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The Intra-Lock Bone Fixation System is indication and fixation of bone graft, bone filling materials, and/or barrier membranes used to regenerate bone in the oral cavity.

The Intra-Lock Bone Fixation System consists of titanium alloy self-tapping screws, which are tapered and have a minimum diameter of 1.5mm with lengths of 3mm, 6mm, 7mm, 8mm, 9mm, 10mm and 11mm and a maximum diameter of 2.0mm with lengths of 4mm, 5mm, 9mm, 11mm, 13mm, and 15mm. Tenting screws are also available in the 1.5 mm diameter. The spacer part of the tenting screws is available in 2mm, 6mm, 8mm and 10mm lengths. The screws are manufactured using Ti-6Al-4V alloy (ASTM F-136) and adhere to standards tested under ASTM F-543. This system also includes accessories used to fixate the screws, membranes or bone graft to the host bone including a tapered driver, and a cassette. The screws are designed for removal from the patient after such time when sufficient bone regeneration is demonstrated. The devices are sold non-sterile. Single-use only.

The provided text is a 510(k) summary for the Intra-Lock Bone Fixation System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting standalone performance studies or clinical trials with acceptance criteria for the new device itself.

Therefore, many of the requested elements about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC studies are not applicable and not found within this document. This is typical for 510(k) submissions where reliance on predicate device performance and non-clinical testing for equivalence is key.

However, I can extract information regarding non-clinical performance data and the reason for the absence of clinical data.

Section 1: Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate, the document does not present "acceptance criteria" in the traditional sense of a performance study for the new device with specific statistical targets (e.g., sensitivity, specificity). Instead, the performance is evaluated against established standards to show that the new device is as safe and effective as the predicate.

The non-clinical performance tests conducted are:

Section 2: Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated for each mechanical test. The document mentions "All tested Unifix screws" for torsion testing, implying a sufficient number for the test.
• Data Provenance: This refers to non-clinical performance data generated by the manufacturer, Intra-Lock International, Inc. It is not patient or human-derived data, so terms like "country of origin" or "retrospective/prospective" are not applicable in this context.

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

• Not applicable. For mechanical and sterilization tests, ground truth is established by engineering standards (e.g., ASTM F-543, ISO 17665-1) and internal quality control, not by human experts adjudicating clinical outcomes.

Section 4: Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving reader disagreement. For non-clinical, objective tests, the results of the test itself determine the outcome.

Section 5: If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study was not done. This device is a bone fixation system, not an imaging or diagnostic AI device that would typically undergo MRMC studies.

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

• Not applicable. This device is a physical medical device (screws), not an algorithm or AI software. Therefore, standalone performance in the context of AI is not relevant.

Section 7: The type of ground truth used

• For mechanical tests: Engineering specifications and standards (e.g., ASTM F543).
• For sterilization: Industry standards (ISO 17665-1).
• For biocompatibility: Benchmarking against previously cleared devices and accepted biocompatibility of materials (ISO 10993-1).

Section 8: The Sample Size for the Training Set

• Not applicable. This product is a physical bone fixation system, not a machine learning or AI algorithm that requires a "training set."

Section 9: How the Ground Truth for the Training Set Was Established

• Not applicable. As stated above, there is no training set for this type of device.

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Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

The Intra-Lock® Dental Implants are titanium screw-type threaded root-form endosseous implants ranging in diameters from 3.75mm - 5.0mm and length from 8mm - 15mm. The implants in this submission include tapered and straight body implants with short and 2mm collars that have horizontal micro-threads and an internal connection to interface with the abutment.

The provided document is a 510(k) Summary for Intra-Lock® Dental Implants. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study with a test set, ground truth, or expert review.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and training set ground truth cannot be extracted from this document.

The key phrases that indicate the nature of this submission are:

• "No new performance testing was conducted." This explicitly states that no new studies (clinical or non-clinical) were performed to establish performance metrics against acceptance criteria for this specific submission.
• "Mechanical bench testing of two previously identified Intra-Lock Dental Implant System worst-case scenario (i.e. smallest diameter implant / angled abutments), which remains applicable for the implants contained in this submission and was previously reviewed in K103194, April 21, 2011 and/or K111199, August 8, 2011." This indicates that any relevant performance testing was conducted for previous submissions (K103194, K111199) and is being referenced, not newly presented or detailed here.
• "Conclusion: Based on the data within this submission, the Intra-Lock dental implants are substantially equivalent to the predicate dental implants identified. The minor differences between proposed devices and the predicate devices raise no new issues of safety, risk to health or effectiveness." This reinforces that the goal is to demonstrate substantial equivalence, not to meet specific quantitative performance criteria through a new study.

