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The Parkell Pit and Fissure Sealant is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite restorations.

The Device is a light-cured, flowable, resin-based sealant for prophylactic sealing of pits and fissures as well as for micro-restorative procedures. The Device is light-curable under standard power (600 mW/cm²) and contains filling agents which cause the Device to release and recharge beneficial ions (fluoride and calcium).

The provided text describes the 510(k) clearance for the "Parkell Pit and Fissure Sealant." However, the clearance letter and accompanying 510(k) summary pertain to a physical dental device (a sealant), not an AI/software medical device.

Therefore, many of the requested criteria regarding AI/software performance studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable and are not mentioned in this document.

The document focuses on the physical and chemical properties of the sealant and compares them to a predicate device. The performance data is based on non-clinical, in-vitro testing of these physical properties.

Below is the information that can be extracted from the provided text, adapted as best as possible to the requested format, with clear indications where information is not applicable (N/A) due to the nature of the device.

Acceptance Criteria and Device Performance for Parkell Pit and Fissure Sealant

This device is a physical dental sealant, not an AI/software medical device. Therefore, the performance evaluation focuses on physical and chemical properties and biocompatibility, not algorithmic performance on image data.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document. The testing was non-clinical (in-vitro).
• Data Provenance: Non-clinical physical property testing. Not applicable for geographical or retrospective/prospective distinctions.

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

• N/A. This is a physical dental material. "Ground truth" in this context typically refers to objective measurements from laboratory testing equipment (e.g., universal testing machines for strength, viscometers for viscosity, etc.), not expert interpretation of data like in AI/imaging studies.

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

• N/A. As above, this is laboratory-based physical property testing, not subjective assessment requiring adjudication.

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

• N/A. This is not an AI-assisted device. No MRMC study was performed.

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

• N/A. This is not an algorithm. Standalone performance is not applicable.

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

• Laboratory Standard Measurements / In-vitro physical property testing. The performance criteria (e.g., strength in MPa, shrinkage in %, viscosity in Pa.s) are based on standardized tests for dental materials.

8. The sample size for the training set

• N/A. This is not an AI/machine learning device. No training set was used.

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

• N/A. As above, no training set was used.

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The Pitkar Spinal Pedicle Screw System is intended for non-cervical posterior and anterolateral fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and/or sacral spine: 1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); 2. Spondylolisthesis; 3. Trauma (i.e., fracture or dislocation); 4. Spinal Stenosis; 5. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); 6. Tumor; 7. Pseudoarthrosis and/or failed previous fusion

The subject system (Pitkar Spinal Pedicle Screw) attaches to the spine through screw, rod, and crosslink components. Furthermore, the system is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. All implants are manufactured from Ti-alloy per ASTM F136.

This submission is for a medical device (Pitkar Spinal Pedicle Screw System), not a software or AI device. Therefore, the requested information on acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not applicable and is not present in the provided text.

The document describes the regulatory review and clearance of a Pitkar Spinal Pedicle Screw System, a physical medical device. The clearance is based on its substantial equivalence to existing legally marketed predicate devices.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical mechanical and material testing, not clinical trials or AI/software performance studies.

Here's a breakdown of what is available in the document regarding how the device meets its "acceptance criteria" (which in this case are related to safety and performance through substantial equivalence):

Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for this physical device are primarily demonstrated through substantial equivalence to predicate devices and adherence to relevant ASTM standards for mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance
There is no specific table of "acceptance criteria" with numerical performance metrics provided in the document for the device itself. Instead, the performance is demonstrated by:

• Static Compression Bending Test
• Dynamic Compression Bending Test
• Static Torsion Test

"The submitted mechanical testing data demonstrates that the proposed device is substantially equivalent to that of the predicate device for the desired indications." |
| Material Composition | "All implants are manufactured from Ti-alloy per ASTM F136." |

2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. For a physical device, this would typically refer to the number of device samples tested in laboratory settings, not patient data sets. The provenance would be the testing facility.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
Not applicable for this type of device submission. Ground truth here is established by engineering and materials science principles and adherence to standards.

