(263 days)
Endoform Dental Membrane is specifically intended for use in extraction sockets and soft tissue grafting. The device contains and prevents migration of guided bone regeneration graft material and prevents loss of alveolar height and ridge following tooth extraction. The device is provided sterile and intended for one-time use.
Endoform Dental Membrane is an ovine derived bioabsorbable extracellular matrix intended for application in dental and periodontal procedures. The device is composed of non-cross linked and non-reconstituted collagen. The device is supplied sterile in a variety of sizes and thicknesses which may be trimmed by a licensed dentist or oral surgeon to meet individual patient needs.
The provided text describes the non-clinical testing performed on the Endoform Dental Membrane to demonstrate its safety and performance. However, it does not include information about acceptance criteria for all the tests, nor does it detail a study that defines "device performance" in terms of clinical or comparative effectiveness against specific criteria in the way you've outlined.
Based on the available text, here's a breakdown of the information that is present, and what is not:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document details numerous non-clinical tests. For many, it states that the device "met the pre-defined specification" or "meets the specification," but it often does not explicitly list the numerical acceptance criteria in this summary. The table below compiles the criteria where they are explicitly mentioned.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Collagen Content | Above 70% total collagen in mass percentage. | Verified to be above 70%. |
| GAG Content | Minimum GAG content specification (value not explicitly stated). | Subject device meets the minimum GAG content specification. |
| DNA Content | Pre-defined DNA content specification (value not explicitly stated). | All EDM devices met the pre-defined DNA contentment specification. |
| Moisture Content | Stipulated moisture content (value not explicitly stated). | Subject device meets the stipulated moisture content. |
| DSC (Melting Point Onset) | Pre-defined melting point onset temperature specification (value not explicitly stated). | Pre-defined melting point onset temperature specification was met. |
| Rehydration Time | Rehydration in less than 5 minutes. | Demonstrated that the subject device can be rehydrated in less than 5 minutes. |
| Tx-100 Residuals | Below predetermined specifications (values not explicitly stated). | Tx-100 residuals were found to be below the predetermined specifications. |
| EDTA Residuals | Below predetermined specifications (values not explicitly stated). | EDTA residuals were found to be below the predetermined specifications. |
| PAA Residuals | Below predetermined specifications (values not explicitly stated). | PAA residuals were found to be below the predetermined specifications. |
| Bioburden | 0). | Found to be permeable to aqueous solutions (PI>0). |
| Suture Retention Strength | ≥ 1.5 N. | Found to meet the defined of = 1.5 N. |
| Modulus of Elasticity | Design specification of modulus of elasticity (value not explicitly stated). | Test results demonstrate that the design specification of modulus of elasticity. |
| Thickness | Specification for all EDM devices (value not explicitly stated). | Found to meet the specification for all EDM devices. |
| Sterilization (SAL) | Sterility assurance level (SAL) of 10-6. | Validated using a 1/2 cycle (overkill) method, all tested devices from three 1/2 cycles and one full cycle were 'sterile'. |
| EO/ECH Residuals | Below specification limits. | Found to present residuals below the specification limits. |
| Packaging | Pouches meet pre-defined specifications for dye penetration, T-peel, and visual inspection (values not explicitly stated). | All pouches meeting the pre-defined specifications. |
| Shelf Life | All devices meet design specifications across all time points tested for biochemical composition, moisture content, suture retention, DSC, and visual inspection. | All devices met the design specifications across all time points tested. |
| Biocompatibility | Biocompatible in accordance with ISO 1099 standards. | Biocompatibility testing data demonstrates that the subject device is biocompatible. |
| Animal Performance (Resorption) | Non-inferior to the reference collagen membrane (Bio-Gide). | Endoform Dental Membrane was found to pass the acceptance criterion. |
| Animal Performance (Cellular Infiltration/Inflammatory Response) | Non-inferior to Bio-Gide. | Endoform Dental Membrane was found to pass the acceptance criterion. |
| Animal Performance (Retention of Bone Grafting Material) | Non-inferior to that of Bio-Gide. | Endoform Dental Membrane was found to pass the acceptance criterion. |
| Animal Performance (Adverse Events) | No adverse events. | No adverse events occurred during execution of the protocol. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes several non-clinical tests but does not explicitly state the specific numerical sample sizes for each test set. It mentions "All EDM devices" or "all samples" in some contexts.
For the Animal Performance Testing:
- Sample Size (Test Set): Not explicitly stated how many animals were used, but it was an ovine (sheep) defect model study using "selected timepoints (week 4, 8 and 16)".
- Data Provenance: Prospective animal study conducted in an ovine (sheep) defect model. The country of origin is not specified, but the applicant's address is New Zealand.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The non-clinical tests described rely on validated laboratory methods and specifications, which are based on scientific standards rather than expert consensus on a test set in the way clinical diagnostic devices might.
For the animal study, the assessment criteria (resorption, cellular infiltration, inflammatory response, retention of bone grafting material, hard tissue infill) would likely be evaluated by veterinarians or pathologists, but the number and qualifications of these experts are not mentioned.
4. Adjudication Method for the Test Set
This information is not provided as the document focuses on laboratory and animal study results rather than human-read test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not performed or described. The document explicitly states: "Clinical data was not required to demonstrate substantial equivalence."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a bioabsorbable extracellular matrix (Endoform Dental Membrane), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.
7. Type of Ground Truth Used
The "ground truth" for the various tests conducted for the Endoform Dental Membrane is based on:
- Validated Test Methods: For biochemical content (collagen, GAG, DNA), physical properties (moisture, DSC, permeability, suture retention, modulus, thickness), residual substances (Tx-100, EDTA, PAA), bioburden, endotoxin, and shelf-life. These are quantitative measurements against predefined specifications.
- Standards Compliance: For biocompatibility (ISO 10993 series), sterilization (ISO 11135), and packaging (ASTM standards).
- Histopathological and Macroscopic Assessment: For the animal performance study, evaluating resorption, cellular infiltration, inflammatory response, and bone graft retention based on examinations at specific time points. This likely involves expert evaluation of tissue samples, but it's not "expert consensus" on a diagnostic task, rather assessment of biological outcomes compared to a reference device.
- "Critically sized" defects: The animal study also demonstrated that untreated controls did not completely regenerate bone, indicating the defects were appropriately sized for evaluating the device's performance.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for this type of device.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.