In essence, this 510(k) submission relies on the established safety and effectiveness of its predicate devices and argues that the new device's differences do not introduce new risks, rather than providing new performance data against acceptance criteria.

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For 3.0mm Intra-Lock® OP Dental Implants:
The 3.0mm Intra-Lock® OP Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. They are also indicated for the rehabilitation of single or maxillary lateral incisors and mandibular lateral incisors. Multiple implants may be restored after a period of delayed loading or placed in immediate function when good primary stability is achieved with appropriate occlusal loading in order to restore normal teeth function.

For 3.75mm, 4.0mm & 4.75mm Intra-Lock® OP Dental Implants:
Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

The Intra-Lock® OP Dental Implants are threaded dental implants diameter 3.0mm, 3.75mm, 4.0mm and 4.75mm, with an integrated straight abutment (implant and abutment arc one piece).

The provided text is a 510(k) Summary for the Intra-Lock® OP Dental Implants. This type of document is for medical device regulation and describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices. It outlines performance testing performed, but it does not detail specific acceptance criteria or report performance data against those criteria in a quantitative manner that would be typical for an AI/ML device study.

Therefore, I cannot fulfill all parts of your request based on the provided text, particularly those related to a study proving the device meets acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/ML device. The document describes mechanical and material testing for an implant, not an AI software.

However, I can extract the information that is present, especially regarding the performance testing performed and the general approach.

Here's the closest I can get to your request based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria or specific numerical performance metrics. Instead, it lists the types of performance testing that were conducted to support the device's intended use and demonstrates substantial equivalence to predicate devices which have implicitly met regulatory acceptance.

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

The document does not specify a "test set" in the context of an AI/ML study, nor does it provide sample sizes for the performance testing mentioned (risk analysis, shelf life, sterilization validation, surface analysis, static/dynamic fatigue).

The data provenance is not mentioned. These are likely lab-based engineering and biological tests rather than clinical data from human subjects or retrospective/prospective medical data.

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

Not applicable. This is a medical implant, not an AI/ML diagnostic or predictive device that relies on expert interpretation of data to establish ground truth for a test set. The validation is based on engineering and material science principles, and comparison to established predicate devices.

4. Adjudication method for the test set

Not applicable for the reasons stated above.

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-assisted diagnostic or interpretation device.

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).

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

For this type of device, "ground truth" is established through:

• Engineering Standards: Compliance with recognized international and national standards for static and fatigue strength (e.g., ISO standards for dental implants, though not explicitly cited, they are implicit in such submissions).
• Material Specifications: Verification of material composition and properties against established biocompatible requirements.
• Sterilization Validation: Confirmation that the sterilization process achieves a predefined sterility assurance level (SAL).
• Bench Testing: Physical testing results (e.g., fatigue cycles, surface roughness measurements) are compared against safety and performance thresholds derived from predicate devices and regulatory guidance.
• Biocompatibility Testing: (Though not explicitly listed in "Performance Testing" for this specific summary, it's a standard requirement for implants and would involve testing for toxicity, sensitization, etc., against biological ground truth).

8. The sample size for the training set

Not applicable. There is no AI/ML component or "training set" in the context of this device.

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

Not applicable for the reasons stated above.

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Intra-Lock® 15° Angled Abutments are intended for use with Intra-Lock® dental implants to support a prosthetic device in partially or fully edentulous patients. The abutments may be used in single and/or multiple tooth application in the mandible or maxilla.

The subject Intra-Lock® 15° Angled Abutment has a narrow prosthetic interface (SQ Platform) and therefore only mates with implants having SQ Platform. The SQ Platform abutments are anodized a magenta color.

The provided text describes the 510(k) summary for the Intra-Lock® 15° Angled Abutment, a dental device, and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the acceptance criteria and study details as requested for an AI/ML device.

