(406 days)
The Modulap Loop is intended for monopolar electrosurgical coagulation/cutting during laparoscopic surgery. It is indicated for the amputation of the uterus during supracervical hysterectomy and for resection of pedunculated subserosal (abdominal) myomas.
It is not intended for use in hysteroscopy or for contraceptive coagulation of the fallopian tubes.
The Modulap Loop is a 5 mm laparoscopic instrument. It consists of a standard insulated monopolar electrosurgical probe, with a flexible wire loop as its distal tip, and a sliding sheath constructed of insulating material. The wire loop is insulated except for a central approximately 1 inch cutting area. The device is a single-use sterile, disposable device. It is compatible with standard electrosurgical generators, and associated cables.
The provided text is related to a 510(k) submission for a medical device called "Modulap Loop." A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing specific acceptance criteria and proving performance against them in the way a clinical study for a novel device would.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, and especially MRMC effectiveness or standalone algorithm performance, is not present in the provided document. This document describes a traditional medical device (unipolar endoscopic coagulator-cutter) and its 510(k) summary for regulatory clearance, not an AI/ML powered device.
However, I can extract what is provided regarding performance testing and the basis for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside "reported device performance" in the typical format you might see for an AI/ML performance study. Instead, it states that various types of testing were performed to support equivalence to the predicate device.
| Acceptance Criteria Category (Implied for Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Performance Testing | "Testing including performance... was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness." |
| Reliability Testing | "Testing including... reliability... was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness." |
| Materials Property Testing | "Testing including... materials property testing... was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness." |
| Biocompatibility Testing | "Testing including... biocompatibility... was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness." |
| Packaging Validation | "Testing including... packaging validation... was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness." |
| Electrical Safety Testing | "Testing including... electrical safety testing... was performed which supports that the Modulap Loop is equivalent to the predicate with regard to safety and effectiveness." |
| Technological Characteristics Equivalence | "The Modulap Loop and the Predicate device (Lina Gold Loop, K070315) are both Monopolar electrosurgical electrode with loop style tip and sliding sheath; sized to pass through 5 mm laparoscopic trocar; and compatible with standard electrosurgical generators. Their indications for use are equivalent, and other technological characteristics such as design, materials, performance, anatomical sites, energy used, human factors, biocompatibility, sterility, electrical safety, mechanical safety and standards met are the same or equivalent." |
| Intended Use Equivalence | "Their indications for use are equivalent." |
2. 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 document. As this is a physical medical device and a 510(k) submission, the "test set" would refer to the number of devices or components tested, and the "data provenance" would refer to where manufacturing and testing took place, if applicable. This level of detail about the testing protocol is not included in this summary.
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 as the document describes a physical surgical device, not an AI/ML algorithm that requires expert consensus for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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
An MRMC study is not applicable as this is a physical surgical device, not an AI/ML algorithm intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is a physical surgical device, not a standalone AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable in the context of an AI/ML ground truth definition. For a physical device, testing typically involves engineering measurements, material analysis, and potentially in-vitro or in-vivo (animal or human clinical) studies to confirm performance against established standards or predicate device performance. The document only generically states "performance, reliability, materials property testing, biocompatibility, packaging validation and electrical safety testing."
8. The sample size for the training set
This information is not applicable as this is a physical surgical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.
(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).