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510(k) Data Aggregation
(406 days)
MODULAP LOOP
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.
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(89 days)
MODULAP
The Candidate Devices are intended for irrigation, evacuation of body fluids, and electrosurgical cutting/coagulation during general laparoscopic surgical procedures, (e.q. laparoscopic cholecystectorny, appendectomy and herniorrhaphy). They are not intended for use in hysteroscopy or for contraceptive coagulation of the Fallopian tube.
The Candidate Devices are indicated for use in patients eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.
When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, suction source, electrosurgical generator and suction/irrigation trumpet valve, the Candidate Devices provide irrigation, suction and electrosurgical cutting and coagulation capabilities to the operative site during general laparoscopic surgical procedures.
Provides electrosurgical cutting and coagulation to the surgical site during general laparoscopic surgical procedures by communicating the high-frequency electric current generated by a legally-marketed electrosurgical generator to the operative site.
The Candidate Devices consist of a stainless steel cannula and connector used to communicate electrosurgical, suction, and irrigation capabilities to the operative site during laparoscopic surgical procedures.
I am sorry, but the provided text focuses on the regulatory submission (510(k) summary) of the Modulap® Disposable Unipolar Electrosurgical Probes and Inserts. This type of document is about demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving performance against specific acceptance criteria.
Therefore, the information you requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided text. The document confirms that the device provides "electrosurgical cutting and coagulation capabilities", but it does not detail how this performance was measured or how acceptance criteria were met through a specific study.
The FDA's 510(k) review process primarily focuses on comparing a new device to an existing, legally marketed predicate device to ensure it is as safe and effective, rather than requiring a full-scale clinical trial to establish de novo performance criteria for every new submission, especially for accessories like these.
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(64 days)
MODULAP
The Candidate Devices are intended for irrigation, evacuation of body fluids, and electrosurgical cutting/coagulation during general laparoscopic procedures, (e.g. laparoscopic cholecystectomy, appendectomy and herniorrhaphy). They are not intended for use in hysteroscopy or for contraceptive coagulation of the Fallopian tube.
The Candidate Devices are indicated for use in patients eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.
The Candidate Devices consist of a stainless steel cannula and connector used to communicate electrosurgical, suction, and irrigation capabilities to the operative site during laparoscopic surgical procedures.
I am sorry, but the provided text does not contain detailed information about acceptance criteria for a device's performance or a specific study proving it meets those criteria. The document is a 510(k) summary for ModulapTM, which is a regulatory submission for premarket notification of a medical device to the FDA.
Here's what the document does provide:
- Device Name: ModulapTM (Reusable Unipolar Electrosurgical Probes and Reusable Unipolar Electrosurgical Inserts)
- Intended Use: Irrigation, evacuation of body fluids, and electrosurgical cutting/coagulation during general laparoscopic procedures.
- Technological Characteristics Summary: The device consists of a stainless steel cannula and connector for electrosurgical, suction, and irrigation capabilities.
- Predicate Device: Nezhat-Dorsey Reusable Electrosurgical Attachments and Nezhat-Dorsey Reusable Electrosurgical Unipolar Inserts.
- Regulatory Outcome: The FDA found the device "substantially equivalent" to predicate devices marketed before May 28, 1976. This means it met the regulatory requirements for market clearance based on its similarities to already approved devices, rather than requiring extensive new clinical trials to prove efficacy from scratch.
The document does not include the following information, which would be necessary to answer your request:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
For devices approved via the 510(k) pathway by demonstrating substantial equivalence, extensive de novo clinical studies with detailed performance metrics and ground truth establishment are often not required to the same extent as for novel devices or those undergoing PMA (Premarket Approval). The focus is primarily on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
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(55 days)
MODULAP
Modulap™ Probe Tips may be used with legally-marketed trumpet valves designed to provide pressurized irrigation solution to the operative site during laparoscopic/endoscopic procedures. The hollow channel present in some of the Modulap™ Probe Tips can also be used to introduce other laparoscopic instruments into the surgical site.
When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, suction source, and Trumpet Valve, the Candidate Device communicates the Trumpet Valve's suction and irrigation capabilities to the operative site during general laparoscopic surgical procedures.
This 510(k) submission describes an aspiration/irrigation cannula called "ModulapTM". The device is a relatively simple surgical tool. The provided text does not include information about acceptance criteria or a study proving the device meets said criteria.
It only describes the device's function, scientific basis, physical/performance characteristics, and intended use. There is no mention of any quantitative performance metrics, clinical trials, or any form of study results.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details, as this information is absent from the provided text.
The closest information provided is about its "Technological Characteristics Summary" which indicates it's a hollow tube and connector used to communicate suction and irrigation capabilities. This is a descriptive summary of its design, not a performance study result.
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