4. Adjudication Method for the Test Set:
Not applicable for this type of device submission. Adjudication methods are typically for clinical data or expert reviews, not mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study was not done. This type of study is relevant for diagnostic imaging AI systems where human readers interpret medical images.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:
Not applicable. This is a physical implant device, not a software algorithm.

7. Type of Ground Truth Used:
The "ground truth" for this device's safety and effectiveness is established through:

• Mechanical Testing Results: Performance against established ASTM standards (ASTM F1717 for static compression bending, dynamic compression bending, and static torsion).
• Material Compatibility and Specifications: Conformance to ASTM F136 for Ti-alloy.
• Substantial Equivalence: Comparison of design features, intended use, indications for use, and function to existing cleared predicate devices.

8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no "training set" in the context of this physical device.

In summary, the provided document is a 510(k) clearance letter for a Class II spinal implant device. The "proof" it meets "acceptance criteria" lies in demonstrating substantial equivalence to predicate devices and adherence to relevant ASTM mechanical testing standards.

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The Pitch-Patch Tissue Reinforcement Device is a single use device intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon or other tendons.

The Pitch -Patch Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendon or other tendons. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

The Pitch-Patch is a permanent implantable device for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon. It is constructed from a warp knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, to cover different tear sizes without trimming (30 x 20 mm and 35 x 25 mm). It should not be cut to size. The device is supplied sterile, by Gamma Irradiation to an SAL of 10-6.

The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a non-absorbable material that has a long history of use in the orthopedic market.

The provided text describes a medical device called the "Pitch-Patch Tissue Reinforcement Device" and its FDA 510(k) clearance application. However, it does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document is a 510(k) summary for a physical surgical mesh device, not an AI software or system. Therefore, details like AI performance metrics (sensitivity, specificity, AUC), test set characteristics, expert ground truth establishment, MRMC studies, or training set details are not applicable to the information given.

The "Performance Data" section lists various mechanical and biological tests for the Pitch-Patch (e.g., Suture Retention, Ultimate Strength, Biocompatibility). These are typical for surgical mesh devices to demonstrate safety and effectiveness for their intended physical function, but they are not the type of acceptance criteria or studies relevant to AI/ML device performance.

Therefore, I cannot provide the requested information for an AI/ML device based on the input text.

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The Everest 20cc Inflation Device/Survival Kit is to be used to facilitate the use of catheters and guide wires during interventional procedures. The Everest 20cc Inflation Device is designed to inflate/deflate balloon catheters as well as to monitor pressure within the balloon. The Y/Tri-Adapter with Hemostasis Valve is designed to be used on a guiding catheter or dilatation catheter to control backbleeding and to provide a port for introduction of fluids into the interventional system. The Guide Wire Insertion Tool is designed to facilitate placement of a guide wire tip through the Y/ Tri-Adanter and into the wire lumen of an interventional catheter. The Guide Wire Steering Handle is designed to hold a small diameter guide wire and provide a handle for manipulating the wire.

Medtronic's Everest™ Disposable Inflation Device is a sterile 20cc inflation device with a locking mechanism that is operated via a trigger. Normally, the locking mechanism is engaged. Once the trigger is pulled back, the locking mechanism is released and the piston can be manually manipulated. The Everest™ 20 Device is outfitted with a manometer with measuring pressures ranging from vacuum to 20 bars in 0.5bar increments. The Everest™ 30 Device is outfitted with a manometer with measuring pressure reading from vacuum to 30 bars in 1 bar increments. A high pressure connecting tube with a male rotating adapter and a disposable 3-way stopcock are also included to aid in preparation of the device. When purchased as a "Survival Kit", the package includes a Y-/ Tri-Adapter with hemostasis valve, a Guide Wire Insertion Tool and a Steering Handle.

The document describes a 510(k) premarket notification for Medtronic's Everest™ Inflation Device and Survival Kits. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing related to packaging and shelf-life, rather than clinical efficacy. Therefore, a traditional "study" proving the device meets acceptance criteria in terms of clinical performance or an AI algorithm's performance isn't applicable here.

