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ACTABOND Topical Skin Adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. ACTABOND Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

ACTABOND Topical Skin Adhesive is a skin closure device that is comprised of a 2-octyl cyanoacrylate liquid adhesive formulation containing D & C Violet #2. The liquid adhesive is supplied sterile within a single use dispensing applicator, which is used to deliver the adhesive to the skin. Once applied, the liquid adhesive polymerizes to form a thin film with strong bonding and tensile properties. In vitro studies have shown that following application, ACTABOND Adhesive acts as a barrier to prevent bacterial penetration. The barrier properties of ACTABOND Adhesive have not been studied in clinical or animal models.

This document is a 510(k) premarket notification for the ACTABOND Topical Skin Adhesive. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with strict acceptance criteria and performance metrics for a novel AI or diagnostic device. Therefore, much of the requested information regarding AI-specific assessments (MRMC studies, stand-alone performance, training set details) is not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to the performance testing performed to demonstrate equivalence to the predicate device.

Here's the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria are not explicitly stated in the provided text as this is a substantial equivalence submission rather than a de novo marketing authorization or a clinical trial report with pre-defined endpoints for efficacy. Instead, the performance studies aimed to demonstrate "equivalence to the predicate device." The "acceptance criteria" can be inferred as achieving comparable results to the predicate device in the listed tests.

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

• Bench Studies: Sample sizes for individual bench tests (viscosity, setting time, strength tests, etc.) are not provided.
• Animal Study: The sample size for the porcine study is not explicitly stated. It refers to "a surgically induced, full thickness, linear wound healing model" and "Both groups" (subject and predicate device groups), implying at least two groups of animals, but the number of animals per group is not specified.
• Data Provenance: The studies were conducted by Bergen Medical Products, Inc. (USA) as part of their design control requirements. The porcine study is an animal model, not human data.

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

• Bench Studies: Not applicable. These are objective physical/chemical measurements.
• Animal Study: A "histological evaluation was also performed." This implies expert pathologists were involved, but the number and qualifications are not specified.

4. Adjudication method for the test set

• Bench Studies: Not applicable. These are quantitative measurements.
• Animal Study: Not specified for the histological evaluation.

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 submission is for a medical device (topical skin adhesive), not an AI or diagnostic imaging device that involves human readers.

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

• Not applicable. This submission is for a physical medical device (topical skin adhesive), not a standalone algorithm.

7. The type of ground truth used

• Bench Studies: Objective physical and chemical measurements (e.g., ASTM standards for strength, measured properties like viscosity, purity).
• Animal Study: Clinical observations of wound healing and histological analysis (microscopic examination of tissue by experts) were used as "ground truth" to compare the wound healing outcomes between the subject and predicate devices.
• Biocompatibility: Standardized ISO methods and biological responses (e.g., cytotoxicity, irritation).

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set. The device formulation and performance are based on established material science and empirical testing.

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

• Not applicable. As there is no training set mentioned.

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The Nfocus Neuromedical Acta Vessel Occlusion System (VOS) is indicated for arterial and venous embolizations in the peripheral vasculature specifically within the abdominal and thoracic cavities.

The Acta "Vessel Occlusion System (VOS) is provided sterile and is intended for one-time use. The implant is a self-expandable, ovoid shaped implant with delivery device. The implant is made from a double layer of Nitinol wire mesh which is secured at proximal and distal ends with platinum marker bands. The delivery device allows the implant to be delivered through commercially available catheters. Detachment of the implant from the delivery device is achieved by operator activation of the delivery handle.

The provided text describes a Premarket Notification [510(k)] Summary for the Nfocus Neuromedical Acta™ Vessel Occlusion System (VOS). This device is an arterial embolization device. The document primarily focuses on establishing substantial equivalence to a predicate device (Amplatzer Vascular Plug) rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the way one might typically find for an AI/ML medical device.

Therefore, many of the requested categories (especially those related to AI/ML device performance, human reader studies, and ground truth establishment for training/test sets) are not directly applicable or explicitly mentioned in this type of regulatory submission for a physical medical device.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria or reported device performance in a table format that mimics an AI/ML model's output metrics (e.g., sensitivity, specificity, AUC). Instead, it lists various tests that have been or will be performed prior to commercialization to ensure the product meets requirements and conforms to needs and intended uses. These are related to the physical integrity, material properties, and functionality of the device.

