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The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.

It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances.

Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.

The Medical Gas Analyzer is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical host device for display of respiratory parameters. It is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the C50 Multi-parameter Patient Monitor as a host backboard display to AG200. The C50 Multi-parameter Patient Monitor produced by Shenzhen Comen Medical Instruments Co., Ltd., which has obtained FDA's 510K clearance (K191106).

The concentrations of CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane can be determined together with derived parameters such as waveform data and inspired / expired concentrations of all gases.

The mainstream probe airway adapter is inserted between the endotracheal tube and the breathing circuit, and the gas measurements are obtained through the windows in the sides of the adapter. Running on a standard low voltage DC 5V, the mainstream probe is designed with portability in mind and has low power consumption.

The mainstream gas analyzers are characterized by the following features:

• Low system integration complexity
• Low power consumption
• Fast startup time
• Low weight

The provided document is a 510(k) clearance letter and summary for the Medical Gas Analyzer (AG200). It does not contain information about a study proving the device meets its acceptance criteria.
The document states: "the subject device does not require clinical test data to support substantial equivalence." This means that the device was cleared based on its similarity to existing devices and bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in a real-world setting.

Therefore, I cannot provide the requested information about the study proving the device meets acceptance criteria, the sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, or training set details as they are not present in the provided text.

However, I can extract the acceptance criteria as reported in the document through comparison with the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "device performance" parameters.

1. Table of Acceptance Criteria and Reported Device Performance (as implied by comparison to predicate/reference devices):

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Dewin Gamete Buffer is intended for human gamete and embryo short-term handling procedures outside the incubator, including washing and intracytoplasmic sperm injection (ICSI).

Dewin Follicle Flushing Solution is intended for use during ovarian follicle flushing and oocyte collection procedures for use in in vitro fertilization procedures.

Dewin One Step Medium is intended for use for culture of embryos from fertilization to the blastocyst stage. This device can be used for transfer of embryos to the uterus.

The DonneVie Dewin Reproductive Media are solutions used in assisted reproductive procedures. The family of Reproductive Media include the following 3 types and their variants:

• Dewin Gamete Buffer [with and without Human Serum Albumin (HSA)];
• Dewin Follicle Flushing Solution;
• Dewin One Step Medium [with and without HSA].

All variants contain gentamicin, an antibiotic agent that suppresses bacterial growth. The Gamete Buffer and Follicle Flushing media are offered in 100mL volume, while the One Step Medium is offered in volumes of 25mL and 50mL. The three Dewin Reproductive Media are used together during an assisted reproductive procedure. The Follicle Flushing Solution is used to first flush/wash the Cumulus-Oocyte Complex after it's removed from the ovary; it is then transferred to the Gamete Buffer for cleaning. After the prepared oocyte has been fertilized, it is transferred to the One Step Medium to culture the embryo from fertilization to blastocyst stage.

The primary glass bottle containers are washed, then sterilized and depyrogenated via dry heat. The bottle caps are supplied sterile by electron beam irradiation. The media are sterile filtered through a 0.2µm filter in an aseptic isolator at DonneVie Medical Technology Co., Ltd.

The provided FDA 510(k) clearance letter describes a medical device called "Dewin Reproductive Media" and presents non-clinical performance testing to demonstrate its substantial equivalence to a predicate device.

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

The acceptance criteria for the Dewin Reproductive Media are primarily derived from the specifications compared to the predicate device and the results expected from specific non-clinical tests.

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

The document does not specify the exact sample sizes for most of the non-clinical tests conducted. For example, it doesn't state how many batches were tested for sterility, pH, osmolality, or endotoxin, nor does it specify the number of mouse embryos used in the MEA tests.

• Provenance: The studies were conducted by DonneVie Medical Technology (Shanghai) Co. Ltd. This implies the data provenance is likely from China, as that is the submitter's location. The studies are non-clinical, meaning they are laboratory tests, not human trials. They are implicitly prospective in the sense that they were designed and executed to test the device's performance against predefined criteria.

