(24 days)
The Stage-1® Temporary/Healing Cap is placed after surgery to protect the Cement on Crown (COC) Abutment until the soft tissue has healed. It can be used alone or as the base for a temporary crown. The healing cap is intended for temporary use only up to 30 days.
The Stage-1 ** Temporary/Healing Cap is a cap which is placed over the COC Abutment for protection during soft tissue healing. The Stage-1® Temporary/Healing Cap also offers a base for placement of a temporary crown. The temporary crown can be bonded directly to the Stage-1® Temporary/Healing Cap.
This submission focuses on "Substantial Equivalence Comparison" for the Stage-1® Temporary/Healing Cap. Instead of providing acceptance criteria and a study demonstrating performance against these criteria, the document asserts substantial equivalence to predicate devices based on shared characteristics. Therefore, the requested information on acceptance criteria and a detailed study proving device performance as typically understood for AI/software-based devices is not applicable to this 510(k) submission.
Specifically, the submission from Lifecore Biomedical, Inc. for the Stage-1® Temporary/Healing Cap (K053643) relies on comparing the new device to existing predicate devices to establish substantial equivalence. It does not present a study with performance metrics against acceptance criteria in the manner one would expect for a diagnostic or AI-driven medical device.
Here's an explanation based on the provided text, addressing why the requested information cannot be fully provided:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable. The submission does not define specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for a clinical study comparing the device against a benchmark. Instead, it argues substantial equivalence. The "performance" is implicitly tied to the predicate devices being legally marketed and safe/effective for their intended use.
2. Sample Size for the Test Set and Data Provenance:
- Not applicable. No test set, as would be used in a performance study, is described. The submission is a regulatory comparison.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. Ground truth establishment is not relevant to this type of substantial equivalence comparison.
4. Adjudication Method for the Test Set:
- Not applicable. No test set or expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. No such study is mentioned or implied. This device is a physical healing cap, not a diagnostic or AI-assisted interpretation tool where reader improvement would be measured.
6. Standalone Performance Study (Algorithm Only):
- Not applicable. There is no algorithm or software component for which standalone performance would be assessed. The device is a physical medical implant accessory.
7. Type of Ground Truth Used:
- Not applicable. Ground truth, in the context of diagnostic performance, is not established for this device.
8. Sample Size for the Training Set:
- Not applicable. There is no machine learning component requiring a training set.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. No training set or ground truth for it exists in this submission.
Summary of Substantial Equivalence Comparison (as provided in the document):
The submission argues substantial equivalence based on the following:
| Feature | Stage-1® Temporary/Healing Cap (New Device) | Predicate Stage-1® COC Abutment Healing Cap (K991114, K994205, K003226) | Predicate PrimaConnex™ Quick-Abutment Temporary/Healing Cap (K051614) |
|---|---|---|---|
| Intended Use | Placed after surgery to protect COC Abutment until soft tissue has healed; can be used alone or as base for temporary crown; temporary use up to 30 days. | Same | Same |
| Basic Healing Cap Design | Same | Same | Same |
| Biocompatible Materials | Implied to be the same as predicates (specifically stated for PrimaConnex™ comparison) | Not explicitly stated in comparison, but inherent to existing device | Same (explicitly stated) |
| Shelf Life | Same | Same | Same |
| Packaging & Sterilization | Same materials and processes | Same materials and processes | Same materials and processes |
The FDA's letter (K053643) confirms that they "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This determination is based on the comparative information provided by the applicant, rather than a performancetesting study with specific acceptance criteria.
§ 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.)