(191 days)
Porcine Anorganic Bone Mineral in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:
- Augmentation or reconstructive treatment of alveolar ridge ●
- o Filling of infrabony periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge o
- Elevation of maxillary sinus floor .
- Filling of periodontal defects in conjunction with products intended for Guided . Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- o Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
Porcine Anorganic Bone Mineral in Delivery Applicator is a porous bone mineral matrix consisting predominantly of calcium phosphate, pre-loaded into a delivery applicator. Porcine Anorganic Bone Mineral in Delivery Applicator is produced by removal of the organic components from porcine bone. Porcine Anorganic Bone Mineral in Delivery Applicator is sterilized by gamma irradiation. The product is non-pyrogenic and for single use only.
This document pertains to a 510(k) premarket notification for a medical device called "Porcine Anorganic Bone Mineral in Delivery Applicator" (K162158). It does not describe an AI/ML device or its performance criteria. Therefore, most of the requested information cannot be extracted.
However, I can provide information about the acceptance criteria and the studies performed to demonstrate substantial equivalence to its predicate device, as presented in the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a "table of acceptance criteria" with numerical performance metrics for the device itself in the way one would for an AI/ML diagnostic or measurement device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Porcine Anorganic Bone Mineral, K140714) through a comparison of technical characteristics and performance testing.
The "acceptance criteria" are implied by the comparison to the predicate device and the successful completion of specified tests. The "reported device performance" is essentially that the device met the requirements of these tests and was found to be substantially equivalent.
Here's a table based on the provided "Summary/Comparison of Technical Characteristics" and "Non-Clinical Performance Testing" sections, focusing on functional acceptance as being equivalent to the predicate or meeting standard test requirements.
| Feature / Test Category | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Indications for Use | Identical to predicate device | Match predicate device |
| Material Source | Identical to predicate device (Porcine Bone) | Match predicate device |
| Material Composition | Identical to predicate device (Calcium phosphate) | Match predicate device |
| Mineral Structure | Identical to predicate device (Carbonate apatite) | Match predicate device |
| Form | Identical to predicate device (Granules) | Match predicate device |
| Color | Identical to predicate device (White to off-white) | Match predicate device |
| Physical Appearance | Identical to predicate device (Porous, irregular-shaped particles) | Match predicate device |
| Product Sizes | New sizes offered, but overall range consistent with predicate's capabilities | 0.25 and 0.5 cc offered. Predicate offered 0.25 cc, 0.5 cc, 1.0 cc, 2.0 cc, and 4.0 cc. (Considered an "additional size" offering rather than a deviation) |
| Particle Size Range | Consistent with predicate device (0.25 - 1 mm or 1 - 2 mm) | 0.25 - 1 mm. Predicate offered 0.25 – 1 mm and 1 - 2 mm. (Within predicate specification) |
| pH | $7.3 \pm 0.1$ (identical to predicate) | $7.3 \pm 0.1$ |
| Resorption Profile | Gradual resorption (identical to predicate) | Gradual resorption |
| Unit Package | Delivery applicator (new feature, but no performance degradation) | Pre-loaded into plastic delivery applicator |
| Sterility | Sterile, SAL 10-6, Gamma irradiation, ISO 11137 (identical to predicate) | Sterile, SAL 10-6, Gamma irradiation, ISO 11137 |
| Pyrogenicity | Non-pyrogenic (identical to predicate) | Non-pyrogenic |
| Single Use/Reuse | Single use only (identical to predicate) | Single use only |
| Biocompatibility of Sterile Finished Device | Meet requirements for cytotoxicity, irritation, and sensitization | Tests performed and demonstrated substantial equivalence |
| Biocompatibility of Delivery Applicator | Meet requirements for cytotoxicity, physicochemical attributes of a polymeric material, containers - plastics, and USP | Tests performed and demonstrated substantial equivalence |
| Biocompatibility of Anorganic Porcine Bone Mineral | Meet requirements for cytotoxicity, sensitization, acute systemic toxicity, genotoxicity, pyrogenicity, implantation, subacute/subchronic toxicity (previously established by predicate) | Applicable previous data used and demonstrated substantial equivalence |
| Sterilization Validation | In accordance with ISO 11137-1 | Performed in accordance with ISO 11137-1 |
| Bench Testing (Delivery Applicator) | Demonstrate functionality and customer assessment | Performed and demonstrated substantial equivalence |
| Animal Performance Testing (Anorganic Porcine Bone Mineral) | Demonstrate performance in an intraoral defect in a canine model (previously established by predicate) | Applicable previous data used and demonstrated substantial equivalence |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of an AI/ML algorithm. The performance testing outlined involved:
- Biocompatibility testing: Standardized tests for medical devices. The sample sizes for these tests are not provided but would typically be dictated by the relevant ISO standards (e.g., ISO 10993).
- Sterilization validation: Performed according to ISO 11137-1. Sample sizes are not specified here but are standard for such validations.
- Bench testing: For delivery applicator functionality. No sample size given.
- Animal performance testing: Referenced as being previously submitted for the predicate device in a canine model. The specific sample size or provenance of this animal study is not detailed in this document.
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)
Not applicable. This device is not an AI/ML diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device is not an AI/ML diagnostic device requiring expert 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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for an AI/ML context. However, for a medical device such as this bone mineral, the "ground truth" for its performance is established through:
- In vitro and material characterization: Chemical composition analysis, physical properties, pH, particle size, etc., against defined standards.
- Biocompatibility studies: Demonstrating safety and biological compatibility according to ISO 10993 standards.
- Sterilization validation: Conforming to sterility assurance level (SAL) requirements.
- Animal performance studies: Demonstrating expected biological response and bone regeneration characteristics in a relevant animal model (canine model referenced).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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.