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SuperLine® implants are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine® implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Single tooth cases on 7 mm length implants are indicated for delayed loading.

The purpose of this submission is to add dental implants to the SuperLine components cleared in K160965. This submission includes two series of implants: SuperLine FXSxxxxB Series and SuperLine FXSxxxx Series.

The FXSxxxB Series has a machined collar height that ranges from 0.03 mm (on the 3.6 mm body diameter implant) to 0.6 mm (on the 5.0 mm body diameter implant). All FXSxxxxB Series implants have an endosseous length of 7 mm, and threaded lengths ranging from of 6.98 mm to 6.4 mm. Other than the endosseous length of 7 mm, the subject device FXSxxxB implants are identical in design and sizes to SuperLine implants cleared in K160965.

The FXSxxxx Series has machined collar 1.5 mm in height for all implant body diameter sizes. For body diameters 4.0 mm to 5.8 mm, the collar has a reverse taper. All FXSxxxx Series implants have an endosseous length of 7 mm, and a threaded length of 5.5 mm. The FXSxxxx series implant design has not been cleared previously by FDA for any body diameter or length.

All subject device implants are manufactured from the same unalloyed titanium conforming to ASTM F67 and have the same surface treatment (S.L.A., Al2O3 blasted and acid etched) as the dental implants cleared in K160965.

All subject device implants are compatible with previously-cleared abutments and prosthetic components from Dentium Co., Ltd., including those cleared in K192436, K141457, and K041368.

The provided document is a 510(k) summary for a medical device (SuperLine dental implants) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document discusses substantial equivalence to predicate devices based on non-clinical data and design comparisons.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study demonstrating device performance against those criteria.

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Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.

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This document is a 510(k) clearance letter for "Dentium Implantium® & SuperLine® Prosthetics." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets them.

The letter primarily focuses on:

• Confirming the substantial equivalence determination.
• Outlining regulatory compliance requirements for the manufacturer.
• Identifying the product code and classification.
• Stating the intended use of the device ("intended for use as an aid in prosthetic rehabilitation").

Therefore, I cannot provide the requested information based on the text provided. This type of regulatory document typically follows the completion of such studies, but does not detail the studies themselves.

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SuperLine is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Not Found

This document is a 510(k) clearance letter for a dental implant device called "SuperLine." It mostly contains regulatory information and does not describe any specific studies or performance criteria in the detail requested. The 510(k) process primarily confirms substantial equivalence to a predicate device, not necessarily extensive clinical performance testing with defined acceptance criteria in the manner of a new drug or novel medical device requiring broad clinical trials.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• This document does not contain a table of acceptance criteria or reported device performance metrics like sensitivity, specificity, AUC, or similar statistical measures. The 510(k) clearance process often relies on testing for substantial equivalence, which may involve bench testing and comparisons to a predicate device's design and materials, rather than detailed clinical performance metrics with defined acceptance criteria against a ground truth as would be seen in AI/CADe device submissions.

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

• Not specified. The document does not describe a clinical test set or its provenance.

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

• Not specified. The document does not describe a test set or ground truth establishment.

4. Adjudication method for the test set:

• Not specified. The document does not describe a test set or adjudication method.

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 an endosseous dental implant, not an AI or CADe system designed to assist human readers. Therefore, an MRMC study with AI assistance is not relevant to this product.

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

• Not applicable. This device is a physical dental implant, not an algorithm.

7. The type of ground truth used:

• Not specified. The document does not describe any ground truth. For a physical implant, "ground truth" related to its performance would typically involve measures of biocompatibility, mechanical strength, osseointegration, and clinical success over time, which are implied by substantial equivalence to a predicate device rather than explicitly detailed here.

8. The sample size for the training set:

• Not applicable/Not specified. This document is for a physical medical device, not an AI model requiring a training set.

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

• Not applicable/Not specified. This document is for a physical medical device, not an AI model.

In summary: The provided document is a regulatory clearance letter for an endosseous dental implant. It confirms the device's substantial equivalence to a legally marketed predicate device, enabling its market access. It does not contain the kind of detailed study design, acceptance criteria, or performance data typically associated with a new AI/CADe device or a clinical trial report. The information requested aligns more with performance evaluations of diagnostic software or AI-powered medical devices.

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Dentium Implantium® & SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Dentium Implantium® / SuperLine® Prosthetics are intended for use as an aid in prosthetic rehabilitation. They consist of Dual Milling Abutment, Dual Abutment, Angled Abutment, Temporary Abutment, Direct-Casting Abutment and Metal Casting Abutment.

