(200 days)
DynaMatrix is intended for use in guided tissue regeneration and bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to enhance alveolar ridges, or to contain or prevent migration of graft material. The device is supplied sterile and intended for one-time use.
DynaMatrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are lyophilized, packaged in a Tyvek pouch, and sterilized using ethylene oxide to an SAL of 10°. The device is available in sheets ranging from 2 cm to 12 cm2, and can be trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane maintains suture tear resistance. It is considered to be a permanent contact implanted device, and is fully biocompatible.
DynaMatrix is available by prescription only and is intended for use in an oral surgery setting for guided tissue regeneration and bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain or prevent migration of graft material. Dynamatrix achieves its intended use by providing a passive, resorbable scaffold to guide epithelial tissue ingrowth and angiogenesis of the epithelial layer in order to maintain space around the bony defect, prevent epithelial down-growth, and allow for new bone formation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DynaMatrix/DynaMatrix Plus device.
Based on the provided text, this document is a 510(k) Summary for a medical device (DynaMatrix/DynaMatrix Plus) seeking substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than performing clinical studies to prove new efficacy.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the traditional sense of a clinical or performance study. Instead, it relies on demonstrating substantial equivalence to a predicate device (DynaMatrix, K082058) and a reference device (Surgisis Periodontal Membrane, K010952).
The key "acceptance criterion" in this context is that the subject device (DynaMatrix/DynaMatrix Plus) is substantially equivalent to the predicate device, meaning it has the same intended use, fundamental scientific technology, and comparable safety and effectiveness.
The "device performance" is primarily presented as being identical to the predicate in all critical aspects except for a dimensional change (additional sizes).
Here's an interpretation based on the provided text:
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (Subject Device) |
|---|---|
| Intended Use (identical to predicate) | DynaMatrix™ is intended for use in guided tissue regeneration and bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain or prevent migration of graft material. (Identical to predicate) |
| Indications for Use (identical to predicate) | DynaMatrix is intended for use in guided tissue regeneration and bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to enhance alveolar ridges, or to contain or prevent migration of graft material. (Identical to predicate) |
| Material Composition (identical to predicate) | Porcine small intestinal submucosa; primarily collagen types I and III (Identical to predicate) |
| Sterilization Method (identical to predicate) | Ethylene Oxide (Identical to predicate) |
| Biocompatibility (no new risks) | Biocompatibility qualification was performed to ensure that no new risks of biocompatibility were present. Validation activities were comprised of a swine pilot study that showed successful incorporation and no foreign body response for devices matching the nominal thickness of the subject device, and FDA clearance of another SIS device with the same nominal thickness (K133306). |
| Safety and Effectiveness (comparable to predicate) | The subject device is identical to the predicate with regard to intended use, indications for use, target population, anatomical site, use setting, performance, materials, compatibility with the environment and other devices, chemical safety, design, standards met, biocompatibility, and sterility. The introduction of new device sizes does not affect the intended use or the substantial equivalence of the product. |
| Dimensional Characteristics (Sizes) (within reference range) | 2 cm² to 12 cm² (Expanded from predicate which ranged 3 cm² to 12 cm², but within the reference device range of 0.5 cm² to 50 cm²) |
| Thickness (within reference range) | 100-800 µm (nominal) (Predicate was 100-300 µm; Reference was 100-800 µm) |
| Resorption Profile (comparable based on thickness) | DynaMatrix: 16 weeks, DynaMatrix Plus: 26 weeks. (Predicate was 16 weeks. The "Plus" variant with increased thickness likely accounts for the 26-week profile, implicitly deemed acceptable due to the reference device's range and prior clearance of similar thickness). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The primary "test set" mentioned for evaluation of the dimensional change is a swine pilot study.
- Sample Size: Not explicitly stated as a numerical count beyond "a swine pilot study."
- Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Likely prospective, as it was conducted for verification activities related to the new device sizes.
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)
The text does not specify the number of experts or their qualifications for evaluating the swine pilot study or establishing any specific "ground truth" through expert consensus. The assessment seems to be based on observed "successful incorporation and no foreign body response."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information is provided regarding an adjudication method for the swine pilot study results. It's implied that the findings of "successful incorporation and no foreign body response" were straightforward and did not require complex adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a biomaterial (bone grafting material), not an AI-assisted diagnostic or therapeutic device. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, this is not an algorithm-only device. It is a physical biomaterial.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the swine pilot study, the "ground truth" appears to be based on histopathological evaluation or direct observation of biological response, specifically "successful incorporation and no foreign body response."
8. The sample size for the training set
This is not applicable as the device is a biomaterial and does not involve AI/machine learning requiring a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable for the reasons mentioned in point 8.
§ 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.