Search Results

This document is a 510(k) submission for a medical device called UltraCal XS, a calcium hydroxide paste used in dentistry. It's a "substantial equivalence" determination, not a study proving the device meets specific performance acceptance criteria in the way an AI/ML device would. Therefore, most of the requested information for an AI/ML study (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) is not applicable here.

However, I can extract and infer some related information regarding the device's technical characteristics and how its equivalence to predicate devices was established.

Here's a breakdown of the applicable information:

1. A table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity, AUC) that an AI/ML study would define. Instead, it demonstrates "substantial equivalence" to legally marketed predicate devices based on technological characteristics, intended use, and safety. Its performance is implicitly shown through comparison to these predicates and successful completion of verification and validation testing.

Characteristic / "Acceptance Criteria" (Implicit)	Reported Device Performance (UltraCal XS)	Comparison to Predicate (DiaPaste K210333)
Product Code	KIF, EJK (Similar to predicates, within accepted codes for this type of device)	Similar
Intended Use	•Temporary dressing for root canals
•Apexification and/or perforation
•Vital Pulpotomy
•Direct Pulp Capping
•Indirect Pulp Capping
•Root resorption
•Root canal filling for primary teeth (Within the scope of predicate devices)	Similar: The Indications for Use of the subject device is within that of the predicate and reference device(s).
Intended User	Licensed Dentist or Dental Professional	Identical
Characteristics (Description)	Aqueous 12.0 to 12.5 pH calcium hydroxide, radiopaque, premixed paste for direct application.	Similar: Subject device and predicates are calcium hydroxide paste with relatively high pH.
Composition	-Calcium hydroxide
-Water
-Barium Sulfate
-Propylene Glycol
-Hydroxypropyl Methylcellulose	Similar: Primary ingredient (calcium hydroxide) is equivalent. Barium sulfate included as radio-opacifier. Differences in other ingredients (thickeners, humectants, etc.) do not raise new safety/effectiveness questions.
Delivery System/Deployment	Product is provided in a 1.2mL syringe with disposable delivery tips.	Similar: Both the subject device and the predicate and reference devices are provided in a pre-filled syringe with or without delivery tips.
Physical Properties	-Viscosity
-Water Removal
-Radio-Opacity (Evaluated through similar testing as predicates, though not directly to ISO 6876 which was deemed not applicable for a temporary dressing as opposed to a sealing material).	Similar: Testing performed to evaluate characteristics of the chemistry. (Note: ISO 6876 applicable for root canal sealing material, not dressing, so direct comparison not made).
Calcium Hydroxide Concentration	35%	Similar: Concentration range is within ranges cleared by FDA and does not raise new questions regarding safety and efficacy.
Patient Population	Individuals of all ages and gender and shall be assessed by the administering dental professional.	Identical
Biocompatibility and Safety	ISO 7405:2018 (Successfully passed all verification and validation testing, including biocompatibility assessment).	ISO 7405 was applied as it is a recommended biocompatibility evaluation standard for this product type.

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. This is a 510(k) submission for a dental filling material, not an AI/ML device relying on a "test set" of clinical data to evaluate algorithmic performance. The submission relies on laboratory testing and comparison to existing devices.

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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device's safety and effectiveness is established through adherence to recognized standards (e.g., ISO 7405 for biocompatibility) and demonstrated substantial equivalence to legally marketed predicate devices, supported by laboratory characterization of its physical and chemical properties.

8. The sample size for the training set

Not applicable.

9. How the ground truth for the training set was established

Not applicable.

Ask a Question

Ask a specific question about this device

K Number

K970114

Device Name

ULTRACAL XS

Manufacturer

ULTRADENT PRODUCTS, INC.