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BC-5D is an assayed whole blood control designed for Mindray BC-5390 (Mindray 5000 series) Auto Hematology Analyzer for the following parameters: WBC, Neu#, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD. PLT. and MPV.

The BC-5D Hematology Control consists of three levels of controls (Low, Normal, and High). It is recommended to perform quality control check using these controls established by the laboratory procedures and/or local/national regulations.

BC-5D Hematology Control is an in vitro diagnostic reagent composed of human erythrocytes, simulated leukocytes, and mammalian platelets in a plasma-like fluid with preservatives. This control is contains stabilized materials that provide a means of monitoring the performance of hematology blood cell counters. It is sampled in the same manner as a patient specimen.

Here's an analysis of the acceptance criteria and study information for the BC-5D Hematology Controls, based on the provided text, while noting limitations due to the document's nature as an FDA 510(k) summary, which often doesn't contain detailed study protocols:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary states, "The BC-5D Hematology Control met the acceptance criteria, as determined during verification, over the life of the product." However, it does not explicitly list the quantitative acceptance criteria for each parameter (WBC, Neu#, Lym#, etc.) nor does it provide a table of the reported device performance values against those criteria. It only indicates that the device met the criteria.

Without the specific numerical ranges for acceptance criteria and the actual performance data, a table like the one requested cannot be constructed from the given text. The relevant section notes that an "assay range" was determined for each parameter, and subsequent validation lots "met the acceptance criteria." This implies that the acceptance criteria revolved around the ability of the control to consistently fall within these established assay ranges.

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

• Sample Size (Test Set): The study involved testing "3 validation lots" of BC-5D Hematology Controls. The document does not specify the number of individual control samples tested within each lot or the number of measurements taken for each parameter.
• Data Provenance: Not explicitly stated, but as a commercial product seeking FDA clearance in the U.S., it's implied that the testing was conducted in a laboratory setting. The data is prospective in the sense that these validation lots were manufactured and tested specifically for the 510(k) submission. No information is given about the country of origin of the data beyond the applicant being R&D Systems, Inc. in Minneapolis, MN, USA.

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

This information is not applicable and therefore not provided in the document because:

• The device is a hematology quality control (QC) mixture, not a diagnostic device that relies on expert human interpretation of results (like an imaging device or a histological slide).
• The "ground truth" for a QC material is its assayed value, typically established by the manufacturer through rigorous testing using a reference method or consensus methods, not by "experts" in the sense of clinicians or radiologists interpreting results.

4. Adjudication Method for the Test Set

This is not applicable and therefore not provided for the same reasons as point 3. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in human expert interpretations, which is not relevant for a quality control material where performance is assessed against pre-defined numerical ranges.

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

No, an MRMC comparative effectiveness study was not done.

• This type of study is relevant for diagnostic devices where human readers (e.g., radiologists, pathologists) interpret data, and the effect of AI assistance on their performance is evaluated.
• The BC-5D Hematology Control is a quality control material for an automated hematology analyzer. It does not involve human interpretation or AI assistance in the diagnostic process itself. Its purpose is to monitor the performance of the analyzer.

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

This question is not directly applicable in the context of this device.

• The BC-5D is a control material, not an algorithm. Its "performance" is its ability to produce consistent and accurate results within its specified assay range when run on the Mindray BC-5390 Hematology Analyzer.
• The analyzer itself (Mindray BC-5390) performs in a "standalone" fashion (algorithm-only processing of samples). The control is used to verify that this standalone analyzer is functioning correctly.
• The study did evaluate the performance of the control material (i.e., its own characteristics like stability and assayed values) without human intervention in the result generation, but this isn't the typical "standalone algorithm performance" evaluation for a diagnostic AI device.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) for a hematology quality control material is its assayed value for each parameter. These values are established by the manufacturer through a combination of:

• Reference methods: Using highly accurate and precise analytical methods.
• Consensus values: Often by analyzing the control material on multiple instruments or by comparing with primary reference standards.
• The document implies that an "assay range" for each parameter was determined during the "manufacture and analysis of three verification lots." This "assay range" essentially defines the expected "ground truth" for the control material when it is functioning correctly.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided.

• "Training set" refers to data used to train a machine learning algorithm.
• The BC-5D Hematology Control is a physical control material, not a machine learning algorithm. Therefore, there is no "training set" in this context.

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

This information is not applicable and therefore not provided for the same reasons as point 8.