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

• Sample Size: Not specified. The document refers to "testing" (e.g., tensile strength, corrosion, simulated use) which typically involves a number of physical units, but the specific sample sizes for each test are not provided.
• Data Provenance: Not applicable in the context of this device type. These are engineering and biocompatibility tests performed on the physical device, not clinical data from patients.

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

• This is not applicable for a physical device like the Acta VOS. "Ground truth" in this context would be engineering specifications and standards, verified by qualified engineers and lab personnel, not medical experts establishing a diagnosis from patient data.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing clinical ground truth from expert reads of medical images/data. For device performance testing, results are measured against established engineering standards and specifications.

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. This is a physical medical device, not an AI/ML algorithm intended to assist human readers. Therefore, an MRMC study is not relevant.

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

• No. This is a physical medical device.

7. The type of ground truth used

• The "ground truth" for this device's performance testing would be established technical specifications, engineering standards, biocompatibility requirements, and regulatory guidelines (e.g., for MRI compatibility, material properties). The device's performance is measured against these established quantitative and qualitative criteria to demonstrate safety and effectiveness and substantial equivalence.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable.

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The Actalyke QC Kits are used to perform quality control assays when using the Actalyke Activated Clotting Time test systems. Blood coagulation instruments and test systems are used in hospitals and/or catherization labs. The AQC-LP is used as a control when the Actalyke system monitors moderately heparinized patients undergoing ECMO procedures or renal dialysis. The AQC-HP is used for QC testing when the Actalyke system is monitoring normal and highly heparinized patients undergoing cardiovascular procedures.

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This document section appears to be an FDA 510(k) clearance letter for a medical device called "Actalyke® QC Kits QAC-HP, AQC-LP." It confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding the acceptance criteria, device performance data, study details, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related information requested.

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• The regulatory classification of the device.
• General controls and regulations applicable to the device.
• The intended use of the device: "The Actalyke QC Kits are used to perform quality control assays when using the Actalyke Activated Clotting Time test systems."

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided document. This type of detailed study data is typically found in the 510(k) submission itself or in separate technical reports, not usually in the FDA clearance letter.

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The Actalyke XL Activated Clotting Time Analyzer and Test Tubes are indicated for use in the measurement of the activated clotting time test (ACT). This system can be used in bypass surgery, vascular surgery, transplant surgery, cardiac catheterization, and coronary angioplasty.

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This is an FDA Premarket Notification (510(k)) letter for the Actalyke® XL Analyzer. It does not contain the detailed study information required to complete your request.

The 510(k) summary (or the full submission, which is not provided here) is where you would typically find the acceptance criteria, study design, and performance data to support substantial equivalence. The letter itself is simply the FDA's decision regarding the premarket notification.

Therefore, I cannot provide the requested information from the text provided.

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Total hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip: fracture of the pelvis and diastrophic variant; inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of non-union; femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity.

When used in combination with an appropriately sized Reflection metal acetabular shell, Reflection Acetabular Liners are intended for cemented or uncemented use. Reflection All Polyethylene Cups are intended for cemented use only. Reflection Acetabular Liners and All Polyethylene Cups are intended for single use only.

The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all orthopaedic implant components manufactured from UHMWPE material in the Reflection Acetabular System (i.e. acetabular liners and all polyethylene cups)

There have been no changes in indications for use, design, or material property changes to any Reflection Acetabular Liner or All Polyethylene Cup components that will be sterilized using the VHP® process.

The VHP® sterilization process uses hydrogen peroxide (H2O2) vapor for sterilization of Reflection Acetabular System components (acetabular liners and all polyethylene cups) manufactured from UHMWPE using the Century SL VHP® Sterilizer. Sterilization is achieved by a series of H2O2 gas injections at deep vacuum set points. Aeration of the medical devices after sterilization is conducted by a series of chamber evacuations.

The provided text describes the 510(k) summary for the UHMWPE Components of the Reflection® Acetabular System, focusing on the VHP® sterilization process. This document does not describe a study involving an AI/Machine Learning device or its performance criteria.

Instead, it details the sterilization process validation for medical devices (acetabular liners and all polyethylene cups made from UHMWPE). The "acceptance criteria" and "device performance" in this context refer to the sterilization efficacy and the material's integrity after sterilization, not the diagnostic performance of an AI system.

