Search Results

PrimaConnex SD Esthetic Contour Zi Abutment is intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

PrimaConnex SD Esthetic Contour 7: Abutment is intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

The provided 510(k) summary for the PrimaConnex® SD Esthetic Contour Zi Abutment (K073032) focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a study with specific acceptance criteria and device performance metrics.

Therefore, the document does not contain information to fill in most of the requested sections regarding acceptance criteria, device performance, study details, sample sizes, expert involvement, or ground truth establishment.

Specifically, there is no mention of a study conducted to prove the device meets any particular acceptance criteria for performance, clinical effectiveness, or standalone algorithm performance. The basis for clearance is substantial equivalence to previously cleared devices.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not define specific acceptance criteria or report on device performance metrics through a study. The substantial equivalence argument rests on similar intended use, materials, design, and packaging.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be provided. No test set or study data is described.

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)

• Cannot be provided. No test set or related ground truth establishment is described.

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

• Cannot be provided. No test set or adjudication process is described.

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

• Cannot be provided. This device is a ceramic abutment, not an AI or imaging device. Therefore, an MRMC study is not relevant, and no such study was performed or reported.

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

• Cannot be provided. This device is a ceramic abutment, not an algorithm. Therefore, no standalone algorithm performance study was performed or reported.

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

• Cannot be provided. No study involving ground truth for performance evaluation is described.

8. The sample size for the training set

• Cannot be provided. As there is no AI component, and no performance study mentioned, there is no training set.

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

• Cannot be provided. As there is no AI component, and no performance study mentioned, there is no training set or ground truth for it.

Summary of Device Equivalence Argument (from the document):

The submission for the PrimaConnex® SD Esthetic Contour Zi Abutment demonstrates substantial equivalence to predicate devices (PrimaConnex RD and WD Esthetic Contour Zi Abutment (K072572), PrimaConnex Esthetic Contour Abutment (K051614), and PrimaConnex Ceramic Abutment (K062876)) based on the following:

• Intended Use: All devices share the same intended use: in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.
• Material: The new device and predicates are manufactured from the same material.
• Design: The new device incorporates the same design as the predicates.
• Packaging: The new device is packaged using the same materials and processes as the predicates.

Therefore, the "proof" that this device meets acceptance criteria is the argument of substantial equivalence to existing legally marketed devices, rather than a de novo performance study against defined acceptance criteria.

Ask a specific question about this device

The Lifecore PrimaConnex® CAD/CAM Abutment System is intended for use as an accessory to a Lifecore PrimaConnex endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. The copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae in the construction of single-unit cement retained restorations on Lifecore PrimaConnex CAD/CAM Abutments.

The PrimaConnex CAD/CAM Abutments and abutment-specific ceramic copings are placed onto the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations.

The abutments and copings are milled using computer-assisted technology that enables the creation of final abutments that are manufactured with specific geometry to meet individual anatomic variations in patient tooth and jaw structure.

This document describes a 510(k) premarket notification for the "Lifecore PrimaConnex® CAD/CAM Abutment System." This is a dental device, specifically an abutment and coping system for endosseous dental implants.

The information provided is primarily focused on establishing substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the US. It does not describe a study involving "acceptance criteria" in the sense of a diagnostic or AI-driven device's performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "study" referred to is a physical performance test for a mechanical device.

Here's an analysis based on the provided text, addressing your questions to the extent possible for this type of device submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device (dental abutment system), the "acceptance criteria" are related to mechanical strength and fatigue resistance, rather than diagnostic accuracy. The study mentioned is "Static and Dynamic Fatigue Testing of Endosseous Dental Implant Systems."

Note: The submission states that the device is "substantially equivalent" to predicate devices, meaning it meets the same functional and safety requirements, which includes performance under mechanical stress. The detailed results of the static and dynamic fatigue testing would be in "Attachment B," which is not provided.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the sample size for the static and dynamic fatigue testing. For physical testing of medical devices, sample sizes are typically much smaller than for clinical studies (e.g., a few units per test condition).
• Data Provenance: The testing was conducted by or for the manufacturer, Lifecore Biomedical, Inc. The country of origin of the data is implicitly the United States (Chaska, MN). The study is prospective in the sense that the tests were designed and executed to evaluate the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This question is not applicable to this type of device submission. The "ground truth" for a mechanical device is established by engineering standards and test methods (e.g., ISO, ASTM standards for dental implant systems) for static and dynamic fatigue, not by expert medical opinion on a diagnosis. The testing itself measures physical properties against these established engineering benchmarks.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for resolving disagreements among human readers or experts in diagnostic studies. For mechanical testing, the "adjudication" is based on whether the device passes the predefined physical test 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

This question is not applicable. This is a physical medical device (dental abutment), not an AI or diagnostic software device. Therefore, no MRMC study or AI-assistance comparison was conducted.