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To power the functions of various devices for which batteries or battery packs are configured.

Since non-rechargeable batteries and battery packs are "device specific" and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, or install these devices.

This battery is shipped only to customers who request a replacement battery for a PhysioControl LP500 AED (OEM P/N: 3005380-026, 11141-00013) or to replace a competitor's replacement battery for the same AED.

Biomedical equipment service professionals therefore know that the intended use is as a replacement battery.

Non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment. These devices provide a means of supplying electrical power through chemical reaction. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current used by the device into which they are installed. The performance and life span of these batteries depends on operating conditions of temperature, current drain, and the discharge method. These parameters are taken into account in designing such batteries. The goal is to develop battery packs that maintain capacity for as high and as long as possible under a specified range of environmental conditions.

This document is a 510(k) summary for a replacement battery pack, not a comparative effectiveness study or a standalone AI algorithm performance study. Therefore, it does not contain the detailed information requested regarding acceptance criteria, study design for proving equivalence, and information about AI model testing.

Here's a breakdown of what can be gleaned from the provided text, and what cannot:

What can be extracted (though not in the format requested as it's not a performance study):

• Device: R & D Battery Pack P/N 6019
• Intended Use: To power functions of various devices, specifically as a replacement battery for a PhysioControl LP500 AED.
• Predicate Device: AMCO Battery Pack P/N 5L500, also used in the PhysioControl LP500 AED.
• Basis of Equivalence: The document states "The design components and functionality of the R & D Batteries Inc. P/N 6019 battery pack is identical to the predicate device. Cell chemistry and type are identical. Sealed (Vented) Lithium / Sulphur Dioxide (Li/SO2)."

Information that is NOT available in this document:

Since this is a 510(k) premarket notification for a battery pack, not a medical device driven by an algorithm or intended for diagnostic/therapeutic functions requiring complex performance metrics, the following information is not applicable or not provided:

1. A table of acceptance criteria and the reported device performance: While there would be internal specifications and performance targets for the battery, this document does not present them as "acceptance criteria" for a primary efficacy or diagnostic study. The equivalence is based on being "identical" to a predicate, not necessarily meeting a specific set of clinical performance cutoffs.
2. Sample size used for the test set and the data provenance: Not applicable. Equivalence is primarily demonstrated through design and material identity, along with bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no ground truth in the context of expert consensus for a battery's performance in this type of submission.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a battery, not an algorithm.
7. The type of ground truth used: Not applicable in the context of clinical outcomes or expert consensus. For a battery, "ground truth" relates to its physical and electrical properties meeting specifications.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable.

What performance/safety testing was done (as per the document):

• Type of Study: Bench tests
• Equipment used: Medtronic's/PhysioControl LP500 AED and a NETECH Model Delta 2200 Defibrillator Analyzer.
• Tests conducted:
  • Life Cycle
  • Temperature
  • Mechanical & Electrical Component Integrity
• Reference: The document refers to "013 Performance Testing for procedures and results," which is an internal document not provided here.

In summary, this document is a regulatory submission demonstrating substantial equivalence of a replacement battery pack to an existing one, based on identical design, materials, and bench testing, rather than a clinical study evaluating diagnostic or therapeutic efficacy of a complex medical device or AI system.

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R&D 5D Retic Control is a tri-level, assayed Hematology control designed to monitor RET%, RET#, IRF and MRV values on Coulter® hematology analyzers.

For in vitro Diagnostic Use Only.

The R&D 5D Retic Hematology Control is an in vitro diagnostic reagent composed of human in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring reticulocyte counting methods. It is sampled in the same manner as a patient specimen.

The provided document describes the R&D 5D Retic Hematology Control, an in vitro diagnostic reagent used to monitor reticulocyte counting methods on Coulter® hematology analyzers. The submission is a 510(k) for substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The study was a laboratory validation study comparing the R&D 5D Retic Hematology Control to its predicate device.

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 for Test Set: "3 validation lots" were used. The document does not specify the number of individual vials or measurements within each lot.
• Data Provenance: The study was conducted by R&D Systems, Inc. in Minneapolis, MN, USA. The data would be considered prospective, as it was generated specifically for this 510(k) submission to demonstrate performance.

