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The Avantik VTM is intended for the collection and transport of upper respiratory clinical specimens containing respiratory viruses, from the collection site to the testing laboratory. The collection system is a culture-based media that is intended to be used with standard laboratory examination, culture or with other assays that utilize stable recoverable infectious viral particles.

The Avantik VTM is a Non-Propagating Transport Medium Device designed to facilitate the secure collection and transportation of biological samples for diagnosing viral infections. The device contains a transport medium that maintains the viability and infectivity of clinically significant viruses en route to testing laboratories. The device can be stored between 2 - 25°C for up to 12 months and is only for use by Health Care Professionals. Upon collection, samples should be immediately placed in the transport tube to maintain optimal conditions. It is recommended to refrigerate the samples between 2 - 8°C or store them on wet ice to maintain a temperature of 2 - 8°C during transit. Post-collection, the specimen can be transported at 2 - 25°C and should be processed within 48 hours. The transport system allows for specimen collection, maintenance through a buffered medium, and contains a pH indicator. The liquid medium consists of a mixture of Hank's balanced salt solution, BSA (Bovine Serum Albumin), L-cysteine, Gelatin, Sucrose, L-glutamic acid, HEPES, Vancomycin, Amphotericin B, Colistin, and Phenol Red. The liquid medium inhibits the growth of competing bacteria and fungus, is non-toxic to mammalian host cells, and supports viral viability during transportation. The device includes a conical polypropylene vial filled with 3 ml of culture medium, secured with a high-density polyethylene screw-on cap.

The document describes the Avantik VTM, a viral transport medium, and its performance data to support substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Note: The document does not explicitly state numerical "acceptance criteria" for viral recovery in terms of a maximum allowable percentage reduction. It presents the "reported device performance" as the observed percentages of reduction. The conclusion states that the device "meets the requirements that are considered essential for its intended use," implying these results were deemed acceptable.

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

• Sample Size for Test Set: The viral recovery study was conducted using three lots of the candidate device. For each lot, three viral strains (Influenza A, RSV, Human Coronavirus NL63) were evaluated at two temperatures (4°C and 22°C) for two time points (0h and 48h). The document does not specify the number of replicates per virus/temperature/timepoint test condition, but the presentation of mean ± standard deviation for percentage reduction suggests multiple measurements were taken for each condition.
• Data Provenance: The document does not explicitly state the country of origin of the data. It is associated with HanChang Medic Co., Ltd. from Republic of Korea, which implies the studies were conducted in relation to this company. The studies are described in a factual manner without indicating whether they were retrospective or prospective, but performance studies for device clearance are typically prospective to gather specific data for the submission.

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 device is a viral transport medium, not an AI or diagnostic imaging device requiring expert interpretation for ground truth. The "ground truth" for the viral recovery study is the quantitative measurement of virus infectivity (e.g., titer) after specific incubation times and temperatures, compared to time 0. This is an objective laboratory measurement, not based on expert consensus or interpretation.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. No expert adjudication was involved in determining the quantitative viral infectivity measurements.

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 Avantik VTM is a viral transport medium, not a diagnostic AI system or an imaging device. Therefore, MRMC studies and assessments of human reader improvement with AI assistance are irrelevant to this device.

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

This section is not applicable. The Avantik VTM is a physical transport medium, not an algorithm.

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

For the viral recovery study, the "ground truth" was established by quantitative measurement of virus infectivity. This is typically done through techniques like plaque assay (PFU/mL) or Tissue Culture Infectious Dose 50% (TCID50/mL), which objectively determine the concentration of viable virus. The "percent reduction in virus infectivity" is calculated based on these measurements at different time points (0h vs 48h).

8. The sample size for the training set

This section is not applicable. This is a physical medical device (viral transport medium), not an AI/machine learning model that requires a training set.

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

This section is not applicable for the same reason as point 8.

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The Avanti Orthopaedics 2.2mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Avanti Orthopaedics 3.2mm, and 4.0mm Cannulated Compression Screws are intended for fixatures, fusions, osteotomies, non-unions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Avanti Orthopaedics Cannulated Compression Screw System are metallic bone screws manufactured from Stainless Steel (ASTM F138). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation. The Avanti Orthopaedics Cannulated screws are cannulated for use with guidewires for precise placement in bone.

