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The ACE Surgical Secure™ Locator® 3.25mm Implant System is is designed to provide intra-bony long term fixation of denture installations in partially or fully edentulous patients.

The ACE Secure™ Locator® 3.25mm Implant System is a set of machined commercially pure (CP) titanium (Grade 4) screws, intended to provide Intra-bony long term fixation of denture installations in partially or fully edentulous patients. The implants are supplied sterlie in 3.25 mm diameter, and in lengths of 8, 10, 11.5, 13, and 15 mm, and with Zest Locator® implant Anchor Abutments and Denture Cap Males (Identical to those cleared under K092594)/n standard tray packaging and include placement instruments.

The screw raw material is Ti (CP-Grade 4) per ASTM F67 standard. The screw Implants, abutments and denture caps are identical In materials and characteristics to that cleared under K092594 and K954513. These screws are supplied sterile in standard Tyveke tray packaging along with applicable instructions for use.

The ACE Secure™ Locatore 3,25mm Implant System Is a comprehensive system using same and similar surgical tools (a Two Step Lag Bur CA is replaced by a Kirschner Pliot Bur, and the optional Parallel Pin/Depth Gauge and 2.8 mm twist drill are now supplied standard) made from high strength corrosive resistant stainless steel (17-4, H-900) and a similar (the predicate tray had holes and markings to accommodate the predicate screw implant sizes, the candidate device will have two trays - one solely for candidate screw implant sizes, and another for the combined predicate and candidate screw implant sizes) polycarbonate sterlization tray accessory as in the predicate ACE Surgical Secure-Mini™ Locator® Implant svstem.

The provided text describes a submission for a 510(k) premarket notification for a dental implant system. The focus of this submission is to demonstrate substantial equivalence to previously marketed predicate devices, rather than conducting a de novo study to establish acceptance criteria based on new performance data.

Therefore, the acceptance criteria and study information typically sought for a new device's performance evaluation (such as those involving AI or diagnostic accuracy) are not present in this document. The "acceptance criteria" here implicitly refer to the demonstration of equivalence to existing, legally marketed devices.

Here's an analysis based on the provided text, addressing your questions where applicable, and highlighting where information is not available:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a bench testing study, not a clinical trial or a study assessing AI performance.

1. Sample size used for the test set and the data provenance: Not applicable in the context of this 510(k) submission. The "test set" here refers to components undergoing bench testing rather than a dataset for an AI model. The document does not specify the number of implants or components tested during bench testing, nor their provenance. The "data provenance" would relate to the manufacturing and testing environment for the physical components.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For bench testing comparing physical device characteristics and performance, "ground truth" would be established by scientific and engineering measurements against established standards or predicate device specifications, not typically by expert consensus in the way clinical diagnostic ground truth is formed.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or AI algorithm evaluations to resolve discrepancies in expert opinions for ground truth establishment. This is a bench testing scenario.

4. 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 submission is for a physical medical device (dental implant system), not an AI/ML-driven diagnostic or assistive device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench testing described, the "ground truth" implicitly relies on engineering standards (e.g., ASTM F67 for titanium raw material) and direct comparison to the physical and functional characteristics of the predicate devices. The goal was to show identical or similar performance.

7. The sample size for the training set: Not applicable. This is not an AI/ML algorithm.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML algorithm.

In summary, this 510(k) notification focuses on demonstrating substantial equivalence to predicate devices through a comparison of device description, materials, intended use, and bench test results. It does not involve the types of studies typically conducted for AI/ML-based devices or devices requiring extensive clinical performance data beyond comparisons to existing, cleared products.

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The ACE Surgical Secure-Mini™ Locator® Implant System is is designed to provide immediate transitional splinting stability or intra-bony long term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients.

The ACE Secure-Mini™ Locator® Implant System is an additional set of machined surgical grade titanium alloy (Ti-6A1-4V ELI) screw implants to the Secure-Mini™ product family, intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. The implants are supplied sterile in 2.3 mm diameter, and in lengths of the 10, 11.5, 13, and 15 mm, and with Zest Locator® Implant Anchor Abutments (cleared under K994257) and Denture Cap Males (cleared under K072878) in standard tray packaging and include placement instruments. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics to that cleared under K073343. These screws are supplied sterile in standard Tvvek™ travs. The ACE Surgical Secure-Mini™ Locator® Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Secure-Mini™ Implant system.

The provided document is a 510(k) summary for a medical device (ACE Surgical Secure-Mini™ Locator® Implant System) seeking substantial equivalence to existing predicate devices. It focuses on demonstrating equivalence through device description, indications for use, materials, bench test results, and labeling, rather than presenting a detailed clinical study with acceptance criteria and performance metrics for a new AI-powered diagnostic device.

Therefore, most of the requested information regarding acceptance criteria, study design elements for AI performance (like sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details), and ground truth establishment is not available in the provided text.

