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ACTIVA PRESTO PACK is intended to be used by dental professionals as a dental filling material for pits, root surface cavities, and Class I, II, III, IV and V restorations include, but are not limited to, direct anterior and posterior restorations (including occlusal surfaces), core build-ups, splinting, and indirect restorations including crowns, inlays, onlays and veneers.

ACTIVA PRESTO™ PACK is an aesthetic, light cure material that contains calcium, phosphate, and fluoride in a durable, wear-resistant resin matrix indicated for all restorative procedures. The material is packable, highly polishable and contains no Bisphenol A, no BisGMA and no BPA derivatives. It is available in various shades, has low solubility, low water sorption, high physical properties, and is bioactive as demonstrated within this 510(k) submission.

The document provided is a 510(k) Premarket Notification from Pulpdent Corporation to the FDA for their device, ACTIVA PRESTO PACK. This submission focuses on demonstrating substantial equivalence to a predicate device, ACTIVA Presto (K153249), rather than presenting a study where a device's performance is measured against acceptance criteria in the format typically used for AI/ML devices.

Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not applicable to the information contained in this document, as it describes a physical dental material, not an AI/ML diagnostic or assistive device.

However, I can extract the comparative performance data between the proposed device and its predicate, which serves a similar function to "acceptance criteria" in that the new device must perform comparably to the predicate.

Here's the information extracted in a modified format to fit the request where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are implied by the performance of the legally marketed predicate device. The new device "ACTIVA™ PRESTO™ PACK" is compared against "Pulpdent ACTIVA™ PRESTO™ (K153249)". Substantial equivalence is demonstrated by comparable physical properties and intended use.

Study Conclusion: The submission concludes that ACTIVA™ PRESTO™ PACK is substantially equivalent to ACTIVA™ Presto™ (K153249) based on comparable design, composition, performance, and intended use. While some physical properties show variation, the overall performance profile is considered acceptable for substantial equivalence for a dental restorative material. The key difference noted is the change from a "flowable" to a "packable/sculptable" composite.

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

This information is not applicable as the document describes a physical medical device (dental filling material), not software or an AI/ML diagnostic. The performance data presented are physical and chemical properties measured in a lab setting, not clinical data from a test set of patients.

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. Ground truth, in the context of AI/ML, refers to definitively established diagnoses or classifications. For a dental material, "ground truth" would be established by standardized laboratory testing methods, not expert consensus on diagnostic images.

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

This information is not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations of images or data, which is not the case for material property testing.

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 information is not applicable as the device is a dental material, not an AI/ML assistive device for human readers.

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

This information is not applicable as the device is a dental material, not an algorithm.

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

The "ground truth" for the performance data in this submission is derived from standardized laboratory testing protocols as per international standards like ISO 4049:2019 for Polymer-based restorative materials. These tests define how to rigorously measure properties like flexural strength, depth of cure, water sorption, etc., ensuring reproducible and objective results.

8. The sample size for the training set

This information is not applicable as the device is a physical material, not an AI/ML device that undergoes "training."

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

This information is not applicable as the device is a physical material, not an AI/ML device.

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The Activatek ActivaPatch ET Intophoresis Patch is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.

The Activatek ActivaPatch ET Iontophoresis Patch consists of a self-contained, disposable single-use iontophoresis patch, instructions for use, and an alcohol prep pad containing 70% isopropyl alcohol.

The ActivaPatch ET lontophoresis Patch contains an electronic module, an Active Electrode, and a Return Electrode. These elements are incorporated under an adhesive non-woven fabric covering which adheres the device to the skin. The overall dimensions of the ActivaPatch ET are 5.7 inches (length), 3.4 inches (width), and 0.2 inches (thickness).

Principle of Operation: Iontophoresis is a process that uses an electrical field across intact skin to propel charged ions into the skin and underlying tissue. The electrodes (Active and Return) are applied directly to the skin to transit the electric field. If the ion is negatively charged, then the negative electrode is designated the Active Electrode and the positive electrode is the Return Electrode. The total dose of all ions transported through the skin is proportional to the total current passed between the electrodes. Units of iontophoresis dosages are conventionally given in terms of mAmp*min, calculated by multiplying the amount of current by the time of application of the current.

