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510(k) Data Aggregation
(35 days)
DEGANIA SILICONE IDENTI LOOPS
The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries, or veins. The Identi Loops is not designed nor indicated for implantation.
The Identi Loops are designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction,, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loops is not designed nor indicated for implantation. The Identi Loops are manufactured using the same manufacturing processes as our previous 510(k). Both this 510(k) and our previous 510(k) are from silicone rubber. The Degania Silicone Identi Loops have similar technical and performance characteristics to the Substantially Equivalent Identi Loops. Both Identi Loops are available in Mini. Maxi and Super Maxi. The Identi Loops and the Identi Loops to which they are Substantially Equivalent are sterilized by the same process.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Degania Silicone Identi Loops:
The provided documents are a 510(k) Summary and an FDA-issued clearance letter for the Degania Silicone Identi Loops. These documents primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting specific performance data from a clinical or technical study in the format typically used for AI/ML device evaluations.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from these documents. The "study" in this context is the submission for 510(k) clearance based on substantial equivalence to a predicate device, not a performance study as would be conducted for a novel device or AI/ML product.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Intended Use: Temporary intraoperative use for identification, retraction, or occlusion of tendons, ureters, nerves, arteries, or veins. Not for implantation. | Substantial Equivalence: The device is "designed and indicated for temporary intraoperative use during various general surgical procedures requiring identification, retraction, or occlusion of tendons, ureters, nerves, arteries or veins. The Identi Loops is not designed nor indicated for implantation." This exactly matches the predicate device. |
| Manufacturing Process: Must be consistent and safe. | Substantial Equivalence: "The Identi Loops are manufactured using the same manufacturing processes as our previous 510(k)." Both are made from silicone rubber. |
| Technical & Performance Characteristics: Must be similar to the predicate. | Substantial Equivalence: "The Degania Silicone Identi Loops have similar technical and performance characteristics to the Substantially Equivalent Identi Loops. Both Identi Loops are available in Mini, Maxi and Super Maxi." The document explicitly states "We are substantially equivalent to ourselves," referring to a previously cleared device from the same manufacturer. This implies that the technical specifications (e.g., material properties, dimensions) are either identical or within acceptable variation to the predicate. |
| Sterilization Method: Must be effective and safe. | Substantial Equivalence: "The Identi Loops and the Identi Loops to which they are Substantially Equivalent are sterilized by the same process." This implies compliance with a validated sterilization method suitable for the device material and intended use. |
| Classification: Regulatory classification (Class II). | Regulatory Clearance: FDA confirmed the regulatory class as II and cleared the device based on substantial equivalence. |
| General Controls Compliance: Adherence to FDA requirements (e.g., GMP, labeling). | FDA Clearance: The FDA letter states that marketing is "subject to the general controls provisions of the Act," including requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. This implies an expectation of compliance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The submission is based on substantial equivalence, not a clinical "test set" with performance data in the typical sense. It relies on the existing safety and effectiveness of the legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. No such "ground truth" establishment process for a test set is described, as the submission focuses on comparing the new device's characteristics to a predicate, not evaluating its performance against a new dataset. The "experts" involved would be the regulatory affairs personnel and potentially internal engineers at Degania Silicone, as well as the FDA reviewers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method is described for a test set. The determination of substantial equivalence is made by the FDA based on the information provided in the 510(k) submission.
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. This is not an AI/ML device, and no MRMC study was performed or is relevant to this type of medical device clearance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided in the context of device performance. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (which in this unique case, is an earlier version of the same manufacturer's device). The argument is that the new device is sufficiently similar to the predicate that it raises no new concerns about safety or effectiveness.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set, this question is not relevant.
In summary: The provided documents represent a 510(k) substantial equivalence submission, which operates on the principle that if a new device is sufficiently similar to a legally marketed predicate device (in terms of intended use, technological characteristics, and safety/effectiveness profile), it does not require a new premarket approval. Therefore, the "study" is the comparison against the predicate, and the "acceptance criteria" are compliance with FDA's substantial equivalence requirements, rather than performance metrics from a traditional clinical study.
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