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510(k) Data Aggregation
(353 days)
Parkell Self-Adhesive Cement is intended for the cementation of indirect restoratives including ceramic, zirconia, composite, and metal-based inlays, onlays, crowns, bridges, and posts.
Parkell Self-Adhesive Cement is a two-component, dual-cured, self-adhesive resin cement. It is designed for luting of indirect restorations (inlays, onlays, crowns, bridges, and endodontic posts) made of metal alloys, composite resins, porcelain, lithium disilicate or zirconia. The material also exhibits high bond strength and is radiopaque to allow visibility of excess in sub-gingival areas. Parkell Self-Adhesive Cement will cure in 10 seconds with a dental curing light emitting blue light at 430 - 480 nm and a minimum intensity of 600 mW/cm². The product will self-cure in 3-4 minutes at mouth temperature. Parkell Self-Adhesive Cement will be provided in 5 mL auto-mix syringes. The device comprises catalyst and base components, which are combined just prior to use via a static (1:1) mixing tip which is affixed to the dual chamber syringe.
The provided document is a 510(k) summary for a dental cement (Parkell Self-Adhesive Cement). It aims to demonstrate substantial equivalence to a predicate device. This type of submission relies heavily on bench testing and biocompatibility studies, rather than clinical performance (human trials) for its primary evidence.
Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context pertains to the non-clinical performance and physical properties of the dental cement, as well as its biocompatibility, when compared to the established standards and the predicate device.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
The document implicitly defines acceptance criteria by comparing the subject device's performance to the predicate device's performance, or to generally accepted values for dental cements (e.g., "Pass/Fail Criteria"). The performance listed is for the standalone (algorithm only without human-in-the-loop performance) of the material itself.
| Property | Predicate Device Performance / Acceptance Criteria (Pass/Fail Criteria) | Parkell Self-Adhesive Cement Performance |
|---|---|---|
| Physical Properties | ||
| Film Thickness (Microns) | ≤ 50 microns | ≤ 50 microns |
| Working time (seconds) @ 35 C | ≤ 60 seconds | ≤ 60 seconds |
| Setting time (minutes) @ 35 C | ≤ 10 minutes | ≤ 10 minutes |
| Flexural strength LC (MPa) | ≥ 50 MPa | ≥ 50 MPa |
| Flexural Strength SC (MPa) | ≥ 50 MPa | ≥ 50 MPa |
| Compressive Strength LC (MPa) | ≥ 200 MPa | ≥ 200 MPa |
| Water Sorption (ug/mm³) | ≤ 40 ug/mm³ | ≤ 40 ug/mm³ |
| Water Solubility (ug/mm³) | ≤ 7.5 u/mm³ | ≤ 7.5 u/mm³ |
| Radiopacity (% Al) | ≥ 100 %Al | ≥ 100 %Al |
| Depth of Cure (mm) | ≥ 1mm | ≥ 1mm |
| Diametral Tensile Strength (MPa) | ≥ 30 MPa | ≥ 30 MPa |
| Barcol Hardness after 20 minutes @35c (MPa) | > 50 MPa | > 50 MPa |
| Barcol Hardness after 20 secs Light Cure each surface (MPa) | > 60 MPa | > 60 MPa |
| Bond Strength (MPa) to Substrates (LC = Light Cure, SC = Self-Cure, Treatment indicated where applicable) | ||
| Dentin LC (None) | ≥ 6 MPa | ≥ 6 MPa |
| Dentin LC (PBA) | ≥ 10 MPa | ≥ 10 MPa |
| Dentin SC (None) | ≥ 3 MPa | ≥ 3 MPa |
| Enamel LC (None) | ≥ 10 MPa | ≥ 10 MPa |
| Enamel LC (H3PO4) | ≥ 10 MPa | ≥ 10 MPa |
| Enamel SC (None) | ≥ 3 MPa | ≥ 3 MPa |
| Lithium Disilicate LC (Silane) | ≥ 5 MPa | ≥ 5 MPa |
| Lithium Disilicate LC (HF) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Zirconia LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Zirconia LC (PBA) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Zirconia LC (HF) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Zirconia SC (SB) | ≥ 5 MPa | ≥ 5 MPa |
| Porcelain LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Porcelain LC (Silane) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Porcelain LC (HF) | N/A (Predicate did not have this indication) | ≥ 10 MPa |
| Porcelain SC (HF) | N/A (Predicate did not have this indication) | ≥ 5 MPa |
| Palladium LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Titanium LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Titanium SC (SB) | ≥ 5 MPa | ≥ 5 MPa |
| Cobalt LC (SB) | ≥ 10 MPa | ≥ 10 MPa |
| Cobalt SC (SB) | ≥ 5 MPa | ≥ 5 MPa |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the numerical sample size (e.g., number of specimens tested for each property). It only indicates that "Performance and Physical Properties" tests were performed.