Instead, the document details the acceptance criteria for packaging performance and shelf-life, and the tests conducted to show the device meets these criteria. The approval is based on the device being "substantially equivalent" to an existing, legally marketed predicate device, not on demonstrating new clinical efficacy.

Here's the information requested, adapted to the context of this device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device relate to its packaging and shelf-life, ensuring it maintains sterility and integrity. The document states that "No new safety or effectiveness issues were raised during the testing. The test data demonstrated that the modified Medtronic's Everest™ Inflation Devices is as safe and effective as the legally marketed predicate device." This implies that all tested criteria were met.

Due to the nature of the document detailing specific tests rather than numerical performance metrics for each acceptance criterion, a direct table of "performance" for each against a criterion is not provided with exact values. However, the document lists the performed tests, which serve as the acceptance criteria. The "Reported Device Performance" is broadly stated as successful.

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

The document does not explicitly state the numerical "sample size" for the non-clinical packaging and shelf-life tests. This type of information is typically found in the full test reports, which are not included in this summary.

The "data provenance" is internal to Medtronic (manufacturer), based on testing performed on the modified Everest™ Inflation Devices. It is retrospective in the sense that the tests are performed on manufactured devices to confirm design and material changes maintain equivalence.

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

This question is not applicable to this type of device submission. The tests are physical and chemical property tests on packaging and product integrity, not diagnostic or clinical assessments requiring expert human interpretation or "ground truth" establishment in the medical sense. The "ground truth" here is the physical measurement or observation of the packaging and device components against engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. Physical performance tests on a device's parts and packaging do not typically involve adjudication methods like those used for interpreting medical images or clinical outcomes. The results are obtained directly from laboratory measurements and observations.

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 (inflation balloon and accessories) is a mechanical tool used in interventional procedures. It is not an AI-powered diagnostic or assistive tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

Not applicable. This device does not involve an algorithm or AI component.

7. The Type of Ground Truth Used

For the non-clinical tests (packaging and shelf-life), the ground truth is established by engineering specifications, industry standards (e.g., ISO 15223-1 mentioned for symbols), and regulatory requirements for medical device packaging integrity and sterility. The outcome of these tests determines if the device meets these pre-defined physical and performance benchmarks.

8. The Sample Size for the Training Set

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

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

Not applicable. There is no training set for this device.

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The Pitch-Patch is a single use device intended to be used for reinforcement of the rotator cuff following or during repair by suture or suture anchors, where weakness exists in the soft tissue.

The Pitch-Patch is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.

The Pitch-Patch is a permanent implantable device for reinforcement of rotator cuff tears. It is constructed from a warp knitted fabric with integral eyelets. It is reinforced around its perimeter and around each eyelet to increase the security of suture attachment. The Pitch-Patch is available in two sizes, to cover different tear sizes without trimming (30 x 20 mm and 35 x 25 mm). It should not be cut to size. The device is supplied sterile.

The Pitch-Patch is made from Polyethylene Terephthalate (PET) also referred as polyester. This a nonabsorbable material that has a long history of use in the orthopedic market.

The provided text describes the 510(k) clearance for the Pitch-Patch Tissue Reinforcement Device. This device is a surgical mesh intended to reinforce the rotator cuff during or after repair.

The information provided focuses on the performance testing conducted to demonstrate the device's substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets them in the context of an AI/software device. The document describes a medical device, not an AI/software device. Therefore, many of the requested points related to AI/software performance criteria (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone algorithm performance) are not applicable or extractable from this document.

However, I can extract information related to the performance studies done for this physical medical device.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the typical sense for an AI/software device (e.g., minimum sensitivity, specificity). Instead, it lists the types of performance tests conducted and concludes that the results demonstrate the device's mechanical properties are appropriate and that differences from predicates do not affect safety and efficacy.

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The Pitkar Sixafix System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth of plates have fused or will not be the crossed with the hardware.

