(80 days)
The Lorenz Lactosorb® Resorbable Laryngotracheal Reconstruction Implants are intended to be used for the temporary treatment and repair of laryngotracheal fractures and laryngotracheomalacia and lumen augmentation in the temporary treatment and repair of glottic stenosis.
The Lorenz Lactosorb® Laryngotracheal Reconstruction (LTR) Implants consist of mesh sheets for the temporary treatment and repair of laryngotracheal fractures and laryngotracheomalacia, and graft plates for lumen augmentation in the temporary treatment and repair of glottic stenosis. The mesh sheets are 0.75mm thick and 50mm wide by 50mm long. The mesh sheets are offered with two different hole configurations to facilitate attachment to the tracheal cartilage using suture and/or screws. The graft plate is a one-piece device consisting of a rectangular base with an elliptical top. The top is available in widths of 3mm, 4mm, 5mm, and 6mm to allow for various amounts of augmentation of the lumen. The base is 0.5mm thick and 10mm wide by 15mm long. The base has holes around the outer edges to allow for fixation to the tracheal cartilage using suture and/or screws. The Lactosorb® Screws and Lactosorb® Direct Drive Screws have a 1.5 diameter with a range of lengths available from 3 to 8mm.
This looks like a 510(k) premarket notification for a medical device. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design for a new AI/ML-based medical device as typically requested.
Therefore, much of the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) is not present in this type of regulatory submission. This submission does not pertain to an AI/ML device, but rather a traditional implant.
However, I can extract what is available and explain why other sections cannot be completed based on the provided text.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Device Performance
The document does not explicitly state acceptance criteria in the form of performance metrics (e.g., sensitivity, specificity, accuracy) that would be expected for an AI/ML device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices and the successful outcome of non-clinical and clinical testing regarding the device's material properties, safety, and function in a biological environment.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criterion (Inferred) | Reported Device Performance (from studies) |
|---|---|
| Biocompatibility/Tissue Tolerance: Device is well-tolerated by tissue. | "Lactosorb® implants were well tolerated by tissue." (Clinical Testing Summary) |
| Structural Support: Device provides adequate support for healing of bone and cartilage. | "Lactosorb® implants... provided adequate support for healing of bone and cartilage." (Clinical Testing Summary) |
| Growth Interference: Potential for lack of interference with growth (advantage over some other materials). | "along with the potential advantage of a lack of interference with growth." (Clinical Testing Summary) |
| Functionality for Laryngotracheal Reconstruction: Acceptable for temporary treatment and repair. | "Animal studies have been undertaken demonstrating the acceptability of Lactosorb® implants for laryngotracheal reconstruction." (Non-Clinical Testing Summary) |
| Advancement in Management: Represents an advancement in the management of specific conditions. | "From these studies it has been concluded that Lactosorb® implants represent an advancement in the management of tracheomalacia and other conditions requiring temporary airway stenting, including graft procedures." (Non-Clinical Testing Summary) |
Study Details (Based on the Provided Text)
Given that this is a 510(k) for an implantable medical device, not an AI/ML algorithm, most of the specific questions regarding AI/ML study design are not applicable or the information is not present in this document.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not specified. The document mentions "Animal studies" and general "Clinical Testing" but does not provide details on the number of subjects (animals or humans) involved in these studies.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be "prospective" in the sense that they were conducted to evaluate the device, but details are not provided.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified. This type of information is not typically included in a 510(k) summary for a physical implant. The "ground truth" would likely be based on clinical observations, histological analysis, and imaging where applicable, assessed by medical professionals involved in the studies.
- Qualifications of Experts: Not specified.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. This concept is typically relevant for studies involving subjective interpretations by multiple human readers (e.g., radiology studies for AI performance). It is not applicable here as the "study" is about the physical performance and biocompatibility of an implant in vivo.
-
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:
- MRMC Study: No, an MRMC study was not done. This device is an implant, not an AI diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Not applicable. This device is not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Inferred from the study summaries, the ground truth for acceptability and performance would likely be based on a combination of:
- Clinical observations/outcomes data: Assessment of healing, support, complications, and overall clinical success.
- Pathology/Histology: For tissue tolerance and integration aspects in animal and potentially human clinical studies.
- Imaging: To assess structural integrity and healing post-implantation.
- Type of Ground Truth: Inferred from the study summaries, the ground truth for acceptability and performance would likely be based on a combination of:
-
The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm.
-
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. This device is not an AI/ML algorithm.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.