- Data Provenance: The data is generated from non-clinical (bench) testing. The country of origin of the data is not specified, but the submission is to the U.S. FDA by a company based in New York. The testing would be considered prospective in the sense that it was conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: This is not applicable to this type of submission. The "ground truth" for the performance and physical properties of the dental cement is established through standardized laboratory test methods (e.g., ISO standards like ISO 4049, ISO 11405, etc.) and direct object measurement, not expert consensus or interpretation.
- Qualifications of Experts: Not applicable, as expert interpretation is not the primary means of establishing "ground truth" for material properties.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic studies involving human readers/interpreters to resolve discrepancies. For bench testing of material properties, the results are quantitative measurements against defined criteria.
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 is a submission for a medical device (dental cement), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, human readers, or AI assistance is involved.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Quantitative measurements against established international standards and defined criteria. For physical properties, the ground truth is derived from the reproducible results of standardized laboratory tests. For biocompatibility, the ground truth is assessed against the requirements of ISO 10993 series of standards.
8. The Sample Size for the Training Set:
- Not applicable. This is a medical device submission based on bench testing of material properties, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no training set for this type of device.
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(30 days)
The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function.
The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations.
The Zeramex® P6 implants are intended for delayed loading.
The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.
The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral incisor in the upper jaw.
The Zeramex® P6 Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® P6 implants may be restored with cement retained abutments or screw retained abutments, depending on the dentist's preference. The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools.
The implants, produced from aluminum toughened zirconia, are provided in three diameters (Ø 3.3 mm, 4.1 mm, and 4.8 mm),three lengths (8 mm, 10 mm, and 12 mm). The implants are designed with an internal cylindrical connection. Anti-rotational features include internal triangular designs and external hexagonal connections; the feature used depends on the restoration method selected.
Straight and angular (15°) cement retained and screw retained abutments, provided in small neck (SN; 4.0mm) and regular neck (RN, 4.8mm) sizes, are compatible for use with the Zeramex® P6 implants. The straight and angular abutments are made from the same zirconium materials as the Zeramex® P6 implants.
The cement retained Zeramex® Zeralock™ straight and angular abutments have a cylindrical connector which fits into the internal cylindrical connection of the implant and a hexagonal design which fits into the implant's internal triangular design and locks the abutment into place. This design mitigates rotation in six possible positions.
The screw retained Zeramex® P6 abutments fit on the implant's external hexagonal connection such that rotation is mitigated in six possible positions. The Zeramex® P6 screw retained abutments are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra (Endolign) screw which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection.
Locator abutments facilitate removable full restoration of the upper or lower jaw. Three sizes (heights 2/3/5 mm) for each platform (SN 4.0mm and RN 4.8mm) are provided for the Zeramex® P6 Dental Implant System and provide the Zeralock™ connection. The Zeramex® P6 Locators are made from ATZ.
The Zeramex® Zeralock™ cement retained abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex® systems: Panavia" (K032455) and 3M ESPE RelyX (K111185).
The screw retained abutments are attached to the implants using carbon-fiber reinforced (CFR) VICARBO screws (made of PEEK-Optima™ Ultra (Endolign)), which are provided as straight and angular screws in SN and RN sizes.