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

This section is not applicable as the studies described are non-clinical laboratory tests, not studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests (e.g., pH value, osmolality, microorganism presence, blastocyst development) is established through established laboratory methods and validated instrumentation, not by expert consensus in a clinical diagnostic context.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, particularly in cases where human readers or diagnosticians are involved and their interpretations need to be reconciled to establish a ground truth. For laboratory tests, the results are typically quantitative or qualitative outcomes determined by a predefined method, eliminating the need for expert adjudication in this typical sense.

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 section is not applicable. The device is a "Reproductive Media," which are solutions used in assisted reproductive procedures (e.g., for washing gametes, culturing embryos). It is not an AI-powered diagnostic device or an imaging system. Therefore, no MRMC study involving human readers or AI assistance would be relevant or conducted for this type of product.

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

This section is not applicable. The device is a reproductive media solution, not an algorithm or an AI system. Its performance is evaluated through physical, chemical, and biological laboratory tests, not through algorithmic output.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests is established through:

• Physicochemical Measurements: For parameters like pH, osmolality, and endotoxin, the ground truth is the numerical value obtained using validated analytical instruments and methods (e.g., pH meter, osmometer, LAL assay).
• Biological Endpoints: For the Mouse Embryo Assay (MEA), the ground truth is the observed development of mouse embryos to the expanded blastocyst stage within a specified timeframe, as assessed under a microscope by trained personnel following a standardized protocol.
• Microbiological Endpoints: For sterility testing, the ground truth is the absence of microbial growth in culture, determined by standard microbiological techniques.
• Regulatory Standards: Compliance with ISO standards for sterilization, biocompatibility, and transportation testing.

8. The Sample Size for the Training Set

This section is not applicable. The Dewin Reproductive Media is a chemical/biological product, not a machine learning model or AI system that requires a "training set." The product's formulation and manufacturing processes are developed through research and development, not by training an algorithm on a dataset.

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

This section is not applicable as there is no "training set" for this type of device.

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The Medical Video Endoscope is designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

The image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery.

The image processor provides power and processes the images for medical electronic endoscope.

The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).

The Medical Video Endoscope is a sterile Medical Video Endoscope. The Image Processor for Endoscopy is a reusable monitor.

The Medical Video Endoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The Image Processor processes the images from the Endoscope and outputs video signals to a display.

This document describes the FDA 510(k) clearance for the Seplou (ZHUHAI) Co., Ltd. Medical Video Endoscope System. It is important to note that this is a medical device clearance, not an AI/ML device clearance. Therefore, the information regarding AI-specific criteria like training sets, expert ground truth, and MRMC studies will not be present in this document. The provided text does not describe an AI/ML device.

Here's an analysis based on the provided document for the Medical Video Endoscope System:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a medical device and not an AI/ML system, the "acceptance criteria" discussed are related to physical, electrical, and performance standards rather than metrics like sensitivity or specificity. The "reported device performance" refers to the device's adherence to these standards.

2. Sample Sizes Used for Test Set and Data Provenance

This is not applicable as the clearance is for a physical medical device (endoscope system) and not an AI/ML algorithm that processes data. The "test set" in this context refers to the physical units and their components undergoing various engineering and performance tests, not a dataset of medical images. The data provenance would be laboratory testing data generated during the device's development and validation.

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

This is not applicable for a non-AI medical device clearance. Ground truth, in the context of AI/ML, refers to definitively labeled data. For this device, "ground truth" would be established through adherence to engineering standards, validated measurement techniques, and industry best practices by qualified engineers and technicians.

4. Adjudication Method for the Test Set

Not applicable for a non-AI medical device clearance. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI ground truth labeling. For a physical device, testing outcomes are typically definitive measurements against established standards.