The provided text describes a 510(k) premarket notification for Avanti Orthopaedics 2.2mm, 2.7mm, 3.2mm, and 4.0mm Cannulated Screws. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing of the device hardware itself, rather than the performance of an AI/ML powered medical device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device (referring to aspects like sample size, ground truth, expert consensus, MRMC studies, etc.) is not present in the provided document.

The document entirely pertains to the physical characteristics and performance of orthopedic screws.

Here's what can be extracted about the non-clinical performance testing of these orthopedic screws:

Summary of Acceptance Criteria and Device Performance for Orthopedic Screws

The provided document describes the acceptance criteria and performance for physical orthopedic devices, specifically Avanti Orthopaedics 2.2mm, 2.7mm, 3.2mm, and 4.0mm Cannulated Screws. The testing is focused on the mechanical properties and safety of the screws, not on an AI/ML algorithm's performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states that "Testing was performed per ASTM F543-17."
• Sample Size: Not explicitly stated in the document. ASTM F543-17 (Standard Specification and Test Method for Metallic Bone Screws) would specify the required number of samples for each mechanical test (e.g., torsion, bending, dynamic fatigue).
• Data Provenance: Not applicable in the context of clinical data/images. This testing pertains to the physical device. The testing was non-clinical (laboratory testing).

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

• Not applicable. Ground truth in this context refers to the physical properties and performance of the screw under specific test conditions, as defined by engineering standards (ASTM F543-17) and FDA guidance. No human expert interpretation of data is involved in establishing "ground truth" for mechanical testing.

4. Adjudication Method for the Test Set:

• Not applicable. This is mechanical testing against defined specifications, not a subjective assessment requiring adjudication.

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

• No. This is a physical medical device (orthopedic screw), not an AI/ML software device. MRMC studies are used for evaluating diagnostic or treatment planning software performance with human readers.

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

• Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used:

• Engineering Standards and Specifications: The "ground truth" for the device's performance is established by the specified mechanical properties and performance requirements outlined in ASTM F543-17 and the FDA guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway". This is objective, measurable data.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires training data.

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

• Not applicable.

In summary, the provided FDA document is a 510(k) submission for conventional orthopedic screws, not an AI/ML device. Therefore, the detailed questions about AI/ML device performance (like training sets, ground truth establishment by experts, MRMC studies, etc.) are outside the scope of this document.

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The Avanti Orthopaedics Ulnar Shortening System is intended for ulnar shortening osteotomy.

The Avanti Orthopaedics Ulnar Shortening System implants are designed for wrist and forearm conditions in which the ulna is, either statically or dynamically, longer than the radius and causing pain and/or dysfunction due to derangement of the distal radioulnar joint (DRUJ) and/or impaction of the carpus. The Avanti Orthopaedics Ulnar Shortening System plates and screws are manufactured from 316LS medical grade implant quality stainless steel. The Avanti Orthopaedics Ulnar Shortening System plate should only be used with the appropriately sized Avanti Orthopaedics screws. The lag screw hole in the ulnar shortening plate provides for orthogonal, compressive fixation of the osteotomy.

This document refers to a medical device, the Avanti Orthopaedics Ulnar Shortening System, not an AI/ML-driven device. Therefore, the questions regarding acceptance criteria, study details, ground truth establishment, and training/test set data are not applicable in the context of an AI/ML device approval.

The 510(k) summary provided in the input focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics, material composition, and intended use.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance: This section is not applicable in the context of AI/ML performance metrics. The submission focuses on demonstrating substantial equivalence to predicate devices. The "Non-Clinical Performance Testing Conclusion" states: "Although non-clinical testing was not necessary, an engineering analysis was provided to show the subject system did not create a new worst case as compared to the reference device K191118 Avanti Distal Radius and Forearm System." This implies that the device's mechanical properties and safety profile are considered acceptable based on comparison to an existing device, rather than specific performance metrics against pre-defined acceptance criteria.

2. Sample Size and Data Provenance: Not applicable for an AI/ML study. The approval is for a physical medical implant.

3. Number of Experts and Qualifications: Not applicable for an AI/ML study.

4. Adjudication Method: Not applicable for an AI/ML study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable for a physical medical implant.

