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SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

Customized 3D Pre-Formed Titanium Membrane. SMARTbuilder System (SB1) is the nonabsorbable membrane that is made of titanium metal to stabilize and support of bone graft after bone transplantation at the area having autogenous bone deficiency in the oral cavity. The SMARTbuilder System (SB1) is made of pure titanium metal and supplied sterile.

The provided text is a 510(k) summary for the OSSTEM Implant Co., Ltd. SMARTbuilder System (SB1). This document states that no clinical studies were submitted and no biocompatibility evaluation was conducted for the SMARTbuilder System (SB1) because it has the same material and manufacturing process as its predicate device and uses Pure Titanium Grade 2 (ASTM F67), which is widely used as a dental material. Therefore, the device's acceptance criteria and studies demonstrating its adherence to these criteria are not detailed in this document.

The submission focuses on establishing substantial equivalence to a predicate device (SMARTbuilder System, K120951) based on shared materials, intended use, and similar design and technological characteristics.

Here is a summary of the requested information based only on the provided text, with many fields necessarily left blank or marked as "Not Applicable (N/A)" due to the absence of clinical study data:

Acceptance Criteria and Device Performance Study Summary for SMARTbuilder System (SB1)

This 510(k) submission, K130840, relies on substantial equivalence to a predicate device and does not include clinical study data to demonstrate the device meets specific acceptance criteria. Therefore, most of the requested information regarding performance metrics, sample sizes, and ground truth establishment is Not Applicable (N/A) in this context.

1. Table of Acceptance Criteria and Reported Device Performance

Since no clinical studies were submitted, there are no specific performance-based acceptance criteria or reported device performance metrics in this document. The "performance" assessment is based on demonstrating substantial equivalence to the predicate device in terms of material, intended use, and similar design.

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

• Test Set Sample Size: Not Applicable (N/A) - No clinical studies or test sets with patient data were submitted.
• Data Provenance: Not Applicable (N/A) - No clinical data was used.

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

• Not Applicable (N/A) - No clinical studies requiring expert-established ground truth were performed or submitted.

4. Adjudication method for the test set

• Not Applicable (N/A) - No clinical studies were performed.

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 (N/A) - This device is a physical medical implant (bone plate/membrane), not an AI-assisted diagnostic or treatment system. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and was not conducted.

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

• Not Applicable (N/A) - This device is a physical medical implant, not an algorithm or software. No standalone algorithm performance was assessed.

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

• Not Applicable (N/A) - No clinical studies requiring ground truth were performed or submitted.

8. The sample size for the training set

• Not Applicable (N/A) - No machine learning or AI components are involved, and thus no training set was used.

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

• Not Applicable (N/A) - No training set was used.

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SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

Customized 3D Pre-Formed Titanium Membrane. SMARTBuilder is the non-absorbable membrane that is made of titanium metal to stabilize and support of bone graft after bone transplantation at the area having autogenous bone deficiency in the oral cavity. The SMARTbuilder is made of pure titanium metal and supplied sterile. The SMARTbuilder system is used with GS3 System (K091208) of OSSTEM Implant Co., Ltd. and US.SS.GS System (K073247) of OSSTEM Implant Co., Ltd.

The provided 510(k) summary for the OSSTEM Implant Co., Ltd. SMARTbuilder System indicates that it is a substantially equivalent device, not a new device requiring extensive performance studies with acceptance criteria. Therefore, the document does not describe acceptance criteria or a study that proves the device meets such criteria in the way a novel medical device would.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Neo Titanium mesh, CTi-mem, K111761, and SQ IS SYSTEM, K090825). This is a common regulatory pathway for devices that have similar intended use, design, and materials to devices already on the market.

Here's an analysis of the provided information in the context of your request:

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

• No explicit acceptance criteria or reported device performance are provided in the traditional sense of a clinical or analytical study with defined endpoints/thresholds.
• The document presents "Substantial Equivalence Matrix" tables, comparing the SMARTbuilder System (and its components like Healing Abutment, Height, Cover Cap) to predicate devices on characteristics such as:
  • Design
  • Intended use
  • Material
  • Dimensions (Width, Diameter, Height)
  • Sterilization
  • Shelf life
• The "performance" demonstrated is that these characteristics are "same" or "similar" to the predicate devices. For example:
  • Material: "Pure Titanium Grade 2 (ASTM F67)" for SMARTbuilder membrane, "Pure Titanium Grade 2 (ASTM F67)" for predicate.
  • Intended Use: "SMARTbuilder is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites." for SMARTbuilder, "For Stabilization and support bone grafts in dento-alveolar bony defect sites" for predicate.
  • Sterilization: "Sterile" for both.
  • Shelf life: "5 years" for SMARTbuilder, no information for predicate (implies it isn't a distinguishing factor for substantial equivalence).
  • Width (D): SMARTbuilder offers 8, 9, 10, 12, while predicate is 12. This shows similarity with some additional options.

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. No test set or performance data from a specific study is presented. The comparison is based on the specifications of the devices themselves, not on a study with a test subject sample.

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. There was no "test set" requiring ground truth established by experts. Substantial equivalence relies on regulatory review of design, material, and intended use claims against predicate devices.

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

• Not applicable. No test set or adjudication process 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

• Not applicable. This device is a dental bone plate/membrane system, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant to this submission.

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

• Not applicable. This device is not an algorithm.

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

• Not applicable. There is no "ground truth" established from studies in this submission. The "truth" for substantial equivalence is based on the characteristics and regulatory status of the predicate devices.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/algorithm device.

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

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

Summary of what the document does communicate regarding evidence for market clearance:

The submission focuses entirely on demonstrating substantial equivalence to already legally marketed predicate devices. The arguments for equivalence are based on:

• Identical Intended Use: The SMARTbuilder system shares the same intended use (stabilizing and supporting bone graft in dento-alveolar bony defect sites) as the predicate devices.
• Similar Design and Technological Characteristics: Dimensions are shown to be similar or within a comparable range. The overall design concept (a pre-formed titanium membrane and associated abutments/caps) is presented as similar.
• Identical Materials: The core materials (Pure Titanium Grade 2, Pure Titanium Grade 4, Titanium alloy Ti 6Al 4V) are identified as the same or highly similar (ASTM F67, ASTM F136) to those used in the predicate devices.
• Identical Sterilization Method: Both the proposed device and predicates are supplied sterile.
• Known Biocompatibility: The submission explicitly states, "Biocompatibility evaluation for SMARTbuilder System is not considered because SMARTbuilder System, which is made with titanium alloy, has been generally and widely used as a dental material such as implant for a long time." This leverages the known safety profile of the materials.
• No Clinical Studies: The submission explicitly states, "No clinical studies are submitted." This reinforces that clearance is based on substantial equivalence to existing devices, not new clinical performance data.

In essence, the "acceptance criteria" for this 510(k) was to successfully argue that the SMARTbuilder System is as safe and effective as the predicate devices based on a comparison of their fundamental characteristics, without requiring new performance studies.

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