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 device is a quality control material for hematology analyzers, not a diagnostic imaging or interpretive device that requires human expert opinion for ground truth. The "ground truth" for a quality control material is its expected range of values when tested on specified instruments, which is typically established through extensive internal testing by the manufacturer using validated reference methods and statistical analysis. The document does not mention the involvement of external experts in establishing the ground truth ranges for the control material itself. The performance comparison is against a predicate device, implying that the predicate's established performance serves as a benchmark.

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

Not applicable. As this is a quality control material, there is no "ground truth" established by human adjudication in the traditional sense of diagnostic assessments. Performance is determined by instrumental readings and statistical comparison to established ranges and predicate device performance.

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 hematology control, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This is a physical control material. The "performance" is its ability to produce expected results on a hematology analyzer, not an algorithm's output.

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

The "ground truth" for a hematology control is its pre-established assayed values and expected ranges for specific parameters (RET%, RET#, IRF, MRV) on designated hematology analyzers. These ranges are determined by the manufacturer through rigorous testing using calibrated instruments and reference methods. The study's aim was to demonstrate that the new control material performs substantially equivalently to the predicate device, meaning its values fall within comparable expected ranges or demonstrate similar precision and stability characteristics.

8. The sample size for the training set

Not applicable. This is a quality control material, not an AI or machine learning model that requires a training set.

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

Not applicable. As above, there is no "training set." The performance characteristics and expected ranges of the control material are established through internal assay and validation processes by the manufacturer.

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The Circumaural Adhesive Replacement is used to make earphones reusable for newborn hearing screening tests. It is a single use disposable to seal the earphones in place during the screening process. This skin adhesive is intended for use on the circumaural area of babies between the ages of 34 weeks (gestational age ) and 6 months. Sites appropriate for this screening test may include the well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

Circumaural Adhesive Replacement is acrylic hydrogel adhesive rings supplied on a release card in a packages of ten. After the original adhesive is removed from the disposable ear couplers, the top liner covers are removed to apply the adhesive rings to the earphones thereby making them reusable and reducing medical test costs. The then reusable ear couplers with the disposable adhesive rings are placed around the infant ears for the duration of the test. The Circumaural Adhesive Replacement is then removed and discarded. After an alcohol wipe of the same earphones, another Circumaural Adhesive Replacement is applied for the next patient test.

This document describes the Circumaural Adhesive Replacement, a disposable hydrogel adhesive for re-using earphones in newborn hearing screening tests.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for specific performance tests (e.g., bench testing for adhesive characteristics). However, it mentions that Biocompatibility testing was performed. For these types of tests (cytotoxicity, sensitization, primary skin irritation), standardized protocols typically involve a certain number of test subjects or samples. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

This information is not provided in the document. The studies described are primarily technical performance tests and biocompatibility, not studies requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided in the document. The tests performed are objective measurements (e.g., passing ISO standards, 0% residue, 100% attachment), not subjective assessments requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an adhesive replacement, not an imaging or diagnostic AI tool that would typically involve human readers.

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

This concept is not applicable to the device described. The "device" is a physical adhesive. The performance tests are for the adhesive's physical and biological properties.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Predicate device's established performance and characteristics: The comparison is against the Natus Flexicoupler's performance, which is already an approved device.
• Objective material and performance specifications: Such as ISO 10993 standards for biocompatibility, and quantitative measures like 100% attachment, 0% residue, and "none" for pain upon removal.

8. The Sample Size for the Training Set

This concept is not applicable as the device is a physical product (adhesive) and not an AI/ML algorithm that requires a training set.

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

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

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a substantial equivalence evaluation compared to a legally marketed predicate device (ALGO-3 Newborn Hearing Screener and Accessories, specifically the Flexicoupler Disposable Earphone accessory, K013317).

The document states:

• Performance Testing:

  • Biocompatibility: Tests were performed, and the device "passed the required skin sensitivity testing criteria." It "met specifications as established in ISO 10993-1 for skin contact," including cytotoxicity, sensitization, and primary skin irritation tests. This directly addresses the "Biocompatibility: Passed ISO 10993" acceptance criterion. The predicate device uses the same materials and meets the same ISO 10993 specifications.
  • Bench Testing: Bench testing "demonstrated that the adhesive characteristics of the Circumaural Adhesive Replacement are substantially equivalent to those of the predicate device." This supports the acceptance criteria related to "Hydrogel Attachment to Coupler" (100%), "Acoustic Seal" (100%), "Adhesive Residue" (0%), and "Pain Upon Removal" (None).

