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Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity.

Bone Screw is using as anchor to fix the bone plate, membrane that cover bone material or block bone for bone regeneration or remodeling. Ø1.2 diameter screw is for fixing non-resorbable membrane or non-resorbable titanium membrane (Osstem OssBuilder OB2 and OB3), cleared in K172354.

The specifications of the proposed device are as follow;

• Bone Screw
• Diameter (mm): Ø1.2
• Length (mm): 3.0, 4.0, 5.0

This document is a 510(k) clearance letter for a bone screw, not a study evaluating an AI/software as a medical device (SaMD). Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and studies proving device performance for an AI/SaMD.

The 510(k) summary focuses on demonstrating "substantial equivalence" of the new Bone Screw device to existing predicate devices based on:

• Indications for Use: The new device has the same intended use as the predicate.
• Technological Characteristics: Similarities in material (Titanium Alloy), manufacturing process (machined), design, and sterilization method (Gamma Irradiation).
• Performance Testing: Non-clinical tests (Driving Torque, Axial Pullout Strength, Torsional Strength) were conducted to show the new device performs comparably to the predicate, especially regarding a new smaller thread diameter.
• Biocompatibility and Shelf-life: Leveraged data from the predicate device due to material and packaging similarities.
• MR Compatibility: Assessed using scientific rationale and published literature, not a study with acceptance criteria.

Therefore, I cannot extract the requested information as it pertains to an AI/SaMD from this document.

If you have a document describing the performance study of an AI/SaMD, I would be happy to help you extract that information.

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The device is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.

SAVE GBR is manufactured by Ti-6Al-4V ELI. The SAVE GBR is composed of GBR Screw and Bone Tack and these screws and tacks are used to fix barrier membranes in bone regeneration procedures.

The diameter of the GBR screw is 1.4 and length is 3.9, 4.38, 5.9, 6.38, 7.9 and 8.38mm. The diameter of the Bone Tack is 2.5 and length is 2.6 and 4.1mm.

These screws and tacks are implanted for a maximum duration of 6 months. The SAVE GBR is provided sterile.

The subject device is compatible with the OssBuilder membrane cleared in K172354.

The provided document is a 510(k) premarket notification for the "SAVE GBR" device, which is an intraosseous fixation screw or wire used in guided bone/tissue regeneration in the oral cavity. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, accuracy, or human reader improvement with AI) is not applicable to this type of regulatory submission.

The document describes non-clinical testing performed to demonstrate the safety and effectiveness of the device compared to its predicates. The "acceptance criteria" here are typically compliance with relevant international standards and equivalence to predicate devices in terms of material, design, and performance characteristics.

Here’s a breakdown of the information that can be extracted from the provided text, addressing the points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) process for this device type doesn't establish numerical "performance" criteria in the way a diagnostic AI device might have sensitivity/specificity targets. Instead, "acceptance criteria" are compliance with standards and demonstration of equivalence to legally marketed predicates. The "reported device performance" reflects how the device met these engineering and material standards.

The following questions are not applicable to this 510(k) submission as it concerns a physical medical device (implants) and not a diagnostic or AI-driven system that would typically undergo such evaluations.

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

• Not Applicable. This document describes non-clinical (biocompatibility, mechanical, sterilization) testing of a physical implant device, not a diagnostic algorithm tested on a dataset of patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Ground truth for a diagnostic algorithm is not relevant here. The ground truth for device safety and performance relies on validated laboratory methods and engineering standards.

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

• Not Applicable. This pertains to expert review of diagnostic cases, which is not relevant for this physical device.

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. MRMC studies are for diagnostic interpretation improvement with AI. This document is for a physical implantable device.

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

• Not Applicable. This refers to the performance of an algorithm; it is not relevant for this physical device.

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

• The "ground truth" for this device's regulatory clearance is compliance with recognized international standards (e.g., ISO, ASTM for materials, sterilization, mechanical properties) and demonstration of substantial equivalence to legally marketed predicate devices through comparative testing and analysis. This is based on objective measurements and verified material properties, not clinical expert consensus on diagnostic images or patient outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI algorithm for this device. Testing involves samples of the physical device for non-clinical evaluations.

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

• Not Applicable. No training set; ground truth is established by engineering and materials science standards.

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Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. Bone Tack is indicated for use to stabilize and support bone graft and/or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.

Bone Screw is using as anchor to fix the bone plate, membrane that cover bone material or block bone for bone regeneration or remodeling. Ø1.4 diameter screw is for fixing membrane or bone plate, and Ø2.0 diameter screw is for fixing block bone. Bone Tack is a stabilizer that can stably fix the membrane in GBR.

The provided document is an FDA 510(k) Premarket Notification summary for a Bone Screw and Bone Tack device. It generally discusses the device's substantial equivalence to predicate devices based on non-clinical testing. However, it explicitly states that no clinical studies were submitted and therefore does not contain information about acceptance criteria or a study proving the device meets them through clinical performance.

