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The Kreativ Mach 7 Air Abrasion system is used for cavity preparation in Classes I, III, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. It may also be used for restoration prophylaxis.

The Mach 7 is an air abrasion pneumatic device which combines pressurized air and aluminum oxide powder to product a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations. The unit is capable of removing dental caries, old restorative materials as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small hand piece which is approximately the size of a high speed dental drill. The system is designed for ease of service and maintenance with readily accessed and refillable canisters for the particulate supply.

The provided text is a 510(k) summary for the Mach 7 device, an air abrasion pneumatic device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting a study with acceptance criteria and performance metrics in the way modern AI/ML device submissions do.

Therefore, many of the requested fields cannot be directly extracted from this document as the type of study and data required for AI/ML device approval were not applicable to this 2000 submission for a dental device.

However, I can extract information related to the device's indications for use and the basis for its approval.

Here's an attempt to answer using the provided text, noting where specific information is absent due to the nature of the submission:

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

This information is not explicitly stated in the provided 510(k) summary. For a device like the Mach 7, which is a physical dental instrument, typical "acceptance criteria" would likely revolve around technical specifications (e.g., air pressure, particulate feed rate, handpiece design) and potentially performance against predicate devices in terms of efficiency or safety through non-clinical testing. However, these specific criteria and the reported performance against them are not detailed in this summary. The submission relies on "substantial equivalence" to predicate devices.

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

This information is not provided in the document. No specific "test set" in the context of data for performance evaluation is mentioned, as this is not an AI/ML device. The basis for approval is substantial equivalence to legally marketed predicate devices.

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 applicable and not provided. No "ground truth" using experts for a test set is mentioned, as this is not an AI/ML device.

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

This information is not applicable and not provided. No adjudication method for a test set 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

This information is not applicable and not provided. A MRMC comparative effectiveness study is relevant for AI/ML-assisted diagnostic devices. The Mach 7 is a physical dental device, not an AI system.

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

This information is not applicable and not provided. The Mach 7 is a physical dental device, not an algorithm.

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

This information is not applicable and not provided. No "ground truth" data is mentioned for this device. The basis for approval is substantial equivalence to predicate devices for its intended use.

8. The sample size for the training set

This information is not applicable and not provided. No "training set" is relevant for this physical dental device in the context of an AI/ML submission.

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

This information is not applicable and not provided.

Summary of Device and Basis of Approval (extracted from the document):

• Device Name: Mach 7
• Company: Kreativ, Inc.
• Device Type: Air abrasion pneumatic device
• Indications for Use:
  • Cavity preparation in Classes I, III, III, IV, and V (Note: Classes I, III, IV, and V are correctly stated, there seems to be a typo repeating "III" in the original text).
  • Removal of tooth structure and restorative dental materials.
  • Site preparation for pit and fissure sealant therapy.
  • Bonding of porcelain and ceramic.
  • Restoration prophylaxis.
• Mechanism: Combines pressurized air and aluminum oxide powder to produce a high velocity stream of particles.
• Predicate Devices: KCP 2000 (K921748), MicroPrep (K932997), Mach 5 (K980216), Mach 6 (K980216).
• Basis for Approval: "Substantial equivalence" to the predicate devices. The document states that the "intended use and technical specifications of the Mach 7 are virtually identical to the predicate devices and the differences in the device only make it easier to use, more reliable and more adaptable to a variety of dental practice situations." This indicates that the study (or more accurately, the comparison provided to the FDA) was a demonstration of this substantial equivalence, likely through detailed comparisons of specifications, materials, and intended uses against the predicate devices, rather than a clinical trial with specific performance metrics and acceptance criteria as would be expected for a novel AI/ML diagnostic or therapeutic device.

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PowerBlock is a white, light reflective, paint on dam which, when light cured, will form a semi-plastic barrier which protects gingival tissue.

PowerBlock is a white, light reflective, paint on dam.

This is a 510(k) clearance letter for the PowerBlock device. It indicates that the device has been found substantially equivalent to a predicate device. However, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance studies.

Therefore, I cannot provide the information requested in your prompt based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness, or the full 510(k) submission which would include the performance data.

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The Kreativ Mach Series Air Abrasion systems are used for cavity preparation in Classes I, II, III, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. They are also used for restoration prophylaxis.

The Mach 5, Mach 5 plus, Mach 6 are pneumatic devices which combine pressurized air and aluminum oxide powder to produce a high velocity stream of particles to perform dental restorative procedures, including preparation for pit and fissure sealant and composite restorations. The units are capable of removing dental caries, old restoration materials, as well as healthy enamel and dentin to prepare the tooth surface for subsequent adhesion of restorative materials. The abrasive particulate is delivered via a small handpiece which is approximately the size of a high speed dental drill. The systems are designed for ease of service and maintenance with readily accessed and refillable canisters for the particulate supply.

The provided text describes a 510(k) submission for dental devices (Mach 5, Mach 5 plus, Mach M, and Mach 6) and focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study designed to prove the devices meet specific performance criteria in the way that an AI/ML device submission would.

Therefore, I cannot provide the requested table and study details. The document is a regulatory submission demonstrating substantial equivalence, not a performance study against predefined acceptance criteria for the devices' operational output.

Ask a specific question about this device

Ask a specific question about this device