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Found 265 results
510(k) Data Aggregation
(496 days)
Multichem ID-G: Multichem ID-G is intended for use as a qualitative positive quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Multichem ID-GNeg: Multichem ID-GNeg is intended for use as a qualitative negative quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Multichem ID-G and Multichem ID-GNeg are each supplied as single level controls. These products are prepared from human plasma. Multichem ID-G contains Hepatitis B Surface Antigen (HBsAg), and lgG antibodies to HIV-1 (Human Immunodeficiency Virus Type 1), HCV (Hepatitis C Virus), HBc (Hepatitis B Core Antigen) and Treponema pallidum. Multichem ID-GNeg does not contain analytes for HBsAg, anti-HIV-1 lgG, anti-HCV lgG, anti-HBc lgG, and anti-Treponema pallidum lgG. These controls are provided in liquid form for convenience. Each control is available as either 1 or 4 vials x 4 ml/vial.
Multichem ID-G is manufactured by adding the required analytes to the negative delipidated human serum base matrix, described above. Human disease state plasma that has tested positive for the required analyte using an FDA-cleared/approved assay is used to spike the base matrix to each target specification and within the ranges set for the Roche Immunoassay systems (Tables 1 and 2).
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(167 days)
Multi-functional Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial stimulation through MC(micro-current) mode.
The Multi-functional Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.
The device is only home environment use, which has some massage heads, and LED light mode (Red and /or Blue lights are output independently) to provides following functions.
a. Micro-current stimulation function.
b. Red LED irradiation function. (Cleared under K252142).
c. Blue LED irradiation.(Cleared under K252142).
d. Hot compress and vibration function.(The vibration is classified as class I and not need for 510K, and the hot compress(39℃±0.5℃) is not for medical purpose).
e. Hot compress function.(The hot compress(35.5℃～38.5±0.5℃) is not for medical purpose).
f. Vibration function(motor vibration).(The vibration is classified as class I and not need for 510K).
Each mode of the device is independent from all other modes of the Multi-functional Facial Beauty Device.
The Multi-functional Facial Beauty Device consists of a main unit, USB charging cable, components shown as following illustration: (Here takes model SKB-2109 and model SKB-2129 as examples)
SKB-2109:
- Intensity indicator
- Mode indicator
- Intensity button
- OFF/ON& Mode switch button
- Massage head
- LED light
- Massage head
- USB charging cable
SKB-2129:
- LEDs (Red)
- Massage head
- Power/Mode/Intensity Button
- RED LIGHT Indicator
- MC Indicator
- Intensity Indicator
- USB charging cable
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(271 days)
The N10, N12, N15, N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis, Heart Rate (HR) and Heart-Rate-Variability(HRV)), interpretations of resting 12-lead ECG, Respiration rate(Resp), Temperature(Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2). The N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are also intended for monitoring, displaying, reviewing, storing, alarming and transferring of physiological parameters including Masimo Rainbow SpO2, Anesthesia gas (AG), oxygen (O2) respiratory gas monitoring, Bispectral Index (BIS), Respiration Mechanics (RM) and Neuromuscular Transmission Monitoring (NMT). All the parameters can be monitored on single adult, pediatric, and neonatal patient except for the following:
- Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
- NIBP measurement continual mode is not applicable to neonates.
- When using COMEN SpO2, the monitor is intended to be used on adult patient only.
- PAWP is intended for adult and pediatric patients only.
- C.O. measurement is intended for adult patients only.
- BIS monitoring is intended for adult patients only.
- RM is intended for adult and pediatric patients only.
- NMT monitoring is intended for adult and pediatric patients only.
The monitors are to be used in healthcare facilities by healthcare professionals or under their guidance.
The Multi-parameter Patient monitors are not intended for emergency and transport use, aircraft environment or home use.
The monitors are not intend for use as apnea monitors.
The monitors are not intended for use in MRI or CT environments.
The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.
There are six (6) models under evaluation, namely N10, N12, N15, N10MPro, N12MPro, N15MPro. All models share the same intended condition of use, the same intended patient population and operator profile, biological safety characteristic and principle of operation. All these models are the same on electric and electrical circuit and components, mechanical construction, software and alarm system. The only difference lies on the screen and configuration of with/without plug-in module slot and the number of battery packs.
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(150 days)
Multi-functional Facial Beauty Device (model: SKB-1909):
- Blue light is intended for the treatment of facial mild to moderate inflammatory acne.
- Red light is intended for the treatment of facial wrinkles.