The provided text describes a 510(k) summary for the ActivaPatch ET Iontophoresis Patch. While it outlines the device's specifications and its comparison to predicate devices, it does not contain information regarding a study that proves the device meets specific performance acceptance criteria based on clinical outcomes or a comparative effectiveness study with human readers.

The "Performance Data" section explicitly states: "There are no applicable Guidance Documents specifically associated with this type of medical device." This indicates that the regulatory submission primarily relies on substantial equivalence to predicate devices rather than new performance studies demonstrating achievement of specific metrics.

Therefore, I cannot populate the requested tables and information fields related to acceptance criteria and performance study details from the provided text.

Here's a breakdown of why the information is missing:

• Acceptance Criteria & Reported Device Performance: This device is undergoing a 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily meeting a set of pre-defined performance acceptance criteria from new clinical trials. The text only compares its specifications (dosage, voltage) to predicate devices, not clinical performance metrics against specific targets.
• Study Details (Sample Size, Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document does not describe any clinical study that was conducted to assess the performance of the ActivaPatch ET Iontophoresis Patch against a set of acceptance criteria. The information provided is primarily about the device's technical specifications and its similarity to existing devices.

In summary, the provided document is a 510(k) submission focused on demonstrating substantial equivalence, not a report of a performance study with defined acceptance criteria and results.

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The devices of Bloretec ActivaPin™ Product Group including ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat and ActivaPin™ HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. The modification of the initial ActivaPin™ Product group 510(k) (K080879) adds one trade name; Biorelec ActivaPin™ HT in the AclivaPin™ Product Group. That device has a small modification to ActivaPin™ Fusion; the instrument accepting hole is made on the both ends instead of one end of the device to enable insertions. The labeling will be revised accordingly.

Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices AclivaPin™, ActivaPin™ Fusion, ActivaPin™ HT, ActivaNail™ Conical and ActivaNail™ Flat.

The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin™ HT is almost identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group. ActivaPin141 HT is the same kind of device as ActivaPin™ Fusion, but it's both ends have an instrument accepting hole. The diameter of ActivaPin™ HT is 1,5 mm and the lengths are 20 - 70 mm.

The devices of Bioretec ActivaPin™ Product Group are indicated for fixation of bone fractures, osteotomies, arthrodeses and osleochondral fractures in the presence of appropriate immobilization.

The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption lakes place within approximately two years thus eliminating the need for implant removal surgery.

This document is a 510(k) summary for a Special 510(k) submission, focusing on a modification to an already cleared medical device, the Bioretec ActivaPin™ Product Group. As such, the purpose of this submission is to demonstrate substantial equivalence to previously cleared devices, rather than to present a de novo study with acceptance criteria and a detailed study report for new device performance.

Therefore, many of the requested items (e.g., specific acceptance criteria, detailed study results proving the device meets those criteria, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable or not present in the provided document. The submission relies on the prior clearance of the predicate devices for performance, safety, and effectiveness.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This is a Special 510(k) for a modification (adding a new trade name and a minor design change) to an already cleared device. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate devices, not to a new performance study against specific metrics. The document states: "The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. ... The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness."

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

Not applicable. No new clinical or performance test set data is presented for this Special 510(k) in the provided summary. The substantial equivalence argument relies on the existing clearances and the minimal nature of the modification.

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 establishment for a test set is discussed in this Special 510(k) summary.

4. Adjudication method for the test set

Not applicable. No test set or adjudication method is discussed.

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

Not applicable. This device is a bioabsorbable fixation pin, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical fixation pin, not an algorithm.

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

Not applicable. No new ground truth is established for this Special 510(k) submission. The safety and effectiveness are supported by the substantial equivalence to predicate devices, which would have had their performance and safety established through prior studies (not detailed in this document). The device itself (a bioabsorbable pin) is evaluated based on its mechanical properties, biocompatibility, and degradation characteristics, often through bench testing and sometimes animal or clinical studies for initial clearance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable. This is a physical medical device.

