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OsseoSpeed™ Angled Abutment EV is intended to be used in conjunction with Astra Tech Implant System EV in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.

The AtlantisTM Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

Atlantis™ Abutment and Atlantis™ Crown Abutment are compatible with Ø5.4 Astra Tech Implant System EV.

OsseoSpeed Angled Abutment EV is designed for multi-unit, screw-retained restorations in a partially or fully edentulous situation. It is provided in three platform diameters (3,6, 4,2 and 4.8 mm) and two angles (20° and 30°). It is intended to fit Astra Tech implants of corresponding diameters cleared under K111287 and K120414. All abutments with a 20°angle are provided in two gingival heights (1.0 and 2.0 mm) with an indexed interface. All abutments with a 30°angle have a non-indexed interface and are provided in two gingival heights (1.0 and 3.0 mm).

OsseoSpeed Angled Abutment EV is not compatible with Astra Tech 3.0 mm diameter implants.

Atlantis Abutment in Zirconia for OsseoSpeed EV is a custom abutment for prosthesis attachment. Atlantis Crown Abutment in Zirconia for OsseoSpeed EV is fabricated as a custom single-tooth final restoration and is shaped in the design of the final prosthesis onto which porcelain is added. Both Atlantis abutments are provided in a platform diameter of 5,4 mm.

The provided text is a 510(k) summary for a medical device (dental abutments) and does not contain information about acceptance criteria or a study proving that the device meets those criteria in the way typically required for AI/ML-based diagnostic devices.

The document discusses the substantial equivalence of the new device to existing predicate devices based on its intended use, design principles, materials, and manufacturing processes. It briefly mentions "Testing of OsseoSpeed™ Angled Abutment EV according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants, was performed and the results show that OsseoSpeed™ Angled Abutment EV has sufficient mechanical strength for the intended clinical application and demonstrate that it is substantially equivalent to the listed predicate devices."

However, this is a mechanical fatigue test, not a clinical performance study with expert ground truth, multi-reader multi-case analysis, or standalone algorithm performance, as would be relevant for an AI/ML device. Therefore, most of the requested fields cannot be filled from the provided text.

Here is an attempt to address the request based on the available information:

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

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 specified for the ISO 14801 test.
• Data Provenance: Not specified, but likely from laboratory testing (in vitro) based on the test type.

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. The ground truth for a mechanical fatigue test is typically defined by the physical properties and performance characteristics measured according to the standard, not by expert interpretation.

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

Not applicable. This concept pertains to human review of diagnostic results, not mechanical testing.

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. This document does not mention an MRMC study or AI assistance.

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

No. This document does not describe an algorithm or AI.

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

For the mechanical test, the ground truth is based on the physical properties and performance characteristics as defined and measured by the ISO 14801 standard.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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Implants:
The Astra Tech Dental Implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

• replacing single and multiple missing teeth in the mandible and maxilla, ●
• immediate placement in extraction sites and in situations with a partially or completely . healed alveolar ridge,
• especially indicated for use in soft bone applications where implants with other implant ● surface treatments may be less effective,
• immediate loading in all indications, except in single tooth situations on implants shorter . than 8 mm or in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

The intended use for OsseoSpeed™ Plus 3.0S is limited to replacement of maxillary lateral incisors and mandibular incisors.

Abutments:
Astra Tech Implant System Plus abutments are intended to be used in conjunction with Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

Atlantis Abutments:
The Atlantis™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The Atlantis™ Crown Abutment in Zirconia is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the crown abutment to the endosseous implant.

The purpose of this submission is to expand the OsseoSpeed™ Plus Implant System to include all the components of the previously cleared OsseoSpeed System. The OsseoSpeed Plus Implant System, cleared September 26, 2011 under K111287, has the same design as the OsseoSpeed system, except for addition of an anti-rotation feature to the implant/abutment interface.