Therefore, I cannot fulfill your request for information related to AI/Machine Learning device acceptance criteria and study details based on the provided text. The questions you've asked (sample sizes for test sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are specific to AI/ML device validation, which is not what this document addresses.

However, I can extract the information related to the sterilization process validation as it appears in the document:

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

Important Note: The questions related to sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set sample size, and how training set ground truth was established are not applicable to this document, as it concerns the validation of a sterilization process, not an AI/ML diagnostic device.

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The ACTAEON™ Probe arthroscopic cartilage stiffness tester is indicated for an arthroscopic in vivo point measurement of articular cartilage stiffness in humans. The ACTAEON™ Probe can be used arthroscopically or in open joint procedures.

The ACTAEON™ Probe is a hand-held device which when activated by the user measures the reaction force (resistance) of articular cartilage against a known rate and force of indentation applied by the disposable indenting tip of the device.

This document does not contain the detailed information necessary to complete all sections of your request. The provided text is a 510(k) summary for the ACTAEON™ Probe, which focuses on regulatory approval based on substantial equivalence to a predicate device, rather than a detailed study report describing acceptance criteria and device performance.

Here's what can be extracted and what is missing:

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

Unfortunately, the provided text does not include a table of acceptance criteria or specific reported device performance metrics. The summary states that "The ACTAEON™ Probe is designed to meet and comply with all sections of IEC 60601," which refers to electrical safety standards, not performance criteria for measuring cartilage stiffness.

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 available in the provided text. A 510(k) summary primarily focuses on demonstrating substantial equivalence, and often such detailed clinical study information is not included in this document type unless a specific performance study was required.

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 available in the provided text.

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

This information is not available in the provided text.

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

The ACTAEON™ Probe is described as an "arthroscopic cartilage stiffness tester," which is a physical measurement device, not an AI or imaging diagnostic tool that would typically involve "human readers" or "AI assistance" in the sense of image interpretation. Therefore, an MRMC study as you've described it is not applicable to this device.

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

This concept is not applicable to this device. The device is a physical probe that measures stiffness; it's not an algorithm operating in a standalone capacity. The human user operates the device.

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

This information is not available in the provided text. For a device measuring stiffness, ground truth would typically come from comparative mechanical measurements or correlation with pathological findings, but the document does not elaborate on this.

8. The sample size for the training set

This information is not available in the provided text. Since this is not an AI/machine learning device, the concept of a "training set" for an algorithm, as commonly understood in modern AI development, is not applicable here. If "training set" refers to calibration or development data for the physical probe, that information is not provided.

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

This information is not available in the provided text and is not applicable in the context of AI/ML training as defined by your request.

Summary of what is available from the document:

• Device: ACTAEON™ Probe, an arthroscopic cartilage stiffness tester.
• Intended Use: For arthroscopic in vivo point measurement of articular cartilage stiffness in humans, usable arthroscopically or in open joint procedures.
• Predicate Device: Artscan 200 Arthroscopic Cartilage Stiffness Tester from Artscan Oy. Helsinki. Finland.
• Regulatory Basis: Substantial equivalence to the predicate device.
• Stated Compliance: Designed to meet and comply with all sections of IEC 60601 (electrical safety).

The provided text serves as a regulatory summary for device clearance, not a detailed technical report of a performance study.

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ActalykeR Mini™ Activated Clotting Time (ACT) Test System is used to perform the activated clotting time test, a whole blood coagulation assay commonly used to monitor heparin anticoagulation during various medical and surgical procedures. This unit is intended for use in a near-patient or patient-care environment.

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The provided text is a 510(k) clearance letter from the FDA for the Actalyke Mini device. It does not contain the specific details about acceptance criteria or a study that proves the device meets those criteria. The letter primarily focuses on the device's substantial equivalence to a legally marketed predicate device and regulatory compliance.

Therefore, I cannot extract the requested information from the provided document.

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Polymerization of light-cured dental materials, Polymerization of restorative composite materials, and, Polymerization of bonding and sealing materials.