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

Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an endoscope system, not an AI diagnostic tool.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

Not applicable. This device is a physical endoscope system, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this medical device's performance is established by:

• International Standards: Adherence to ISO, ASTM, and IEC standards for biocompatibility, sterilization, electrical safety, EMC, optical performance, and packaging.
• Engineering Specifications: The device's measurable physical and optical properties meeting predefined design specifications.
• Comparison to Predicate Device: Demonstrating substantial equivalence to a legally marketed predicate device, implying similar performance characteristics.

8. Sample Size for the Training Set

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

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

Not applicable for the same reason as above.

Summary of Device and Performance:

The Seplou (ZHUHAI) Medical Video Endoscope System aims to provide an image solution for endoscopy and endoscopic surgery within the urinary tract and interior of the kidney. It consists of multiple models of flexible endoscopes and an image processor.

The device's performance has been demonstrated through a series of non-clinical tests to meet established regulatory and industry standards. This includes:

• Biocompatibility: Evaluated according to ISO 10993-1, covering cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogens.
• Sterilization and Shelf Life: Validated via ISO 11135:2014 for sterilization, ISO 10993-7:2008 for EO/ECH residuals, and ASTM F1980-21 for accelerated aging to support a 3-year shelf life. Package validation was also done per ISO and ASTM standards.
• Electrical Safety and EMC: Complies with IEC 60601-1 (general medical electrical equipment safety), IEC 60601-2-18 (endoscopic equipment specific safety), and IEC 60601-1-2 (electromagnetic compatibility).
• Software Verification and Validation: Conducted and documented as per FDA guidance.
• Bench Performance Testing: Included optical performance (according to ISO 8600 series, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range compared to the predicate device) and mechanical tests (use-life of bending section, control knob, connection strength, tensile force, and corrosion resistance).

The conclusion states that these performance tests and compliance with voluntary standards confirm the substantial equivalence of the proposed Medical Video Endoscope system to its predicate device (K172098). No clinical studies were deemed necessary for this clearance.

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The Heager Medical Laser Family device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The Heager Medical Laser Family generates a 980nm wavelength laser to act on a target tissue to achieve hemostasis, ablation, and coagulation of the target tissue. The Heager Medical Laser Family generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The Heager Medical Laser Family has following characteristics:

• Dual wavelengths
• Temperature monitoring system

This document is a 510(k) clearance letter for a medical laser device, not a study report. Therefore, it does not contain the specific details about acceptance criteria and study results you requested in the format typically found in a clinical or performance study.

Based on the provided FDA 510(k) clearance letter for the Heager Medical Laser Family, here's what can be extracted and what information is not available within this document:

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

The document does not explicitly state acceptance criteria in a quantitative, measurable way for device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it demonstrates substantial equivalence to predicate devices based on technical specifications and adherence to recognized electrical and safety standards.

The "reported device performance" is primarily presented as technical specifications and compliance with safety standards rather than clinical performance metrics.

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

This information is not available in the provided document. As this is a 510(k) for a laser surgical instrument, the primary "test set" would be the device itself tested against engineering and safety standards, not a clinical data set in the way an AI/diagnostic device would have. The document explicitly states: "No clinical study implemented for the Diode laser therapy device."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available. Given that "No clinical study implemented," there would be no ground truth established by experts in a clinical context for the purpose of a study demonstrating effectiveness. The "ground truth" here is the adherence to engineering standards and technical specifications.

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

This information is not available. Adjudication methods are typically associated with clinical studies involving human observers or raters, which were not conducted for this 510(k) submission.

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

This information is not applicable and not available. This is a laser surgical instrument, not an AI software/diagnostic device that would involve human readers or AI assistance in interpretation.

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

This information is not applicable and not available. This is not an algorithm or AI device.

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

The "ground truth" in this 510(k) context is primarily compliance with recognized electrical, safety, and performance standards (e.g., IEC standards) and technical specifications of the device, demonstrated through non-clinical testing.

8. The sample size for the training set

This information is not applicable and not available. There is no "training set" in the context of an AI/machine learning model for this type of laser device 510(k) submission.