The OsseoSpeed Plus System includes implants with diameters ranging from Ø3.0 mm to Ø5.4 mm and lengths ranging from 6 mm to 17 mm. Radiographic guides are available for all implant sizes. Abutments sizes range from Ø3.0 mm to Ø5.4 mm in straight and angled designs ranging from 15° to 30°. Abutment designs include coverscrews, healing abutments, temporary abutments, cast-to abutments, ball abutments, straight and angled abutments.

This 510(k) Premarket Notification for the OsseoSpeed™ Plus Dental Implant System primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. Therefore, the information provided does not detail specific acceptance criteria for a new clinical study and a study that proves the device meets those criteria, as one would typically find for a novel device.

The submission is for an expansion of an existing system (OsseoSpeed™ Plus) to include components from the previously cleared OsseoSpeed System (K111287). The core argument for substantial equivalence is based on the device having the "same intended use and design principles" and "same technological characteristics" as predicate devices, supported by non-clinical testing.

Here's an analysis of what is available in the document, acknowledging that typical clinical study acceptance criteria and results are not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this submission relies on substantial equivalence and non-clinical testing, explicit acceptance criteria tied to a clinical performance study with defined metrics (e.g., success rates, complication rates) are not provided in the document.

The "acceptance criteria" here are implicitly linked to demonstrating that the OsseoSpeed™ Plus system is as safe and effective as the predicate devices. The non-clinical data presented aims to show that any differences in technological characteristics do not raise new issues of safety or efficacy.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission, as there is no specific clinical test set described from a prospective study. The evaluation relies on non-clinical engineering and bench testing data, and the historical performance of the predicate devices. The document does not specify sample sizes for the non-clinical tests, other than referencing the types of tests performed (e.g., ISO 14801).
• Data Provenance: The referenced predicate devices would have been previously marketed (interstate commerce prior to May 28, 1976, or reclassified devices). The non-clinical testing data would typically be generated in a lab setting by the manufacturer (Astra Tech AB, Sweden, or its testing partners).

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

• This question is not applicable for this submission. The ground truth, in the absence of a clinical study, is the established safety and efficacy of the predicate devices, supported by the non-clinical testing confirming that the new device variant performs similarly. Expert consensus on clinical outcomes for a novel test set is not described.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical test set requiring an adjudication method by experts for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• No. This type of study is not mentioned or implied in this 510(k) submission, as it focuses on dental implants, not image-based diagnostic aids or similar devices where MRMC studies are common.

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

• Not applicable. The OsseoSpeed™ Plus is a physical dental implant system, not a software algorithm or AI-driven device.

7. The type of ground truth used

• The "ground truth" for this 510(k) clearance is primarily:
  • The established safety and efficacy profile of the legally marketed predicate devices.
  • Bench test results and engineering analyses (e.g., mechanical strength, dimensional accuracy, surface characteristics) demonstrating that the subject device performs comparably to the predicates and meets relevant standards (like ISO 14801).
  • The regulatory precedent set by the predicate devices.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of a machine learning algorithm for this physical device. If referring to product development and testing, the sample size for non-clinical tests would be defined by engineering standards and internal validation protocols, but specific numbers are not provided in this summary.

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

• Not applicable. As there is no training set for an AI algorithm, this question doesn't apply. The "ground truth" for the overall submission is based on regulatory precedent and engineering validation against established standards and predicate devices.

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LoFrio® Single Use Urinary Catheter is intended for intermittent urinary catheterization.

The LoFrice Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. This device is a single-use disposable unit and is packaged in a thermoformed tray with a heat sealed paper lid. The catheter is available in a variety of lengths and configurations to accommodate individual anatomy of both male and female users. Both Nelaton (straight tip) and Tiemann (curved tip) designs are available.

The provided text is a 510(k) Summary for the LoFric® Single Use Urinary Catheter. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific, quantitative acceptance criteria through a study with a test set, ground truth, or expert review in the way that an AI/ML medical device submission would.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not present in the provided 510(k) summary.