Healing caps and gingivaformers are also provided in the system. These components, provided in SN and RN sizes, are manufactured from PEEK and are connected to the implant using a screw. The Zeramex® P6 Gingivaformers are provided in two (2) lengths (3 mm and 4 mm). Provisional restoration components may be used to support temporary crowns after the healing period. The Zeramex® P6 Provisional Restoration SN and RN are made of PEEK. The Zeramex® P6 Provisional Restoration Screw is made of carbon fiber reinforced PEEK.
A closure screw (Ø3.5 mm) may be used in lieu of the healing cap to allow the gingiva to cover the platform during the healing period. This component is manufactured from PEEK.
This document is a 510(k) summary from the FDA for a dental implant system. As such, it does not contain the detailed information required to describe acceptance criteria and associated study results for a medical device's performance.
Specifically, the document states under "VII. Performance Data": "New performance data is not required in support of this submission. The sterilization validation, shelf-life studies, biocompatibility studies, mechanical testing, and clinical studies from K152385 are applicable to this submission." This indicates that the current submission (K163043) is relying on previously submitted data for its predicate device (K152385) and does not present new performance studies. The changes made in this 510(k) (addition of a closure screw, administrative updates, additional contraindications, and a minor word revision in the Indications for Use) were deemed not to require new performance data.
Therefore, I cannot provide the information requested in your prompt because the provided document does not contain new performance study data, acceptance criteria, sample sizes, expert qualifications, or adjudication methods for the Zeramex® P6 Dental Implant System related to this specific 510(k) submission (K163043). The document is a regulatory approval notice based on substantial equivalence, not a detailed report of a new performance study.
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(338 days)
The Zeramex® P6 Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function.
The Zeramex® P6 Dental Implant System can be used for single or multiple unit restorations.
The Zeramex® P6 implants are intended for delayed loading.
The Zeramex® P6 implants are specially indicated for patients with metal allergies/ intolerances and chronic illness due to metal allergies/intolerances.
The Zeramex® P6 (Ø3.3mm SN) implant may only be used in the anterior teeth in the lower jaw and lateral teeth in the upper jaw.
The Zeramex® P6 Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® P6 implants may be restored with cement retained abutments or screw retained abutments, depending on the dentist's preference. The Zeramex® P6 implants are placed using the Zeramex® P6 surgical tools.
The implants, produced from aluminum toughened zirconia, are provided in three diameters (Ø 3.3 mm. 4.1 mm. and 4.8 mm),three lengths (8 mm, 10 mm, and 12 mm). The implants are designed with an internal cylindrical connection. Anti-rotational features include internal triangular designs and external hexagonal connections; the feature used depends on the restoration method selected.
Straight and angular (15°) cement retained and screw retained abutments, provided in small neck (SN: 4.0mm) and regular neck (RN. 4.8mm) sizes, are compatible for use with the Zeramex® P6 implants. The straight and angular abutments are made from the same zirconium materials as the Zeramex® P6 implants.
The cement retained Zeramex® Zeralock™ straight and angular abutments have a cylindrical connector which fits into the internal cylindrical connection of the implant and a hexagonal design which fits into the implant's internal triangular design and locks the abutment into place. This design mitigates rotation in six possible positions.
The screw retained Zeramex® P6 abutments fit on the implant's external hexagonal connection such that rotation is mitigated in six possible positions. The Zeramex® P6 screw retained abutments are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra (Endolign) screw which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection.
Locator abutments facilitate removable full restoration of the upper or lower jaw. Three sizes (heights 2/3/5 mm) for each platform (SN 4.0mm and RN 4.8mm) are provided for the Zeramex® P6 Dental Implant System and provide the Zeralock™ connection. The Zeramex® P6 Locators are made from ATZ.
The Zeramex® Zeralock™ cement retained abutments are bonded to the implants using dental cements which have been tested and validated for use with the Zeramex® systems: Panavia" (K032455) and 3M ESPE RelyX (K111185).