6. Standalone Performance: Not applicable for a physical medical implant.

7. Type of Ground Truth Used: Not applicable for an AI/ML study. For a physical implant, the "ground truth" would be established through engineering analysis, material testing, and clinical outcomes in predicate devices.

8. Sample Size for Training Set: Not applicable for a physical medical implant.

9. How Ground Truth for Training Set Was Established: Not applicable for a physical medical implant.

In summary: The provided document is for the regulatory clearance of a physical orthopedic implant, not an AI/ML software device. Therefore, the detailed questions about acceptance criteria, study design, and ground truth for AI/ML performance are not relevant to this specific regulatory submission. The clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices, which focuses on aspects like material, design, and intended use.

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The system intended for fixation of fractures, osteotomies, and non-unions, involving the radius, ulna, and carpals. Additionally, the wrist fusion plates may be used for wrist arthrodesis.

The Avanti Distal Radius and Forearm System includes volar plates, wrist fusion plates, spanning plates, forearm plates, ulnar plates, and cannulated screws, with screw and peg fasteners, for the fixation of fractures, malunions, and osteotomies. Distal radius and forearm fixation plates may be placed on the volar or dorsal surface of the radius and along the shaft of the radius and ulna on the carpal bones. Features of the system include pre-contoured plates to fit the anatomy of the distal radius, a low-profile design to minimize soft tissue irritation, low contact design to optimize blood supply, and bi-planar angulated screw holes for ease of drilling and to optimize fixation and subchrondral support. All plates are manufactured from medical grade stainless steel per ASTM F138 or ASTM F139 and are electropolished per ASTM F-86. The Volar PEEK Plate has a polyetheretherkeytone that is preassembled to the plate and is sourced from Invibio, LTD. The PEEK insert allows insertion of both locking and non-locking fasteners with an infinite variable angle up to 11 degrees using the drill guide provided in the system. All plates include low-profile geometry to minimize soft tissue irritation and the option of compression or locking cortical screws. The Avanti Distal Radius and Forearm System includes self-tapping screws, listed below, that are manufactured from medical grade stainless steel per ASTM F138, electropolished per ASTM F-86, and are compatible with all Avanti plate configurations. All fasteners but the Cannulated Screw are intended to be used with the plates. The cannulated screws can be used for fracture fixation that is appropriately sized for the device which is determined through surgeon discretion.

The provided text describes a 510(k) premarket notification for the "Avanti Distal Radius and Forearm System," a metallic bone fixation appliance and accessories. This is a medical device submission, and the content focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of diagnostic or predictive performance.

Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not applicable to this type of submission.

Here's why and what information can be extracted:

• This is a 510(k) submission for a physical medical device (orthopedic implants), not a software or AI-based diagnostic/predictive device. The criteria for clearance are based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, typically through bench testing (non-clinical performance).
• The "study" refers to non-clinical performance testing, not a clinical trial comparing performance against acceptance criteria for a diagnostic measure.

Information that can be extracted relevant to the "study":

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 is not a study involving human or image-based test sets. The "test set" here refers to physical devices or components used in mechanical bench testing. The summary does not specify the number of devices or components tested for each non-clinical test, nor their provenance in the context of "data provenance."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study requiring expert-established ground truth for a diagnostic outcome.

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 is not an AI-assisted diagnostic device.

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

7. The type of ground truth used:
Not applicable in the context of diagnostic performance. For the described non-clinical testing, the "ground truth" implicitly refers to established material properties and mechanical performance standards (ASTM standards) that the device must meet to be considered equivalent to its predicates.

8. The sample size for the training set:
Not applicable. There is no "training set" in the context of an AI/ML algorithm.

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

In summary: The provided document is a regulatory submission for a physical medical device, not a software or AI product. The "study" referenced is non-clinical bench testing to demonstrate mechanical performance and substantial equivalence to existing devices, not a study of diagnostic accuracy or reader performance. Therefore, most of the questions are not relevant to this document.

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The Avanti is an optical coherence tomography system intended for the in vivo imaging, cross-sectional, and threedimensional imaging and measurement of anterior ocular structures, including retina, retinal netve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma, pachymetry, corneal power, and anterior chamber of the eye. With the integrated normative database, Avantitative tool for the comparison of retinal nerve fiber layer, and optic disc measurements in the human eye to a database of a known normal subjects. It is indicated for use as a diagnostic device to aid in the detection and management of ocular diseases.

