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Steri-Oss' ImProv Temporary Dental Cement is intended for cementing (luting) of crown and bridge prostheses to natural tooth abutments.

Steri-Oss' ImProv Temporary Dental Cement serves as a cement for the temporary retention of crown and bridge prostheses. The cement is an anaerobic two part paste which self-cures upon mixing. The product is provided in two syringe-like cylinders made of a polyalkylene material, one containing 10 grams of cement Part A and one containing 10 grams of cement Part B.

The provided text is a 510(k) submission for Steri-Oss' ImProv Temporary Dental Cement. In this type of submission, the manufacturer claims substantial equivalence to previously cleared predicate devices, rather than conducting new performance studies against specific acceptance criteria.

Specifically, the document states: "Performance Data: Not applicable". This means that the submission does not include primary data from a study designed to meet specific acceptance criteria for the device's performance. Instead, substantial equivalence is claimed based on similar technological characteristics (e.g., curing type, system, cement base) to the predicate devices.

Therefore, I cannot provide the requested information for the following points as no such study or acceptance criteria are described in the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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The intended use for these devices is to serve as support for prosthetic devices to restore patient chewing function.

The Steri-Oss Replace Cylindrical Implant is designed to serve as support for prosthetic devices to restore patient chewing function. Natural dentition is composed of a root (subgingival) and a crown (supragingival). The implant is designed to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial dentition and the prosthetic device is designed to serve as the crown. The implants are 3.25, 4.3, 5.0 or 6.0 mm in diameter and from 10 - 16 mm in length and are composed of titanium. They are tapered, cylindrical and have a hexed head. The implants may be non-coated or coated (HA or TPS). The Replace Cylindrical Implants utilize color coding.

The provided document is a 510(k) premarket notification for a medical device (Steri-Oss Replace Cylindrical Implants). It does not contain any information about acceptance criteria or a study proving device performance against such criteria.

The document states "Performance Data: Not applicable" (page 2 of 2 in {1}). This indicates that no specific performance studies were included or deemed necessary for this particular 510(k) submission, likely because substantial equivalence was claimed to a predicate device based on material, sterility, intended use, and general characteristics, rather than new performance claims requiring extensive testing.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and performance studies based on the provided text.

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The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.

This device is designed to serve as support for prosthetic devices to restore patient chewing function. This implant is 3.25 mm in diameter, 10 to 16 mm in length, and is fabricated from titanium alloy. They are threaded and have a superior external hex. The threaded portion of the implant body has a 50 micron thick plasma sprayed hydroxyapatite coating, and the surface of the external hex is anodized magenta in color.

The provided text is a 510(k) summary for a dental implant device and does not contain information about acceptance criteria, performance studies, or clinical trial results that would typically be found for a medical diagnostic device. It focuses on demonstrating substantial equivalence to a predicate device.

Therefore, the requested information cannot be extracted from the provided text.

Here is why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: The document does not define any acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or report performance metrics from a study.
2. Sample size used for the test set and the data provenance: There is no mention of a "test set" or any data used for evaluating the device's performance.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as no ground truth was established for a performance study.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states "Performance Data: Not applicable," which means no such study was conducted or provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as this is a physical medical device, not a diagnostic algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Device description (material, dimensions, coating).
• Intended use (support for prosthetic devices to restore patient chewing function).
• Comparison to predicate devices to establish substantial equivalence based on technological characteristics (material, surface characteristics, sterility).
• The FDA letter confirms substantial equivalence without requiring performance data for this specific type of submission.

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The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.

Steri-Oss 3.25 mm Replace Implant: This device is designed to serve as support for prosthetic devices to restore patient chewing function.
This implant is 3.25 mm in diameter, 10 to 16 mm in length, and is fabricated from titanium allov. They are threaded and have a superior external hex. The threaded portion of the implant body has a 50 micron thick plasma sprayed titanium powder coating, and the surface of the external hex is anodized magenta in color.

The provided text describes a 510(k) submission for a dental implant and explicitly states "Performance Data: Not applicable." This indicates that no specific studies proving the acceptance criteria for the device were conducted or required for this particular submission. The submission relies on claiming substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because the document clearly states that performance data is not applicable.

