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BC-5 Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions.

BC-5 Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

BC-5 Red and Blue light in combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.

BC-5 Red and Infrared light in combination is intended to emit energy in the red and infrared region of the spectrum to treat dermatological conditions, specifically indicated to treat periorbital wrinkles.

BC-5 Infrared is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

BC-5 is a light-based photobiomodulation system intended for performing non-invasive, low-level light therapy (LLT). It is used to deliver visible light wavelengths to treat dermatological conditions or to apply near infrared to the skin for topical heating.

BC-5 is a transportable, vertical system with an attached, four-panel treatment head that is manually adjusted to an appropriate distance above the patient's skin. The device does not contact the patient.

System components include a mains-powered control unit with touch-input control panel and microprocessor circuit; adjustable treatment head; and base with casters for transportability. An autolift pole connects the treatment head to the top of the main unit. An emergency stop switch allows the user to quickly shut the system down.

The technological heart of the system is RGB-IR chips (red-green-blue-near infrared). The user can select from the following five different programs, depending on type of dermatological condition and desired electromagnetic wavelength or combination of wavelengths: red, blue, red and blue, red and infrared. The first four are intended to treat skin conditions, while the fifth is intended for topical heating indications.

The entire system is reusable and is cleaned before each use.

The provided document is a 510(k) summary for the BC-5 device, a light-based photobiomodulation system. It primarily focuses on demonstrating substantial equivalence to a predicate device (Lightwave Professional Deluxe) through comparison of features and non-clinical bench testing. It does not present clinical study data for device performance against specific acceptance criteria related to its stated indications for use (e.g., treatment of acne, wrinkles, pain relief).

Therefore, I cannot directly answer your request for acceptance criteria and a study proving the device meets those criteria with specific performance numbers, sample sizes, expert involvement, or MRMC studies, as this information is not contained within the provided 510(k) summary.

The document discusses non-clinical bench testing to demonstrate the device's safety and performance with respect to electrical safety, EMC, risk management, software, non-laser light, and usability engineering. These are tests to ensure the device itself is safe and functions as designed, not clinical efficacy trials.

Here's an attempt to structure the information based on your request, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria presented in this document are primarily related to substantial equivalence to a predicate device and adherence to non-clinical safety and performance standards, rather than clinical efficacy metrics for the specified dermatological and pain relief indications.

Important Note: This table reflects the engineering and safety performance criteria for device clearance via 510(k), not clinical efficacy outcomes for treating medical conditions. The document asserts that the device is substantially equivalent to a predicate device which already has established clinical indications, implying that similar clinical performance is expected. No new clinical studies are presented to prove the BC-5's efficacy against its indications.

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

• Test Set Sample Size: Not applicable. The "tests" described are non-clinical bench tests (e.g., electrical safety, EMC), not clinical trials involving patient data.
• Data Provenance: Not applicable for clinical study data. The data provenance discussed relates to compliance with international standards for device manufacturing and testing.

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

Not applicable for the type of testing presented. Ground truth in this context refers to established engineering standards (e.g., IEC, ISO) and the device's performance against these standards. The experts involved would be engineers and quality assurance professionals performing and reviewing the bench tests.

4. Adjudication Method for the Test Set

Not applicable, as there are no clinical results needing adjudication. The testing involved passing/failing against engineering specifications.

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

No. An MRMC study is a type of clinical study typically used for diagnostic devices to assess the performance of human readers with and without AI assistance. This document describes a therapeutic device and no such clinical study is mentioned.

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

Not applicable. The BC-5 is a physical medical device (light therapy system), not an algorithm or software-only diagnostic tool.

7. The Type of Ground Truth Used

The "ground truth" for the substantial equivalence claim is based on:

• Predicate Device Equivalence: The legally marketed Lightwave Professional Deluxe (K082586) and its established indications and performance.
• Compliance with Recognized Standards: International standards for medical device safety, electrical performance, software, risk management, and usability (e.g., IEC 60601-series, ISO 14971, IEC 62304, IEC 62366).
• Physical and Technical Characteristics Comparison: Demonstrating that the BC-5's specifications (wavelengths, dose ranges, dimensions, power, etc.) are comparable or do not raise new safety/effectiveness concerns compared to the predicate.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI algorithm submission requiring a training set.