• Technological Comparison & Materials: The device uses the same material (acrylic hydrogel) as the predicate device. The contact area, earphone component, indications for use, shelf life, and prescription status are also identical to the predicate.

The conclusion from testing is that "In all material respects, the Circumaural Adhesive Replacement on the Natus Flexicoupler is substantially equivalent to the predicate device. Both use acrylic hydrogel adhesives. Test results support the conclusion that the adhesive performance is substantially equivalent to the predicate devices, and there are no differences in construction and materials between the devices to pose new questions of safety or effectiveness."

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The R&D Body Fluid-I Control is an assayed hematology control intended to monitor the reliability of hematology instruments that quantitatively measure red and white blood cell counts in cerebrospinal fluids, serous fluids, and synovial fluids.

For in vitro Diagnostic Use Only

The R&D Body Fluid-I is an assayed, in vitro, whole blood control composed of human and bovine cells in a plasma-like fluid with preservatives. Three levels are available and each level of control is packaged in a tube containing 3 mL of the control material. It is sampled in the same manner as a patient specimen.

The provided text describes the R&D Body Fluid-I Hematology Control, an in vitro diagnostic device. This device is a quality control material, not a diagnostic algorithm, and therefore the acceptance criteria and study design elements typically associated with AI/ML-based diagnostic devices (like sample size for test sets, ground truth establishment by experts, MRMC studies, or standalone performance) are not applicable in this context. The study performed is a stability and reproducibility study for a control material, not a clinical study to assess diagnostic accuracy.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Three lots were tested to verify the closed vial and open vial stability and lot to lot reproducibility." Each lot contained 3 levels of control material. The specific number of individual samples tested per lot/level or the total number of measurements is not explicitly provided.
• Data Provenance: The studies were internal validation studies conducted by R&D Systems, Inc. The data is prospective, generated specifically for these validation tests. The country of origin for the data generation would be the USA, where R&D Systems, Inc. is located.

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

• This question is not applicable as the device is a quality control material, not a diagnostic algorithm. Ground truth, in the sense of a clinical diagnosis or expert-labeled data, is not established for this type of product. The "ground truth" for a control material is its expected target values and ranges, which are determined by the manufacturer through rigorous testing and assaying on reference instruments.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on diagnostic tasks. This device is a control material, and its performance is assessed against predefined statistical ranges and stability profiles, not through expert consensus on qualitative interpretation.

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 question is not applicable. An MRMC study is designed to evaluate the impact of an AI diagnostic tool on human reader performance. This device is a quality control material and does not involve AI or human interaction in a diagnostic capacity that would necessitate such a study.

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

• This question is not applicable. A standalone performance study evaluates a diagnostic algorithm's accuracy independent of human intervention. The R&D Body Fluid-I Hematology Control is a physical control material, not a software algorithm. Its "performance" is its ability to maintain its assayed values within specified ranges over time and under various conditions.

7. The Type of Ground Truth Used

• The "ground truth" for this device (a hematology control) is its assigned target values and acceptable ranges for red and white blood cell counts. These values are established by the manufacturer through repeated measurements on calibrated reference instruments. The acceptance criteria for stability and reproducibility are defined relative to these established target values and ranges.

8. The Sample Size for the Training Set

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

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

• This question is not applicable. As it's not an AI/ML algorithm, there is no training set or associated ground truth in that context.

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The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental posterior fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Epicage Interbody Fusion Device is a PEEK implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is designed with openings for bone growth and fusion. The rib allow for flexure of the device during insertion. The device is available in two lengths to accommodate various patients' anatomy. Each of these sizes is available in 4 heights ranging from 8mm to 14mm in 2mm increments.

The provided text describes pre-clinical performance testing for the Epicage Interbody Fusion Device, which is intended for interbody fusion procedures. This device is a PEEK implant designed to provide mechanical support to the lumbar spine during biologic fusion.

Here's an analysis of the acceptance criteria and study to prove the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The text indicates that the device's performance was evaluated against established ASTM standards and a recognized protocol for expulsion testing. The reported performance is a qualitative statement of meeting these standards and being "substantially equivalent" to predicate devices. Specific quantitative acceptance criteria or performance metrics are not explicitly provided in the extract.