The document focuses on:

• Device Identification: Name, common name, classification, and predicate devices.
• Intended Use/Indications: To support prosthetic devices with Intra-Lock® dental implants in partially or fully edentulous patients.
• Technological Characteristics: Narrow prosthetic interface (SQ Platform), magenta anodization.
• Mechanical Testing: Static and dynamic fatigue testing in accordance with ISO 14801:2007.
• Substantial Equivalence: Claim that the device is substantially equivalent to predicate devices based on design, materials, intended use, and operational principles, raising no new safety or effectiveness issues.

There is no mention of acceptance criteria related to algorithms, performance metrics like accuracy, sensitivity, specificity, or any studies involving AI/ML models, human readers, or ground truth establishment for such models.

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The Intra-Lock Dental Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prothesis, from single tooth replacement to full arch reconstruction, They are intended for immediate function on single and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

The Intra-Lock Endosseous Dental Implant System with Blossom is a screw-type implant system with a cutting design that incorpoarates at least one cutting surface on each thread. It ranges in diameter from 3.4 to 6mm. The 3.4, 4, and 6mm have a straight body design and there is also a 4mm with a conic body design. The internal connection is a six-spline taperlock design. Abutments include straight, flat top (a wedge shape), o-ball, and 15° & 25° angled (4mm and 6mm only). Prosthetic interface varies with the width of the implant. The 3.4mm has a narrow interface, the 4mms have a standard interface and the 6mm has a wide interface. The angled abutments do not come in narrow interface because of the small diameter of the narrow interface implant.

This document is a 510(k) Summary of Safety and Effectiveness for a medical device called the "Intra-Lock Dental Implant System with Blossom." It describes a dental implant system and presents information to demonstrate its substantial equivalence to previously marketed predicate devices.

Based on the provided text, the device itself is a dental implant, not an AI/ML powered device, therefore no information regarding AI/ML powered device acceptance criteria, study design or performance is available.

The relevant "Testing" section states: "Fatigue testing according to ISO 14801 was done with both angled abutments in order to demonstrate the design changes did not change the fatigue properties. The fatigue properties of the new design are similar to those of the predicate device."

Therefore, the only acceptance criteria and study data provided relate to the physical properties of the dental implant, specifically its fatigue properties.

Here's the breakdown of the information that can be extracted, and where AI/ML related information is explicitly not present:

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

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

• Sample Size: Not specified for the fatigue testing. (e.g., how many implants were tested, how many cycles).
• Data Provenance: The standard used for testing is ISO 14801, an international standard. No information regarding country of origin of the data or whether it was retrospective or prospective is given.

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

• This question is not applicable as the "ground truth" for a mechanical fatigue test is determined by the physical failure of the device, not expert opinion.

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

• This question is not applicable as there is no human adjudication involved in a mechanical fatigue test.

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 question is not applicable as the device is a physical dental implant, not an AI/ML powered device that would involve human readers or AI assistance.

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

• This question is not applicable as the device is a physical dental implant, not an AI/ML algorithm.

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

• The ground truth for the fatigue test is the physical failure or successful endurance of the dental implant under specific cyclic loading conditions, as defined by the ISO 14801 standard. This is a mechanical performance ground truth.

8. The sample size for the training set

• This question is not applicable as there is no mention of an AI/ML model and therefore no "training set."

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

• This question is not applicable as there is no mention of an AI/ML model and therefore no "training set" ground truth.

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ReOss" Powder, Putty and Gel are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

ReOss™ is a hydrophilic, highly porous, resorbable, synthetic copolymer permeated with osteoconductive sub-micron particles of Hydroxyapatite. It is configured as a multi-pore, three-dimensional scaffold that is engineered to integrate with the physiochemical state of bone tissue.

ReOss™ is available as a Powder, Putty or Reverse Phase Injectable Gel.

Products are provided in sterile packaging in various dosage volumes.

This 510(k) summary (K082419) pertains to the ReOss™ Products, which are bone grafting materials. Based on the provided text, the submission is an Abbreviated 510(k), which relies on conformity with FDA guidance documents instead of new clinical study data to demonstrate substantial equivalence. Therefore, the information requested regarding acceptance criteria, device performance, and study details like sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly available within this document.