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

This question is not applicable. This is not an algorithm or AI-driven device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering standards and established physical test methods for dental implant systems, specifically related to static and dynamic fatigue strength. These standards define the acceptable performance limits for such devices.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of a physical medical device like a dental abutment. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set was Established

This question is not applicable. As there is no training set for this type of device.

Summary for K072241 (Lifecore PrimaConnex® CAD/CAM Abutment System):

This 510(k) submission successfully demonstrated substantial equivalence to predicate devices for a dental abutment system. The "study" referenced is focused on mechanical performance testing (static and dynamic fatigue) rather than clinical diagnostic accuracy or AI performance. The acceptance criteria and performance are based on engineering standards and physical test results, confirming the device's mechanical integrity and safety for its intended use, rather than a statistical evaluation of diagnostic accuracy.

Ask a specific question about this device

Lifecore's implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The PrimaSolo One-Piece (3.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for single-stage surgical procedure and is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

Lifecore Dental Implants are root-form, endosseous implants with a roughened surface. The modification proposed in this submission will modify the Resorbable Blast Media (RBM) implant surface to add a micro-texture surface morphology to the existing macrotexture. The change to the RBM surface will be incorporated into all Lifecore implant systems that have the RBM surface (Restore, Stage-1, Renova, PrimaSolo and PrimaConnex).

The provided text describes a 510(k) submission (K072768) for Lifecore Biomedical, Inc.'s dental implants with a surface modification. However, the document does not contain any information regarding specific acceptance criteria, device performance metrics, or details of a study (sample sizes, ground truth establishment, expert qualifications, etc.) that would prove the device meets such criteria.

The submission is a Special 510(k) for a surface modification, meaning the primary focus is on demonstrating substantial equivalence to a predicate device, not necessarily on new performance studies with quantitative acceptance criteria against reported performance metrics in the same way a de novo device might.

The document mainly focuses on:

• Identifying the submitter and device.
• Describing the device and the proposed surface modification (adding a micro-texture to existing macrotexture on RBM implants).
• Stating the intended use.
• Asserting substantial equivalence to predicate devices based on identical intended use, biocompatible materials, design, shelf life, packaging, and sterilization.
• The FDA's decision letter confirming substantial equivalence.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I describe a study that proves the device meets these criteria, as this information is not present in the provided text.

The text does not include:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for a test set, data provenance, or details of any specific study used to prove performance.
3. Number or qualifications of experts used for ground truth.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size for human readers.
6. Information on standalone algorithm performance.
7. The type of ground truth used (pathology, outcomes data, etc.).
8. The sample size for a training set.
9. How ground truth for a training set was established.

Ask a specific question about this device

The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

AutoPulse Resuscitation System Model 100 ("Device") is an automated, portable, battery powered device that compresses the chest of an adult human as an adjunct to manual CPR. The Device consists of a single use chest compression assembly (CCA) that includes a patient liner, and a reusable platform that contains a user control panel, a drive mechanism, a control system, and a power system (rechargeable battery).

This document is a 510(k) Summary for the AutoPulse® Resuscitation System Model 100, which is an external cardiac compressor. The summary primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, performance metrics, or study designs typically found in clinical validation studies.

Therefore, I cannot provide the requested information such as a table of acceptance criteria and reported device performance, sample sizes for test or training sets, data provenance, details on expert opinion for ground truth, or adjudication methods, as these details are not present in the provided text.

The document states that "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to the predicate device. Testing of the device modifications demonstrates the device meets and improves upon the predicate device." However, no specific performance metrics or the results of these tests are provided.

The provided text focuses on the regulatory submission process and the determination of substantial equivalence, rather than a clinical study evaluating defined performance criteria.

Ask a specific question about this device

PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

PrimaConnex Ceramic Abutments are intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.

This device is a ceramic abutment for dental implants and its approval is based on substantial equivalence to predicate devices, not on a study with specific acceptance criteria and performance metrics like those for AI/ML devices. Therefore, much of the requested information (sample size, expert ground truth, MRMC study, stand-alone performance, training set details) is not applicable to this type of medical device submission.