The ACTA OEM Module is a sub-assembly of the ACTA Polymerization Light Curing Device which received 510(k) clearance for the polymerization of light-cured dental materials, the polymerization of restorative composite materials, and the polymerization of bonding and sealing materials (K961735) on July 31, 1996. The ACTA OEM Module maintains all the same functions and main components of the ACTA: it is a stand-alone sub-assembly manufactured by SATELEC with all the same components and materials used in the manufacture of the original ACTA product, which can be used in standard dental units. The intended use, technical performance, and clinical indications are identical to those of its predicate device, the ACTA (K961735).

The ACTA OEM Module is a multi-purpose high intensity curing light generator kit to be marketed as a modular sub-assembly ("Original Equipment Manufacturer" - OEM) The ACTA OEM Module, similar to its predicate to manufacturers of dental units. device ACTA (K961735) operates by producing a visible blue light in the 400 to 520 nm waveband of the spectrum which enables the polymerization of composite materials.

The ACTA OEM Module light will cure all dental restoratives activated by light in that wavelength range. The radiation from the halogen bulb (44 watt) is selectively reflected, focused, and filtered to reduce the ultraviolet, infrared radiation and unneeded visible light. Thus, only the radiation in the appropriate band is available to be absorbed by the light cured composite material. The radiation necessary for this process is in the wavelength range of 400 to 520 nanometers. A built-in filter system blocks the nonessential emitted radiation outside this blue radiation wavelength range.

An ergonomic handpiece is supplied with ACTA OEM Module Kit and is designed for ease of use, comfort and convenience. The handpiece casing is made of thermoplastic allov. The handpiece houses the low voltage halogen lamp, and a lamp cooling fan. The kit also includes a disconnectable silicone cord, and a box which consists of one (1) deflector of a 0.3 in, one (1) optic fiber of ø 0.3 in , four (4) protection caps. one (1) 44 W bulb, and one (1) instruction booklet. The Kit includes a connection diagram and PC board as well.

The provided document describes a 510(k) premarket notification for a medical device, the ACTA OEM Module, a polymerization light-curing device. The document primarily focuses on establishing substantial equivalence to a predicate device (ACTA, K961735) rather than conducting a separate study to prove the device meets specific acceptance criteria based on direct performance measurements.

Therefore, for many of the requested categories, the information is not directly available in this 510(k) summary.

Here's an breakdown of the available information:

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

The document does not provide specific quantitative acceptance criteria or a performance table. The core argument for acceptance is substantial equivalence to a predicate device.

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

Not applicable. There was no specific "test set" of patient data or clinical samples used to evaluate the ACTA OEM Module's performance against predefined acceptance criteria. The evaluation was based on a comparison to the predicate device.

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

Not applicable. No expert review of a "test set" to establish ground truth was conducted for this 510(k) submission.

4. Adjudication method for the test set

Not applicable. No test set adjudication method was used.

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 light-curing device, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

Not applicable. This device is a physical instrument, not an algorithm. Its "standalone" performance is inherent in its operation as a light-curing device, which is considered equivalent to the predicate device.

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

Not applicable. No direct "ground truth" was established for the ACTA OEM Module's performance in a study. The "truth" for its safety and effectiveness is inferred from its substantial equivalence to the previously cleared predicate device.

8. The sample size for the training set

Not applicable. As a medical device that cures dental materials, there is no "training set" in the context of an algorithm or AI model for this product.

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 Actalyke Activated Clotting Time System and Test Tubes are intended for use in the measurement of the activated clotting time test (ACT). Current markets using the ACT include: bypass surgery, vascular surgery, transplant surgery, renal dialysis, ECMO, cardiac catheterization and Percutaneous Transluminal Coronary Angioplasty (PTCA), Critical Care, and other medical therapies requiring heparin anticoagulation.

The Actalyke System is a portable, battery operated device designed to perform a range of whole blood coagulation tests at the patient's bedside using Activated Clotting Time (ACT) measurement techniques. Each test well of the Actalyke Instrument incorporates a highly sensitive clot detection mechanism. Operationally, the detection mechanism comprises a magnet located inside a test tube and two solid state magnetic detectors positioned within the test well - one situated at 0° and another situated at 90° with respect to the test tube. When a test tube is inserted into the test well, the detector at 0° senses the presence of the magnet as the tube slowly rotates. As clotting forms, the fibrin strands cause the magnet to rotate within the tube such that its presence is sensed by the detector at 90° (indicating the occurrence of clotting and triggering end-point detection). This two-point detection sensing system is an improvement in ACT detection methods and minimizes the possibility of a missed end-point. Each Actalyke test tube has a barcode label affixed to it, which is read by the Actalyke instrument to determine the test tube type (i.e., celite, kaolin, or glass bead), If the result is printed (optional), the normal range for the identified test tube type will be printed. The lot number and expiration date of each tube are also identified on the barcode label.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Actalyke System appear to be based on demonstrating "normal ranges" and "high correlation" with the legally marketed predicate device, the HEMOCHRON Whole Blood Coagulation System, across different test tube types (Celite, Kaolin, Glass Bead). Since specific quantitative acceptance thresholds are not explicitly stated, the reported performance is compared directly to the predicate device's performance in the provided tables.