The Avanti with the AngioVue software feature is indicated as an aid in the visualization of vascular structures of the retina and choroid in normal subjects with glaucoma and retinal diseases. The AngioAnalytics software feature of AngioVue is indicated for the measurement of vascular density, the foveal avascular zone, the thickness of retinal layers, and nerve fiber layer, and measurement of optic disc parameters in normal subjects with glaucoma and retinal diseases.

The Avanti is a computer-controlled ophthalmic imaging system that acquires cross-sectional tomograms of the anterior and posterior ocular structures (including cornea, anterior chamber angle, retina, ganglion cell complex, retinal nerve fiber layer, and optic disc). It employs noninvasive, non-contact, low-coherence interferometry to obtain these high-resolution reflectance images and, by rapidly repeating the cross-sectional image at same location, to produce high resolution motion-contrast images of the retina microvasculature. Using this non-invasive optical technique, the Avanti produces high-resolution cross-sectional tomograms of the eye without contacting the eye. It also produces images of the retina and layers of the retina from an en face perspective (i.e., as if looking directly in the eye) and non-invasive angiographic imaging of the retinal microvasculature based on OCT angiography (OCTA). Qualitative analyses are provided for the cornea and layers of the cornea, the retina and layers of the retina, the optic disc and the nerve fiber layer, and the retinal microvasculature.

The provided text describes acceptance criteria and study details for the Optovue Avanti device. Here's a structured summary based on your request:

Acceptance Criteria and Device Performance

The document does not explicitly present a discrete "table of acceptance criteria and reported device performance" as typically found in clinical trial reports with pass/fail metrics against a predefined threshold. Instead, it details various performance metrics (repeatability, reproducibility, agreement) in descriptive tables (Tables 6-16 for AngioRetina scans, Tables 12-13 for AngioDisc scans, Tables 27-31 for Corneal Epithelial Thickness R&R, and Tables 39-43 for Corneal Epithelial Thickness Agreement with Manual measurements) that implicitly demonstrate the device's performance is acceptable for its intended use, especially when compared to predicate devices or manual methods.

The overall conclusion states: "The results from the software, non-clinical and clinical performance testing demonstrate that the Avanti device with software modification is as safe and effective as its predicate devices." This implies that the performance demonstrated in the various tables met the internal acceptance criteria for substantial equivalence.

As a representative example, here's how some of the reported performance metrics could be conceptualized in a table:

Detailed Study Information:

1. A table of acceptance criteria and the reported device performance:
   As noted above, explicit pass/fail acceptance criteria are not presented in a direct table. The document demonstrates performance across various metrics and clinical populations. The overall "acceptance" is implied by the FDA's clearance of the device based on the provided data and the statement of substantial equivalence to predicate devices. The tables throughout the document (e.g., Tables 6-16, 27-31, 39-43) present the reported device performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Clinical Performance Testing (Section 1 - AngioVue R&R):
     • Sample Size: 67 participants (15 Normal, 16 Glaucoma, 36 Retinal conditions).
     • Provenance: Prospective, observational study conducted at a single clinical U.S. site.
   • FAZ Parameter Validation (Section 2 - non-vascular FAZ Parameters):
     • Sample Size: 30 eyes of 26 subjects.
     • Provenance: Case series from 3 clinical sites (country not specified, but likely U.S. given the FDA submission). Data origin (retrospective/prospective) is not explicitly stated, but the "case series" implies existing data.
   • FAZ Parameters Agreement between 3-mm AngioRetina and 6-mm HD AngioRetina Scans (Section 3):
     • Sample Size: 62 subjects/eyes (from the R&R study data set, after exclusions).
     • Provenance: Derived from the prospective R&R study data.
   • Retinal Thickness, RNFL Thickness, and Disc Measurements Agreement Evaluation (Section 4):
     • Sample Size: 67 subjects for Full and Inner Retina thickness; 31 subjects for RNFL thickness and optic disc measurement.
     • Provenance: Subset of the prospective R&R study data.
   • Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping with SD-OCT (Section 5):
     • Sample Size: 60 participants (12 Normal, 12 Contact Lens, 11 Dry Eye, 12 Post-LRS, 13 Keratoconus).
     • Provenance: Prospective, observational study conducted at a single clinical U.S. site.
   • Evaluation of the Agreement of the Corneal Epithelial Thickness Mapping with SD-OCT (Section 6):
     • Sample Size: 85 subjects (17 Normal, 15 Contact Lens, 18 Dry Eye, 19 Post-LRS, 16 Keratoconus).
     • Provenance: Prospective, observational study conducted at three study sites (country not specified, but likely U.S.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • FAZ Parameter Validation (Section 2): "Three readers experienced in FA image grading performed FAZ measurements." Specific qualifications (e.g., years of experience, board certification) are not provided.
   • Corneal Epithelial Thickness Agreement (Section 6): "Manual measurements performed by three qualified graders." Specific qualifications are not provided.