Multi-functional Facial Beauty Device (model: SKB-1703):
- Blue light is intended for the treatment of facial mild to moderate inflammatory acne.
Multi-functional Facial Beauty Device (models SKB-1803, SKB-1809, SBK-2109, SKB-2129, SKB-2208PRO and SKB-2209):
- Red light is intended for the treatment of facial wrinkles.
The Multi-functional Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.
The device is only home environment use, which has some massage heads, and LED light mode (Red and /or Blue lights are output independently) to provides following functions.
a. Micro-current stimulation function.
b. Red LED irradiation function.
c. Blue LED irradiation.
d. Hot compress and vibration function.(The vibration is classified as class I and not need for 510K, and the hot compress (39℃±0.5℃) is not for medical purpose).
e. Hot compress function.(The hot compress (35.5℃～38.5±0.5℃) is not for medical purpose).
f. Vibration function.(The vibration is classified as class I and not need for 510K).
Each mode of the Multi-functional Facial Beauty Device is independent from all other modes of the device.
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(1 days)
- Direct restorations in all cavity classes (I-V)
- Base / liner under direct restoration
- Veneering of discolored anterior teeth
- Splinting of mobile teeth
- Extended pit and fissure sealing in molars and premolars
- Repair of composite/ceramic veneers
- Retention of thermoplastic aligners
The addition of anti-microbial particles to MultiMatch Flow Chameleon AntiMicrobial Composite reduces demineralization and the total amount of bacteria at the material surface, which is part of the caries-formation process.
Premier's MultiMatch Flow Chameleon AntiMicrobial Composite is a low viscosity, light-cured, radiopaque, flowable nano-hybrid composite. It is for use in direct Class I-V restorations as a base liner, indirect restorations, and for retention of clear aligners. The restorative has an antimicrobial additive which reduces demineralization and total amount of bacteria at the material surface. The restorative is available in one chameleon shade to fit a variety of tooth-colored shades.
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(29 days)
MultiPulse TFL Laser system and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
- Urethral Strictures
- Bladder Neck Incisions (BNI)
- Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BPH)
- Transurethral incision of the prostate (TUIP)
- Laser Resection of the Prostate Laser Enucleation of the Prostate
- Laser Ablation of the Prostate
- Condyloma
- Lesions of external genitalia
- Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
- Treatment of distal impacted fragments remaining in the ureters following lithotripsy
- Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
- Endoscopic fragmentation of renal calculi
- Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed
Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitis, Hemorrhoids, Cholecystectomy, Benign and Malignant Neoplasma, Angiodysplasia, Colorectal cancer, Telangiectasia, Telangiectasia of the Osler-WeberRenu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions.
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) including: Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including: Percutaneous Laser Disc Decompression/Discectomy, Foraminoplasty, Ablation and coagulation of soft vascular and nonvascular tissue in minimally invasive spinal surgery.
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue: Intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septum by incision, excision, ablation and/or vessel coagulation, Soft tissue excision procedures such as excisional conization of the cervix.
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: Endonasal/sinus Surgery, Partial turbinectomy, Polypectomy, Dacryocystorhinostomy, Frontal Sinusotomy, Ethmoidectomy, Maxillary antrostomy, Functional endoscopic sinus surgery, Lesions or tumors (oral, nasal, glossal, pharyngeal and laryngeal), Tonsillectomy, Adenoidectomy.
General surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Cholecystectomy, Lysis of adhesion, Appendectomy, Biopsy, Skin incision, Tissue dissection, Excision of external tumors and lesions, Complete or partial resection of internal organs, tumors and lesions, Mastectomy, Hepatectomy, Pancreatectomy, Splenectomy, Thyroidectomy, Parathyroidectomy, Herniorrhaphy, Tonsillectomy, Lymphadenectomy, Partial Nephrectomy, Pilonidal Cystectomy, Resection of lipoma, Debridement of Decubitus Ulcer, Hemorrhoids, Debridement of Statis Ulcer.
The MultiPulse TFL laser system and its fiber optic delivery system is a laser Class IV, operating in CW or pulsed mode at a wavelength of 1940 nm. The laser power up to 200W is transmitted through different optical fibers. Besides of the optical bench the device consists of a power supply, a water cooling unit and a control electronic. The device is operated by a touch screen and a foot switch.
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(126 days)
The Multi4 System is intended for use by trained urologists for endoscopically controlled tissue resection and coagulation, and removal of bladder tumors (TURBT) via suction channel under controlled flow conditions following resection using a monopolar resectoscope. The Multi4 System is also intended to deliver injectable materials into the urinary bladder wall during transurethral endoscopic procedures.