Here's a breakdown of the relevant information from the provided text, indicating why certain sections of your request cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided because a traditional "acceptance criteria" and "reported device performance" (in terms of sensitivity, specificity, accuracy, etc.) are not applicable for a device seeking substantial equivalence based on material and design similarities, rather than performance against a diagnostic or predictive task.

2. Sample size used for the test set and the data provenance

Not applicable. There was no "test set" in the context of evaluating an AI/ML device. The device is a physical component.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the sense of expert consensus on diagnostic labels, is not relevant for this type of device.

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. This device is not an AI/ML tool intended to assist human readers.

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. For this type of device, the "ground truth" is largely based on material properties, mechanical testing (which would be referenced in a more detailed submission, but not in this summary), and clinical experience with similar devices. The 510(k) summary focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" for physical medical devices like this.

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

Not applicable.

Summary of the Approval Basis for K062876:

The approval of the PrimaConnex® Ceramic Abutments is based on demonstrating substantial equivalence to predicate devices. This means the manufacturer showed that their new device is as safe and effective as a legally marketed device that is not subject to PMA (Pre-market Approval).

The arguments for substantial equivalence presented in the K062876 summary are:

• Identical Intended Use: The device shares the same intended use as some predicate devices.
• Identical Design: The device shares the identical design with one predicate (PrimaConnex Esthetic Contour Abutments).
• Identical Biocompatible Material: The device incorporates the identical biocompatible material as some predicate devices.
• Same Shelf Life: The device has the same shelf life as one predicate.
• Same Packaging and Sterilization: The device is packaged and sterilized using the same materials and processes as some predicate devices.
• Same Fundamental Scientific Technology: The device incorporates the same fundamental scientific technology as one predicate.

In essence, Lifecore Biomedical, Inc. successfully argued that the PrimaConnex® Ceramic Abutments are sufficiently similar to already approved devices in terms of function, materials, and manufacturing processes, and therefore do not raise new questions of safety or effectiveness.

Ask a specific question about this device

PrimaConnex Ceramic Copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae, in the construction of single-unit cement retained restorations.

The copings are designed to fit Lifecore's PrimaConnex Quick-Abutment.

Lifecore Biomedical PrimaConnex Ceramic Copings are pre-manufactured for use as a core structure in the construction of single-unit cement retained restorations. The Ceramic Copings will be offered in three sizes; Small Diameter (SD), Regular Diameter (RD), and Wide Diameter (WD) to fit with the corresponding PrimaConnex Quick-Abutments, previously cleared under K051614. The Ceramic Coping contains an internal flat for anti-rotation and is cemented onto the Quick-Abutment after completion of the prosthetic restoration.

The Ceramic Copings are manufactured from Yttria-Stabilized Tetragonal Zirconia (Y-TZP) in conformance with ISO Standard 13356, Implants for Surgery – Ceramic Abutments Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP).

The provided text is a 510(k) summary for a dental device, the Lifecore PrimaConnex™ Ceramic Coping. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with specific acceptance criteria, statistical analyses, or detailed performance metrics typically found in clinical trial reports for diagnostic or AI-driven devices.

Therefore, many of the requested elements (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, ground truth details, effect sizes) are not applicable or not present in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

Since this is a submission for a device component (ceramic coping for dental restorations) and the 510(k) process focuses on substantial equivalence, there are no explicit "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or reader agreement) in this document. Instead, the "acceptance criteria" can be inferred as demonstration of substantial equivalence to existing, legally marketed predicate devices, primarily based on material conformity and intended use.

The device performance is described in terms of its characteristics and conformity to standards, rather than clinical efficacy data.

Study Information

1. Sample size used for the test set and the data provenance:

   • Not applicable/Not provided. This is a material and design equivalence submission, not a study evaluating performance on a patient test set.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not provided.

3. Adjudication method for the test set:

   • Not applicable/Not provided.

4. 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 not an AI-driven device or a diagnostic device subject to MRMC studies.

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable. The "ground truth" equivalent for this type of submission is the established safety and effectiveness of the predicate devices and the conformity of the new device's material and design to relevant standards which ensures performance comparable to the predicates without raising new safety/effectiveness concerns.

7. The sample size for the training set:

   • Not applicable/Not provided.

8. How the ground truth for the training set was established:

   • Not applicable/Not provided.

Ask a specific question about this device

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:

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.