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

   • FAZ Parameter Validation (Section 2): Graders were "masked to each other's results through the entire grading process". No explicit mention of an adjudication process (e.g., tie-breaking by a senior reader) if reader consensus was needed. It seems individual reader measurements were compared against the device.
   • Corneal Epithelial Thickness Agreement (Section 6): Similar to FAZ, graders were masked. No explicit mention of an adjudication process.

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

   • No MRMC comparative effectiveness study involving human readers with/without AI assistance is described in this document. The studies primarily focus on the device's technical performance (repeatability, reproducibility, and agreement with human or phantom measurements) rather than its impact on human reader performance.

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

   • Yes, a standalone performance evaluation was done for the Non-clinical Performance Testing (phantoms) to validate the accuracy of the software's vessel density measurements (Section 7, page 7-8). The tables (e.g., for 3-mm AngioRetina Scan) present the difference between software-reported values and "expected 'vascular' density values computed directly from the model." This represents an algorithm-only performance assessment against a known ground truth.

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

   • Non-clinical Performance Testing (Phantoms): "Known ground truth" from 3D phantom models with predefined vessel densities.
   • Clinical Performance Testing (R&R of AngioVue, Retinal/RNFL/Disc Measurements): Implicitly, the Avanti software's measurements were compared against its own repeated measurements (for R&R) and against the predicate device's measurements (for agreement), establishing consistency and comparability rather than an external "ground truth" like pathology.
   • FAZ Parameter Validation: Manually graded FAZ measurements from fluorescein angiography images by "three readers experienced in FA image grading." This is a form of expert consensus/manual measurement ground truth.
   • Corneal Epithelial Thickness Mapping Agreement: Manual measurements performed by "three qualified graders" using a caliper tool on a previously cleared device. This is a form of expert consensus/manual measurement ground truth.

8. The sample size for the training set:

   • The document does not specify the sample size of any training set used for the device's algorithms. This information is typically proprietary to the manufacturer and not included in 510(k) summaries unless directly relevant to a specific re-training or modification evaluation.

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

   • Since the training set size is not provided, the method for establishing its ground truth is also not detailed in this document.

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The AVANTICARE SA4021 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The AVANTICARE SA4021 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The provided text K060068 is a 510(k) summary for a medical device called AVANTICARE SA4021 scooter. It outlines the device description, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with performance evaluations for AI/software-based medical devices.

The document is for a physical medical device (an electric scooter) and the provided information focuses on regulatory classification and substantial equivalence to legally marketed devices based on inherent technical specifications and intended use, rather than performance metrics from a clinical study or benchmark testing.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because the provided text does not contain this information.

Specifically, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The AVANTICARE SA4022 scoter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated po lition.

The AVANTICARE SA4022 scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The provided text is a 510(k) summary for the AVANTICARE SA4022 scooter, a motorized three-wheeled vehicle. The document explicitly states that there are minor differences in performance specifications between the AVANTICARE SA4022 scooter and its predicate device, the Bewell SC 20 (K043326). However, the submission asserts that "these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness."