Here's why and what can be inferred:

• Abbreviated 510(k): The document explicitly states: "This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.'" This means the manufacturer is demonstrating substantial equivalence by showing conformity to recognized standards or guidance documents, rather than conducting new clinical performance studies specifically for this device.
• Safety and Performance: The document states that Intra-Lock International "has provided information to demonstrate conformity with FDA's guidance document entitled Bone Grafting Materials, 872.3930 and Resorbable calcium salt bone void filler device 888.3045." This implies that the device's design and manufacturing meet the safety and performance requirements outlined in those guidance documents. However, the specific acceptance criteria and performance data from a dedicated study of the ReOss™ device itself are not presented here.
• Conclusion: The conclusion states: "Based on the indications for use, technological characteristics, and comparison to predicate devices, the Intra-Lock ReOss" products have been shown to be safe and effective for its intended use." This re-iterates the substantial equivalence claim without detailing specific study results.

Therefore, the table and detailed study information requested cannot be fully populated from the provided text.

Here's a breakdown of what can be stated, acknowledging the limitations:

1. Table of acceptance criteria and reported device performance:
   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds for a new clinical study. Instead, the acceptance criteria are implicit in the conformity to FDA guidance documents (Bone Grafting Materials, 872.3930 and Resorbable calcium salt bone void filler device 888.3045) and the equivalence to predicate devices. These guidance documents likely outline performance characteristics (e.g., biocompatibility, biodegradation rate, osteoconductivity) that the device implicitly meets by design and material composition.
   • Reported Device Performance: No specific performance metrics (e.g., success rates, bone regeneration volume, adverse event rates from a study of ReOss™) are reported in this summary. The device's performance is inferred to be "safe and effective" based on its similarity to legally marketed predicate devices and compliance with relevant guidance.

2. Sample size used for the test set and the data provenance: Not applicable or provided, as no new clinical test set data from a study of ReOss™ is presented. Data provenance relates to predicate devices, but specific details are not given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided, as no new clinical test set requiring ground truth establishment for ReOss™ is described.

4. Adjudication method for the test set: Not applicable or provided.

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 bone grafting material, not an AI-based diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a bone grafting material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new study of ReOss™. The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate devices as determined by their previous regulatory clearances and real-world use overseen by FDA.

8. The sample size for the training set: Not applicable or provided, as no new clinical study data from a training set for ReOss™ is presented. (This question is typically relevant for AI/ML devices).

9. How the ground truth for the training set was established: Not applicable or provided.

In summary: This 510(k) summary demonstrates substantial equivalence by referencing existing FDA guidance and comparing the ReOss™ products to predicate devices, rather than presenting results from a de novo clinical study of the device's performance against specific acceptance criteria.

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The Intra-Lock Mini Drive Lock™ Implant System Prosthetics have been designed to restore partially or fully edentulous patients. The abutments have been designed to be used in either the mandible or maxilla and to support removable or fixed prosthesis.

The Intra-Lock Mini Drive-Lock™ Dental Implant System Prosthetics consist of straight and angled cement retained abutments in various sizes. There are also provisions on the implants for overdenture retention abutment allowing for tissue born or combination tissue and tooth born removable prosthetic appliances. The prosthetics allow for full arch restorations, for either fixed or removable prosthetic appliances. The abutment raw materials consist of Titanium Alloy for Surgical Implant Applications (as per ASTM F 136) Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy. The abutment components are non sterile packaged.

The provided text describes the regulatory clearance of a dental implant system and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or technical study setup.

The submission is an "Abbreviated 510(k)," meaning it relies on demonstrating conformity with FDA guidance documents and substantial equivalence to predicate devices rather than presenting new performance data from a dedicated study.

Therefore, I cannot fulfill the request for information regarding:

• A table of acceptance criteria and reported device performance: This type of data is not present in the provided document.
• Sample size used for the test set and data provenance: No test set is described.
• Number of experts used to establish ground truth and qualifications: No ground truth establishment process is described.
• Adjudication method: Not applicable as no test set or ground truth establishment is described.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
• Standalone (algorithm only) performance: Not applicable as this is a physical dental device, not an algorithm.
• Type of ground truth used: Not applicable as no ground truth is established.
• Sample size for the training set: Not applicable as this is a physical device, not a machine learning algorithm.
• How the ground truth for the training set was established: Not applicable.