However, if this were a different kind of medical device submission where performance data was applicable, here's how I would structure the answer based on your request, using placeholders for the missing information:

Acceptance Criteria and Study to Prove Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: [Number of samples/cases, e.g., "500 images", "100 patient records"]
• Data Provenance: [e.g., "Retrospective, collected from [Country/Countries]] hospitals between [Start Date] and [End Date].", "Prospective, collected from [Country/Countries] in a multi-center study from [Start Date] to [End Date]."]

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

• Number of Experts: [e.g., "3 experts"]
• Qualifications of Experts: [e.g., "Board-certified Radiologists with an average of 15 years experience, specializing in neurological imaging.", "Pathologists with over 10 years of experience in oncological pathology.", "Clinical neurologists with at least 5 years of post-residency experience."]

4. Adjudication method for the test set

• Adjudication Method: [e.g., "2+1 adjudication method, where two experts independently reviewed each case, and a third, more senior expert adjudicated any disagreements.", "3+1 adjudication method, with three independent reviewers and a fourth senior reviewer for discordance.", "Consensus panel of X experts after independent review.", "No adjudication; single expert review."]

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 Conducted?: [Yes/No]
• Effect Size (if Yes): [e.g., "Human readers' diagnostic accuracy improved by an average of X% (e.g., 5% increase in AUC from 0.85 to 0.90) when using AI assistance compared to without AI assistance (p < 0.001).", "The sensitivity of human readers increased by X% and specificity by Y% with AI assistance."]

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

• Standalone Performance Study Conducted?: [Yes/No]

7. The type of ground truth used

• Type of Ground Truth: [e.g., "Pathology confirmed diagnosis (gold standard).", "Expert consensus among a panel of X specialists.", "Follow-up clinical outcomes data.", "Surgical confirmation.", "Independent imaging modality (e.g., MRI as ground truth for CT)."]

8. The sample size for the training set

• Training Set Sample Size: [Number of samples/cases, e.g., "10,000 images and their corresponding labels."]

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

• Training Set Ground Truth Establishment: [e.g., "Ground truth for the training set was established by a single expert radiologist from de-identified clinical reports and images.", "Automated extraction from electronic health records, followed by expert validation of a subset for quality control.", "Crowdsourcing annotations with a physician oversight for quality checks."]

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The intended use for this device system is to serve as support for prosthetic devices to restore patient chewing functions.

Individual components fulfill the following purposes:

Steri-Oss 3.25 mm Replace Implant: This device is designed to serve as support for prosthetic devices to restore patient chewing function.

Steri-Oss 3.25 mm Replace Healing Screw: This device is designed to protect the internal threads of the implant during healing.

Steri-Oss 3.25 mm Replace Healing Abutment: This device is designed to expand the gingival tissue during the healing phase to maintain the appropriate abutment fit.

Steri-Oss 3.25 mm Replace Abutment: This device is designed to serve as a base for prosthetic devices which restore patient chewing function.

The implants are 3.25 mm in diameter, are 10 to 16 mm in length, and are fabricated from titanium alloy. They are tapered, threaded, and have a superior external hex. The healing screw, healing abutment, and abutment are also fabricated from titanium alloy. Portions of the surface of each of the components are anodized magenta in color.

This looks like a 510(k) summary for a medical device (Steri-Oss 3.25 mm Replace Dental Implant System) seeking substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics.

Therefore, the requested information elements (acceptance criteria table, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are not present in the provided text. The document states "Performance Data: Not applicable" which indicates that a detailed performance study as you've requested was not submitted or deemed necessary for this 510(k) clearance due to the nature of the device and its claimed substantial equivalence to existing predicate devices.

The general structure of a 510(k) summary usually involves comparing the new device to a legally marketed predicate device(s) in terms of intended use, technological characteristics, and safety and effectiveness. If the new device is substantially equivalent to a predicate, specific performance acceptance criteria and detailed study results might not be required in the same way as for a novel device undergoing a PMA (Premarket Approval) process.

Based on the provided text, here's what can be extracted:

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

• Not applicable. The document states "Performance Data: Not applicable." The submission focuses on demonstrating substantial equivalence to predicate devices based on material, surface characteristics, and sterility, rather than meeting specific performance criteria through a new study.