The document states: "In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Secure-Mini™ Locator® Implant System and the specified predicate devices." This implies that the 'acceptance criteria' were met by demonstrating non-inferiority or equivalence to the predicate devices through bench testing. However, the exact quantitative acceptance criteria and the detailed results of these bench tests are not provided.

Here's a breakdown of what can be extracted and what is not available:

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

2. Sample size used for the test set and the data provenance: Not applicable. This was a bench testing study, not a study involving patient data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic AI sense was established by experts; rather, the performance was assessed relative to predicate devices through engineering/bench testing.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 is not an AI-powered diagnostic device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic AI. The "ground truth" for the bench testing would be established engineering standards or the performance of the predicate devices.

8. The sample size for the training set: Not applicable. This is not an AI-powered device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.

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The ACE Surgical Secure-Mini™ Implant System is intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture instally or fully edentulous patients.

The ACE Surgical Secure-Mini™ Implant System is a set of machined surgical grade titanium alloy screws, intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture instally or fully edentulous patients. The implants are supplied sterile in 2.3 mm diameter, and in lengths of 10, 11.5, 13, and 15 mm, in standard trays and include placement instruments. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics to that cleared under K951392. These screws are supplied sterile in standard Tyvek™ trays. The ACE Surgical Secure-Mini™ Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Miniboneplate system.

The provided text describes a medical device, the ACE Surgical Secure-Mini™ Implant System, and its 510(k) submission for market clearance. However, the document does not include detailed information about acceptance criteria or a specific study designed to prove the device meets these criteria in the way typically expected for a diagnostic or AI-powered device.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of:

1. Device description
2. Indications for use
3. Bench test results
4. Materials
5. Labeling

The key statement regarding performance is: "In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Prov+ Screw System and the specified predicate devices."

Given this, I cannot provide the requested information in the format of acceptance criteria and a study proving their fulfillment as the document implies a comparison study rather than a de novo performance study against defined acceptance criteria.

However, I can extract the available information as it relates to the type of assessment conducted:

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

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

• The document mentions "bench test results" but does not specify the sample size for these tests.
• Data provenance is not explicitly stated, but "bench testing" typically implies laboratory-controlled tests rather than human clinical data.

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

• This information is not applicable as the clearance is based on substantial equivalence demonstrated through bench testing, not expert-adjudicated clinical data.

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

• Not applicable, as there is no mention of expert adjudication for a test set.

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-powered device, nor is there any mention of a human-in-the-loop or MRMC study.

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

• Not applicable. This device is a dental implant system, not a software algorithm.

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

• The "ground truth" for demonstrating substantial equivalence relied on measurable physical and mechanical properties compared during "bench testing," and the comparison of device characteristics (materials, indications for use, design) to legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This device does not involve a training set as it is not a machine learning model.

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

• Not applicable. This device does not involve a training set.

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The ACE Tru-FIX™ Implant System is indicated for use to stabilize and support bone graft and or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.

The ACE Tru-FIX™ Implant System is a set of machined surgical grade titanium alloy (Ti-OAL-AV ELI) screws, intended to stabilize and support bone graft and or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects. The implants are supplied sterile in 3.0 mm and 15 mm, in standard tray packaging and include placement instruments. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in the screw raw materials and characteristics to that cleared under K951392. These screws are supplied in ACE Surgical TRU-Fix™ trays. The ACE Surgical TRU-Fix™ Implant System is a comprehensive system retaining prosthetic components, if applicable, of the ACE Surgical Orthodontic Miniboneplate system.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for the ACE Tru-FIX™ Implant System, which focuses on establishing substantial equivalence to previously marketed predicate devices rather than demonstrating performance against defined acceptance criteria through a clinical study.

The core of this submission is a comparison of technological characteristics and intended use to predicate devices, using:

1. Device description
2. Indications for use
3. Bench test results
4. Materials
5. Labeling

It explicitly states: "In particular, the bench testing the ACE andidn's for use, 3) benefit test results, 17 materials, and by is effectiveness between the ACE Cal TRU-Fix™ Implant System and the specified predicate devices." This indicates that bench testing was performed, but details about specific acceptance criteria, methodology, sample sizes, and outcomes are not provided in this summary.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study design, ground truth, or expert involvement because this information is not present in the provided text.

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The ACE Surgical Orthodontic Bone Screw System is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. It is intended for single use only.

The ACE Surgical Orthodontic Screw System is a is a set of machined surgical grade titanium alloy (Ti-6AI-4V ELI) screws, intended for orthodontic use, constructed with a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. This head design also permits the use of the screw with the orthodontic appliances (bracket, wire, elastic head, etc.) The tip of the screw is designed available to self drilling and self-tapping, supplied in 1.2/1.5mm and 1.5/1.8mm tapered thread, both with a 3.0mm diameter head and in lengths of 6,8,10mm. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics that cleared under K951392. These screws are supplied sterile in standard Tyvek™ mylar packaging.