2. Sample Size and Data Provenance

The provided text focuses on pre-clinical bench testing. It does not describe a clinical study involving human patients. Therefore, there is no "test set" in the context of patient data nor data provenance from specific countries or retrospective/prospective collection methods. The "samples" would refer to the physical Epicage Interbody Fusion Device units used for mechanical testing. The specific number of devices tested for each type of performance test is not mentioned.

3. Number of Experts and Qualifications

This information is not applicable as the study described is pre-clinical bench testing of a mechanical device, not an evaluation requiring expert interpretation of medical images or patient outcomes.

4. Adjudication Method

This information is not applicable for the same reason as point 3. Bench testing results are typically based on objective measurements from laboratory equipment.

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

No. The provided text describes pre-clinical bench testing of a mechanical device. It does not involve human readers interpreting images or considering AI assistance.

6. Standalone Performance Study (Algorithm Only)

The device described is a physical medical implant (interbody fusion device), not a software algorithm. Therefore, "standalone" algorithm performance is not applicable. The performance testing focuses on the mechanical integrity and behavior of the implant itself.

7. Type of Ground Truth Used

The ground truth for the performance testing is based on the objective measurements obtained from standardized mechanical tests (ASTM standards and a recognized expulsion protocol). For example, the "ground truth" for static axial compression would be the force/displacement curves and failure points measured according to the ASTM F2077-03 standard. The study aims to demonstrate that the device's mechanical properties meet the expectations for its intended use and are comparable to predicate devices.

8. Sample Size for the Training Set

There is no "training set" in the context of an algorithm or machine learning model, as this is a physical medical device.

9. How Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for a physical medical device.

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R&D XERet Control is a tri-level, assayed Hematology control designed to monitor values on Sysmex® hematology analyzers. For in vitro Diagnostic Use Only

The R&D Systems XERet Hematology Control is an in vitro diagnostic reagent composed of human and porcine cells in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring reticulocyte counting methods. It is sampled in the same manner as a patient specimen.

The provided text describes the acceptance criteria and the study for the R&D XERet Hematology Control. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: "Laboratory testing of 3 validation lots" was performed.
• Data Provenance: Not explicitly stated, but based on the manufacturer's location (Minneapolis, MN, USA) and the submission to the FDA, it's highly likely the data is from the USA and is prospective as it's part of a validation study for a new product.

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

• This information is not provided in the document. The "ground truth" for a hematology control typically refers to the expected range of values for given parameters, which are often established through rigorous internal testing and statistical analysis by the manufacturer, rather than by external expert consensus in the same way, for example, a diagnostic image might be.

4. Adjudication Method for the Test Set

• This information is not explicitly stated. Given the nature of a hematology control (monitoring quantitative values), adjudication by multiple experts in the traditional sense (e.g., 2+1, 3+1) is typically not applicable. The performance is assessed against predefined statistical ranges and comparisons to a predicate device.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human interpretation is involved, such as medical imaging. The R&D XERet Hematology Control is an in vitro diagnostic reagent used to monitor automated hematology analyzers, not directly interpreted by human readers in the same context as an MRMC study.

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

• Yes, performance evaluation was done for the device itself. The device is a "control" for an analyzer, so its "standalone" performance relates to its ability to maintain stable and accurate assay values over time (stability, precision) and perform comparably to its predicate. The text states: "Laboratory testing of 3 validation lots has shown the R&D XERet Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device."

7. The Type of Ground Truth Used

• The ground truth for a hematology control is established by determining its assayed values and expected ranges for the measured parameters (RBC, RET%, RET#, IRF). This is typically done through a process of:
  • Manufacturer's internal testing: Extensive testing of multiple lots to establish mean values and standard deviations for each parameter.
  • Comparison to a predicate device: The study explicitly mentions "substantial equivalence... to the predicate device," implying the predicate's established performance serves as a reference point for acceptable ranges.
  • Statistical analysis: To define the "range" within which the control should perform.
  • Therefore, the ground truth is primarily based on established reference values/ranges derived from the manufacturer's testing and comparison to a legally marketed predicate device.

8. The Sample Size for the Training Set

• The document does not provide information regarding a training set. Hematology controls are manufactured to specific specifications and then
  validated; they are not "trained" in the typical machine learning sense. The "3 validation lots" are part of the testing/validation phase.

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

• As a training set is not applicable or mentioned for this device, a method for establishing its ground truth is also not provided.

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These electrodes are to be used in the neonatal or pediatric unit of hospitals for the resting ECG monitoring of newborn and premature birth infants. They are applied to the surface of the body, single use only, and disposable. These electrodes should be changed every 24 hours.