The screw retained abutments are attached to the implants using carbon-fiber reinforced (CFR) PEEK-Optima™ Ultra (Endolign) screws (provided as straight and angular screws in SN and RN sizes).
Healing caps and gingiva formers are also provided in the system. These components, provided in SN and RN sizes, are manufactured from PEEK and are connected to the implant using a screw. The Zeramex® P6 Gingiva formers are provided in two (2) lengths (3 mm and 4 mm). Provisional restoration components may be used to support temporary crowns after the healing period. The Zeramex® P6 Provisional Restoration SN and RN are made of PEEK. The Zeramex® P6 Provisional Restoration Screw is made of carbon fiber reinforced PEEK.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Zeramex® P6 Dental Implant System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not explicitly state pre-defined acceptance criteria (e.g., a specific percentage for success rates or a certain threshold for complications). Instead, it describes a retrospective clinical study and non-clinical tests whose positive results support the substantial equivalence claim.
However, based on the non-clinical and clinical study outcomes, we can infer the implied acceptance criteria from the reported success:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Non-Clinical: | |
| Cleaning and Sterilization Validation (ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2) | Device met standards (implied by positive review). |
| Shelf-life, Packaging, and Transport Validation (ASTM F1980, ASTM F88, ASTM F1886, ASTM F1929, ISO 11607-1, ISO 11607-2) | Device met standards (implied by positive review). |
| Biocompatibility (ISO 10993-5) | Device met standards (implied by positive review). |
| Surface Chemical & Roughness Analysis (XPS, SEM, Contact Angle) | Analysis performed; results support design (implied by positive review). |
| Fatigue Testing (ISO 14801, for new and aged samples) | Device met standards (implied by positive review). |
| Clinical: | |
| Absence of Post-operative Complications (e.g., anesthesia, paresthesia, mandibular fracture, alveolar ridge height loss, adverse impact on adjacent teeth, abnormal/prolonged pain, fistula, infection, osteomyelitis) | No complications reported at implant placement, loading, and follow-up (up to >1 year). |
| Absence of Adverse Reactions (e.g., infection, pain, altered sensation, TMJ problems, implant loss, implant breakage, abutment breakage) | No adverse reactions reported at implant placement, loading, and follow-up (up to >1 year). |
| Absence of Screw Issues (movement, fracture, replacement) | No reports of screw movement, fracture, or replacement. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Test Set): 19 patients, receiving a total of 35 screw-retained abutments. Follow-up data was obtained on 15 of those patients (representing 27 screw-retained abutments). Specific follow-up numbers are:
-
6 months follow-up: 8 patients
-
1 year follow-up: 3 patients
-
- Data Provenance: Retrospective clinical data. The country of origin is not explicitly stated in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish a "ground truth" for the retrospective clinical test set. The data appears to rely on clinical observations and professional documentation from the treatment of the 19 patients. It's implied that the treating clinicians (dentists/surgeons) made the assessments of complications and adverse events.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical test set data. Given it's retrospective clinical data, it's highly likely that the outcomes were recorded as part of routine patient care, without a formalized independent adjudication process mentioned for the purpose of this 510(k) submission. Therefore, the adjudication method is effectively "none" in the context of this regulatory submission.
5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the safety and performance of the device itself, not on comparing differences in human reader performance with or without AI assistance, as the device is a dental implant system, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The Zeramex® P6 Dental Implant System is a physical medical device (dental implant and associated components), not an algorithm or software-as-a-medical-device (SaMD). Therefore, "standalone algorithm performance" is not relevant to this submission.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" was based on clinical observations and outcomes data from real patients. This includes:
- Absence of complications (e.g., infection, pain, fracture).
- Absence of adverse events.
- Stability and function of the implant and abutment over time.
For the non-clinical studies, the "ground truth" was established by adherence to recognized international and national standards (e.g., ISO, ASTM) for material properties testing, biocompatibility, sterilization validation, and fatigue strength.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. This is a traditional medical device submission, not an AI/ML device. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned or implied for an AI/ML device, this question is not applicable.
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