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The ActiV.A.C., InfoV.A.C., V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings.

When used on open wounds, they are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

When used on closed surgical incisions, they are also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

Negative pressure wound therapy system for application to surgically closed incisions.

Here's an analysis of the provided text regarding the acceptance criteria and study for the K120033 device:

Based on the provided K120033 510(k) Summary, the submission is focused on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study with explicit acceptance criteria.

The 510(k) Summary for K120033 states that the "V.A.C. Therapy Systems are substantially equivalent to the Prevena Incision Management System (K100821) in terms of safety, function and indications for use." The primary purpose of this submission is to expand the existing indications for use of the V.A.C. Therapy Systems to include closed surgical incisions, which is an indication already cleared for the predicate device, Prevena Incision Management System.

Therefore, the "acceptance criteria" discussed are centered around demonstrating equivalence to the predicate device's performance for this specific extended indication, rather than quantitative performance metrics for the device itself.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an equivalence submission, the "acceptance criteria" are implied by the demonstration of equivalence to the predicate device for the extended indication. There are no explicit quantitative performance metrics or acceptance criteria stated for the device's performance that are typically seen in a de novo study.

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

The submission explicitly states:

• "Non-clinical tests were not necessary to demonstrate substantial equivalence."
• "Clinical tests were not necessary to demonstrate substantial equivalence."

This indicates that no test set (clinical or non-clinical) with a sample size was used or reported in this 510(k) submission to directly evaluate the device's performance against specific acceptance criteria. The equivalence was established based on existing knowledge of the device's functionality and the predicate's cleared indications. Therefore, there is no information on data provenance.

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

Since no test set (clinical or non-clinical) was used, no experts were utilized to establish ground truth for a test set within this submission.

4. Adjudication Method for the Test Set

As no test set was used, there was no adjudication method employed or reported in this submission.

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 not an AI-powered diagnostic or assistive tool. It is a negative pressure wound therapy system. Therefore, no MRMC comparative effectiveness study was done and the concept of human readers improving with AI assistance is not applicable.

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

This device is a physical medical device (negative pressure wound therapy system), not an algorithm or AI. Therefore, a standalone performance study in this context is not applicable. The "performance data" section states that non-clinical and clinical tests were not necessary to demonstrate substantial equivalence.

7. The Type of Ground Truth Used

Given that no clinical or non-clinical tests were conducted for this specific submission to demonstrate performance, no "ground truth" was established or used in the context of validating a device's performance against a reference standard. The claim is based on the equivalence of the subject device's known functionalities to the predicate device's cleared indications.

8. The Sample Size for the Training Set

This submission is not for an AI model or a device that requires a training set. Therefore, there is no training set or associated sample size.

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

As there is no training set, this information is not applicable.

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The Activator V-E is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Activator V-E Spinal Adjusting Instrument." This letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain the kind of information typically associated with a study that proves a device meets acceptance criteria using performance metrics like accuracy, sensitivity, specificity, or F1-score. This type of information is usually found in detailed clinical study reports, scientific publications, or specific sections of a 510(k) submission that describe performance testing.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. It does not necessarily require the presentation of novel clinical performance data demonstrating specific quantitative acceptance criteria in the same way a de novo application or a premarket approval (PMA) might.

Therefore, I cannot extract the requested information from this document. It does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size for test sets or data provenance for performance studies.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for test sets.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. Type of ground truth used for such studies.
8. Sample size or ground truth establishment for a training set (as this is not an AI/ML device document).

The document is purely a regulatory clearance letter acknowledging substantial equivalence based on information submitted previously by the manufacturer, but the letter itself does not detail the specific performance studies.

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The ActivaTek ActivaPatch Iontophoresis System is intended to be used for the administration of soluble salts into the body for medical purposes and as an alternative to hypodermic injection.

The ActivaTek ActivaPatch Iontophoresis System (Iontophoresis Patch) consists of a self-contained, disposable single-use iontophoresis patch, instructions for use, and an alcohol prep pad containing 70% isopropyl alcohol.