The Neonatal ECG Electrodes are three prewired ECG electrodes supplied on the same release card in a single package. The electrodes are a multi-layer construction containing a first layer surface (made of tricot/polyester fabric, polyethylene foam, or polypropylene substrate), a second layer ( metallic with Ag/AgCl coating ) prewired for connection to patient leadwires, and a third layer (made of biocompatible conductive hydrogel coupling media) The electrodes are placed on the neonate patient's chests.

Here's a breakdown of the acceptance criteria and study information for the Neonatal ECG Electrodes (KD912744), based on the provided document:

This 510(k) summary does not describe an AI/ML device or a comparative effectiveness study involving human readers with and without AI assistance. The device is a traditional medical device (ECG electrodes) and the testing focuses on its physical and electrical performance against recognized standards. Therefore, many of the requested categories (like MRMC study, standalone algorithm performance, training set details, and expert qualifications for ground truth) are not applicable to this submission.

1. Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria was primarily bench testing to assess electrical characteristics and biocompatibility testing. The submission explicitly states:

• "The Neonatal ECG Electrodes and the predicate devices all meet the specifications as established in ANSI/AAMI EC12:2000/(R) 2005 and ANSI/AAMI EC53:1995/(R) 2008."
• "Biocompatibility testing was performed, and the device passed the required skin sensitivity testing criteria."
• "Bench testing demonstrated that the characteristics of the Neonatal ECG Electrodes are substantially equivalent to those of the predicate devices."

The conclusion is that "Test results support the conclusion that the electrical output is substantially equivalent to the predicate devices, and there are no differences in construction and materials between the devices to pose new questions of safety or effectiveness."

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the electrical performance bench tests. For biocompatibility, it states "Biocompatibility testing was performed," but does not detail the number of samples or subjects.
• Data Provenance: The data is from bench testing (electrical and physical characteristics) and biocompatibility testing. The country of origin is not explicitly stated, but it would be expected to be from controlled laboratory environments. The nature of these tests is inherently prospective as they are conducted specifically for the device submission.

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

• Not Applicable. This is a hardware medical device (ECG electrodes). Ground truth in this context refers to established technical standards (ANSI/AAMI EC12 and EC53) and laboratory measurements, not expert review of images or clinical data.

4. Adjudication Method for the Test Set

• Not Applicable. As noted above, this involves technical measurements against standards, not subjective assessments requiring adjudication.

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

• No. An MRMC study was not done. This type of study is relevant for AI/ML diagnostic aids where human interpretation is involved. This device is an electrode.

6. Standalone Performance Study (Algorithm Only)

• No. This is a hardware device; there is no "algorithm" in the sense of AI/ML software for standalone performance evaluation.

7. Type of Ground Truth Used

• Technical Standards and Lab Measurements: The ground truth for this device's performance is defined by the requirements outlined in ANSI/AAMI EC12:2000/(R) 2005 (for ECG electrodes) and ANSI/AAMI EC53:1995/(R) 2008 (for biocompatibility and skin contact). The device's performance was measured against these objective standards.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. There is no training set for this type of device.

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R&D Retic-I Plus Control is a tri-level, assayed hematology control designed to monitor values obtained from automated reticulocyte counting methods.

For in vitro Diagnostic Use Only

The R&D Systems Retic-I Plus Hematology Control is an in vitro diagnostic reagent composed of human and avian erythrocytes in a plasma-like fluid with preservatives. It is composed of stabilized materials that provide a means of monitoring automated reticulocyte counting method. It is sampled in the same manner as a patient specimen.

Here's an analysis of the provided text regarding the R&D Systems Retic-I Plus Hematology Control, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states that "Laboratory testing of 3 validation lots has shown..." This indicates a test set size of 3 lots of the Retic-I Plus Hematology Control.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the study was retrospective or prospective, but the nature of device validation testing generally implies a prospective study design where the device is tested under controlled conditions.

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

This information is not provided in the document. The study appears to be a laboratory validation of a control material against a predicate device, rather than a clinical study requiring expert assessment of individual cases. The ground truth for a hematology control would typically be established by precise measurements using well-calibrated reference methods or instruments, not by human expert consensus on specific cases.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess cases and discrepancies need to be resolved. This study focuses on the performance, precision, and stability of a laboratory control material.