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

This information is not applicable and not available for the same reason as point 8.

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The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8/Nuda/Aquila/Malody Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic,adult cephalic,trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , Laparoscopic, trans-esoph(Cardiac) exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

The MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

The provided FDA 510(k) Clearance Letter states that clinical studies were Not Applicable for the Mindray Diagnostic Ultrasound System (K251192) to support substantial equivalence. Therefore, there is no information in this document about acceptance criteria or a study proving the device meets specific performance criteria through clinical data.

The letter explicitly states:
"8. Clinical Studies
Not applicable. The subject of this submission, MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Instead, the submission relies on:

• Comparison with Predicate Devices: The document extensively details how the subject device is comparable and substantially equivalent to existing cleared predicate devices (e.g., MX7 (K241432), TEX20 (K241201), Resona I8W (K240115), TE Air (K240906), Consona N6 (K221300), QLAB (K190913)) in terms of intended use, imaging modes, features, functions, and technological characteristics.
• Non-clinical Tests: The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, in compliance with various recognized standards (e.g., NEMA UD 2-2004, ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 14971, ISO 10993-1).

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device performance as they would apply to clinical efficacy/performance for a new AI/software component, because this information is not present in the provided 510(k) summary. The clearance is based on substantial equivalence to existing predicate ultrasound systems and non-clinical safety/performance testing.

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The TMC Implant Fixation System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The system can be used in both pediatric (aged > 12-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples:

• Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:

• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Crescentic osteotomy
• Proximal Chevron osteotomy
• Distal Chevron osteotomy (Austin)
• Transverse osteotomy

• Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis

• First metatarsal fracture fixation

• Flatfoot Osteotomies

• Lateral Column Lengthening (Evans Osteotomy)
• Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

• Mid / Flatfoot Fusions

• LisFranc Arthrodesis and/or Stabilization
• Intercuneiform Fusions
• Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• Calcaneo-Cuboid (CC) Fusion

• Medial Column Fusion

The TMC Implant Fixation System is comprised of straight, L-shaped, H-shaped, anatomically curved plates, intramedullary plates, cannulated and non-cannulated compression implants, and associated instruments. It includes 2.5 mm, 2.7 mm, 3.0 mm, and 3.3 mm diameter cannulated and non-cannulated, locking, and non-locking screws in lengths ranging from 10-36 mm. The plates, screws, and compression implants are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. All implantable components are manufactured from implant grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

This document describes the regulatory clearance of a medical device, the "TMC Implant Fixation System," not an AI diagnostic device. Therefore, many of the requested categories for AI-specific studies are not applicable. I will extract the information that is relevant to the provided text.

Here's an analysis of the provided FDA 510(k) clearance letter:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size (Test Set): Not explicitly stated. The document refers to "testing and analysis" between the subject and predicate devices for mechanical properties. This typically involves a defined number of test specimens (e.g., plates, screws) for each test type, but the exact quantity is not detailed in this summary.
• Data Provenance: Not applicable in the context of clinical data for an AI device. The testing described is mechanical, performed on physical device samples.

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

• Not applicable. This device is a metallic bone fixation system, and the "ground truth" for mechanical testing is established by recognized engineering standards (like ASTM F382) and FDA guidance, not by expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

• Not applicable. Mechanical testing results are objective measurements (e.g., force, displacement, cycles to failure) against predefined pass/fail criteria, not subjective human assessments requiring adjudication.

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

• No. This is a medical device for bone fixation, not an AI diagnostic tool. MRMC studies are used for evaluating diagnostic performance with and without AI assistance.

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

• No. This is a physical implant system, not a software algorithm.

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

• For mechanical performance: The ground truth refers to established engineering standards (ASTM F382) and FDA guidance for orthopedic implants. Performance is measured against physical properties like strength, fatigue resistance, and screw pullout force.