The Multi4 System is an electrosurgical system used during urethral resection procedures of adult patients. The system, intended to remove and collect tissue from the bladder, includes a single-use electrosurgical instrument, known as the Multi4 B, as well as the reuseable Multi4 Pump. The Multi4 Pump administers energy from an external electrosurgical unit to the handheld Multi4 B instrument, which has electrosurgical functions and allows for fluid transport and tissue sample collection. The Multi4 B instrument accesses the bladder through the working channel of a commercially available cystoscope. The Multi4 System is a prescription device intended for use in professional healthcare facilities by healthcare professionals (HCPs).
The Multi4 System consists of the following components:
• Multi4 Pump (with Integrated Fluid Control)
o Footswitch
• Multi4 B
o Resectoscope & Needle
o Simple4tainer (For collection of gross resected tissue pieces for pathology)
The provided FDA 510(k) clearance letter and summary for the Multi4 System primarily focuses on demonstrating substantial equivalence to predicate devices through design similarity, material composition, intended use, and technological characteristics. The document details extensive non-clinical testing performed to ensure safety and effectiveness.
However, the provided text does not contain details about acceptance criteria, the study design, or performance metrics in a way that allows for the construction of a table comparing acceptance criteria with reported data, nor does it provide information on sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The document does mention:
- Non-Clinical Testing: Software Verification and Validation Testing, Sterility Testing, Packaging Testing, Shelf-life Testing, Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, Pyrogenicity), Electrical Safety & EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-2), Integrity Testing, Functional Testing (Cut and coagulation, aspiration, irrigation, injection), Dimensional Inspection and Testing, Simulated Use Testing.
- Lack of Clinical Study: The "SUMMARY OF NON-CLINICAL TESTING" section and the overall context strongly suggest that the clearance was based on non-clinical data demonstrating equivalence to predicate devices, rather than a clinical study evaluating specific performance metrics against acceptance criteria for a new AI/algorithm. There is no mention of "ground truth" as it would apply to an AI study (e.g., expert consensus, pathology, outcomes data).
Therefore, I must state that the requested information regarding acceptance criteria, study data for AI performance, sample sizes for AI test/training sets, expert roles, adjudication, and MRMC studies is not present in the provided text. The document focuses on demonstrating substantial equivalence via engineering and bench testing, not clinical performance or AI/algorithm validation with a test set and ground truth in the manner typically required for AI-driven devices.
Without this specific information from the provided text, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI-driven device with performance metrics.
If this were an AI device, the missing information would be crucial for understanding its validation. For this specific device and the information provided, the "acceptance criteria" were met by demonstrating that the Multi4 System performs as safely and effectively as its predicate devices through rigorous non-clinical testing.
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(86 days)
The Multi M Series is used in the manufacture of dental prosthesis.
Multi M Series is zirconia-based ceramic provided in various shapes such as round and it is used to manufacture cores of all ceramic crowns and is classified into ISO 6872 Type 2 Class 5. It is used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers 278 different shades to meet the needs of different patients' tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine. Multi M Series offers various types as follows: W-type, Z-type. These different types are to accommodate the different types of the jig that is built-in CAD/CAM machine. Users can choose a type which fits the jig they have.
This document is a 510(k) clearance letter for a medical device called "Multi M Series", which is a dental material. The standard 510(k) clearance process by the FDA does not typically include the kind of clinical study details usually associated with AI/ML-based diagnostic devices (e.g., sample size for test sets, expert consensus, MRMC studies, effect size of AI assistance). This device is a material, not a diagnostic algorithm.
Therefore, many of the requested points regarding acceptance criteria and study details (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of device and submission. The "study" here refers to non-clinical performance and biocompatibility testing against international standards.
However, I can extract the relevant information where it exists:
The device in question, "Multi M Series," is a dental material (zirconia-based ceramic) used to manufacture dental prosthetics, not an AI-powered diagnostic device. Therefore, the "acceptance criteria" and "study" described are based on non-clinical performance and biocompatibility testing against established international standards for dental materials, rather than clinical efficacy studies with human subjects or AI algorithm performance benchmarks.
Acceptance Criteria and Device Performance
The acceptance criteria are derived from ISO 6872 (for ceramic materials) and ISO 10993 (for biocompatibility).