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

• Not applicable. No test set or related performance data is mentioned.

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

• Not applicable. No test set or ground truth establishment process is described.

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

• Not applicable. No test set or adjudication method 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:

• Not applicable. This device is a dental implant system, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

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

• Not applicable. This is not an algorithm-based device.

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

• Not applicable. No ground truth is established for performance testing. Substantial equivalence is claimed based on comparison to predicate devices.

8. The sample size for the training set:

• Not applicable. No training set is mentioned as this is a physical medical device, not a machine learning model.

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

• Not applicable. No training set or ground truth establishment is mentioned.

Summary of what is provided regarding comparison:

The document focuses on a comparison to predicate devices to establish substantial equivalence.

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The cement is indicated for use in the cementing (luting) of a implant prosthesis.
Steri-Oss Until . Implant Cement is indicated_ for .... cementing (luting) of a implant prosthesis.

The Steri-Oss Until Implant Cement serves as a cement for retention of armund on mixing cement serves as a cement roll - that is self cured on mixing The cement is a cwo pars pars provided in two 10 gram containers of polyalkylene material.

The provided text is a 510(k) submission for the Steri-Oss Until Implant Cement. It details the device's description, intended use, and comparison to a predicate device for substantial equivalence. However, this document does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot provide the requested information from the given input. The 510(k) summary focuses on demonstrating equivalence to a predicate device rather than presenting performance data against predefined acceptance criteria from a specific study.

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The intended use of Steri-Oss' Bio-Esthetic Indirect Abutment, an abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous or partially edentulous patient) can be attached, yet remain retrievable.

How device functions: The Steri-Oss Lingual Bio-Esthetic Indirect Abutment is designed to be used in conjunction with endosseous implants as part of a system to provide support for prosthetic appliances to restore patient chewing function, and includes utilization of a lingual refaining screw for abutment retention which allows retrievability.

Scientific concepts; Natural dentition is composed of a root (subgingival) and a crown (supragingival). Implant system designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The abutment must be securely fastened to the implant. A lingual retaining screw may be used for this purpose, while retaining retrievability.

Characteristics: The Bio-Esthetic Indirect Abutment is a conventional abutment designed for use with a lingual screw which, when tightened, retains the abutment in place.

Here's a breakdown of the requested information based on the provided 510(k) summary for the Bio-Esthetic Indirect Abutment:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The 510(k) submission states: "Performance Data: Not applicable." This explicitly indicates that no performance study (clinical or non-clinical) was conducted or provided to demonstrate that the device meets specific acceptance criteria in the traditional sense of a study with defined endpoints and statistical analysis.

Instead, the submission relies on the concept of substantial equivalence to a predicate device (Friatec's "Frialit-2 MH-6 Abutment"). The acceptance criteria are implicitly met by demonstrating that the new device has the same or similar technological characteristics and intended use as the legally marketed predicate device, and does not raise different questions of safety and effectiveness.

Therefore, the "study" that proves the device meets the acceptance criteria is the comparison to the predicate device as presented in Table 6.1 and the accompanying textual description. The FDA's issuance of the 510(k) clearance signifies their agreement that, based on this comparison, the new device is substantially equivalent to the predicate.

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

• Sample Size: Not applicable, as no performance study with a test set was conducted.
• Data Provenance: Not applicable.

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

• Not applicable, as no performance study with a test set requiring ground truth establishment was conducted.

4. Adjudication method for the test set:

• Not applicable, as no performance study with a test set was conducted.

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:

• No, an MRMC comparative effectiveness study was not done. This device is a dental implant abutment, not an AI-powered diagnostic or assistive tool for human readers.

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

• No, a standalone performance study was not done. This device is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable, as no performance study requiring ground truth was conducted. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable, as this is a physical medical device, not a machine learning model.

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The intended use for Steri-Oss' tiodized® screws is the screw retained attachment of prosthetic components to one another and to dental implants.

