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Bond Bone™ is indicated for use in the following ways: by itself in bone regenerative techniques, mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and to provide a resorbable barrier over other bone graft material.

Bond Bone™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. When mixed with saline, Bond Bone forms a paste and hardens via a cementitious reaction. The product is provided sterile and for single patient use.

The provided text describes a 510(k) premarket notification for a medical device called Bond Bone™, a synthetic bone grafting material. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials with acceptance criteria for device performance in human subjects.

Therefore, many of the requested sections (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this 510(k) submission as no such studies were conducted or reported for this device to prove its performance against acceptance criteria in the traditional sense of a clinical trial. The device's performance is demonstrated through its equivalence to the predicate device.

Here's the breakdown based on the provided text:

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

Since this is a 510(k) submission demonstrating substantial equivalence to a predicate device, there are no explicit "acceptance criteria" for clinical performance that the device had to meet. Instead, the acceptance criteria are implicitly that the new device's chemical and physical characteristics must be equivalent to those of the predicate device.

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

• Sample Size: Not applicable. The submission focuses on physical and chemical testing, not clinical performance with a "test set" of patient data.
• Data Provenance: Not applicable for clinical data. The tests were likely conducted in a laboratory setting, presumably by the manufacturer (MIS Implants Technologies Ltd. or its contracted labs). The country of origin of the company is Israel.

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. No "ground truth" established by human experts for a clinical test set in this type of submission. The performance assessment was based on objective physical and chemical measurements.

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

Not applicable. No clinical test set or human adjudication was 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. This is not an AI/software device, and no MRMC study was performed.

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

Not applicable. This is a bone grafting material, not an algorithm or AI device.

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

Not applicable. The "truth" for this submission refers to the measured physical and chemical properties of the device, compared to those of the predicate. These are objective laboratory measurements, not ground truth derived from clinical observations.

8. The sample size for the training set

Not applicable. There's no training set for an algorithm as this is a physical medical device.

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

Not applicable.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" in this context is a series of chemical and physical performance tests conducted on the Bond Bone™ device. The goal of these tests was to demonstrate that the new Bond Bone™ product is substantially equivalent to its predicate device, Bond Bone™ from Augma Biomaterials Ltd. (K083858).

The text states:
"Bond Bone™ has been tested for a number of chemical and physical characteristics: chemical composition, phase composition, trace of impurities, density and porosity, particle size, morphology, setting time and reaction temperature, compressive strength and elastic modulus, pH analysis and dissolution rate. All these characteristics are equivalent to those of the predicate device."

This series of laboratory tests, comparing the new device's properties to those of the predicate, serves as the evidence that the device meets the (implicit) acceptance criteria for substantial equivalence. The "acceptance criteria" here are that the new device's properties fall within a range considered equivalent to the predicate device's established properties. The study concludes that based on these tests, the device has the "same performance characteristics" as the predicate device.

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The UNO Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by adjacent teeth and roots, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more Ø3.0 mm implants adjacent to one another. The UNO Narrow Implant is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

The UNO Narrow Implant is a self tapping, root-form, two piece screw type dental implant, indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The UNO Narrow Implant is provided in one diameter (3 mm) in the following lengths: 10mm, 11.5 mm, 13mm and 16mm. The implants are tapered with double thread (2mm pitch) for fast insertion. The implants surface is sand blasted and acid etched. The UNO Narrow Implant is a two piece device whereas the implant is to be used in combination with replaceable ball attachments anchor screws and healing caps. The Uno implants and healing caps are supplied sterile and are intended for single use only. The ball attachment anchor screws are supplied non-sterile since immediately after their placement the ball attachments are used for impression coping in plastic materials. The UNO Narrow Implants are made of Ti6AL4V ELI complying with standard ASTM F 136-02- Standard Specification for Wrought Titanium-6Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

This document is a 510(k) summary for the UNO Narrow Implant, a dental device. It asserts substantial equivalence to a predicate device, the OsseoSpeed™ Narrow from Astra Tech AB. The summary does not describe an AI/ML device, nor does it present any studies or data related to AI/ML device performance. Therefore, I cannot provide the requested information about acceptance criteria or study details from this document.

The document discusses the following:

• Company Name: MIS Implants Technologies Ltd.
• Device Name: UNO Narrow Implant
• Predicate Device: OsseoSpeed™ Narrow from Astra Tech AB (K080396)
• Description of the device: Self-tapping, root-form, two-piece screw-type dental implant, made of Ti6AL4V ELI.
• Indications for Use: Placement in specific regions of partially edentulous jaws where horizontal space is limited, to support prosthetic devices.
• Substantial Equivalence: Claimed due to same intended use and equivalent performance characteristics, manufactured from the same Titanium alloy.
• Conclusion: The device is substantially equivalent to its predicate.

There is no mention of acceptance criteria, device performance metrics, sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance studies, training sets, or how ground truth was established, as these are concepts relevant to AI/ML device testing, which is not applicable to this 510(k) submission.

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The Uno - One Piece Screw-Type 3.0 mm Dental Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices of partificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.0 mm Dental Implant is made of one piece solid material comprised of the implant and abutment one piose bend Mandibular central and lateral incisors must be splinted if using two or more 3.0 mm implants adjacent to one another. The If acting on a can factured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.