The Iontophoresis Patch consists of an electronic module, an LED indicator, an active electrode, and a return electrode. These elements are incorporated under an adhesive foam covering which adheres the device to the skin. Its dimensions are 5.7 inches (length), 3.4 inches (width), and 0.2 inches (thickness).

The Iontophoresis Patch is designed to deliver a calibrated and fixed half dose of 40 mAmpminutes and a full dose of 80 mAmpminutes.

The ActivaPatch Iontophoresis System sequence of operation is signaled by its LED.

• a) The operator applies the ActivaPatch to the skin.
• b) The operator then pulls the tab located on the outer surface of the patch.
• c) In the Initial Skin Impedance Measurement Phase, the ActivaPatch measures voltage across the active and return electrodes to indicate the level of skin impedance. For high skin impedance, the LED flashes once every 4 seconds. This indicates that the skin impedance is too high for iontophoretic delivery. The treatment timer is not started. For moderate skin impedances, the LED flashes pulses four times every 30 seconds. The patch continues to monitor the skin impedance but does not turn on the treatment timer. When the skin impedance becomes optimal, the LED blinks once every 30 seconds. This indicates that the impedance is appropriate to start an iontophoretic treatment session and the ActivaPatch starts the treatment timer.
• d) In the First Half Dose Delivery Phase, the ActivaPatch LED continues to blink once every 30 seconds. This phase lasts 80 minutes and delivers an ionic dosage of 40 mA*minutes. At the end of the First Half Dose Delivery, the LED blinks short-long-short sequences every 30 seconds for 3 minutes. This signals to the user that the transition to the Second Half Dose Delivery Phase has begun.
• e) During the Second Half Dose Delivery Phase, the ActivaPatch LED blinks two pulses every 30 seconds. During this final phase, another 40 mA*minute dose is delivered. At the end of the delivery, the power in the device is automatically shut off and the LED does not blink.
• f) If at any time the skin impedance increases to high levels (e.g., the electrode falls off of the skin site) the ActivaPatch goes into the Skin Measurement Phase and the LED flashes pulses once every 4 seconds. The treatment timer is suspended and restarts when the skin impedance falls to optimal levels.

The provided text is a 510(k) summary for the ActivaTek ActivaPatch Iontophoresis System. It focuses on establishing substantial equivalence to predicate devices rather than directly presenting a study with acceptance criteria and measured performance.

Therefore, many of the requested items (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not available in this type of regulatory submission. This document aims to demonstrate that the new device is as safe and effective as existing, legally marketed devices, rather than proving its "performance" against specific acceptance criteria in a detailed clinical study.

However, I can extract the acceptance criteria as implied by the device's specifications and the implicit "performance" is that it functions as described and is equivalent to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The "study that proves the device meets the acceptance criteria" is implicitly the technical and performance testing conducted by ActivaTek Inc. to demonstrate that the device functions according to its design specifications, allowing the FDA to determine substantial equivalence. Details of these specific tests are not provided in this 510(k) summary but would be part of the full 510(k) submission. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent..." This indicates that the submitted documentation (including test reports, bench data, etc., which are not in this summary) was sufficient for their decision.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not provided in the 510(k) summary. Given the nature of an iontophoresis patch, testing would likely involve bench testing (electrical output, dosage accuracy, impedance monitoring), biocompatibility, and potentially limited human use studies for skin irritation or functionality, rather than large-scale clinical trials that would have clearly defined test sets and data provenance.

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)
Not applicable and not provided. The function of this device is largely objective (delivering a specific electrical dose) and does not involve subjective interpretation requiring expert ground truth in the way medical imaging AI might.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable and not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an iontophoresis patch, not an AI or imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, but a hardware medical device with some automated operational sequences. Its "standalone" performance would be its ability to deliver the specified dose and manage impedance as described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a device like an iontophoresis patch, the "ground truth" for its performance would be derived from:

• Bench Test Measurements: Direct electrical measurements of current, voltage, time, and calculated dosage.
• Engineering Specifications: Adherence to defined parameters (e.g., 40 mAmpminutes, 80 mAmpminutes, 6V).
• Predicate Device Equivalence: Demonstrating that its performance characteristics are comparable to legally marketed predicate devices, which themselves have an established safety and efficacy profile.