8. The sample size for the training set:

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

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

• Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the TMC Implant Fixation System meets acceptance criteria was a series of mechanical performance tests. The primary testing included:

• Static 4-point bend testing
• Dynamic 4-point bend testing
• Axial pullout testing

These tests were conducted in accordance with established standards:

• ASTM F382 Standard Specification and Test Method for Metallic Bone Plates was used for the 4-point bend testing.
• Modified acceptance criteria derived from the FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (issued November 22, 2024) were used for the axial pullout testing.

The document states that "The testing and analysis demonstrated that the subject devices met all acceptance criteria and therefore are substantially equivalent to the predicate devices." This substantial equivalence determination suggests that the new device's mechanical performance is comparable to or better than that of the legally marketed predicate devices, thereby assuring its safety and effectiveness for its intended use.

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The mOm Essential Incubator is indicated for thermoregulation for both premature and full-term infants up to a maximum of 6 kg (13 lbs).

The mOm Essential Incubator is not intended for home use.

The mOm Essential Incubator, ME1, is a neonatal incubator used for thermoregulation for both premature and full-term infants up to a maximum of 6 kg (13 lbs). Power is sourced either from an external AC supply or an internal rechargeable battery.

The mOm Essential Incubator (ME1) is intended to provide a heated environment with a stable temperature for infants who require assistance with thermoregulation but do not require a humidity-controlled environment. The ME1 should only be used within healthcare settings providing neonatal and infant care, by properly trained personnel, as directed by an appropriately qualified attending physician familiar with current known risks and benefits of infant incubator use.

The mOm Essential Incubator provides a filtered air system creating a thermally controlled environment based on air temperature control. It provides incubation as well as a degree of isolation for infants who may be near others or being cared for in clinical areas. The incubator is designed to allow adequate visibility and access to the infant to deliver care.

The Infant Compartment is designed to be disassembled and packed into a compact unit for storage and transportation and must be assembled before use. It has been designed as a cost-effective alternative to traditional incubators.

The mOm Essential Incubator is made up of several key components and sub-assemblies, which are assembled by the user prior to use:

• The incubator base unit, which includes the device's electronics, fan, heating system, display and controls.
• A rigid front panel which contains a door and two portholes.
• A flexible panel that makes up the top and rear of the infant compartment – this includes an inflatable section and is supplied with a manual inflation bulb.
• A rigid top and back U-shaped panel which provide the structure for the top and rear of the infant compartment.
• Two side panels which form the ends of the infant compartment.

An infant mattress is supplied, which is inserted into the infant compartment. A skin temperature probe is also supplied. An optional cart (trolley) is available.

The provided 510(k) clearance letter pertains to the mOm Essential Incubator (ME1), a Class II medical device. It focuses on the device's technical specifications and comparison to a predicate device (Isolette® 8000 plus), as well as a range of non-clinical bench testing to demonstrate safety and effectiveness.

*Crucially, this document does not describe a study involving a test set, expert ground truth establishment, a multi-reader multi-case (MRMC) study, or a standalone algorithm performance study.

The "study" referenced in the provided text is a collection of non-clinical performance data and bench testing to demonstrate the device meets various safety and performance standards for neonatal incubators. It explicitly states: "Bench testing of the mOm Essential Incubator met all relevant requirements for neonatal incubators. Testing was performed in accordance with applicable standards, to characterize and evaluate the device, including performance testing, functional/operational testing, verification and validation, biocompatibility, human factors, risk analysis and verification of risk control measures. Testing included accessories and optional components."

Therefore, I cannot populate the requested sections related to traditional "studies" with human readers, expert ground truth, or AI performance metrics, as this device is a physical medical device (an incubator) not a software-driven diagnostic or AI-powered system that would require such studies.

However, I can extract the acceptance criteria and the results of the non-clinical testing for critical device features based on the provided document.

Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Bench Testing)

The acceptance criteria for the mOm Essential Incubator (ME1) are largely aligned with international standards for medical electrical equipment and infant incubators (e.g., IEC 60601 series) and are demonstrated through direct comparison to the predicate device and specific non-clinical tests.