Here's why and what information is provided:

• 510(k) for Catheters vs. AI/ML Devices: The LoFric® catheter is a physical medical device. Its submission focuses on demonstrating that it is "substantially equivalent" to an existing, legally marketed device (the Astra Tech LoFric® Single Use Urinary Catheter - K896750) in terms of intended use, operating principle, design, materials, manufacturing, and sterilization. This is a comparison against a similar existing device, not a performance evaluation against pre-defined statistical acceptance criteria for a new algorithmic output.
• Performance Testing: The summary mentions "Performance testing and biocompatibility testing were submitted to address efficacy and safety of the device and to show substantial equivalence to the predicate device." However, it does not provide any details about:
  • Specific acceptance criteria for these tests.
  • The quantitative results of these tests.
  • The sample sizes for these tests.
  • How "ground truth" was established (as it's not relevant for a physical device's performance like this).
  • Expert involvement or adjudication methods.
  • Multi-reader multi-case studies or standalone algorithm performance.

In summary, none of the specific details you requested (points 1-9) are available in this 510(k) summary because it pertains to a physical, non-AI medical device and follows the substantial equivalence pathway, not a performance study pathway that would typically involve such metrics.

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Implants:

OsseoSpeed™ Plus implants of the Astra Tech Implant System Plus are intended to be used:

• · To replace missing teeth in single or multiple unit applications within the mandible or maxilla
• · For immediate placement in extraction sites and partially or completely healed alveolar ridge situations
• · For both one- and two-stage surgical procedures
• · Especially well in soft bone applications where implants with other implant surface treatments may be less effective
• · Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

Abutments:

Astra Tech Implant System Plus abutments are intended to be used in conjunction with the Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

OsseoSpeed Plus implants are straight, self-tapping, threaded, root-form dental implants provided in multiple diameters and lengths with the previously cleared OsseoSpeed™ surface. Implants are available in diameters of 3.6 mm, 4.2 mm and lengths of 9 mm, 11 mm and 13 mm. The neck portion of the implant includes the MicroThread™ design. A new anti-rotation interface with 6 keyway cross section connections allows for six abutment positions. All other features and procedures of OsseoSpeed Plus implants are the same as presently cleared OsseoSpeed implants.

OsseoSpeed Plus abutment components consist of cover screws, healing abutments and abutments with corresponding screws. Cover screws and healing abutments are provided in sizes to match the implant platform. Healing abutments are provided in sizes to match the implant platform and various gingival diameters and gingival heights. OsseoSpeed Plus abutments have three design types, cylindrical, asymmetric and angled (20°). Each abutment design type is provided in three platform diameters (3.6, 4.2 and 4.8 mm), two prosthetic margin diameters (4.5 and 5.5 mm or 5.5 and 7.0 mm) and two gingival heights (low = 1.5- 2.5 mm and high = 2.5-3.5 mm) for a total of eleven abutment design combinations.

To assist in preoperative treatment planning of position and direction of implant placement, transparent radiographic implant guide sheets are provided with magnifications from 1.0X to 1.8X. The radiographic implant guides are usable with all OsseoSpeed Plus implants.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the Astra Tech Implant System Plus:

Important Note: This 510(k) summary is for a dental implant system. The information provided is typical for medical devices that aim to demonstrate substantial equivalence to previously cleared predicate devices, rather than a clinical study establishing efficacy from scratch. Therefore, many of the typical "AI/algorithm performance study" criteria you listed (like MRMC studies, training set details, or ground truth establishment for a test set in the AI context) are not applicable to this type of device submission.

The "study" in this context refers to performance testing designed to show that the new device's technological changes do not raise new issues of safety or efficacy compared to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices. This is achieved by showing that the subject device has the same intended use, technological characteristics, materials, and provides similar performance without raising new issues of safety or efficacy. The specific performance test mentioned is compliance with ISO 14801.