1. Open and closed fracture fixation
2. Pseudoarthrosis or non-union of long bones
3. Limb lengthening by epiphyseal or metaphyseal distraction
4. Correction of bony or soft tissue deformities
5. Correction of segmental or nonsegmental bony or soft tissue defects
6. Post-Traumatic joint contracture which has resulted in loss of range of motion

The purpose of this submission is to request clearance for the new Pitkar Sixafix System. The Pitkar Sixafix System includes a web based software that is designed to assist the physician in performing precise deformity or fracture reduction and should always be used with hardware. The Sixafix System software receives inputs from measurements taken by the physician and produces outputs recommending adjustments to the fixator that define a correction path for the deformity. To guide the surgeon, detailed information is provided in Software manual. The implantable components are manufactured from Stainless Steel per ASTM F138. The system will be provided in non-sterile configuration and will require steam sterilization prior to use.

This looks like a 510(k) premarket notification for a medical device called the "Pitkar Sixafix System," which is a metallic bone fixation appliance. The document describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the provided text does not contain information about acceptance criteria, specific device performance metrics (like sensitivity, specificity, accuracy), or any details about a clinical study involving human or even simulated test sets to prove the device meets acceptance criteria in the way you've outlined for an AI/software-based device.

This document focuses on:

• Device Description: A web-based software to assist physicians with deformity/fracture reduction, used with hardware (implants made of Stainless Steel and appliances from Aluminium).
• Indications for Use: Broad orthopedic applications for adults, children (3-12), and adolescents (12-21) where growth plates are fused or not crossed.
• Predicate Device: Smith & Nephew Inc. - Taylor Spatial Frame (K970748).
• Technological Characteristics: Similar design features, materials, and sterilization to the predicate device.
• Non-Clinical Tests:
  • Software Verification and Validation: Mentions FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This generally refers to testing the software's functionality, reliability, and security, not its diagnostic accuracy or clinical effectiveness in a statistical sense.
  • ASTM F1541-02: Standard Specification and Test Methods for External Skeletal Fixation Devices, covering mechanical tests like bending, axial load, and torsion. This assesses the physical hardware components, not the software's performance.
  • Biocompatibility: Stated to meet ISO 10993-1 due to using commonly available materials with a long history of clinical use.

Therefore, based only on the provided text, I cannot complete your requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or comparative effectiveness for an AI/software device's diagnostic or clinical performance.

The "software" component appears to be a tool for calculating adjustments for a physical fixator based on physician measurements, rather than an AI/ML algorithm performing analysis or diagnosis from medical images or data. The "Software Verification and Validation" mentioned would likely pertain to ensuring these calculations are correct and the software functions as intended, not a statistical evaluation of diagnostic accuracy or clinical impact against a ground truth.

If this were an AI/ML device, the FDA would typically require a much more detailed clinical or performance study section with specific metrics and methodologies. This document is typical of a hardware device with a software component that aids in calculation/planning, rather than a diagnostic AI.

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Pitkar External Fixation System- Rail Mechanism consist of Rail Fixation System and ALFA Fixator System. Their components are intended to be used on adult or pediatric patients as required.

A. Rail fixation System
1.Fracture fixation
2.For correcting diaphyseal deformities. metaphyseal deformities with or without shortenings
3.Correction of bony or soft tissue deformities
4.Limb Lengthening
5.For treating non-union and mal-union
6.Bone transport application

B. ALFA Fixator System
1.Open and closed fracture fixation
2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction:
3.Pseudoarthrosis of long bones;
4.Limb lengthening;
5.Infected fractures or non-unions; and
6.Correction of long bone deformities.

Note: For Rail Fixation System and ALFA Fixator System

1. For Adult Assembly: Population to be adult males and females for given indications
2. For Pediatric Assembly: Population to be between age of 5 to 10 for given indications
3. It is recommended to avoid operating on children under the age of five, in case of pediatric application

Pitkar External Fixation System- Rail Mechanism. The subject application has two devices covered that fall under Rail fixation category. Both the systems have Adult & Pediatric apparatus. Both the systems have different Rail design & clamps design. They are designated as: 1. Rail Fixation System 2. Alfa Fixator System Thus, there will be two subject devices for approval under this heading as both these systems have same application, device description, Indications, material composition etc.