8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that would require a "training set."

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

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The devices of Bioretec ActivaPin™ Product Group including ActivaPin™, ActivaPin™ Fusion, ActivaNail™ Conical and ActivaNail™ Flat are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices ActivaPin™ ActivaPin™ Fusion, ActivaNail™ Conical and ActivaNail™ Flat. The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin" is identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group are its modifications. ActivaPin™ Fusion is the same as ActivaPin™, but its both ends are tapered. ActivaNail™ Conical and ActivaNail™ Flat are also ActivaPin™'s modifications with conical and flat heads. All pins of Bioretec ActivaPin™ Product Group are available in several different dimensions, including diameters of 1.5 - 3.2 mm and lengths of 5 - 70 mm. The devices of Bioretec ActivaPin" Product Group are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption takes place within approximately two years thus eliminating the need for implant removal surgery.

I am sorry, but the provided text describes a 510(k) submission for a medical device (Bioretec ActivaPin™ Product Group) and determines its substantial equivalence to a predicate device.

It does not contain information about acceptance criteria, device performance metrics, clinical study design, sample sizes, expert involvement, or ground truth establishment. The document is a regulatory filing, not a clinical study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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Activated Aspartate Aminotransferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate aminotransferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

Abbott Laboratories Activated AST is an in vitro diagnostic assay for the quantitation of aspartate aminotransferase (also known as serum glutamic oxaloacetic transferase or SGOT) in human serum or plasma. The Abbott Laboratories Activated AST assay is a clinical chemistry assay in which the aspartate aminotransferase catalyzes the transfer of the amino group from L-aspartate to a-ketoglutarate, in the presence of pyridoxal-5'phosphate, forming oxaloacetate and L-glutamate. Oxaloacetate in the presence of NADH and malate dehydrogenase (MDH) is reduced to L-malate. In this reaction, the NADH is concomitantly oxidized to NAD. The reaction is monitored by measuring the rate of decrease in absorbance at 340 nm due to the oxidation of NADH to NAD.

Here's an analysis of the provided text regarding the Abbott Laboratories Activated AST assay, structured to address your specific points:

Since this document describes a diagnostic assay and not an AI/ML device, many of the requested points related to AI/ML specific studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance) are not applicable. The study design described is a comparative performance study against a predicate device, which is standard for in vitro diagnostic (IVD) assays for 510(k) clearance.

Acceptance Criteria and Study Summary for Abbott Laboratories Activated AST Assay

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are implicitly defined by the demonstration of comparable performance to the predicate device, specifically in terms of correlation (regression analysis) and precision.

• ARCHITECT c8000: 0.999 (slope 1.01, Y-intercept -4.15 U/L)
• ARCHITECT c16000: 0.999 (slope 1.03, Y-intercept -3.75 U/L) |
  | Precision (Total %CV) | Acceptable within-laboratory precision for different AST levels (typically varies by concentration). | ARCHITECT c8000:
• Level 1 (43 U/L): 4.5% (20 Day)
• Level 2 (192 U/L): 1.0% (20 Day)
• Level 3 (23 U/L): 2.4% (5 Day)
• Level 4 (3,437 U/L): 0.7% (5 Day)
  AEROSET System:
• Level 1 (46 U/L): 2.3% (5 Day)
• Level 2 (205 U/L): 0.7% (5 Day)
  ARCHITECT c16000 System:
• Level 1 (45 U/L): 1.8% (5 Day)
• Level 2 (197 U/L): 0.5% (5 Day) |
  | Linearity | Demonstrate accuracy across a clinically relevant range. | Linear up to 1,985 U/L. |
  | Limit of Quantitation (LoQ) | Define the lowest concentration that can be accurately measured. | 5 U/L (with Flex Rate linearity up to 5,364 U/L). |

The study demonstrates that the Abbott Laboratories Activated AST assay on various Abbott platforms (AEROSET, ARCHITECT c8000, ARCHITECT c16000) achieves a very high correlation (0.999) with the predicate device (Abbott AST Activated, K981221) on the AEROSET System. The reported precision (total %CV) values are varied but generally low, indicating good reproducibility. The linearity and limit of quantitation also support the device's performance across its intended measuring range.

