(171 days)
The LRT Attachment System is indicated for providing a mean of attaching a removable prosthetic device to an endosseous implant body.
Alike the Locator implant, the O-ring Prosthetic Attachment and the Nobel Ball Attachment systems, the LRT Attachment System provides a mean for attaching a removable prosthetic device to an endosseous implant body with the use of a mechanical based retention, hence eliminating permanent structures that prevent easy access to implant abutments.
The LRT Attachment System requires the use of two ball abutments to receive the The presence of additional implant abutments, although not attachment. mandatory, contributes to the support and stability of the prosthesis. These abutments are cone shaped and mate with a reciprocal cover in the denture base.
All predicate devices are snap-on devices. The retentive female part is embedded in the denture part and snaps on another part (e.g. a ball abutment). The retentive action relies on the expansion and constriction of the metal female counterpart. The LRT Attachment System provides for an innovative solution by featuring a lock-release retention system activated by digital pressure. This mechanical lock/release action offers ease of manipulation. One of the key elements of the LRT Attachemt System is the easily identified "buttons" of the lock/release mechanism which allow an assistant to manipulate the denture for the severely impaired person.
The provided document is a 510(k) summary for the LRT Attachment System, which is an accessory to endosseous dental implants. It outlines the device description, indications for use, and a brief description of testing performed. However, it does not contain specific acceptance criteria, detailed study results with performance metrics, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study details, standalone algorithm performance, or training set information.
Based on the provided text, here's what can be inferred and what information is missing:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document generally states that the device was "found substantially equivalent to the cited predicates." | In-vivo testing: Eased handling of the lock/release mechanism. |
| Clinical testing (over 18 years): Found substantially equivalent to cited predicates (Locator implant anchor K994257, Ball Attachment system K955372, O-ring Prosthetic Attachment K001638). | |
| In-vitro biocompatibility testing: Cytotoxicity screening assays (USP 87) successfully performed. |
Without explicit acceptance criteria in the document, it's impossible to create a quantitative table. The reported "performance" focuses on affirming substantial equivalence and successful biocompatibility rather than specific metrics against predefined thresholds.
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. The document mentions "over 18 years of clinical testing" but does not give a specific number of patients or cases in these tests.
- Data Provenance:
- Country of Origin: Not specified for the clinical testing. The submitter is from Montréal, Québec, CANADA, but the location of the clinical tests is not mentioned.
- Retrospective or Prospective: Not specified. The "over 18 years of clinical testing" suggests a long-term, possibly prospective, study or a collection of clinical observations over time, but this is not explicitly stated.
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 information is not provided in the document. The document refers to "clinical testing" but does not detail how "ground truth" or outcomes were assessed, nor who assessed them.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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 MRMC study was performed or described. The device is a mechanical attachment system for dental prosthetics, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, this question is not applicable to the device described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical, mechanical system for dental prosthetics, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The term "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. The "clinical testing" would have assessed patient outcomes, device retention, ease of use, stability, and absence of adverse events. The document states "the device was found substantially equivalent to the cited predicates" in these clinical tests and that "Cytotoxicity in-vitro screening assays... were successfully performed." These imply comparison against established benchmarks or standards rather than an "expert-established ground truth" for diagnostic accuracy.
8. The sample size for the training set:
- Not applicable / not provided. As a mechanical device, there is no "training set" in the context of machine learning. The "over 18 years of clinical testing" might be considered a form of iterative development and refinement, but it does not constitute a "training set" in the computational sense.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.)