Ask a specific question about this device

Lifecore Biomedical Dental Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The PrimaConnex™ Internal Connection Implant is a threaded implant that is intended for immediate placement and can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.

The PrimaConnex Internal Connection Implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction into the extraction socket.

The PrimaConnex Internal Connection Implant is intended for immediate provisionalization with non-occlusal load. Immediate Provisionalization is described by the International Congress of Oral Implantologists (ICOI) as a clinical protocol or the placement of an interim prosthesis with or without occlusal contact with the opposing dentition at the same critical visit of implant placement. The PrimaConnex Internal Connection Implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.

The Lifecore Biomedical PrimaConnex Internal Connection Implant System consists of two-stage, root-form tapered and straight-walled threaded dental implants and associated abutment systems, which provide the clinician with screw-retained, cement-retained, and overdenture abutments. The system also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauges, abutment drivers, latch-type drivers, and hand-piece adapters. Lifecore PrimaConnex implants are available with a Resorbable Blast Media (RBM) roughened surface. All implants have an internal connection as an anti-rotational feature for the prosthetics.

This 510(k) premarket notification for the Lifecore PrimaConnex™ Internal Connection Implant System does not include a study with acceptance criteria and device performance results as typically requested for AI/ML device submissions. Instead, it demonstrates substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested sections (e.g., acceptance criteria, test set sample size, ground truth details, MRMC study, standalone performance) are not applicable or cannot be extracted from the provided text. The document focuses on comparing the new device's design, materials, intended use, and general characteristics to existing FDA-cleared dental implants to show that no new questions of safety or effectiveness are raised.

Here's an attempt to address the prompts based on the available information, noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. For a device showing substantial equivalence, specific "acceptance criteria" and direct "device performance" in the context of a new study are typically not presented in this format. The acceptance is based on demonstrating similarity to predicates.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable/not provided. There is no "test set" in the context of a new performance study described. The 510(k) relies on comparison to predicate devices, not on new clinical performance data with a specific test cohort.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/not provided. Since no new clinical study with a "test set" is described, there's no ground truth established by experts for performance evaluation.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no "test set" or adjudication process described.

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 or described in this 510(k) submission. The submission is based on demonstrating substantial equivalence to predicate devices, not on a new comparative effectiveness study.

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

This information is not applicable/not provided. The device is an endosseous dental implant system, which is a physical medical device, not an AI/ML algorithm. Therefore, "standalone algorithm performance" is not relevant here.

7. The Type of Ground Truth Used

This information is not applicable/not provided. As no new performance study is described, there is no "ground truth" established for the device's performance in the context of this 510(k) summary. The "truth" for substantial equivalence is based on established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a physical dental implant, not an AI/ML system. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided. As explained above, there is no "training set" for this device.

Summary of the 510(k) Submission:

The provided document is an Abbreviated 510(k) Premarket Notification for the PrimaConnex™ Internal Connection Implant System. This type of submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than providing extensive new clinical study data with detailed performance metrics and acceptance criteria.

Key points from the document indicating an equivalence approach:

• Section 5. Substantial Equivalence Comparison: This section explicitly states the purpose is to compare the new device to identified predicates.
• The document highlights similarities in:
  • Intended Use: "The PrimaConnex Internal Connection Implant System has a substantially equivalent intended use as the identified predicates."
  • Fundamental Scientific Technology: All are "threaded, root form implants constructed of titanium."
  • Size and Materials: "similar in size and materials."
  • Sterilization: "sterilized via gamma irradiation and intended for single use only."
  • Instrumentation: "include instruments to assist with the implant procedure."
• Conclusion: "When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaConnex Internal Connection Implant System."

The FDA's response (SEP - 9 2005 letter) confirms this: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

Therefore, the "study" proving the device meets "acceptance criteria" here is the comparison to established predicate devices, and the "acceptance criteria" is essentially demonstrating that the new device is as safe and effective as the predicates, raising no new safety or effectiveness concerns. No specific quantitative performance metrics beyond this comparison are presented in the provided text.

Ask a specific question about this device

Lifecore Biomedical Dental Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

Specific Intended Uses: The PrimaSolo One-Piece (3.5 – 5.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for single-stage surgical procedure and cemented restorations. It is intended for immediate placement and can be restored with a temporary prosthesis in single tooth applications with good quality bone.