This document describes the 510(k) premarket notification for the "Pitkar External Fixation System - Rail Mechanism." This device is intended for orthopedic procedures such as fracture fixation, deformity correction, and limb lengthening.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each non-clinical test. It mentions that the device performance was "demonstrated against applicable standards ASTM F1541-02" for mechanical tests and "meets the ISO 10993-1 standard requirements" for biocompatibility.

The data provenance is retrospective, as the justification for biocompatibility relies on the device being comprised of "the same material and have the same manufacturing, body contact, and sterilization properties as other commercially available devices and materials with a long history of clinical use in orthopedic implants." The mechanical tests are also non-clinical and performed under controlled laboratory conditions rather than on patient data.

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

This information is not applicable as the described tests are non-clinical engineering and materials tests, not studies involving expert medical interpretation or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable as the described tests are non-clinical engineering and materials tests, not studies requiring adjudication of various expert opinions.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (external fixation system), and the performance evaluation is based on non-clinical mechanical and biocompatibility testing, not on human interpretation of images or data.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done. This submission is for a physical medical device, not an algorithm or AI software. All tests conducted were on the physical components of the device.

7. Type of Ground Truth Used

The ground truth used for the performance evaluation consists of established engineering standards and material science principles.

• For mechanical tests (Axial Load, Torsion, Fatigue, Cantilever Bending, 4-Point Bending), the ground truth is adherence to the specifications and performance requirements outlined in ASTM F1541-02.
• For biocompatibility, the ground truth is compliance with the requirements of ISO 10993-1 and the demonstrated safe use of similar materials in predicate devices.

8. Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set. The device's performance is not learned from data but inherent in its design, materials, and manufacturing.

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

This information is not applicable for the reasons stated in point 8.

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Pitkar Locked Plating System is indicated for fixation of fractures and non-unions of various bones including the humerus, radius, ulna, femur, tibia, fibula and clavicle, including in osteopenic bone.

The purpose of this submission is to request clearance for the new Pitkar Locked Plating System. The Pitkar Locked Plating System implants are designed to address fractures of the humerus, radius, ulna, femur, tibia, fibula, and clavicle. The system is comprised of plates, screws and instruments to facilitate the installation of the implants. The plates and screws are manufactured from Titanium Alloy per ASTM F136. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.

This document is a 510(k) summary for the Pitkar Locked Plating System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for an AI/algorithm-based device.

Therefore, based on the provided text, I cannot describe the acceptance criteria and the study that proves an AI/algorithm-based device meets the acceptance criteria. The document describes a metallic bone fixation appliance, which is a physical medical device, not a software or AI product.

The relevant sections of the document discuss:

• Device Description: Plates, screws, and instruments manufactured from Titanium Alloy for fixation of fractures.
• Performance Data (Nonclinical): This refers to mechanical testing of the physical implants, such as bend tests for plates and torsional/pull-out tests for screws, against ASTM standards. It also mentions biocompatibility.
• Comparison to Predicate Devices: The rationale for substantial equivalence is based on similarities in design, materials, and sterilization to existing marketed devices.

There is no mention of:

• AI or algorithms
• Test sets, training sets, or data provenance
• Experts establishing ground truth for image analysis
• Adjudication methods
• Multi-reader multi-case (MRMC) studies
• Standalone algorithm performance
• Effect size of human readers with/without AI assistance

In summary, the provided document does not contain the information needed to answer your request about acceptance criteria and study proving an AI/algorithm-based device meets those criteria.

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BA Pit & Fissure Sealant is intended to seal pit and fissure depressions/faults in the biting surfaces of teeth. For dental professional use only.