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

Not applicable.

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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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The BC-5390 Auto Hematology Analyzer is a quantitative, automated hematology Analyzer for in vitro diagnostic use in clinical laboratories. The BC-5390 Auto Hematology Analyzer provides complete blood count (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV) and leukocyte 5-Part differential (Neut, Lym#, Mon#, Eos#, Bas#, Neu%, Lym%, Mon%, Eos%, Bas%) for whole blood specimens collected in a salt of EDTA [dipotassium (K2) or tripotassium (K3)) obtained from venous or capillary blood collection. The purpose of the BC-5390 Auto Hematology Analyzer is to identify the normal human patient, with normal system-generated parameters, from patients whose results require additional studies.

The BC-5390 Auto Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories. It is only to be used by trained laboratory professionals to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies.

The BC-5390 Auto Hematology Analyzer system consists of:

• Instrument: Sample Processing Unit (SPU) and Data Managing Unit (DMU)
• . Reagents M-53D DILUENT M-5LEO(I) LYSE M-5LEO(II) LYSE M-53LH LYSE PROBE CLEANSER
• Controls

BC-5D Hematology Control (High, Normal, Low, Pending) Note: Controls for BC-5390 Auto Hematology Analyzer will be submitted in parallel with this 510(k) by R&D Systems as separate 510(k).

• . Calibrator
  SC-CAL PLUS Hematology Calibrator (cleared as K955925)

The Analyzer provides analysis results of 21 parameters, 3 histograms and 1 scattergram of human blood. It supports two test panels: CBC and CBC+DIFF.

Here's an analysis of the acceptance criteria and study details for the Mindray BC-5390 Auto Hematology Analyzer, based on the provided text:

Key Takeaways on Device Performance:

The device's performance was primarily evaluated through a method comparison study against a predicate device (Sysmex XE-2100) and various studies adhering to CLSI (Clinical and Laboratory Standards Institute) guidelines. The results generally indicate good correlation and adherence to predefined specifications, supporting the device's substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a single, dedicated table with numerical targets, but instead describes performance studies and states that results "met the pre-defined specification" or "were within the specifications." The table below synthesizes the implicit acceptance criteria based on the reported study results, primarily from the method comparison against the predicate device (Sysmex XE-2100).

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

• Test Set Sample Size:

  • Method Comparison: 1531 whole blood samples (collected in K2EDTA).
  • WBC Morphology Flagging: 1514 samples.
  • Precision/Repeatability: Not explicitly stated, but "whole blood samples" for repeatability, and "three levels of samples" from commercial control material BC-5D (tested in duplicate, twice daily for 20 days across 3 sites) for reproducibility (total 240 replicates per level across all sites).
  • Linearity: Dilutions prepared from commercial analogs (WBC, PLT) or fresh whole blood (RBC/HGB), with 7 subsequent dilutions, each run in triplicate.
  • Carryover: High and low samples tested in triplicates.
  • Interference: Whole blood samples with added interfering substances.
  • Comparison of Whole Blood Mode and Predilute Mode: 124 leftover whole blood samples.
  • Comparison of CBC and CBC+DIFF Mode: 103 leftover whole blood samples (Whole blood CBC vs CD) and 75 samples (Predilute CBC vs CD).
  • Comparison of Capillary and Venous Blood: 57 paired specimens.
  • Comparison of K2EDTA and K3EDTA Anticoagulants: 70 paired fresh whole blood samples.
  • Sample Stability: Fresh samples covering normal and medical decision range.
  • Adult Reference Interval: 251 donors (121 male, 130 female).
  • Pediatric Reference Interval: 161 pediatric samples (45 neonate, 26 infant, 57 child, 33 adolescent).
  • LoB, LoD, LoQ: Five blank samples and five low-level samples, each tested 12 times.

