(86 days)
Periogenix is a periodontal wound dressing intended to protect injured periodontal tissue (gums) by forming a temporary physical barrier to avoid further irritation.
Periogenix consists of thirty (30) disposable, single use dental trays and a canister of topical periodontal paste (TPP). The TPP is dispensed into the single use disposable dental tray, which together provide a moist temporary physical barrier that covers the site of application to avoid further irritation.
The provided text describes a 510(k) summary for a medical device called Periogenix, a periodontal wound dressing. However, this document does not contain specific acceptance criteria, reported device performance metrics, or details about a study that "proves" the device meets acceptance criteria in the way that would typically be presented for an AI/ML device (e.g., sensitivity, specificity, or AUC).
The document states that "Biocompatibility, animal, and clinical testing have been performed and have shown that the proposed Periogenix is safe and effective for its intended use." This indicates that studies were conducted to support the device's safety and effectiveness for its intended use, which is protecting injured periodontal tissue. However, the results and specific acceptance criteria from those studies are not detailed in this 510(k) summary.
Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study details cannot be extracted from this document, as it pertains to a physical medical device (periodontal dressing) and not an AI/ML system.
Here's a breakdown of what can be inferred or stated as missing based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics (e.g., "90% reduction in irritation"). The general acceptance criterion is that the device "is safe and effective for its intended use," as determined by the performed biocompatibility, animal, and clinical testing.
- Reported Device Performance: Not detailed in terms of quantifiable outcomes. The document generally states that testing "has shown that the proposed Periogenix is safe and effective for its intended use." Specific performance metrics from these studies are not included in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. "Clinical testing" is mentioned, implying human subjects were involved, but the number is not provided.
- Data Provenance: Not specified. The country of origin and whether the data was retrospective or prospective are not mentioned.
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 is not applicable as the device is a physical periodontal dressing, not an AI/ML system requiring expert-based ground truth for image interpretation or diagnosis. The "ground truth" would likely relate to clinical outcomes (e.g., healing, reduction in irritation) observed in patients by clinicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device and study description. Clinical trial outcomes are typically assessed by clinicians and statisticians in a different manner than an AI/ML system's performance on a test set.
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/ML 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 device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a periodontal dressing, the "ground truth" for showing effectiveness would likely be based on clinical outcomes data (e.g., assessment of wound healing, reduction of pain/irritation, absence of adverse events) in subjects who used the device, possibly compared to a control group or predicate devices, as observed and documented by clinicians.
8. The sample size for the training set
- Not applicable for this type of medical device. The concept of a "training set" is relevant to machine learning, not typical clinical evaluations of physical devices. The "clinical testing" would involve a cohort of patients, but they are not a "training set" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable.
Summary based on the provided text:
The document broadly states that biocompatibility, animal, and clinical testing were performed to demonstrate the device's safety and effectiveness for its intended use. However, it does not provide the specific quantitative acceptance criteria or detailed performance results from these studies. It also does not discuss AI/ML-specific concepts like test sets, training sets, expert adjudication, or MRMC studies.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.