(267 days)
The Oral Matrix is intended for use in extraction sockets only to contain or prevent migration of graft material. The device is supplied sterile and intended for one time use.
The Oral Matrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are freeze-dried, packaged in a Tyvek pouch, and sterilized using ethylene oxide to achieve a SAL of 10-6.
The Oral Matrix is available in eighteen different models, the differences between the models are shown in the table below.
| Model | Size (cm) | Tolerance | Thickness |
|---|---|---|---|
| SIS-ORP-4L-1×1 | 1×1 | ||
| SIS-ORP-4L-2×2 | 2×2 | ||
| SIS-ORP-4L-2×3 | 2×3 | ||
| SIS-ORP-4L-3×3 | 3×3 | ||
| SIS-ORP-4L-4×3 | 4×3 | ||
| SIS-ORP-4L-6×6 | 6×6 | ||
| SIS-ORP-4L-1.5×1.5 | 1.5×1.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×5 | 3×5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-2.5×1.5 | 2.5×1.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-5×4 | 5×4 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-4×6 | 4×6 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-7×7 | 7×7 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×3.5 | 3×3.5 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-3×7 | 3×7 | ±0.2cm | 0.05~0.13mm |
| SIS-ORP-4L-4×4 | 4×4 | ||
| SIS-ORP-4L-5×5 | 5×5 | ||
| SIS-ORP-4L-6×8 | 6×8 | ||
| SIS-ORP-4L-8×8 | 8×8 |
The provided document describes the "Oral Matrix" device and its FDA 510(k) summary, which often includes information on acceptance criteria and supporting studies. However, this specific document focuses on demonstrating substantial equivalence to a predicate device rather than providing explicit acceptance criteria with numerical targets for clinical performance metrics or a detailed standalone study for human-in-the-loop performance. Instead, it relies on non-clinical and animal studies to justify equivalence based on product performance and composition.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly list quantitative acceptance criteria in a table format with specific performance targets for the device's intended clinical use (e.g., success rate of socket preservation, bone regeneration metrics). Instead, it presents various non-clinical and animal study findings which implicitly serve as evidence that the device performs similarly to the predicate device or meets regulatory standards.
Implicit "Acceptance Criteria" through Equivalence and Standards Compliance:
| Category | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Product Performance Comparison | Burst Strength: Similar to predicate device. | |
| Suture Retention Strength: Similar to predicate device. | ||
| Tensile Strength: Similar to predicate device. | ||
| Physical Performance: Similar to predicate device. | "The test results demonstrate the subject device has the similar product performance as those of the predicate device." (No specific numerical values provided for either subject or predicate) | |
| Product Composition Comparison | Total Protein Content: Similar to predicate device. | |
| Total Sugar Content: Similar to predicate device. | ||
| Lipid Content: Similar to predicate device. | ||
| DNA Residue: Similar to predicate device. | ||
| Peroxyacetic Acid Residue: Similar to predicate device. | "The test results demonstrate the subject device has the similar product composition as those of the predicate device." (No specific numerical values provided for either subject or predicate) | |
| Virus Inactivation | Sum of log clearance of DNA and RNA virus from inactivation processes is at least 6 logs greater than anticipated virus concentration in unprocessed animal source (according to ISO 22442-3:2007). | "The test results demonstrate that the virus inactivation processes of the subject device reduce more than 6 logs virus." |
| Package Integrity Testing | Seal Strength: No less than 1.5N/15mm (according to ASTM F88/F88M-15). | |
| Dye Penetration: No dye penetration across the package (according to ASTM F1929-15). | ||
| ASTM F1886: Compliance with standard. | "The test results demonstrate the sterility maintenance package of the subject device meets the requirements of standards and thus provides sterility maintenance for the finished device." (No specific values provided, but compliance stated) | |
| Shelf Life Testing | Device safety and effectiveness maintained for the claimed shelf life (24 months) based on package integrity and product performance. | "The test results demonstrate the subject device can claim 24 month as shelf life." |
| Biocompatibility | No negative impacts from materials used (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogen, Implantation, Subchronic systemic toxicity, Bacterial reverse mutation, Mouse lymphoma TK assay, Hemolysis, Complement activation, Partial thromboplastin time, Chronic system toxicity, Chemical Characterization). | "The test results demonstrate there are no negative impacts from the materials that are used in the subject device." Specific results include: No Cytotoxicity; No Sensitization; No Intracutaneous Reactivity; No Acute Systemic Toxicity; Non irritant after Implantation; No Subchronic Systemic Toxicity; No Bacterial Reverse Mutation; No mutagenic to mouse lymphoma cell; No Hemolysis; Pyrogen meet the acceptable USP limits; No Complement Activation; No Partial Thromboplastin; No Chronic System Toxicity; No unacceptable risks associated with the extract based on the chemical characterization evaluation. (All indicate successful meeting of acceptance criteria for benign biological response.) |
| Animal Study (Performance/Safety) | Ability to preserve the teeth extraction socket, comparable to predicate device and superior to blank control group. | "The results demonstrated that the subject device has ability to preserve the teeth extraction socket compared with predicate device." and "it was similar compared with the predicate device." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Sets:
- Non-Clinical (Product Performance, Composition, Package Integrity, Shelf Life, Biocompatibility): The document doesn't specify sample sizes for these tests. The data provenance is not explicitly stated as country of origin, but the sponsor is Beijing Biosis Healing Biological Technology Co., Ltd. from China, and the testing was likely conducted in a setting compliant with international standards (ISO, ASTM). These are generally prospective tests conducted specifically for the submission.
- Virus Inactivation: Not specified, but likely an in-vitro study designed to demonstrate log reduction, which is a prospective test.
- Animal Study: The sample size for the canine model is not specified. The study was performed in an animal model, which is a prospective study. Data provenance in terms of country is not specified, but usually, animal studies are conducted by or for the submitting company.
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 section is not applicable as the document describes non-clinical and animal studies, not studies involving human expert interpretation for ground truth. Ground truth for these types of tests is established through laboratory methods and histopathological analysis (for the animal study), not expert consensus on human data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable as the studies described (non-clinical, animal) do not involve human interpretation or adjudication processes typical of clinical diagnostic studies.
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 MRMC comparative effectiveness study was done or mentioned. The device is a bone grafting material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. The device is not an algorithm, but a physical bone grafting material. There is no "algorithm only" performance to evaluate. The performance evaluations described are for the physical properties and biological effects of the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Non-Clinical (Product Performance, Composition, Package Integrity, Shelf Life): Ground truth is established by physical and chemical measurements against established standards (e.g., ASTM, ISO guidelines) and comparative data from the predicate device.
- Virus Inactivation: Ground truth is established by virological assays to determine viral load reduction.
- Biocompatibility: Ground truth is established by in vitro and in vivo biological assays (e.g., cytotoxicity, sensitization, implantation responses) adhering to ISO 10993 series standards.
- Animal Study: Ground truth for socket preservation would be established by histopathological examination of the extracted socket sites, potentially including measurements of bone formation, reduction in ridge resorption, and inflammation, compared to control groups.
8. The sample size for the training set
Not Applicable. The device is a bioabsorbable extracellular collagen membrane matrix, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of an AI model.
9. How the ground truth for the training set was established
Not Applicable. As explained 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.