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Standard/Requirement | Predicate Device (Zmaxx T Series) Performance | Subject Device (Multi M Series) Performance | Meets Acceptance Criteria? |
|---|---|---|---|---|
| Mechanical/Physical | ||||
| CTE | ISO 6872 | (10.6 ± 0.5) × 10⁻⁶ K⁻¹ | (10.6 ± 0.5) × 10⁻⁶ K⁻¹ | Yes |
| Flexural Strength | ISO 6872 | > 600 MPa | > 800 MPa | Yes (exceeds predicate) |
| Chemical Solubility | ISO 6872 | < 2000 µg/cm² | < 100 µg/cm² | Yes (exceeds predicate) |
| Biocompatibility | ||||
| Cytotoxicity | ISO 10993-5 | Non-toxic and biocompatible | Non-toxic and biocompatible | Yes |
| Sensitization | ISO 10993-10 | Non-toxic and biocompatible | Non-toxic and biocompatible | Yes |
| Irritation | ISO 10993-10 | Non-toxic and biocompatible | Non-toxic and biocompatible | Yes |
| Systemic Toxicity | ISO 10993-11 | Non-toxic and biocompatible | Non-toxic and biocompatible | Yes |
Note: The reported performance for "Multi M Series" either meets or exceeds the requirements set by the ISO standards and, in some cases, the performance of the predicate device (e.g., higher flexural strength, lower chemical solubility).
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each mechanical or chemical test. Typically, these are defined within the referenced ISO standards (e.g., ISO 6872 specifies sample numbers for flexural strength testing).
The testing was conducted by DMAX Co., Ltd., which is based in Daegu, Korea. The data would be considered prospective, as it was generated specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a material, not a diagnostic or AI device requiring expert interpretation for ground truth. "Ground truth" for this device is based on objective, quantifiable physical, chemical, and biological measurements performed according to standardized protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as above. There is no expert adjudication for material property testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This is not an AI-assisted diagnostic device, and therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device relies on objective measurements defined by international standards:
- Physical/Chemical Properties: Measured values obtained through standardized laboratory tests (e.g., flexural strength, chemical solubility, CTE) as per ISO 6872 and ISO 13356. These are quantitative and inherently objective.
- Biocompatibility: Results from established in vitro and in vivo toxicology tests (e.g., cytotoxicity, sensitization, irritation, systemic toxicity) as per ISO 10993 series, which assess the material's interaction with biological systems based on predetermined endpoints.
8. The sample size for the training set
This is not applicable as this is a physical material, not a software algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is a physical material, not a software algorithm.
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(225 days)
The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surqical procedures in urology.
MultiCut Solo consists of a special endoscopic handpiece in which a blade is inserted which mechanically shreds the tissue. The blade is driven by a dc motor, which is integrated in the handpiece. The motor itself is driven by a motor driver PCB. The blade can rotate at different speeds and thereby change the direction of rotation periodically (so called oscillation). The morcellator handpiece is also connected by an aspiration tube set to a peristaltic aspiration pump. By this pump the crushed tissue can be transported through a hollow channel in the handpiece to a waste container. The device is available with either sterile single use blades and non-sterile reusable blades.
The provided text is related to a medical device submission (K240831) for the MultiCut Solo Morcellator. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study for a new device.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in the provided text.
The document states that the MultiCut Solo Morcellator is a modification of an already cleared device (K213597), with the specific modification being the addition of sterile single-use blades. The submission focuses on non-clinical performance data to support the substantial equivalence.
Here's what can be extracted from the text regarding the device's assessment:
1. A table of acceptance criteria and the reported device performance
- No specific acceptance criteria or performance metrics related to diagnostic accuracy or clinical outcomes are provided. The submission focuses on product safety and function rather than a software algorithm's diagnostic performance.
- The document mentions that the device "successfully passed the following testing" and "is in compliance with all applicable sections of the above-mentioned performance standards." These relate to the safety and functionality of the device and its components, particularly the new sterile single-use blades. The "performance" in this context refers to meeting engineering and safety standards, not clinical diagnostic accuracy.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The document describes non-clinical performance data (e.g., sterilization validation, biocompatibility) rather than a test set for diagnostic 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)
- Not applicable. There is no mention of expert-established ground truth for a diagnostic test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication is described.
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. The MultiCut Solo is a mechanical morcellator, not an AI diagnostic device, and thus no MRMC study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The assessments made (e.g., sterilization effectiveness, biocompatibility) are based on established scientific methods and standards (e.g., EN/ISO 10993, IEC 60601 series) rather than a clinical ground truth for diagnostic accuracy.