Reported Device Performance:
The document states: "Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the summary. For mechanical testing under ISO 14801, a specific number of implants would be tested, but this number is not disclosed in the provided text.
• Data Provenance: The testing was conducted by or for Astra Tech AB, a Swedish company. The summary doesn't specify if the testing itself was performed in Sweden or elsewhere, nor does it specify if human data (e.g., retrospective or prospective patient data) was used. Given it's ISO 14801, it is almost certainly bench-top mechanical testing, not human patient data.

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

This information is not applicable as the "test set" in this context refers to mechanical performance testing, not human-interpreted data requiring expert consensus or ground truth establishment in the way it would be for an AI algorithm.

4. Adjudication Method for the Test Set

This information is not applicable for mechanical performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic or screening devices, especially those involving human interpretation of images, to assess reader performance with and without an AI aid. This 510(k) is for a physical medical implant device.

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

Not Applicable. This device is a physical dental implant, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the mechanical performance testing (ISO 14801), the "ground truth" would be the objective measurements of force, cycles to failure, or displacement as defined by the standard, measured by calibrated equipment. It is not expert consensus, pathology, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

Not Applicable. This 510(k) is for a physical medical device, not an AI algorithm. Therefore, there is no "training set."

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

Not Applicable. As there is no training set for an AI algorithm, this question is irrelevant to this device submission.

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Astra Tech Implant System abutments are intended to be used in conjunction with the Astra Tech Implant System in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. Highly angled abutments on small diameter implants are not recommended for use in the molar region. ZirDesign is not recommended for use in the molar regions.

The Astra Tech Implant System has been modified to increase treatment options by adding new abutment shapes in titanium and zirconia. Both abutment designs are provided in multiple sizes with straight and angled versions. The hex interlocking anti-rotation mechanism for indexing with the implant remains unchanged from the predicate devices. As with the predicate devices, Astra Tech's Conical Seal Design™ is used for the internal connection with the implant to achieve a tight and stable interface.

The provided text describes modifications to the Astra Tech Implant System, specifically the addition of new abutment shapes, and asserts their substantial equivalence to predicate devices, but it does not contain acceptance criteria for device performance or a study proving that the device meets such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing performance against specific acceptance criteria for a novel device.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria: The document does not define any specific numerical or categorical acceptance criteria for performance metrics (e.g., strength, durability, fit).
• No Performance Study Details: While it states "Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801," it does not provide any results from this testing, nor does it detail the study design elements requested (sample size, data provenance, ground truth establishment, expert qualifications, etc.).
• Focus on Substantial Equivalence: The entire submission hinges on the argument that the modified device is "substantially equivalent" to existing predicate devices, implying that its performance is expected to be similar, rather than proving it meets new, pre-defined acceptance criteria.

Therefore, I cannot populate the table or provide the requested details because the input text does not contain this information.

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The OsseoSpeed implants are intended to be used:

• to replace missing teeth in single or multiple unit applications within the mandible or . maxilla
• for immediate placement in extraction sites and partially or completely healed alveolar . ridge situations
• for both one- and two-stage surgical procedures o
• especially well in soft bone applications where implants with other implant surface . treatments may be less effective
• together with immediate loading protocol in all indications, except in single tooth ● situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate
• together with immediate loading protocol for single-tooth restorations on implants 8 mm . or longer
• with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and . central incisors.

Astra Tech Implant System implants are intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The new components of the Astra Tech Implant System included in this submission are OsseoSpeed TX implants which have a narrower tapered apex design compared to OsseoSpeed implants (K053384). They are placed using a modified drilling protocol with new conical drill sizes. The modified drilling protocol is specifically designed for soft bone applications. All other features and procedures of OsseoSpeed TX implants remain the same as those for OsseoSpeed implants.

The purpose of this submission is to add the OsseoSpeed TX implants to the present product line and expand device claims regarding primary stability of Astra Tech Implant System implants.