• Data Provenance:

  • Country of Origin: Not explicitly stated for all studies. The method comparison was done at "three actual user sites." The comparison of capillary and venous blood, and K2EDTA vs K3EDTA anticoagulants were done at "the U.S. site" or "clinical laboratory in U.S." This implies at least some data originated from the US, but a global origin is not ruled out for all studies.
  • Retrospective or Prospective: Not explicitly stated. The description "whole blood samples... were analyzed," "patient's samples covered the normal and most abnormal conditions," "leftover whole blood samples," and collection of "fresh samples" suggests a mix, and for studies like method comparison and flagging, samples from a patient population would likely be collected prospectively or retrospectively from a clinical lab biobank. The reference interval studies explicitly describe collecting samples, indicating these were prospective.

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

• Number of Experts: For the WBC manual differential (used as ground truth for WBC morphology flagging rate), "three manual wedge smears were prepared and stained with Wright-Giemsa stain. A 400 cell WBC differential was performed on two smears per CLSI H20-A2." This implies at least two experts (or a single expert doing two reads, which is less likely for independent confirmation) were involved in the manual differential portion. The document doesn't specify if these were consensus reads or independent.
• Qualifications of Experts: Not explicitly stated for the manual differential readers. It mentions "trained laboratory professionals" in the device description, implying that these professionals would be performing the manual differentials. CLSI H20-A2 typically refers to the standard for manual differential counting, which implies trained medical technologists or clinical laboratory scientists.

4. Adjudication Method for the Test Set

• Method Comparison and Flagging: For the WBC manual differential, it states "A 400 cell WBC differential was performed on two smears per CLSI H20-A2." It does not explicitly mention an adjudication method (like 2+1 or 3+1). It's possible that if two readers performed the differential, a consensus or third reader was used for discordant results, but the document doesn't detail this. It simply states the manual differential was performed "per CLSI H20-A2," which provides guidelines for the procedure.

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

• No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done.
  • This study evaluates the improvement in human reader performance (e.g., accuracy, efficiency) with the assistance of an AI algorithm compared to performing the task without AI assistance. The document describes a standalone device, an automated hematology analyzer, which performs the cell counting and differential analysis itself. The comparison is between the device and a predicate device, and between the device and manual methods, not human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone study was done.
  • The "Method Comparison" study (pages 9-10) directly compares the BC-5390 Auto Hematology Analyzer's quantitative results for 21 parameters against a legally marketed predicate device, the Sysmex XE-2100 Automated Hematology Analyzer. This is a standalone performance evaluation of the new device against an established one.
  • The "WBC Morphology Flagging Ability" (page 10), which compares the BC-5390's flagging rate to manual WBC differential, is also a standalone performance assessment of the device's ability to identify abnormal samples.
  • All the other performance characteristic studies (Precision, Linearity, Carryover, Interference, Sample Stability, LoD/LoQ/LoB) evaluate the BC-5390's performance in isolation or against defined standards, without human intervention in the primary measurement process once the sample is loaded.

7. Type of Ground Truth Used

• Predicate Device Measurements: Primarily used for most quantitative parameter comparisons (e.g., WBC, RBC, HGB, etc.), where the Sysmex XE-2100 (K992875) was the reference. This represents an established and FDA-cleared measurement method.
• Expert Manual Differential: Used for the WBC morphology flagging ability study (400-cell WBC differential performed on manual wedge smears per CLSI H20-A2). This is a form of expert consensus/manual reference.
• Dilution Series / Established Standards: For linearity, carryover, and LoD/LoQ/LoB studies, the ground truth was based on prepared dilution series and reference materials.
• Literature Reference Intervals: For pediatric reference interval verification, the ground truth was published pediatric intervals from "Mayo and IOWA literature."

8. Sample Size for the Training Set

• The document does not provide information on the sample size used for the training set. This is typical for a 510(k) summary, which focuses on device validation/verification testing rather than details of the algorithm's development (training).

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

• As the document does not provide information on the training set, it also does not explain how the ground truth for any potential training set was established.

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