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The Unscented Menstrual Tampons are inserted into the vagina to absorb menstrual discharge.

The unscented menstrual tampons consist of a tampon, including an absorbent pledget ("absorbent core") completely surrounded by an overwrap ("security veil") and a removal string ("withdrawal cord"), and an applicator (only for the applicator tampon). The tampon design is cylindrical, bullet-like shape. The applicator has a smooth, rounded tip to ease insertion.

According to different composition materials and design styles, the unscented menstrual tampons of this submission are divided into 3 categories (Unscented menstrual long applicator tampon, Unscented menstrual Cardboard Applicator Tampon, Unscented menstrual Digital Tampons) and 6 sub-categories (Organic cotton + Two Plastic tube, Cotton + cardboard tube, Organic cotton + cardboard tube, Cotton (digital style), Organic cotton(digital style), viscose(digital style).

The tampons are provided in 4 absorbencies: Light(L) (≤6g), Regular(R) (6-9g), Super (S)(9-12g) and Super Plus (SP)(12-15g). Only some sub-categories of tampons contain all absorbencies. Each device is individually wrapped and then packaged in sealed multi-unit containers for retail sale. All tampons and applicators are provided non-sterile and for single use only.

The provided FDA 510(k) clearance letter and summary for K251033 pertains to unscented menstrual tampons, which are medical devices designed for absorbing menstrual discharge. This documentation focuses on demonstrating the substantial equivalence of the new tampons to a predicate device (K232598) primarily through material composition, design, and physical performance characteristics, rather than performance metrics related to diagnostic accuracy or clinical outcomes that would typically involve AI/ML models or human reader studies.

Therefore, many of the requested points regarding acceptance criteria and study details for AI/ML device performance (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable to this type of device submission. The "acceptance criteria" here relate to meeting established safety and performance standards for tampons.

Here's an analysis based on the provided document:

Device Type: Unscented Menstrual Tampons (medical device, not AI/ML driven)

Purpose of the Study (as described): To demonstrate substantial equivalence of the subject device (new tampons) to a legally marketed predicate device (existing tampons) by showing that differences in material composition and design do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a tampon submission, the "performance" relates to physical and biocompatibility characteristics, not diagnostic accuracy. The acceptance criteria are implicit in the standards followed and the successful completion of the tests.

• Pledget length (Dry): 37±3.0--50±3.0 mm
• Pledget diameter (Dry): 11.5±1.0--15.2±1.0 mm
• Total length of product: 118.0±2.0 mm
• Length of push rod: 70±1 mm
• Outside diameter (outer tube): 14.5±0.2--16.2±0.2 mm
• Weights: L: 3.90-4.40g; R: 4.45-5.15g; S: 5.65-6.45g; SP: 6.45-7.35g
  These differ from the predicate's specific values but are deemed "not raise different questions of safety and effectiveness." |
  | Functionality (Absorbency) | Meet industry standards for relevant absorbency ratings (e.g., Light (≤6g), Regular (6-9g), Super (9-12g), Super Plus (12-15g)). | Absorbency categories are listed, aligning with standard ranges. Performance data showing the specific absorbency achieved for each tampon type would be in the full submission, but the table indicates these categories are used. |
  | General Safety/Effectiveness | Overall safety and effectiveness comparable to predicate. | "The nonclinical tests demonstrate that the subject device, Unscented Menstrual Tampon, is as safe and effective as the legally marketed predicate device (K232598). Therefore, the subject device is substantially equivalent to the predicate device." |

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

• Sample Size for Test Set: Not explicitly stated in the provided summary for any of the biocompatibility, microbiology, or chemical residue tests. These tests are typically performed on a representative sample of units to demonstrate compliance with standards.
• Data Provenance: The manufacturing company is Unibeauty (Hubei) Technology Co.,Ltd. in Xiantao City, Hubei Province, China. The document does not specify the country of origin for the data itself (e.g., where the lab testing was performed) beyond the company's location. The studies described are "nonclinical performance testing." implicitly prospective, as they were conducted to support the 510(k) submission.