Therefore, I cannot provide details for most of your requested points, as they pertain to clinical or comparative effectiveness studies that were not performed or reported in this document.

Here's what can be extracted based on the information provided, and what cannot:

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

• Cannot be provided. The document does not specify acceptance criteria for clinical performance or any reported device performance that would meet such criteria. It focuses on demonstrating substantial equivalence through comparison to predicate devices and non-clinical testing.

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

• Cannot be provided. No clinical test set was used or reported in this submission. The non-clinical testing details do not specify sample sizes in a way that aligns with "test set" for performance evaluation.

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 clinical test set or ground truth establishment by experts is mentioned.

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

• Cannot be provided. No clinical test set or adjudication method is mentioned.

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. No MRMC study was done, and the device is a medical implant, not an AI diagnostic tool.

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

• Cannot be provided. The device is a medical implant, not an algorithm.

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

• Cannot be provided. No clinical ground truth was established as no clinical studies were performed.

8. The sample size for the training set

• Cannot be provided. No training set for an algorithm was used.

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

• Cannot be provided. No training set or ground truth for it was established.

Summary of what the document does provide regarding testing:

The manufacturer performed non-clinical testing to support the substantial equivalence claim. These include:

• Biocompatibility evaluation: Considered following FDA Guidance Document Use of International Standard ISO 10993-1 and ISO 10993 suite of standards. This leveraged information from reference device K172354.
• Sterilization Validation and Shelf-life: Considered following ISO 11137 and ISO 11607 suites of standards. Endotoxin batch testing is in place per the FDA Guidance Document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
• Mechanical Properties: Evaluated following ASTM F543 with a "worst-case scenario."

The document explicitly states: "No clinical studies are submitted." (Page 7, Section 8)

Therefore, based solely on the provided text, no information is available about clinical acceptance criteria or studies proving device performance against such criteria. The submission relies on substantial equivalence to predicate devices and non-clinical testing.

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The OssBuilder System is used for space maintenance and stabilization of bone grafting material in an alveolar bone defect site.

OssBuilder System is consisted of metal devices, OssBuilder, Healing Cap, Cover Cap, OB Anchor, and Tenting Screw, and is intended for use to stabilize and support of bone graft in dento-alveolar bony defect sites.

Tenting Screw, a product in the OssBuilder System product group, is a temporary dental implant that can be implanted in the bone defect site of the alveolar bone to fix the guided tissue regeneration material.

Healing Cap is used by connecting with the Tenting Screw to bind OssBuilder during osseointegration.

This document describes the premarket notification (510(k)) for the OssBuilder System, an intraosseous fixation device. It asserts substantial equivalence to predicate devices based on non-clinical performance testing. Due to the nature of this submission, which focuses on demonstrating substantial equivalence through non-clinical testing rather than clinical study, many of the typical elements expected for evaluating AI/algorithm performance (e.g., ground truth establishment with experts, MRMC studies, training/test set details) are not applicable or provided.

Here's a breakdown of the available information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device, the "acceptance criteria" are not reported as specific performance metrics like accuracy, sensitivity, or specificity, which would be common for diagnostic AI/software. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices through:

• Identical or similar design, operating principle, and intended use as predicates.
• Identical or similar materials.
• Successful non-clinical performance testing (bench tests) demonstrating comparable mechanical properties.
• Validated sterilization and shelf-life.
• Biocompatibility evaluation.

The reported device performance heavily relies on comparisons to predicate devices in the following aspects:

2. Sample Size for the Test Set and Data Provenance

This submission does not involve an AI/algorithmic device that would typically have a "test set" of patient data for performance evaluation. The "tests" performed are bench tests on the physical device components.

• Sample Size: Not explicitly stated as a number of devices/units tested, but refers to "Bench tests evaluated for OssBuilder System according to ASTM F543" for "worst-case insertion in block material." The assumption is that standard engineering testing practices for mechanical properties were followed.
• Data Provenance: The tests are laboratory-based bench tests, not patient data from a specific country. They are likely conducted at the manufacturer's facility or a contracted testing lab. The submission is made by a company based in the Republic of Korea (Osstem Implant Co., Ltd.) with a US correspondent (Hiossen Inc.).

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

Not applicable. As this is a physical medical device submission demonstrating substantial equivalence through non-clinical testing, there is no "ground truth" derived from human experts interpreting medical images or data. The "ground truth" for mechanical properties is established by the specifications defined in standards like ASTM F543 and the performance of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Mechanical properties are measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/software device, and therefore, no MRMC comparative effectiveness study was performed.

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

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the performance specifications and characteristics of the legally marketed predicate devices and generally accepted industry standards (e.g., ASTM F543) for mechanical properties testing, along with established biocompatibility guidelines (ISO 10993-1). The manufacturer demonstrates that the new device meets or is "substantially equivalent" to these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."

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

Not applicable. There is no training set for this type of device.

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