pre-clinical in vivo as well as bench top testing," but it does not specify the sample size for these tests, the type of data (e.g., if it involved human subjects or materials), or the provenance of any data.
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)
- Information Not Provided: This question is more relevant to studies involving interpretation by human experts, such as medical image analysis. For a specimen retrieval bag, the "ground truth" would likely relate to objective physical properties or functional performance, not expert consensus on interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Information Not Provided: Adjudication methods are typically associated with resolving disagreements in expert interpretations, which is not applicable to the type of testing described for this device.
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, an MRMC study was not done.
- Explanation: An MRMC study is relevant for AI/ML-based diagnostic devices that assist human readers (e.g., radiologists interpreting images). The ENDOPOUCH PRO is a surgical instrument, not an AI/ML diagnostic aid. The document does not describe any such study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done.
- Explanation: This question also pertains to AI/ML algorithms. The ENDOPOUCH PRO is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implied Ground Truth: For the "bag strength" testing, the ground truth would likely be established through objective physical measurements (e.g., tensile strength testing) rather than expert consensus, pathology, or outcomes data, as it's a mechanical property. The document doesn't specify the exact metrics or methods for establishing this.
8. The sample size for the training set
- Information Not Applicable/Provided: As this device is not an AI/ML algorithm, there is no "training set."
9. How the ground truth for the training set was established
- Information Not Applicable/Provided: As this device is not an AI/ML algorithm, there is no "training set" and thus no ground truth established for one.
Summary of Study (as described for the ENDOPOUCH PRO Specimen Retrieval Bag):
The study referenced is "Pre-clinical in vivo as well as bench top testing." The purpose of this testing was to "verify that the product meets the performance requirements described." The key finding reported is that the device "has greater bag strength than either predicate device."
This documentation focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and functional performance testing, which is typical for a 510(k) submission of a conventional medical device. It does not involve AI/ML components or associated study methodologies like MRMC, standalone algorithm performance, or extensive details on ground truth establishment relevant to AI.
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.