Summary of Reported Device Performance:

• Normal Range Studies: The Actalyke System, using its own tubes, demonstrated normal ranges largely overlapping with or comparable to the Hemochron system using its own tubes, when tested on healthy patient samples (as shown in the detailed tables for Celite, Kaolin, and Glass Bead).
• Correlation Studies (with varying heparin): The Actalyke Instrument and Actalyke ACT tubes showed "high correlation" with the Hemochron Instrument and Hemochron ACT tubes across different heparin concentrations for all three tube types (Celite, Kaolin, Glass Bead), indicating similar performance in measuring coagulation time under anticoagulation. This was visually represented and stated generally as "high correlation" in the DATA SUMMARY.

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

• Sample Size (Normal Range Studies):
  • Celite Normal Range Study: 15 patient samples (S011-S024 excluding some, plus S002).
  • Kaolin Normal Range Study: 15 patient samples (S033-S040, S004, S005, S009, S030, S031, S037, plus 11L001).
  • Glass Bead Normal Range Study: 15 patient samples (S051, S027, S025, S052, S028, S019, S035, S045, 11L001, S049, S048, S006, S016, S030, S009).
• Sample Size (Correlation Studies):
  • The sample size for the heparin correlation studies is not explicitly stated as a number of individual patients. However, the data represents "mean data" for varying heparin concentrations (0, 1, 3, 5 u/ml for Celite & Kaolin; 0, 0.3, 0.6, 1, 2 u/ml for Glass Bead), suggesting multiple measurements per heparin concentration. Given the normal range studies used 15 patients, it's plausible similar numbers were used for correlation, but it's not confirmed.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The patient IDs (e.g., S011, S002) suggest individual patient data was collected, but we cannot deduce if it was prospective or retrospective from the provided text.

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

Not applicable. This device measures a physical property (clotting time) directly, rather than relying on expert interpretation of images or other qualitative data. The "ground truth" is the measured Activated Clotting Time (ACT) itself, or comparison to an established, legally marketed device (HEMOCHRON system).

4. Adjudication Method (for the test set)

Not applicable. As noted above, the device measures a physical property directly. There is no qualitative assessment or interpretation by experts that would require an adjudication method. The study design involves direct comparison of measurements between the Actalyke system and the predicate device.

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

No. This is not applicable to the Actalyke System. An MRMC study typically involves human readers interpreting cases (e.g., medical images) with and without AI assistance to assess changes in diagnostic performance. The Actalyke System is a point-of-care coagulation analyzer, not an AI-powered diagnostic imaging tool that assists human readers.

6. Standalone Performance Study

Yes, a standalone performance was done in the "Normal Range Study" for each tube type. The Actalyke instrument was used with Actalyke tubes to establish normal ranges, which were then compared to the normal ranges obtained by the Hemochron instrument with Hemochron tubes. Additionally, the correlation studies implicitly demonstrate standalone performance when the Actalyke instrument is used with Actalyke tubes across varying heparin concentrations.

7. Type of Ground Truth Used

The ground truth used is predominantly:

• Comparison to a Legally Marketed Predicate Device: The performance of the Actalyke System is evaluated by comparing its results directly to those obtained from the HEMOCHRON Whole Blood Coagulation System, which is the established standard.
• Measured Activated Clotting Time (ACT): For the normal range studies, the ACT measurements from healthy individuals define the "normal range." For the correlation studies, the measured ACT values at different heparin concentrations serve as the primary data point for comparison.

8. Sample Size for the Training Set

Not applicable. The Actalyke System does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense. It is a hardware device based on magnetic detection principles. The studies described are performance validation studies, not training of an algorithm.

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

Not applicable, as there is no "training set" for this device.

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