The PrimaSolo One-Piece (3.0mm) Implant is a threaded one-piece implant with an integrated abutment designed for Single-Stage procedure and is indicated for use in the treatment of missing maxillary lateral and mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The implants must be splinted if using two or more 3.0mm implants adjacent to one another.

The Lifecore PrimaSolo™ One-Piece Implant System is a one-piece implant incorporating both the implant and the abutment into one piece of machined titanium allov. It is designed for one-stage surgical procedures and utilizes cement-retained restorations. It is designed to be used for immediate placement and temporization on single and multiple-tooth restorations. The system also includes healing caps and surgical instrumentation: tissue punches, twist drills, surgical taps, parallel pins, try-ins, surgical depth probe, latch-type implant drivers, and ratchet adapters . Lifecore PrimaSolo One-Piece Implants are available with a Resorbable Blast Media (RBM) roughened surface.

This 510(k) premarket notification is for the Lifecore PrimaSolo™ One-Piece Implant System, a dental implant system. The document does not contain details about specific acceptance criteria, device performance results, or a clinical study in the way one would typically describe for AI/software-as-a-medical-device.

Instead, this document focuses on demonstrating substantial equivalence to previously marketed predicate devices, which is the primary pathway for 510(k) clearance for medical devices like this.

Based on the provided text, here's a breakdown of what can be extracted and what cannot:

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

This information is not present in the provided document. The 510(k) pathway for traditional medical devices like implants often relies on demonstrating that the new device has the same technological characteristics and intended use as predicate devices, or that any differences do not raise new questions of safety or effectiveness. This typically involves performance bench testing (e.g., mechanical strength, fatigue, biocompatibility) and sometimes animal or limited human studies, but the specific acceptance criteria and results of such tests are not detailed in this summary document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not present. As this is not a study evaluating an AI/ML algorithm or a complex diagnostic device in the way implied by these questions, there is no "test set" in that context. The substantial equivalence argument relies on comparison to predicate devices, material testing, and design specifications.

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 present. "Ground truth" in the context of expert consensus is not applicable here as there is no diagnostic or interpretive task being performed by an algorithm.

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

This information is not present.

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:

This information is not present. This is not an AI-assisted device, so an MRMC study related to human reader improvement is irrelevant.

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

This information is not present. This is a physical medical device, not an algorithm.

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

This information is not present.

8. The sample size for the training set:

This information is not present. There is no "training set" as this is not an AI/ML device.

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

This information is not present.

Summary of what the document does provide regarding "acceptance criteria" and "study":

The "acceptance criteria" for this device, as per the 510(k) pathway, implicitly revolve around demonstrating substantial equivalence to predicate devices in terms of:

• Intended Use: The PrimaSolo™ One-Piece Implant System has a "substantially equivalent intended use" to its listed predicate devices (Section 5).
• Technological Characteristics: The device and predicates are "similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with roughened surfaces." They are "similar in size and materials" (Section 5).
• Safety and Effectiveness: "When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaSolo One-Piece Implant System" (Section 5).

The "study" that proves the device meets these (implicit) acceptance criteria is the 510(k) premarket notification itself, which presents the comparison between the new device and the legally marketed predicate devices. The FDA's clearance letter (pages 3-5) confirms that they have "reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent...".

In essence, for this type of device and submission, the "proof" is the successful argument of substantial equivalence to existing devices that have already been deemed safe and effective for their intended use. This typically involves:

• Engineering analysis
• Materials testing
• Biocompatibility testing
• Mechanical property testing (e.g., fatigue, fracture resistance)

However, the specific data from such tests and the quantitative acceptance criteria for those tests are beyond the scope of this summary document.

Ask a specific question about this device

CalMatrix Calcium Sulfate Bone Graft Binder, when mixed with allograft or other bone Gallwathx Calcium Oulfato Drives of maxillary and mandibular osseous and periodontal defects such as:

• Intrabony/infrabony defects .
• Furcation defects .
• Recession defects .
• Dehiscence/fenestration defects (natural teeth and prosthetic root form implants) ●
• Extraction socket (ridge preservation) defects .
• Ridge augmentation defects .
• Sinus lift defects .
• Endodontic bony defects .

Lifecore Biomedical Calcium Sulfate Bone Graft Binder (CalMatrix) is a calcium sulfate material that contains resorbable surgical grade plaster of paris with approximately 10% of a pharmaceutical grade sodium carboxymethylcellulose (CMC).