The document focuses on the regulatory process for enabling the marketing of the device based on its substantial equivalence to previously approved devices and adherence to relevant guidance documents.

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Mini Drive-Lock™ Dental Implants are intended for use as a self-tapping titanium screw for transitional or intra-bony long-term applications. Mini Drive-Lock™ Dental Implants are indicated for long-term maxillary and mandibular tissue-supported denture stabilization. Multiple implants should be used and may be restored after a period of time or placed in immediate function.

The Intra-Lock Mini Drive-Lock™ Dental Implant System consists of machined Titanium, screw-form dental implants, 2.0mm and 2.5mm in diameter and available in lengths of 10mm, 11.5mm, 13mm, 15mm and 18mm. The implant raw material consists of Titanium Alloy for Surgical Implant Applications (as per ASTM F 136 Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401). The implants are sterile packaged.

The provided text describes a 510(k) summary for the "Mini Drive-Lock™ Dental Implant System." This document is a premarket notification to the FDA for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria from a specific clinical study with performance metrics.

Therefore, it is not possible to extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text. The document is primarily a regulatory submission outlining the device's description, intended use, and comparison to existing legally marketed devices.

Specifically, the document states: "This submission is a Traditional 510(k) as described in Safety and Performance: FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Intra-Lock International has provided information to demonstrate conformity with FDA's guidance document entitled Endosseous Implants 872-3640."

This indicates that the submission relies on demonstrating substantial equivalence, not necessarily on a new clinical study with specific acceptance criteria and performance outcomes.

Without a clinical study report or a different type of performance testing document, the information requested in points 1-9 cannot be provided.

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1. MILO™ Implants are indicated for long-term maxillary and mandibular tissuesupported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function.

2. MILO™ Implants are indicated for the rehabilitation of single and/or multiple maxillary lateral incisors. They are also indicated for the rehabilitation of single and/or multiple mandibular central and lateral incisors. The implants may be restored after a period of time or placed in immediate function.

The Intra-Lock MILO™ Dental Implant System consists of machined titanium, screw-form dental implants 3.0mm in diameter. They are available in lengths of 10mm, 11.5mm, 13mm and 15mm. The implants' raw material is Titanium Alloy for Surgical Implant Applications (as per ASTM F 136 Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS) R56401). The implants are sterile packaged.

The provided text is a 510(k) summary for a dental implant system (Intra-Lock MILO™ Implant) and does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

The 510(k) summary focuses on establishing substantial equivalence to predicate devices, providing a device description, intended use, and the FDA's clearance letter. It does not include the details typically found in a clinical study report or performance testing document that would describe acceptance criteria and how they were met.

Therefore, I cannot provide the requested information based on the provided text.

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Intra-Lock International Angled Prosthetic Abutments are intended to prosthetically restore Endosseous Implants. These abutments are designed to be used on single tooth applications and or multiple tooth bridge applications. They are intended to be used when minor correction or alignment will improve the aesthetics of the final restoration.

The Intra-Lock International Angled Prosthetic Abutments are an accessory to the Intra-Lock Endosseous Dental Implants. They perform the function of connecting the laboratory fabricated prostheric bridge or crown to the implanted dental implant. They are manufactured from Titanium Alloy (6 Al-4V ELI, ASTM F136) and are provided in a number of sizes to accommodate tissue depth. These prositietic abutments are provided in non-sterile packaging.

This document is a 510(k) summary for the Intra-Lock International Angled Prosthetic Abutments. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

The document is a "Special 510(k): Abbreviated 510(k)" relying on conformity with FDA's guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA." This type of submission generally means that the manufacturer is demonstrating that their device meets recognized standards or guidance documents, rather than conducting a de novo performance study with specific quantitative acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text. To answer your questions, I would need a different type of document, such as a full performance study report or design verification and validation report, which would detail specific acceptance criteria and the results of tests performed to meet them.

Based on the provided text, I can only state the following:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The document states "Intra-Lock International has provided information to demonstrate conformity with FDA's guidance document entitled: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA." This implies conformity to general requirements and standards, not specific quantitative acceptance criteria for device performance in the context of a clinical study.
• 2. Sample sized used for the test set and the data provenance: Not applicable, as no specific performance study with a test set is described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 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 physical medical device (dental abutment), not an AI-powered diagnostic or assistive technology.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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