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

• Sample Size for Test Set: The document does not explicitly state the number of samples used for the method comparison (correlation) or precision studies. It mentions "Comparative performance studies were conducted" and "Precision studies were conducted," providing the results without specific sample counts for each.
• Data Provenance: The document does not specify the country of origin of the data. Given the "Abbott Laboratories" submitter in Irving, TX, USA, it is highly probable the studies were conducted in the USA. The studies are prospective in nature, as they involve running samples on the new device and comparing them to a predicate device, which implies collecting or generating data for the specific purpose of the 510(k) submission.

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

This is not applicable as this is an in vitro diagnostic assay, not an AI/ML device relying on human expert annotations for ground truth. The "ground truth" for this assay is the measurement obtained from the legally marketed predicate device, which itself would have undergone rigorous validation.

4. Adjudication Method for the Test Set

Not applicable for an in vitro diagnostic assay. Performance is assessed by direct comparison of numerical results to the predicate device and established analytical performance metrics (e.g., correlation, precision).

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 an in vitro diagnostic assay, not an AI/ML device for aiding human readers.

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

For an IVD, the "standalone" performance is essentially what is evaluated. The device itself (reagents + instrument system) performs the measurement. The results of the comparative performance studies and precision studies represent the standalone performance of the assay. There isn't an "algorithm only" in the sense of AI/ML, but rather the chemical reaction and photometric measurement by the instrument.

7. The Type of Ground Truth Used

The ground truth for demonstrating substantial equivalence is the performance of the legally marketed predicate device (Abbott AST Activated assay, K981221 on the Abbott AEROSET System). The goal is to show the new device yields "similar results" and "similar Performance Characteristics" to this predicate.

8. The Sample Size for the Training Set

Not applicable. This is an IVD assay, not an AI/ML device that requires a training set in that context. The "training" for such a system would involve method development and optimization, but not in the sense of machine learning.

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

Not applicable, as there is no "training set" in the context of an AI/ML device. For an IVD, the initial method development and optimization would rely on established analytical chemistry principles and potentially reference methods, but this is distinct from establishing ground truth for machine learning.

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The Activator V is indicated for chiropractic adjustment of the spine and extremities. It is intended for external use only.

The Activator V is a hand-held electromechanical chiropractic adjusting instrument with a plunger-like mechanism that is intended to be used for chiropractic adjustment of the spine and extremities. The device is only intended to be used by a health care professional licensed by the state in which he or she practices. The thrust is provided by battery power rather than manual force. This makes it easier and less tiring for the chiropractor.

Here's a breakdown of the acceptance criteria and study information for the Activator V, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document indicates that the device's performance aligns with the stated acceptance criteria: "The Activator V has been mechanically tested and shown to deliver approximately 75, 125, 175 or 250 N, depending on the selected thrust setting." The rechargeable battery's safety and performance were also confirmed through manufacturer testing.

Study Information

1. Sample size used for the test set and the data provenance: The document does not specify a separate "test set" in the context of clinical data for performance evaluation in humans. The performance data provided is related to mechanical testing of the device itself, not patient outcomes. Therefore, sample size and data provenance for a human test set are not applicable or provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is the physical output of the device (thrust force), established through mechanical testing, not by expert consensus on clinical data.

3. Adjudication method for the test set: Not applicable. As the performance relates to mechanical testing of force output, an adjudication method for a clinical test set is not relevant.

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 device is a chiropractic adjusting instrument; it is not an AI-powered diagnostic or interpretive tool that would involve human "readers" or an MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself performs a standalone function (delivering thrust). The "performance data" provided refers to the mechanical output of the device without human intervention beyond selecting the thrust setting.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the performance claims (thrust delivery) is based on mechanical measurements of force output.

7. The sample size for the training set: Not applicable. The Activator V is a mechanical device, not an AI or algorithmic system that requires a "training set."

8. How the ground truth for the training set was established: Not applicable, as no training set is relevant for this device.

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