The Uno - One Piece Screw-Type 3.5 mm Dental Implants are indicated for use in surgical and restorative applications for placement in the premolar, cuspid and incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. The Uno - One Piece Screw-Type 3.5 mm Dental Implants are made of one piece solid material comprised of the implant and abutment one piooo oone matting are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02.

The Uno - One Piece Screw-Type Dental Implant 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 chewing function. The Uno - One Piece Screw-Type Dental Implant is made of one piece solid material comprised of the implant and abutment combination.

The Uno implants are provided in two diameters. The Uno 3.0 mm dental implant is indicated for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions. The Uno 3.5 mm dental implant is indicated for placement in the premolar, cuspid and incisor regions.

The Uno implants are manufactured of Titanium alloy Gr. 5 complying with standard ASTM F136-02. The Implants are provided in several lengths of 10mm, 13mm and 16mm with diameters of 3.0mm, 3.5mm. The implants surface is sand blasted and acid etched to improve the osseointegration. The implants are tapered with double thread (2mm pitch) for fast insertion.

The Uno implants are supplied sterile and are intended for single use only.

This 510(k) submission for the "Uno - One Piece Screw-Type Dental Implant" does not describe a study to prove the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested sections (e.g., acceptance criteria, reported device performance, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test set, training set details) are not applicable or cannot be extracted from the provided text.

The document primarily details the device description, intended use, and argues for its equivalence to a previously cleared device.

Here's an analysis based on the information available:

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

• Not Applicable. The submission does not define specific "acceptance criteria" for performance that would be met through testing. Instead, it relies on demonstrating that the device is manufactured from the same material and has similar technological characteristics to the predicate device, implying equivalent performance.

2. Sample sized 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 data is described. The submission relies on a comparison to a predicate device, not new clinical or performance testing data.

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. No test set requiring ground truth establishment is described.

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

• Not Applicable. No test set requiring adjudication 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, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to "human readers improving with AI" is irrelevant to this submission.

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

• Not Applicable. This is a physical medical device (dental implant), not a standalone algorithm.

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

• Not Applicable. No new clinical or performance data requiring ground truth is presented in this submission. The "ground truth" for the submission is the established safety and effectiveness of the predicate device based on its prior clearance.

8. The sample size for the training set

• Not Applicable. There is no training set mentioned as this is not a machine learning device.

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

• Not Applicable. There is no training set mentioned.

Summary of what the submission does present regarding equivalence:

The submission argues for Substantial Equivalence based on the following:

• Same Intended Use: The Uno implant has the same intended use as the ZIMMER DENTAL ONE-PIECE IMPLANT (K052997). Both are for placement in the jaw to support prosthetic devices and restore chewing function.
• Equivalent Performance Characteristics: The submission states that
  • Both products are manufactured from the same material: Titanium alloy Gr. 5 complying with standard ASTM F136-02.
  • "All other technological characteristics are similar and show equivalent performance capabilities." (This is a general statement, and specific comparative data is not provided in the text.)
• Material: Titanium alloy Gr. 5 complying with ASTM F136-02 for both the Uno implant and the predicate device.

Conclusion stated in the document:
"The evaluation of the Uno - One Piece Screw-Type Dental Implants does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to its predicate device."

Essentially, the "study" proving the device meets criteria is the argument for substantial equivalence to a device already deemed safe and effective by the FDA, rather than new, independent testing against pre-defined acceptance criteria.

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The Ortho Anchor Screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.

The MIS Ortho Anchor Screws are self-tapping screws that are used as fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. The screw is manufactured as one piece screw made of medical grade 5 Titanium alloy complying with the standard ASTM F136-02. The upper head of the screw has a cross-hole through which a wire can pass to fix the mandible and maxilla in the orthodontic procedure. The screw head is special designed to assist the use of orthodontic appliances. The Ortho Anchor Screws are provided in several lengths ranging between 5-10mm and diameters of 1.4mm, 1.6mm and 2mm. The screws are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are supplied sterile.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance metrics.

The document is a 510(k) summary for Ortho Anchor Screws, which primarily focuses on demonstrating substantial equivalence to a predicate device. This type of submission relies on showing that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria.

Therefore, I cannot provide the requested information in a table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

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The Mistral one stage screw-type dental implant 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.

The Mistral is a one stage, screw-type, internal octagon dental implant and is provided in the following range of dimensions:

• Diameters: 3.75. 4.10 and 4.80 mm
• Length: 8, 10, 11.50, 13 and 16 mm
  All implants are manufactured from medical grade 5 pure titanium, which meets requirements of standard ASTM F136.
  The required surface roughness and microgeometry of the implants is achieved by blasting sand particles and acid etching. Blasted surfaces archive more bone contact with the implant surface.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria for the "Mistral one stage screw-type dental implant."

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.

The key points from the provided text are:

• Predicate Device: One stage implant from MIS Dental Implant System (K040807).
• Description of Device: Mistral is a one-stage, screw-type, internal octagon dental implant made from medical grade 5 pure titanium with a sand-blasted and acid-etched surface.
• Indications for Use: Placement in the upper or lower jaw to support prosthetic devices for restoring chewing function.
• Substantial Equivalence: The device is considered substantially equivalent to the predicate device because it has the same intended use and equivalent performance characteristics.
• Conclusion: No additional concerns regarding safety and effectiveness were identified, leading to substantial equivalence.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth was established for the training set.

This information is typically found in design validation reports or detailed performance studies, which are not part of this 510(k) summary document.

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