8. The sample size for the training set
- Not applicable. The device is not based on machine learning or AI that would require a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary, the provided FDA 510(k) summary focuses on the technical safety and performance of a medical device (a morcellator) and its components, specifically regarding modifications and substantial equivalence to a predicate device, rather than on the diagnostic accuracy or clinical efficacy that would involve the type of acceptance criteria and study designs typically associated with AI/software-as-a-medical-device (SaMD) clearances.
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(422 days)
The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NBP). non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults.
The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, basal metabolism and free fat mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.
The Multi-parameter detector is a device designed for measuring of the patient's physiological parameters. The Multi-parameter detector can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.
The Multi-parameter detector are non-invasive body composition analyzers. The devices employ BIA (Bio-electrical Impedance Analysis) method and then measure body composition using an experimentally derived algorithm.
The Multi-parameter detector integrates an FDA market cleared devices, All-in-One Health Monitor (K170047) for measurement of oxygen saturation of arterial hemoqlobin (SpO2).
The provided document is a 510(k) summary for a "Multi-parameter detector." It outlines the device's characteristics, intended use, and substantial equivalence to predicate devices, along with non-clinical and clinical testing performed. However, it does not provide the detailed acceptance criteria and "study that proves the device meets the acceptance criteria" in the format requested, particularly for an AI/algorithm-based device study.
The document primarily focuses on demonstrating substantial equivalence based on performance standards for traditional medical devices (blood pressure, SpO2, temperature, body composition) rather than the rigorous evaluation of a new AI/ML-driven diagnostic or assistive technology.
Here's a breakdown of what can be extracted and what is missing based on your prompt:
Extracted Information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides performance standards and reports whether the device met them, rather than a direct "acceptance criteria" table with specific quantitative thresholds and exact results for each parameter alongside performance metrics like sensitivity/specificity for an AI.
| Parameter | Acceptance Standard (from document) | Reported Device Performance (from document) |
|---|---|---|
| NIBP (Non-Invasive Blood Pressure) | Average difference: ≤ ±5.0 mmHg; Standard deviation: ≤ 8.0 mmHg (per ISO 81060-2:2018) | Achieved: Average value of difference within ±5.0mmHg, standard deviation not greater than 8.0mmHg. (Based on 119 subjects) |
| TEMP (Forehead Temperature) | Max allowable error: ±0.2°C for 35.0-42.0°C; Clinical repeatability: ≤ ±0.3°C (per ISO 80601-2-56:2017+AMD1:2018) | Achieved: 105 subjects did not exceed max allowable error of ±0.2°C (in 35.0°C-42.0°C range); Clinical repeatability did not exceed ±0.3°C. |
| SpO2 (Pulse Oximetry) | Accuracy claim: ±3% for 70%-100% range (per ISO 80601-2-61:2017) | Verified via prior clearance (K170047, which inherited from K063641 compliant with ISO 9919:2005). ARMS of 1.49 for 70%-100%, meeting ±3% claim. |
| PR (Pulse Rate) | (Implicitly tied to SpO2, no specific criteria or performance given) | Verified via prior clearance (K170047, which inherited from K063641). |
| Height/Weight/Impedance | Internal standards applied. | "Tested... according to our internal standards." (No specific acceptance criteria or performance numbers reported in this summary.) |
2. Sample Size Used for the Test Set and Data Provenance:
- NIBP: 119 subjects.
- TEMP: 105 subjects.
- SpO2: 10 healthy subjects (aged 22-40, Fitzpatrick 2-6), but this was for the integrated FDA cleared device (K170047), not a new test for this submission's SpO2 component.
- Data Provenance: The NIBP and TEMP clinical studies were described as "single-center, randomized, self-controlled clinical trial[s]" conducted by Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. This implies prospective data, likely from China given the company's location.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not explicitly stated in the document.
- For NIBP and TEMP, the ground truth was established by comparison with "registered mercury thermometer and desktop sphygmomanometer." This implies these are the "gold standard" reference devices, not human experts.
4. Adjudication Method for the Test Set:
- Not applicable/Not stated. The ground truth was based on direct measurements from reference devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:
- No. This type of study is typical for AI/ML diagnostic tools assisting human readers (e.g., radiologists). The device in question is a multi-parameter measurement device, not an AI diagnostic tool requiring human reader studies to demonstrate assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The performance metrics (accuracy, standard deviation) for NIBP, TEMP, and SpO2 are reported for the device itself compared to reference standards, indicating standalone performance. The document describes the device directly measuring these parameters.
7. The Type of Ground Truth Used:
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