The Binder is a white, free-flowing powder. Calcium sulfate (CS) hemihydrate and PHARMACEUTICAL grade sodium carboxymethylcellulose are commercially available as raw materials for use in several orthopedic and dental devices. Calcium sulfate/CMC, when used in conjunction with demineralized bone matrix (DBM), controls the particles in the bony defect where bony walls may be insufficient to stabilize the graft. It increases the graft volume, and reduces particle migration during the early healing phase. CalMatrix remains pliable after mixing which allows the clinician an extended time period to complete the bone regeneration procedure.

The CalMatrix™ Calcium Sulfate Bone Graft Binder 510(k) submission (K041324) does not present acceptance criteria or a study directly proving the device meets specific performance criteria in the way typically seen for diagnostic or AI-driven medical devices. Instead, the submission focuses on establishing substantial equivalence to legally marketed predicate devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission does not define specific quantitative acceptance criteria or present a table of device performance against such criteria. The "performance data" section describes animal studies confirming biocompatibility and new bone growth, but these are not framed as meeting pre-defined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. There isn't a "test set" in the context of evaluating a diagnostic or AI device's performance metrics. The "animal studies" involved "animal models," but the specific number of animals or defects is not provided.
• Data Provenance: The animal studies were conducted using calcium sulfate/CMC with and without DBM. The country of origin is not specified, but the submission is to the US FDA. The studies appear to be prospective to evaluate the biocompatibility and bone growth response of the material. "Clinical use of this product was evaluated in animal and human studies," but details on the human studies are not provided in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. There is no "ground truth" establishment in the context of diagnostic assessment for this type of device submission. The animal studies would likely have involved veterinary pathologists or orthopedic surgeons assessing findings.

4. Adjudication Method for the Test Set

Not applicable. No diagnostic test set or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is relevant for evaluating human reader performance with and without AI, which is not the focus of this device submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI/algorithm-driven device.

7. Type of Ground Truth Used

For the animal studies, the "ground truth" would implicitly be histopathology and radiographic assessment to confirm "new bone growth" and "no inflammatory or foreign body response."

8. Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-driven device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of the Device's "Proof" of Meeting "Acceptance Criteria" (Substantial Equivalence Approach):

The "acceptance criteria" for the CalMatrix™ Calcium Sulfate Bone Graft Binder are implicit in the substantial equivalence pathway for FDA 510(k) clearance. The manufacturer's proof that the device meets these (unwritten) criteria is based on:

• Technological Characteristics Comparison: CalMatrix is composed of calcium sulfate hemihydrate with carboxymethylcellulose (CMC). It is compared to:
  • CAPSET Calcium Sulfate Bone Graft Barrier (K955096): Also composed of calcium sulfate hemihydrate.
  • ALLOMATRIX® Putty (K020895): Utilizes the same calcium sulfate (CS)/CMC blend.
    The primary difference is that ALLOMATRIX comes pre-mixed with DBM, while CalMatrix is mixed by the clinician. The submission argues they are substantially equivalent in "mechanical characteristics, product configuration, anatomical site, safety characteristics, and sterilization."
• Intended Use Comparison: The indications for use for CalMatrix are explicitly stated as "the same as CAPSET" and are for treating multiple types of maxillary and mandibular osseous and periodontal defects.
• Performance Data (Biocompatibility and Bone Growth):
  • Animal Studies: These studies demonstrated that the materials (calcium sulfate/CMC, with and without DBM) were well tolerated, showing "no inflammatory or foreign body response," and "substantial new bone growth" in filled defects. While not providing specific quantitative acceptance thresholds, these findings support the material's safety and efficacy for its intended use, aligning with the expected performance of predicate devices.
  • Historical Use: The submission heavily relies on the "well-documented" historical use and established biocompatibility of calcium sulfate (Plaster of Paris) and the widespread use and known biocompatibility of sodium carboxymethylcellulose (CMC) in medical devices. This serves as a significant part of the "proof" for safety and general expected performance.
• Conclusion of Equivalence: The manufacturer concludes that the data supports substantial equivalence based on indications for use, product design and configuration, and materials used, directly comparing it to the specified predicate devices.

In essence, the "study" demonstrating that CalMatrix meets its "acceptance criteria" is the presentation of comparative analysis, biocompatibility data from animal studies, and reliance on the long-standing safety and efficacy profile of its constituent materials (calcium sulfate and CMC) in comparison to predicate devices, rather than a prospective study against novel, quantitatively defined performance metrics.

Ask a specific question about this device