The provided text describes a 510(k) premarket notification for the Astra Tech Implant System. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria for a novel device. Therefore, the "acceptance criteria" and "study proving the device meets acceptance criteria" as typically understood for a new therapeutic or diagnostic device (e.g., specific clinical endpoints, sensitivity/specificity thresholds) are not explicitly present in the document in the format requested.

Instead, the submission's goal is to show the new OsseoSpeed TX implants (with a narrower tapered apex design and modified drilling protocol for soft bone) are substantially equivalent to existing legally marketed devices. The "acceptance criteria" in this context would be the successful demonstration of this substantial equivalence, and the "study" is the comparison testing performed to support this claim.

Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" for a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Testing was performed to compare OsseoSpeed TX implants using the new soft bone drilling protocol with OsseoSpeed implants using the standard drilling protocol. Calculations also were made to determine bone to implant contact for the two implant/drilling protocol combinations."

• Sample Size: The exact sample size for this comparative testing is not specified in the provided text.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be laboratory/non-clinical testing given the nature of comparing drilling protocols and bone-to-implant contact for implants.

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

This type of information (expert review for ground truth) is typically relevant for diagnostic devices interpreting medical images or data. For a dental implant's mechanical stability and bone-to-implant contact, the "ground truth" would be established through direct physical measurements, imaging, or histological analysis, rather than expert consensus on interpretation. Therefore, this information is not applicable and not provided in the document for an implant device.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are primarily used in studies where multiple human readers interpret data, and discrepancies need to be resolved. Since the "testing" described involves comparing implant performance characteristics (mechanical stability, bone-to-implant contact) through presumably laboratory or animal studies, an adjudication method in this sense is not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for comparing the performance of human readers, typically with and without AI assistance for diagnostic tasks. This submission is for a dental implant, which is a therapeutic device, not a diagnostic one involving human interpretation of cases. Therefore, this type of study was not done and is not applicable.

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

No. This question is also relevant for diagnostic devices, specifically AI algorithms. The Astra Tech Implant System is a physical dental implant, not an algorithm. Therefore, a standalone algorithm performance study was not done and is not applicable.

7. The Type of Ground Truth Used

For the performance testing described ("compare OsseoSpeed TX implants... with OsseoSpeed implants... Calculations also were made to determine bone to implant contact"), the ground truth would be based on:

• Direct measurements/experiments: For primary mechanical stability and bone-to-implant contact, this would typically involve biomechanical testing (e.g., insertion torque, removal torque, pull-out strength tests) and potentially histological analysis or micro-CT imaging to quantify bone-to-implant contact in animal models or ex vivo samples.
• The document implies these were obtained through calculations and comparative testing, which points to direct experimental data rather than expert consensus, pathology (in the clinical sense for a patient), or outcomes data (long-term clinical results).

8. The Sample Size for the Training Set

This question is applicable to machine learning algorithms. Since the Astra Tech Implant System is a physical medical device (dental implant) and not an AI/ML algorithm, there is no training set and therefore no specified sample size for it.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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Astra Tech Implant System is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The OsseoSpeed Narrow product line shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.

The fluoride-modified implant surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Astra Tech Implant System is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations. Immediate loading of single tooth restorations is not recommended for the OsseoSpeed™ 4.0S - 6 mm implant.

Astra Tech Implant System implants, abutments, prosthetic components and accessories are intended for supporting prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. All components of the Astra Tech Implant System are identical to those presently marketed. The purpose of this submission is to expand device claims.

This 510(k) summary for the Astra Tech Implant System (K091239) does not contain information on acceptance criteria or a study proving device performance against such criteria.

The document is a standard 510(k) submission summary, which focuses on demonstrating substantial equivalence to a predicate device. It defines the intended use and describes the device, but does not present specific performance metrics, clinical study data, or acceptance criteria that would typically be found in a study proving device performance.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as that information is not present in the provided text.