Pit and Fissure sealants are used as a preventive measure to fill defects and prevent decay within crevices, voids or fissures on the surface of teeth. These voids are more challenging to keep free of substances that can lead to caries and eventual breakdown of tooth structure. BA Pit & Fissure Sealant is a material designed to fill these voids with a wear resistant material, ultimately preserving natural tooth structure.

BA Pit & Fissure Sealant is a light activated / photopolymerizable, glass filled, urethane dimethacrylate material that is placed onto an etched enamel surface and light activated for 20 seconds. The result after application is a tooth that has been sealed with a tough, wear resistant material.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly state "acceptance criteria" with numerical targets for each test. Instead, it presents the results of various non-clinical performance tests for the subject device (BA Pit & Fissure Sealant) and then compares them to a predicate device (Pulpdent (Activa) Pit & Fissure Sealant with MCP) and sometimes a reference device (Prevent Seal) to establish substantial equivalence. The "acceptance criterion" in this context is generally that the subject device's performance is "similar" or "equivalent" to the predicate device, or that any differences do not raise additional concerns regarding safety or efficacy.

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

The document describes non-clinical benchtop testing. For these types of tests, sample sizes are typically specified within the referenced ISO or ADA standards. However, the exact sample sizes for each specific test conducted for K190998 are not explicitly mentioned in the provided text.

The data provenance is retrospective, as the tests were conducted prior to the 510(k) submission to demonstrate substantial equivalence. The country of origin of the data is not specified, but given the applicant is Apex Dental Materials, Inc. with an address in Lake Zurich, Illinois, it is likely the studies were conducted in the USA or by contract labs.

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

This section is not applicable as the document describes non-clinical benchtop performance testing, not studies involving human interpretation or expert-established ground truth. The "ground truth" for these tests would be the measurement obtained from the laboratory instruments according to the specified standards.

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

This section is not applicable as the document describes non-clinical benchtop performance testing, not studies involving human reading or adjudication.

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 section is not applicable. The device is "BA Pit & Fissure Sealant," which is a material used for dental sealing, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI component is mentioned.

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

This section is not applicable. The device is a physical material (dental sealant), not an algorithm or software device.

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

The "ground truth" for the non-clinical tests is based on measurements obtained following standardized test methods (e.g., ISO, ADA standards). For example, for compressive strength, the ground truth is the force at which the material fractures, as measured by a testing machine according to the specified standard.

8. The sample size for the training set

This section is not applicable. The device is a physical material, not an AI model, and therefore does not have a "training set."

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

This section is not applicable. The device is a physical material, not an AI model, and therefore does not have a "training set" or ground truth relevant to AI model training.

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The Pitkar External Fixation System is indicated for both adults and pediatric patients for:

1. Open and closed fracture fixation
2. Pseudoarthrosis or non-union of long bones
3. Limb lengthening by epiphyseal or metaphyseal distraction
4. Correction of bony or soft tissue deformities
5. Correction of segmental or nonsegmental bony or soft tissue defects
6. Post-Traumatic joint contracture which has resulted in loss of range of motion

The purpose of this submission is to request clearance for the new Pitkar External Fixation System. The implantable components are manufactured from Stainless Steel per ASTM F899. The system will be provided in non-sterile configuration and will require to be steam sterilized by the user prior to use.

The provided text is a 510(k) summary for the Pitkar External Fixation System. It describes the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical testing. However, it does not include information about acceptance criteria or a study proving that a device meets those criteria, especially in the context of an AI/ML-based device.

Instead, this document focuses on demonstrating substantial equivalence through non-clinical performance and similarity to predicate devices, which is a common regulatory pathway for medical devices that are not AI/ML-based.

Therefore, I cannot extract the requested information about acceptance criteria for an AI/ML device, the performance of such a device, sample sizes, ground truth establishment, or human reader effectiveness from this document. The document explicitly states "Clinical Tests: o N/A," indicating no human clinical trials were conducted for this submission.

If you have a document pertaining to an AI/ML device with details of its validation study, I would be happy to analyze it for the requested information.

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