They are supplied non-sterile and sterilized by the recommended sterilization method in user's manual.

The materials of the Implantium & SuperLine Prosthetics are as follows; Pure Titanium Grade 4: Dual Milling Abutment, Dual Abutment, Angled Abutment and Temporary Abutment.

Co-Cr-Mo alloy (conform to ASTM F799) and Polyacetal (POM): Metal Casting Abutment,

Gold Alloy and Polyacetal (POM): Direct Casting Abutment.

This document is a 510(k) premarket notification for a dental prosthetic device, not an AI software. Therefore, the requested information about acceptance criteria, study design referencing AI/ML performance, and related ground truth establishment methods is not present in the provided text.

Specifically, the document focuses on demonstrating substantial equivalence of the Dentium Implantium® & SuperLine® Prosthetics to legally marketed predicate devices based on:

• Indications for Use: The devices are intended as an aid in prosthetic rehabilitation, matching the predicate devices.
• Design and Materials: Similarities in materials (Pure Titanium Grade 4, Co-Cr-Mo alloy, Gold Alloy, Polyacetal) and general shapes are emphasized. Minor differences in dimensions (total length, diameter, hex height) are noted but deemed not to affect application.
• Performance Bench Testing: Biocompatibility testing (ISO 10993-1) and mechanical performance testing (ISO Static compressive, ISO Fatigue, Corrosion Testing, Adaptation Accuracy) are reported.
• Non-clinical Testing: This includes "Reliability Calculation and Testing," "Fatigue Strength Testing," and "Static Load Failure Testing" in accordance with FDA guidance for dental implants/abutments.

The provided text does not contain:

• Any mention of acceptance criteria or performance metrics related to an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
• Details on a test set's sample size for an AI/ML model, its provenance, or how ground truth was established by experts.
• Information on Multi-Reader Multi-Case (MRMC) studies or human-in-the-loop performance with AI assistance.
• Details about training sets for an AI/ML model.

Therefore, I cannot provide the requested table or study details specific to AI/ML device performance. The information in the document pertains to the physical and material characteristics and safety/performance of a traditional medical device (dental prosthetics).

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Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Dentium Implantium and SuperLine Abutments are intended for use an aid in prosthetic rehabilitation. The abutments were originally cleared under 510(k) K041358. The modified designs proposed in this submission consist of the Angled Screw Abutment, Cover Screw, and Screw Abutment Cylinders. Abutments are supplied non-sterile and autoclaved by the end user.

This document describes the Dentium Implantium® and SuperLine® Abutments, which are dental abutments. The information provided focuses on the device's technical specifications and performance testing, rather than a study on an AI/ML-driven device with acceptance criteria typically associated with diagnostic algorithms.

Therefore, the requested information on acceptance criteria, reported device performance, sample sizes for test and training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable in the context of an AI/ML evaluation study.

The document discusses performance testing in a general device context, not related to an AI/ML algorithm's diagnostic accuracy. It uses "acceptance criteria" in the sense of the device meeting established specifications through bench testing and biocompatibility assessments, rather than diagnostic performance metrics like sensitivity or specificity.

Here's a breakdown of the available information, noting where the requested AI/ML specific details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional medical device (dental abutments), the "acceptance criteria" are related to mechanical and biological performance, not diagnostic accuracy.

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

• Test Set Sample Size: Not specified in terms of number of cases/patients. The "test set" here refers to physical abutment samples used for bench testing.
• Data Provenance: Not applicable in the context of patient data. The testing was conducted on device samples.

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

• Number of Experts: Not applicable. Ground truth for dental abutment performance (e.g., fatigue failure) is established through standardized engineering tests, not expert interpretation of cases.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Bench tests have objective Pass/Fail criteria based on physical and material properties.

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

• MRMC Study: No. This is not an AI/ML device.

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

• Standalone Performance Study: No. This is not an AI/ML device.

7. The type of ground truth used

• Type of Ground Truth: For biocompatibility, it's based on biological response to material samples (e.g., cell viability, immune reaction). For mechanical performance, it's based on physical failure thresholds and material integrity standards (e.g., absence of fracture after specified cycles, material composition specified by ASTM standards).

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires training data.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

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The DANA Diabecare® II external programmable syringe infusion pump and the SUPERLINE-EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets are indicated for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pump and administration sets are not intended for use with blood or blood products.

