(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.
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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.
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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.
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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.
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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.
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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.
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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:
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm.
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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.
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OCT 1 8 2001
Summary of Safety and Effectiveness
Specification Holder:
Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, FL 32218-2480 Establishment Registration: 1032347 Walter Lorenz Surgical, Inc. is a wholly owned subsidiary of Biomet, Inc.
| Contact Person: | Sheryl MalmbergWalter Lorenz Surgical, Inc.Jacksonville, FL 32218Phone: (904) 741-4400 ext. 255Fax: (904) 741-4500 |
|---|---|
| ----------------- | ------------------------------------------------------------------------------------------------------------------------------------ |
Lorenz LactoSorb® Laryngotracheal Reconstruction Implants Proprietary Name:
Ear Nose & Throat Synthetic Polymer Material Common Name:
Classification Name: 21 CFR 874.3620
Legally Marketed Devices to which substantial Equivalence is Claimed: Eliachar Laryngeal foam Stent (K000154), Lorenz Stent (K896667), and Montgomery Laryngeal Stent (K842287).
Device Description: 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.
Intended Use: 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.
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Summary of Technologies:
| ComparisonInformation | Lorenz Lactosorb®LaryngotrachealReconstructionImplants | Eliachar LaryngealFoam Stent | Lorenz Stent | MontgomeryLryngeal Stent |
|---|---|---|---|---|
| Manufacturer | Walter LorenzSurgical, Inc. | Hood Laboratories | Walter LorenzSurgical, Inc. | Boston MedicalProducts, Inc. |
| 510(k) | New | K000154 | K896667 | K842287 |
| Indications for Use | Reconstruction forstenosis,tracheomalacia, andlaryngeal fracture. | Reconstruction forstenosis andlaryngeal fracture. | Glottic andsubglottic stenosisaud upper trachealstenois with orwithout laryngealstenosis | For the preventionand treatment oflaryngeal stenosiswhen the glotticstenosis involvesthe midglottis,posterior glottis,supraglottis, andsubglottis,singularly or incombination. |
| Design | Prefabricated | Prefabricated | Prefabricated | Prefabricated |
| Material | Lactosorb® | Silicone Foam | PTFE | Silicone |
| Sizes | 50 x 50mm mesh,50 x 50mm sheet15 x 10mm platewith 4 available topwidth sizes (3,4,5,and 6mm) | 2 sizes: 25mm,40mm, 15mm and25mm, 52mm,17mm | 16 sizes, rangingfrom 6 mm to18mm | Child, Small Adult,Medium Adult, andLarge Adult |
| Method of Placement | Screws and/orSutures | Adherence tolaryngeal contourswith strap foradditional controland anchoring | Sutures | Sutures withsilicone buttons |
| Method ofDeployment | Not applicable | Not applicable | Not applicable | Not applicable |
Non - Clinical Testing: Animal studies have been undertaken demonstrating the acceptability of Lactosorb® implants for laryngotracheal reconstruction. 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.
Studies have been undertaken demonstrating the acceptability of Lactosorb® Clinical Testing: implants for laryngotracheal reconstruction. From these studies it has been concluded that Lactosorb® implants were well tolerated by tissue and provided adequate support for healing of bone and cartilage, along with the potential advantage of a lack of interference with growth.
Lactosorb is a trademark of Biomet, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with a human profile visible in the negative space between the wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2001
Walter Lorenz Surgical, Inc. c/o Ms. Sheryl Malmerg Regulatory Manager 1520 Tradeport Drive Jacksonville, FL 32218-2480
Re: K012409
Trade/Device Name: Lorenz Resorbable Laryngotracheal Reconstruction Implants Regulation Number: 21 CFR 874.3620 Regulation Name: Ear Nose and Throat Synthetic Polymer Material Regulatory Class: II Product Code: NHB Dated: July 19, 2001 Received: July 30, 2001
Dear Ms. Malmerg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally presidents in a classification for your device and thus, permits your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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STATEMENT OF INDICATIONS FOR USE
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Lorenz Resorbable Laryngotracheal Reconstruction Implants
Indications For Use:
The Lorenz Resorbable Laryngotracheal Reconstruction Implants are intended to be used for the The Lorenz Resorbable Laryligotracheal Recomed Seconders, Maryneofracheomalacia, and lumen temporaly treatment and repair of raily agently of glottic stenosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter-Use (Optional Format 1-2-96) |
|---|---|---|---|
| --------------------------------------- | ---------------------------------------------------------------- | ---- | ----------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Devices | |
| 510(k) Number | 2012409 |
001
§ 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.