The document states: "Astra Tech AB demonstrated that, for the purposes of FDA's regulation of medical devices, the Astra Tech Implant System is substantially equivalent in indications and design principles to predicate devices..." This implies that the 'study' conducted was a comparison to existing, legally marketed devices, rather than a de novo clinical trial with defined acceptance criteria and performance metrics. Substantial equivalence does not require new performance data if the new device is sufficiently similar to a predicate.

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OsseoSpeed™ Profile is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate.

The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. OsseoSpeed Profile is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.

The OsseoSpeed™ Profile is a self-tapping, threaded, root-formed dental implant, intended for supporting prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. It is made from titanium with a microroughened and fluoride-modified surface, designated OsseoSpeed. It includes a contoured coronal margin that mimics the contour of alveolar bone and is designed to create a more desirable esthetic effect.

The provided text is a 510(k) summary for the OsseoSpeed™ Profile dental implant and a subsequent FDA clearance letter. It describes the device's intended use and classification, and states that it is substantially equivalent to predicate devices. However, this document does not contain information about specific acceptance criteria or an analytical study with performance metrics.

Therefore, I cannot provide the requested table of acceptance criteria and device performance, nor details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training/test set ground truth establishment.

The document primarily focuses on:

• Device Description: Self-tapping, threaded, root-formed dental implant made from titanium with a microroughened and fluoride-modified surface, designed for supporting prosthetic devices. It also notes a contoured coronal margin for esthetic effects.
• Intended Use: To replace missing teeth in single or multiple unit applications, usable in single-stage or two-stage surgical procedures, indicated for immediate implantation in extraction sites or healed alveolar ridges. It can be immediately loaded when primary stability is achieved. It is also indicated for use in soft bone applications.
• Substantial Equivalence: The manufacturer demonstrated the device is substantially equivalent to predicate devices for its indications and design principles.

Missing Information:

The document lacks critical experimental data typically found in a clinical study report or a more detailed 510(k) submission that would include performance testing. To answer your questions, I would need a document that presents:

1. Specific performance metrics and their acceptance thresholds. (e.g., success rate, survival rate, bone loss measurements, ISQ values, etc.)
2. Details of a study conducted to demonstrate these metrics. This would include information on the study design, patient population, data collection, and statistical analysis.

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OsseoSpeed™ Narrow is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The OsseoSpeed Narrow product line shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.

The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. OsseoSpeed Narrow is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.

Osseospeed Narrow is a self tapping, threaded, root-form dental implant intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. It is made from titanium with a micro-roughened and fluoride-modified surface, designated OsseoSpeed.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a dental implant called "OsseoSpeed™ Narrow," primarily focusing on its administrative information, device description, intended use, and substantial equivalence to marketed devices. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes for test sets, data provenance, or ground truth establishment.
3. Information on expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
4. Details on training set size or how its ground truth was established.

The document is a regulatory submission for market clearance, not typically a detailed report of performance studies with specific statistical metrics against predefined acceptance criteria.

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Astra Tech Implant System abutments are intended to be used in conjunction with Astra Tech Implant System implants in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

The Astra Tech Implant System has been modified to increase treatment options by adding a new component, an additional abutment for provisional restorations.

The provided text describes a 510(k) summary for a medical device modification, specifically the "Astra Tech Implant System, New Component." However, it does not contain information about acceptance criteria, the study that proves device meets acceptance criteria, detailed performance data, sample sizes, ground truth establishment, or expert involvement.

The document is a regulatory submission discussing the device's administrative information, intended use, description, and equivalence to a predicate device. It explicitly states that the modification "has the same intended use, uses the same operating principle, incorporates the same basic design, and is packaged using the same materials and processes" as the unmodified predicate device. This implies that the modification is considered substantially equivalent based on these similarities, rather than requiring a new, comprehensive performance study against specific acceptance criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone performance data.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of information is typically found in a clinical study report or a more detailed performance evaluation, which is not present in the provided 510(k) summary. The 510(k) process for device modifications often focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new, extensive performance studies with detailed acceptance criteria if the changes are minor and do not alter the fundamental safety or effectiveness of the device.

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