The DANA Diabecare® II insulin pump, SUPERLINE-EasyRelease (EasyRelease) Infusion Set, and Soft-Release Infusion Sets are modifications of the DANA Diabecare® insulin pump and SUPERLINE infusion set that were described in K001604, the 510(k) premarket notification for the DANA Diabecare® insulin infusion pump. The modifications made to the parent DANA Diabecare® insulin pump to produce the modified DANA Diabecare® II Insulin Pump were limited to software modifications including changes to the basal and bolus insulin delivery modes. features accessed via the password-protected (lock-out) mode, and the addition of alarms, a fail-safe function, and the ability to store and retrieve information (alarm, bolus dose, daily insulin dose). The overall design of the proposed EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets is identical to the design of the parent SUPERLINE Infusion Set. The design modifications are limited to the following: - Addition of a site for disconnecting the insulin pump from the infusion set . without removing the needle from the abdomen - Replacement of the infusion needle with an indwelling soft cannula (Soft-. Release-R and Soft-Release-ST only) The two versions of the Soft-Release Infusion Sets differ in the design of the detachment site and cannula assembly. The Soft-Release-R Infusion Set has a sliding lock detachment site and a "rectangular" cannula oriented perpendicular to the infusion tubing axis. The Soft-Release-ST has a turning screw lock detachment site that uses a conical fitting and a straight cannula oriented parallel to the infusion tubing axis. There are minor differences in the materials used for the construction of the proposed EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets as compared to the parent SUPERLINE.

Here's an analysis of the provided text regarding the DANA Diabecare® II Insulin Pump and SUPERLINE Infusion Sets, focusing on acceptance criteria and supporting studies:

It's important to note that the provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full, detailed study report with extensive acceptance criteria and performance statistics like a PMA. Therefore, some of the requested information (especially quantitative data, training set details, or complex study designs like MRMC) is not explicitly present or as detailed as one might expect in a scientific publication.

Acceptance Criteria and Reported Device Performance

The document describes several performance tests and their outcomes, which serve as the acceptance criteria for ensuring the modifications made to the device still meet safety and effectiveness standards.

Additional Information on the Study (if available)

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

   • The document does not explicitly state the sample sizes for the burst, bioburden, insulin potency, or shelf-life testing. These would typically be determined by statistical methods or regulatory guidance for such tests.
   • The data provenance (e.g., country of origin, retrospective/prospective) is not specified. Given the manufacturer is from Korea, it's likely the testing was performed there or by a contract lab; however, this is not confirmed in the text. This is a design verification activity, not a clinical trial.

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

   • This question is not applicable to the described performance testing. The "ground truth" for burst, bioburden, and insulin stability tests is typically established through objective measurements against defined chemical, physical, and microbiological standards, not relying on expert interpretation in the same way as, for example, image interpretation in a diagnostic device.

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

   • This question is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, where there might be disagreement. These are objective engineering and laboratory tests.

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:

   • This is not applicable as this device is an insulin pump and infusion set, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was mentioned or would be relevant.

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

   • Not applicable as this is a medical device (pump and infusion sets), not a standalone algorithm or AI. While the pump has software with algorithms, the "standalone" performance here relates to the device's functional integrity (e.g., accurate insulin delivery, absence of leaks), not an AI's interpretative power.

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

   • For the described tests:
     • Biocompatibility: Ground truth is established by adherence to ISO 10993-1 standards and validated laboratory test results (e.g., cytotoxicity assays, sensitization tests).
     • Burst Testing: Ground truth is the physical presence or absence of leakage under specified pressure.
     • Bioburden Testing: Ground truth is the microbiological count meeting sterility assurance levels.
     • Insulin Potency Assay: Ground truth is the measured concentration/activity of insulin remaining relative to a control or baseline, determined by validated chemical assays.
     • Shelf-Life Testing: Ground truth is the maintenance of all specified performance criteria (e.g., sterility, dimensional stability, material integrity, functional operation) over the stated period.
   • These are all objective, laboratory-based measurements against established scientific and regulatory standards.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning model, so there is no "training set." The development of the device involves engineering design, material selection, and verification testing.

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

   • Not applicable, as there is no training set for this type of device.

In summary: The provided 510(k) summary focuses on demonstrating the safety and effectiveness of the physical device modifications through performance testing against established engineering and regulatory standards (e.g., biocompatibility, physical integrity, stability). It does not involve AI or diagnostic interpretations, thus many of the questions related to AI/algorithmic performance, human readers, and ground truth in that context are not relevant to this submission.

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