(361 days)
Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Noris Medical Zygomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae.
The Noris Medical Dental Implants System includes Multi Unit and Vari Connect abutments with various gingival heights and angles (17°, 30°, 45°, 52°, 60°), and Vari Connect Extenders. The system also includes abutment fixation screws. The abutments are intended to be used with specific Noris Medical Dental implants (K151909 and K140440). The Multi-Unit system provides a solution for screw-retained prostheses, while the Vari-Connect system is for removable prostheses. The components are manufactured from Titanium alloy.
The provided text describes a 510(k) submission for the Noris Medical Dental Implants System. While it discusses the device's equivalence to predicate devices and presents clinical data, it does not explicitly state acceptance criteria or a specific study proving the device meets those criteria in the format requested.
Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of:
- Intended Use: Similar to predicate devices.
- Technological Characteristics: Similar to predicate devices (e.g., material, design, connection type).
- Performance Testing: Biocompatibility, sterilization, and mechanical fatigue tests were performed, but specific acceptance criteria for these tests within the context of a "device performance" summary are not detailed.
- Clinical Data (Real-World Evidence): Retrospective studies on both a predicate device and the subject device are presented to support clinical performance, but these are comparative rather than against pre-defined acceptance criteria for a new device.
Therefore, many of the requested fields cannot be directly extracted from the provided text because the study presented is a comparative effectiveness study (comparing the Noris Medical device to predicate devices and real-world evidence, which serves as a benchmark rather than a fixed acceptance criterion).
However, I can extract information related to the clinical data presented, which serves as the closest equivalent to a "study" proving performance in this context of a 510(k) submission.
Here's an attempt to answer the questions based on the available information, noting where information is not present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of explicit acceptance criteria with numerical targets. Instead, it relies on demonstrating "substantial equivalence" and reporting success rates from retrospective clinical studies, comparing them to predicate device performance.
| Acceptance Criteria (Inferred/Benchmark from Predicate) | Reported Device Performance (Noris Medical MU Abutment) |
|---|---|
| Clinical Success Rate: Comparable/Non-inferior to predicate device (Nobel Biocare's 95.3% patient success, 95.9% implant/abutment success at 2 years, and 93.5% survival rate for 60° Zygomatic implant/abutment within 6-48 months) | Clinical Success Rate: 100% (No failures) for 88 Multi Unit abutments (follow-up period 6-47 months) |
| Adverse Events/Complications: Comparable to predicate device | No adverse events nor inflammation reported. |
| Stability/Micro Movements: No micro movements (Implicit from success definition) | No micro movements observed. |
| Bleeding/Soft Tissue Downgrowth: No bleeding or soft tissue downgrowth (Implicit from success definition) | No bleeding or soft tissue downgrowth observed. |
| Pain: No pain (Implicit from success definition) | No pain observed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Subject Device (Noris Medical Multi Unit):
- Sample Size: 33 patients, encompassing 88 Multi Unit abutments.
- Data Provenance: Retrospective study. Country of origin not explicitly stated but the company is "Noris Medical Ltd. 8 Hataasia street, Nesher 3688808, Israel," suggesting the data could be from Israel or a region where Noris Medical devices are used. The implants were placed between 2013 and 2020.
- Predicate Device (Nobel Biocare Multi Unit):
- Sample Size: 44 completely edentulous maxillary rehabilitations (77 Multi unit abutments).
- Data Provenance: Retrospective study, "Real-world evidence... from the literature" (Ref. 1: J. Clin. Med. 2021, 10, 3600). The specific country of origin for this study is not detailed beyond the journal citation, but the reference indicates "Armando L, Miguel de Araújo Nobre, Ana Ferro, Carlos Moura Guede, Ricardo Almeida and Mariana Nunes," suggesting a potential origin in Portugal or similar European context.
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 document does not specify the number or qualifications of experts used to establish the ground truth for either the Noris Medical or Nobel Biocare retrospective studies. Clinical outcomes (success/failure) were reported, likely by the treating clinicians or study investigators, but expert adjudication details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not specify any adjudication method for the clinical outcomes reported in either retrospective study.
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, an MRMC comparative effectiveness study was not done. The studies presented are clinical outcome studies on dental implants and abutments, not diagnostic imaging studies involving human readers and AI. This question is not applicable to the type of device and studies described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm-only) performance study was not done. This product is a physical dental implant system, not a software algorithm. This question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For both the Noris Medical and Nobel Biocare clinical studies, the "ground truth" was based on clinical outcomes data (prosthetic success, abutment success, complications, absence of micro movements, bleeding, soft tissue downgrowth, pain) observed over a follow-up period by clinicians.
8. The sample size for the training set
- The document describes studies for substantial equivalence and clinical performance evaluation, not machine learning model training. Therefore, a "training set" in that context is not applicable or described. The clinical studies mentioned are test sets for device performance.
9. How the ground truth for the training set was established
- As a "training set" is not applicable in this context, the method for establishing its ground truth is also not applicable.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)