(76 days)
Intended to be used in edentulous patients as an anchor to support a prosthesis.
The Nobelpharma 17° Angulated Abutment is an abutment used with an endosseous implant. The abutment sits upon the implanted fixture and is used to support prosthetic devices and restore chewing functions in edentulous patients. The only modification is the narrowing of the base and external diameter of the abutment; and narrowing of the diameters of the abutment screws, adding one series of abutments to fit the smaller diameter fixtures previously cleared.
This document is a 510(k) Pre-Market Notification for a medical device called the "BRANEMARK SYSTEM® 17° Angulated Abutment." This submission is a modification of an already cleared device, K944962. The key information for your request is largely absent because this is a 510(k) submission for a modification to an existing device, and the documentation focuses on demonstrating substantial equivalence rather than presenting new performance study data with acceptance criteria for a novel device.
Here's an analysis based on the provided text, highlighting what is and isn't available:
1. A table of acceptance criteria and the reported device performance
- Not provided. The document states that the "technological characteristics between the modified version of the 17° Angulated Abutment and the earlier version are identical." The changes are described as "minor dimensional changes to the diameter of the abutment and abutment screw." For a 510(k) for a minor modification, extensive performance testing with defined acceptance criteria is typically not required if the changes are deemed to not affect the safety or effectiveness. The submission relies on the predicate device's established safety and effectiveness.
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 provided. No new performance testing data (and therefore no test set sample size or provenance) is mentioned, as the device is a minor modification of an already cleared product.
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 provided. As no new performance studies are described, there's no mention of experts establishing a ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No new performance studies are described, so 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 document describes a dental implant abutment, not an AI-powered diagnostic device. Therefore, MRMC comparative effectiveness studies or human-in-the-loop performance details are irrelevant and not present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This pertains to an abutment for an endosseous implant, which is a physical medical device, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. Since no new performance studies are detailed, there is no mention of how "ground truth" was established. The effectiveness of the device is inferred from the predicate device through substantial equivalence arguments.
8. The sample size for the training set
- Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. As this is a physical medical device and not an AI/ML algorithm, there is no concept of a "training set" or establishing ground truth for it.
Summary of Device and 510(k) Context:
- Device: BRANEMARK SYSTEM® 17° Angulated Abutment, an abutment for endosseous dental implants.
- Modification: Narrowing of the base and external diameter of the abutment, and narrowing of the diameters of the abutment screws, to fit smaller diameter fixtures.
- Predicate Device: The previous version of the same device, K944962.
- Basis for Clearance: Substantial equivalence to the predicate device, based on the argument that the "technological characteristics... are identical" and the changes are "minor dimensional changes" that do not affect safety or effectiveness.
- Intended Use: To be used in edentulous patients as an anchor to support a prosthesis.
In essence, this 510(k) submission for K961736 is for a minor modification of an already cleared device. The "study" proving it meets acceptance criteria is the argument of substantial equivalence to the predicate device, rather than new, extensive performance testing with explicit acceptance criteria. The FDA's clearance letter (SEP 17 2010) confirms the device's substantial equivalence to legally marketed predicate devices.
§ 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.)