The ACE Surgical Orthodontic Bone Screw System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Miniboneplate system.

The provided text describes a 510(k) submission for the ACE Surgical Orthodontic Bone Screw System. This is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria through a clinical or algorithmic study in the way a diagnostic AI device might.

Therefore, many of the requested categories for AI device evaluation (like sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not applicable to this type of submission.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence): The primary acceptance criterion for this 510(k) notification is to demonstrate that the ACE Surgical Orthodontic Bone Screw System is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.

Reported Device Performance:
The submission states the following to support substantial equivalence:

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

• Sample Size: Not applicable. This submission relies on bench testing, material specifications, and comparison to predicate devices, not a clinical "test set" of patient data for performance evaluation in the context of an AI/diagnostic device.
• Data Provenance: Not applicable. The "data" here refers to design specifications, material standards (ASTM F136), and results from bench tests conducted by the manufacturer, rather than clinical patient data.

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

• Not applicable. There is no "ground truth" derived from expert review of a test set in this 510(k) submission. The evaluation is based on engineering principles, material science, and comparison to existing devices.

4. Adjudication method for the test set

• Not applicable. No clinical test set or adjudication process for diagnostic performance is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is not a study assessing human reader performance or AI assistance.

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

• Not applicable. This device is a physical orthodontic screw, not an algorithm, and therefore doesn't have "standalone" algorithmic performance in the sense of AI.

7. The type of ground truth used

• Ground Truth: For the purpose of a 510(k) of this nature, the "ground truth" for demonstrating substantial equivalence is effectively derived from established engineering standards, material specifications, and the historical safety and effectiveness records of the legally marketed predicate devices. The bench test results serve to confirm the new device meets performance characteristics equivalent to those established standards and predicates.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" for this type of medical device submission.

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

• Not applicable.

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The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is intended to be used by itself in bone regenerative techniques; mixed with other suitable bone filling agents to prevent particle migration in an osseous defect, and, to provide a resorbable barrier over other bone graft material.

The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is a medical grade calcium sulfate hemihydrate. The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is intended to be used by itself in bone regenerative techniques. The ACE SurgicalPlaster Calcium Sulfate Hemihydrate is designed to set-up in vivo. It is mixed with small amounts of regular saline solution to produce a putty-like paste and it is applied on bone defects in amounts of 0.5 cc to 5.0 cc. The setting of the paste over may be set using a small square of sterile gauze soaked in the fast setting solution. With time, the ACE SurgicalPlaster Calcium Sulfate Hemihydrate dissolves and recedes leaving behind spaces that have been found to stimulate bone in-growth.

The provided text is a 510(k) summary for a medical device (ACE SurgicalPlaster Calcium Sulfate Hemihydrate) seeking substantial equivalence to a predicate device. It specifically states:

"Among the information and data presented in the 510(k) submission to support the substantial equivalency among the Miorination and data presented in the origins damicate device are 1) device are: 1) device of the ACE Surgical Flaster Oalerials, and 4) labeling. In particular, the information demonstrated description, a) indications for asc, of materials, and 1) ias civing ess between the ACE SurgicalPlaster Calcium Sulfate Hemihydrate and the specified predicate device."

This excerpt indicates that the 510(k) submission relies on demonstrating substantial equivalence based on device description, indications for use, materials, and labeling. It does not describe a clinical study or performance data with specific acceptance criteria that the device had to meet through testing.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them because the provided text does not contain that level of detail, as it's a summary of a regulatory submission primarily focused on demonstrating substantial equivalence, not reporting on a performance study with quantitative results.

If this were a submission for a new device requiring performance testing, such a study would typically be included. For a 510(k) for substantial equivalence, clinical performance studies are not always required if equivalence can be demonstrated through other means (e.g., comparison of technological characteristics).

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The ACE CONNECT™ Internal Connection Screw Dental Implant System is intended to be used in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations.

The ACE Surgical Internal Connection Screw Dental Implant System is a machined commercially pure titanium screw form implant intended to be implanted into the upper or lower jaw to serve as an anchor for a fixed dental prosthesis or single tooth restorations, constructed with an internal hexagon feature for inserting the implant into its surgical site, and to stabilize the prosthesis for rotational load, used to reconstruct the dentition of a patient who is wholly edentulous, supplied in diameters of 3.75. 4.0. 4.75, and 5.75 mm, and in lengths of 8, 10, 11.5, 13, and 15 mm. The implant raw materially pure titanium CP-4 as specified in ASTM F67-95 - Standard Specification for Unalloyed Titanium for Surgical Implant Applications. The implant surface is roughened by means of a blast media process to aid in implant adhesion. The candidate devices are identical in materials and characteristics to that cleared under K954513.