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

• Was it done?: No. The document describes a laboratory validation study comparing the new control material's performance to a predicate device, not a human reader study evaluating the effectiveness of AI assistance.
• Effect size of human reader improvement with AI vs. without AI assistance: This information is not applicable as an MRMC study was not performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was it done?: Yes, in essence. The study described focuses on the inherent performance of the Retic-I Plus Hematology Control as a standalone product. While it's not an "algorithm" in the typical AI sense, the control material itself is the "device" being evaluated for its performance characteristics (stability, precision, staying within assay range) independent of human interpretation of individual patient samples. The performance described ("remaining within the assay range over the life of the product," "substantial equivalence in performance, precision and stability") refers to the intrinsic behavior of the control.

7. Type of Ground Truth Used

The ground truth used for this device appears to be based on:

• Assay Range: The acceptable range of values for reticulocyte counts that the control should maintain. These ranges would likely be established through rigorous laboratory testing on reference instruments or methods.
• Predicate Device Performance: The established, known performance (stability, precision) of the legally marketed predicate device (R&D Systems Advia Retic Plus Hematology Control). The new device's performance is compared against this established benchmark to demonstrate "substantial equivalence."

8. Sample Size for the Training Set

This information is not provided and is not applicable for this type of device. Hematology control materials are not "trained" in the way an AI algorithm is trained. Their performance characteristics are inherent to their formulation and manufacturing process, which are then validated through testing.

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

This information is not provided and is not applicable for this type of device, as there is no "training set" in the context of an AI algorithm learning from data. The properties of the control material (e.g., stability, assay range) are determined intrinsically and validated experimentally.

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It is an established laboratory procedure to use a stable control to monitor the performance of diagnostic tests. HCT Extended Hematology Control is an assayed control designed to monitor values obtained from automated, semi-automated and manual methods. For in vitro Diagnostic Use Only

HCT Extended Hematology Control is an in vitro diagnostic reagent composed of human erythrocytes suspended in a plasma-like fluid with preservatives. It is an assayed whole blood control designed to monitor values obtained from automated, semi-automated and manual methods. It is sampled in the same manner as a patient specimen.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HCT Extended Hematology Control:

Please note: The provided text is a 510(k) summary for a diagnostic test control (Hematology Quality Control Mixture), not an AI/ML powered device. Therefore, many of the typical acceptance criteria and study design elements found in AI/ML performance studies (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable or explicitly mentioned in detail in this type of submission. The focus for a control device is typically on demonstrating stability, precision, and equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: The document states that "Laboratory testing of 3 validation lots" was performed. This refers to manufacturing lots of the control material, not a dataset of patient samples. The number of individual test runs or replicates within these lots is not specified.
   • Data Provenance: Not explicitly stated, however, as a laboratory control, the testing would have been conducted internally by R&D Systems, Inc. The document does not refer to patient data from a specific country or whether it was retrospective or prospective in the context of typical AI/ML studies.

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

   • Not applicable / Not stated. For a hematology control, "ground truth" is typically established by the manufacturer through precise analytical methods and quality control procedures, not by expert review of individual cases. The "assay range" is determined by the expected values on various instruments.

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

   • None. This concept is not relevant for a quality control material where performance is assessed analytically against predefined ranges, not through subjective interpretation requiring adjudication.

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:

   • No. This is not an AI/ML device and therefore no MRMC study was performed. The device is a diagnostic reagent (control), not an AI-assisted interpretation tool.

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

   • Not applicable. This is not an algorithm or AI device. Its "performance" refers to its analytical characteristics (stability, precision) when tested in a laboratory setting using standard laboratory instruments.

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

   • Manufacturers' established assay ranges and analytical precision. The "ground truth" for a control device is its expected value range and stability, which is determined by the manufacturer based on analytical testing, calibration to reference methods (if applicable), and established quality control principles.

7. The sample size for the training set:

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

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

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

Summary Context:

This 510(k) pertains to a hematology quality control product. Its purpose is to ensure laboratory instruments are performing correctly by providing a known sample with expected assay ranges. The "study" described is a validation of the control's performance, precision, and stability against the manufacturer's established criteria and in comparison to a previously cleared predicate device. The core requirement for clearance is demonstrating "substantial equivalence" to the predicate, meaning it performs similarly and has the same intended use and technological characteristics. The provided text confirms that the device passed its internal acceptance criteria, primarily revolving around maintaining its assay range over its specified lifespan.

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