Attachment of prosthetic components to one another and to implants can be achieved with screw fasteming systems. The attachment is secured by the application of torque to the screw. Screws used to fasten the prosthetic components can sometimes loosen. The greater the preload that is applied. the less chance there is that the screw will eventually become loose. Titanium screws that have been "tiodized" can be preloaded to a much greater torque than untreated prosthetic component screws and thus are less likely to loosen. Tiodized® screws are manufactured in diameters (across the head) ranging from 0.086 to 0.106 inches and lengths ranging from 0.160 to 0.576 inches and are composed of titanium alloy that has been subjected to a proprietary anodization process. The screws are slotted or are internally or externally hexed for acceptance of driving tools such as screw drivers, hex drivers and wrenches. Tiodized screws are provided sterile, and are packaged either individually or in sets of up to 6 screws. Tiodized® screws may also be packaged with dental implants or dental implant prosthetic components.

The provided text does not contain information about acceptance criteria and a study proving a device meets those criteria. The document is a 510(k) summary for a "Tiodized® Screw," and it focuses on device description, intended use, and comparison to a predicate device for demonstrating substantial equivalence.

Specifically, the "Performance Data" section explicitly states "Not applicable." This indicates that the submission does not include preclinical or clinical performance data, acceptance criteria, or a study to demonstrate performance against such criteria.

Therefore, I cannot provide the requested information.

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The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.

The Steri-Oss Replace Titanium Implant System is designed to serve as support for prosthetic devices to restore patient chewing function. Natural dentition is composed of a root (subgingival) and a crown (supragingival). Designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The implants are 4.3, 5.0 or 6.0 mm in diameter, from 10 - 16 mm in length and are composed of titanium. They are tapered, threaded and have a hexed superior surface. The Replace Titanium Implant System utilizes color coding.

This document, a 510(k) summary for the Steri-Oss Replace Titanium Implant System, lacks the specific details required to fully address your request. This type of submission, especially from 1997, typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive performance data from clinical studies with detailed acceptance criteria.

Here's an analysis based on the provided text, highlighting what is and is not present:

Key Takeaway: The document explicitly states "Performance Data: Not applicable." This indicates that the submission did not include studies with acceptance criteria in the way you're asking. The basis for clearance was likely a comparison of material and superficial characteristics to a predicate device already on the market.

Here's a breakdown of the requested information, noting where it's absent:

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

• Not Provided. The document states "Performance Data: Not applicable." This means there are no reported device performance metrics against predefined acceptance criteria for the Replace Titanium Implant System in this submission. The substantial equivalence argument is based on material and surface characteristics being similar to the predicate, not on a clinical performance study with statistical endpoints.

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

• Not Provided. Since no performance data is applicable, there's no test set, sample size, or data provenance mentioned related to clinical performance.

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 Provided. This is relevant for studies where expert review is used to establish ground truth (e.g., image analysis, clinical outcome assessment). Since no such performance studies are mentioned, this information is absent.

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

• Not Provided. As no test set performance studies are described, there's no mention of an 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 Provided. These types of studies are typically for AI/software devices. This document describes a physical medical device (dental implant).

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

• Not Provided. This is also relevant for AI/software devices. This document describes a physical medical device.

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

• Not Provided. No ground truth for performance assessment is mentioned, as no performance studies are described.

8. The sample size for the training set.

• Not Provided. This is relevant for AI/machine learning models. This document describes a physical medical device.

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

• Not Provided. This is also relevant for AI/machine learning models. This document describes a physical medical device.

Summary of Device and Claim:

• Device: Steri-Oss Replace Titanium Implant System (Endosseous implant).
• Intended Use: To restore masticatory function in edentulous and/or partially edentulous patients.
• Mechanism: Functions as the root of an artificial tooth, supporting prosthetic devices.
• Key Characteristics: 4.3, 5.0, or 6.0 mm diameter; 10-16 mm length; tapered, threaded, hexed superior surface; titanium composition; color-coded.
• Predicate Device: Steri-Oss Titanium Implants, Healing Screws, Healing Abutments, and Abutments.
• Substantial Equivalence Claim: Based on material (Titanium) and sterility being the same as the predicate. The only difference noted is the "Surface characteristics" being "Non-color coded" for the predicate versus "Color coded" for the Steri-Oss device, which is presented as a minor difference not impacting safety or effectiveness.

In conclusion, this 510(k) summary provides very limited information regarding clinical performance studies or acceptance criteria because the submission strategy was based on demonstrating equivalence to an already marketed device rather than providing new performance data.

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