The ACE Surgical Internal Connection Screw Dental Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Screw Dental implant to assist with the implant's insertion and final prosthetic fabrication.

The provided text describes a 510(k) submission for a dental implant system and focuses on demonstrating substantial equivalence to a predicate device, rather than proving a specific performance metric against pre-defined acceptance criteria through a clinical study. Therefore, much of the requested information (like sample sizes, expert qualifications, adjudication methods for clinical data, MRMC studies, or standalone algorithm performance) is not applicable or not present in this document.

The "acceptance criteria" for this device's submission revolves around demonstrating that its technological characteristics and performance are "substantially equivalent" to an already cleared predicate device.

Here's a breakdown of the information that is available and addresses as much of your request as possible:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission relies on bench test results for mechanical performance comparison, rather than a clinical "test set" of patient data. The document does not specify the number of implants or test cycles used in the bench tests.
• Data Provenance: Not applicable for clinical data. The performance data comes from bench testing.

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

• Not applicable. As this is a 510(k) submission primarily relying on bench testing and comparison to a predicate, there is no mention of "ground truth" established by experts in the context of a clinical test set. The "ground truth" for the submission is the regulatory requirement of substantial equivalence, judged by the FDA.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical "test set" requiring adjudication.

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

• No. An MRMC study was not done. This device is a dental implant, not an imaging or diagnostic AI device that would typically undergo such a study.

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

• No. This is a physical medical device (dental implant), not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the established performance and safety profile of the predicate device (ACE Surgical Screw Dental Implant System, K954513). The study's goal was to demonstrate that the new device met this "ground truth" of performance through bench testing and design comparisons.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical dental implant, not an AI/ML algorithm that requires a "training set."

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

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

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The Ace HA Screw Dental Implant System is intended to be used in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations.

Not Found

I am sorry, but based on the provided text, I cannot answer your request. The document is a 510(k) premarket notification acceptance letter for a dental implant system. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the following information that would allow me to answer your questions:

• Acceptance criteria and reported device performance: There are no specific performance metrics, benchmarks, or test results mentioned for the Ace HA Screw Dental Implant System.
• Details of any studies: There is no description of any clinical or non-clinical studies conducted for this device, including information on sample sizes, data provenance, ground truth establishment, expert involvement, or adjudication methods.
• Information regarding AI or algorithm performance: The device described is a physical dental implant system, not a software device or an AI-powered system. Therefore, questions related to standalone algorithm performance, AI assistance, or MRMC studies are not applicable.

The document is purely an administrative confirmation of market clearance based on substantial equivalence, not a detailed report of device testing or performance.

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The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones.

Clinical Indications are as follows:

• · Tumor Resections
• Severe trauma which make continuous bone segments no longer possible
• · Bone grafting defects
• · Severe open mandibular fractures
• · Facial deformity corrections

The ACE/Normed Transport Distraction Device is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE/Normed Transport Distraction Device. This ACE/Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones.

This document is a 510(k) clearance letter from the FDA for a medical device called the "Normed Bone Transport" (also referred to as the ACE/Normed Transport Distraction Device). This type of document does not contain the detailed study information, acceptance criteria, or performance data that your request asks for.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance against specific, pre-defined acceptance criteria in the way a clinical trial for a new drug or a novel high-risk device might.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not present. The clearance is based on substantial equivalence, not a performance study as described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present.
4. Adjudication method for the test set: Not applicable/not present.
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 device is a mechanical distraction device, not an AI-powered diagnostic or assistive technology. Therefore, this type of study is not relevant and not present.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not present for the clearance determination.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

• Device Name: Normed Bone Transport / ACE/Normed Transport Distraction Device
• Regulatory Class: II
• Product Code: JEY
• Indications for Use: Designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. Specifically, it's indicated for maxillofacial alveolar and small craniofacial skeletal bones, with clinical indications including tumor resections, severe trauma, bone grafting defects, severe open mandibular fractures, and facial deformity corrections.
• Contraindications: Insufficient available bone, poor bone quality, generalized diseases, allergies, or habits that may contribute to poor healing or osteogenesis (e.g., uncontrolled diabetes, blood dyscrasias, hyperthyroidism, AIDS, alcohol addiction, psychiatric disorders, oral infections, malignancies, myocardial infarction within the last 12 months, heavy smoking, use of chewing tobacco, poor oral hygiene). Requires good medical health status and history, plus a radiographic evaluation of anatomical conditions.

To find the kind of detailed study information you're asking for, you would typically need to consult a 510(k) summary (if available publicly in more detail than this letter), a premarket approval (PMA) application, clinical study reports, or peer-reviewed publications associated with the device if such studies were conducted and published. The provided letter is merely the FDA's decision regarding substantial equivalence.

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