(126 days)
Periophil ß -TCP is indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil ß -TCP can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.
Periophil 8 -TCP is a bone graft substitute. Periophil 3 -TCP is a microporous and macroporous calcium phosphate ceramic consisting of beta tricalcium phosphate (6-TCP). Periophil ß -TCP is available as granules and is provided sterile for single patient use.
Periophil B -TCP is a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Periophil ß -TCP slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. There is progressive resorption for 4 to 12 months (may vary patient to patient) of Periophil B -TCP resorbable bone filler.
The provided document is a 510(k) summary for a medical device called Periophil β -TCP, a synthetic bone graft material. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with detailed performance metrics.
Therefore, many of the requested details about acceptance criteria, device performance, study design, and ground truth establishment are not explicitly present in this type of regulatory submission. This document highlights biocompatibility, sterilization, and material conformance to standards, which are aspects of safety and effectiveness, but not in the format of a clinical or standalone performance study as typically expected for diagnostic devices.
Here's a breakdown of the information that can be extracted or deduced, and what is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance targets. The "acceptance criteria" for this 510(k) submission are primarily based on demonstrating substantial equivalence to predicate devices regarding intended use, technological characteristics, safety, and effectiveness. The report indicates compliance with the ASTM F1088 "Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation" for chemical safety (heavy metal trace element levels).
- Reported Device Performance:
- Biocompatibility: "non-toxic, non-allergenic, biocompatible, and elicit no inflammation. No adverse effects or foreign body reactions have been reported." This is based on documented history of β-TCP and identical materials to a predicate device (K063634).
- Sterilization: "Sterilized using gamma radiation," validated to "10 SAL" (Sterility Assurance Level).
- Resorption: "slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. There is progressive resorption for 4 to 12 months (may vary patient to patient)." This is a general characteristic, not a reported performance metric from a specific study within this document.
- Chemical Safety: Conforms to ASTM F1088 for heavy metal trace element levels.
Table (based on available information):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | Stated to be substantially equivalent to K063634, K051885, and K082917 for indication for use, technical characteristics, and safety/effectiveness. Specifically, "Periophil β -TCP is substantially equivalent in indication for use, technical characteristics, and is as safe as the predicate device K063634 - RTR Syringe." |
| Biocompatibility (non-toxic, non-allergenic, non-inflammatory) | "well documented" for β-TCP. Utilizes identical materials to K063634 and "has the same type and duration of patient contact." "consistently proven to be non-toxic, non-allergenic, biocompatible, and elicit no inflammation. No adverse effects or foreign body reactions have been reported." |
| Sterility Assurance Level (SAL) | Achieved "10 SAL" using gamma radiation, validated via overkill methodology. |
| Chemical Safety (Heavy Metal Trace Elements) | Conforms to "ASTM F1088 "Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation"" required specifications. |
| Resorbability | "Slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. There is progressive resorption for 4 to 12 months (may vary patient to patient) of Periophil β -TCP resorbable bone filler." (This is a product characteristic, not a measured performance against a quantitative target from a specific study described here.) |
| Risk Management (ISO 14971) | Risks identified through a risk assessment procedure in accordance with ISO 14971. (This indicates a process was followed, not specific performance metrics or outcomes). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Explicitly Stated: This document does not describe a clinical performance study with a "test set" in the context of device performance as one might expect for a diagnostic or AI-driven device. The pre-clinical tests performed relate to material specifications (ASTM F1088) and biocompatibility, which typically don't involve "test sets" of patient data in the same way. The biocompatibility claim references "well documented" evidence for β-TCP, implying existing literature, but no specific study with sample size, provenance, or retrospectivity/prospectivity is detailed within this submission.
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 / Not Stated: Since there is no described clinical "test set" requiring ground truth establishment, this information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Stated: As there's no clinical test set described, no adjudication method is mentioned.
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 a bone graft material, not an AI-driven diagnostic device, so an MRMC study and AI assistance effect size are not relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical bone graft material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Explicitly Stated in a clinical context: For the material properties, the "ground truth" is provided by compliance with the ASTM F1088 standard. For biocompatibility, it relies on "well documented" evidence for β-TCP and comparison to the predicate device's materials. No clinical outcomes data or pathology as "ground truth" for a specific performance study is detailed here.
8. The sample size for the training set
- Not Applicable: This is not an AI/algorithm-based device and does not involve a training set.
9. How the ground truth for the training set was established
- Not Applicable: As above, no training set for an algorithm is involved.
Summary of what the document does provide regarding "proof":
The "study that proves the device meets the acceptance criteria" in this 510(k) submission primarily relies on:
- Predicate Device Comparison: Demonstrating substantial equivalence to existing legally marketed devices (K063634, K051885, K082917) in terms of Indications for Use, technological characteristics, safety, and effectiveness.
- Compliance with Standards: Conformance to recognized consensus standards like ASTM F1088 for chemical safety.
- Material Biocompatibility Documentation: Referencing existing knowledge and safety history of β-TCP as a biomaterial.
- Validated Manufacturing Processes: Sterilization validation to a specific SAL.
- Risk Assessment: Adherence to standards like ISO 14971 for risk identification.
In essence, this is a regulatory filing focused on establishing substantial equivalence rather than presenting a novel clinical performance study with defined acceptance criteria and performance metrics in the way a new diagnostic or AI device might.
§ 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.