Crucially, the provided document does not contain explicit acceptance criteria or a detailed study demonstrating that the device meets specific performance criteria. The basis for substantial equivalence is the assertion that any differences in performance specifications are minor and do not impact safety or effectiveness.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer based on the provided text, with clear indications where the information is not present:

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

   Acceptance Criterion	Reported Device Performance
   Not explicitly stated in the document. The submission focuses on substantial equivalence to a predicate device rather than specific performance metrics.	"minor differences in performance specifications" compared to Bewell SC 20 (K043326). These differences are asserted not to alter intended function/use or raise new safety/effectiveness questions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample size: Not specified.
   • Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • This information is not applicable and not present in the document. The substantial equivalence argument is based on comparing device specifications and intended use against a legally marketed predicate device, not on clinical performance evaluated by experts against a ground truth.

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

   • Not applicable and 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

   • Not applicable and not present. This device is a mobility scooter, not an AI-assisted diagnostic tool.

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

   • Not applicable and not present.

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

   • Not applicable. The "ground truth" in this context is the predicate device's established safety and effectiveness, implied by its legal market status.

8. The sample size for the training set

   • Not applicable and not present. This device is not an AI/machine learning model that requires a training set.

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

   • Not applicable and not present.

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Avanti's VDRL antigen and Buffered Saline are intended for use in the Venereal Disease Research Laboratory (VDRL) slide test for syphilis. The VDRL slide test is a non-treponemal, micro-flocculation test, that provides both qualitative and semi-quantitative results. The test is for the detection of IgM and IgG anticardiolipin antibodies in serum specimens.

The Venereal Disease Research Laboratory slide test is a test for the detection of syphilis. The test employs an antigen containing cardiolipin, phosphatidylcholine (lecithin), and cholesterol dissolved in ethanol. The antigen is suspended in a buffered saline solution, which flocculates when combined with serum containing IgM and IgG anti-cardiolipin antibodies. The IgM and IgG antibodies are produced in response to infection by Treponema pallidum the causitive agent of syphilis. The flocculation forms a three-dimensional lattice structure that can be seen at low magnification (10x oculars and 10x objective) with a light microscope.

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

Device: Avanti Polar Lipids VDRL Antigen Slide Test Kit
Intended Use: For use in the Venereal Disease Research Laboratory (VDRL) slide test for syphilis, a non-treponemal, micro-flocculation test that provides both qualitative and semi-quantitative results to detect IgM and IgG anticardiolipin antibodies in serum.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Specificity and Sensitivity (Performance Data): 100 documented cases of syphilis.
• Sample Size for Reproducibility Data: Not explicitly stated, but “specimens from a blind, coded panel” were used. The number of specimens in this panel is not provided.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "documented cases of syphilis," implying these were existing patient samples with established diagnoses.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The ground truth is referred to as "documented cases of syphilis," which implies a clinical diagnosis, but the method or personnel establishing this documentation are not detailed. For reproducibility, "different clinicians" were involved, but their qualifications are not given.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth of the "documented cases of syphilis." The ground truth appears to be based on pre-existing diagnostic records. For reproducibility, results from different clinicians were compared, but no formal adjudication process between them is outlined beyond comparing an end point within two doubling dilutions of the "true end point."

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

No, an MRMC comparative effectiveness study was not done. The study focuses on the performance of the Avanti Polar Lipids VDRL Antigen Slide Test Kit itself, not on how human readers' performance might improve with or without AI assistance. This device is an antigen for a manual slide test, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, a standalone performance assessment was conducted. The sensitivity and specificity reported are those of the "Avanti Polar Lipids, Inc. VDRL Antigen Slide Test Kit" itself, meaning the kit's ability to react correctly with samples. While a human is involved in observing the flocculation under a microscope, the performance metrics are attributed to the device's ability to yield the correct reaction, forming the basis for a diagnosis. It's a test kit, not an algorithm, so algorithm-specific standalone performance isn't applicable in the modern AI sense. However, the data presented pertains to the device's inherent performance.

7. The Type of Ground Truth Used

The ground truth used for sensitivity and specificity was based on "documented cases of syphilis." This broadly refers to clinical diagnosis or confirmed cases (likely by other established methods for syphilis diagnosis). For reproducibility, a "true end point" was mentioned, which would presumably be a previously established titer for the control specimens in the blind panel.

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI components. This device is a traditional in vitro diagnostic (IVD) test kit, not an AI/ML-based device.

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

As no training set is mentioned (since it's not an AI/ML device), this information is not applicable.

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