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510(k) Data Aggregation
(143 days)
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."
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Same intended use as predicate devices. | The Astra Tech Implant System Plus implants and abutments have the same intended use as the predicate devices: replacing missing teeth, immediate placement, one- and two-stage procedures, soft bone applications, and supporting crowns/bridges/overdentures. |
| Same operating principle as predicate devices. | The device "uses the same operating principle" as predicate devices. | |
| Same basic design (with minor modifications not raising new safety/efficacy concerns). | The device "incorporates the same basic design." The main technological change is a new anti-rotation feature (keyway cross section) which is "similar to the cam anti-rotation mechanism of the CAMLOG Implant System." This difference "does not raise new issues of safety or efficacy." | |
| Same materials as predicate devices. | The device "incorporates the same materials." | |
| Similar packaging and sterilization methods as predicate devices. | The device "has similar packaging and is sterilized using the same materials and processes." | |
| Mechanical Performance | Compliance with ISO 14801 (Dynamic loading for endosseous dental implants). | "Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801." (The specific results of this testing are not detailed in this summary, but the inclusion of this testing is noted.) |
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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(435 days)
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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(247 days)
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
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (as demonstrated) |
|---|---|
| Intended Use: Device has the same intended use as predicate devices. | The OsseoSpeed implants are intended to replace missing teeth, for immediate placement, and for one- and two-stage surgical procedures. Claims expanded for soft bone applications and immediate loading protocols where appropriate. This aligns with or expands upon the predicate devices' intended uses. |
| Technological Characteristics: Device has the same operating principle, basic design, materials, packaging, and sterilization methods as predicate devices. | Implants are made of commercially pure titanium (ASTM F67) and encompass similar physical dimensions. Packaged in similar materials and sterilized using similar methods. The OsseoSpeed TX implants have a narrower tapered apex design compared to OsseoSpeed implants (K053384) but are considered an evolution within the same system. |
| Performance: Demonstrated equivalence in performance characteristics relevant to the intended use, particularly for the new design features. | Testing was performed to compare OsseoSpeed TX implants (new drilling protocol) with OsseoSpeed implants (standard drilling protocol). Calculations were made to determine bone-to-implant contact. The design of OsseoSpeed TX implants, combined with the soft bone drilling protocol, results in improved primary mechanical stability of the implant. This supports the expanded claims for soft bone applications. |
| Safety and Effectiveness: No new questions of safety or effectiveness are raised. | The FDA’s clearance letter states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...". This implies that the FDA concurred that no new safety or effectiveness concerns were raised that would prevent market clearance. |
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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(148 days)
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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(14 days)
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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