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

Not applicable. This submission is for a physical medical device (tampons), not an AI/ML diagnostic device that requires expert human interpretation to establish ground truth for testing. The "ground truth" here is established by standardized laboratory testing methods (e.g., chemical analysis, microbiological assays, physical measurements) interpreted by qualified laboratory personnel, not by medical experts forming a consensus on image interpretation.

4. Adjudication Method for the Test Set

Not applicable. As this is not a study involving human readers or interpretation, there is no adjudication method in the sense of resolving discrepancies between expert opinions. Laboratory results are typically verified through standard lab practices and quality control processes.

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

No. An MRMC study is relevant for AI/ML diagnostic tools to assess the impact of AI assistance on human reader performance. This submission is for a physical device, so no such study was conducted or is relevant.

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

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is established through:

• Standardized Laboratory Testing Results: Biocompatibility (cytotoxicity, sensitization, irritation), microbiology (growth of bacteria, toxin production), chemical residue analysis, and physical property measurements (dimensions, weight, absorbency).
• Compliance with Recognized Standards: The tests were conducted according to international standards like ISO 10993 series and FDA guidance documents specific to menstrual tampons.

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML model that requires a training set.

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

Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment for a training set.

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The Aqua Medical RF Vapor System is indicated for use in the coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE) and Radiation Proctitis (RP). The device is to be used in adults only.

The Aqua RF Vapor Ablation System is a catheter-based device that uses radiofrequency (RF) energy to produce heated water vapor for the coagulating and ablating tissue. The RF energy heats liquid as it flows through the catheter, creating steam that is directed to the target tissue. The system includes the following components:

• Aqua RF Vapor Generator: A software-controlled RF generator is operated through a graphical user interface (GUI) and incorporates a syringe pump that delivers saline to the catheter. The catheter connects, fluidically and electrically, to the generator. A foot pedal is used to control the RF energy and vapor delivery.
• Aqua RF Vapor Catheters: disposable, sterile, single-use catheters with a diameter of 7F (2.3 mm) with an outer catheter sheath that is 10.5F and a length between 145 cm and 210 cm. Catheters are designed to be used through an endoscope working channel diameter of 3.7mm. This submission included only the modified circumferential catheter.
• Cassette (Syringe and Tubing): Tubing and syringe (60cc) provide a means of delivering saline to the catheter during treatment.

This 510(k) clearance letter pertains to the Aqua Medical RF Vapor Ablation System. However, the provided document does not include acceptance criteria or the study details that prove the device meets such criteria.

The document states that "The proposed modifications do not introduce new safety and effectiveness concerns and support the company's substantial equivalency claim" and mentions "supporting non-clinical data" and "bench testing and scientific rationales." It lists various performance tests conducted for the Generator, Catheter, and Cassette components, but it does not provide any quantitative acceptance criteria or performance results from any clinical or even pre-clinical study testing the device's efficacy against specific metrics.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment based solely on the provided text.

The information given is limited to:

• Device Name: Aqua Medical RF Vapor Ablation System
• Indications for Use: Coagulation and ablation of bleeding and non-bleeding sites in the gastrointestinal tract (e.g., Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, Angiodysplasia, Gastric Antral Vascular Ectasia (GAVE), Radiation Proctitis (RP)) in adults.
• Modifications: To the generator, Cassette (syringe and tubing), and circumferential catheter.
• Tests Performed (Non-Clinical):
  • Generator: EMC & Electrical Safety, Software validation, Generator Hardware Verification
  • Catheter: Hardware Verification Testing, Simulated-use tissue validation (Lean Beef Testing)
  • Cassette: Biocompatibility, Shelf-Life assessment, Sterilization Validation
• Conclusion: The device is substantially equivalent to the predicate device, and modifications do not raise new safety or effectiveness concerns.

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