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Ask a specific question about this device

The NEUROVENT is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-P is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-PX is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-P-TEMP is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP-IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-PTO is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The NEUROVENT-PTO-2L is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The BOLT(-DRILL) KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The DRILL KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The Tunneling KITs are indicated to provide a cranial access for catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The RAUMEDIC® NEUROMONITORING-SYSTEM consists of several different models of probes and probe catheters capable of performing one or several different functions:

• Models with a dedicated lumen can be used for drainage of cerebrospinal fluid (CSF).
• Models equipped with ICP sensors can determine the level and change in intracranial pressure (ICP).
• Models equipped with temperature thermistors can monitor intracranial temperature.
• Models equipped with fiber optic sensors can monitor partial tissue oxygen pressure (ptiO2).

The RAUMEDIC® NEUROMONITORING-SYSTEM is intended to be used in conjunction with previously cleared RAUMEDIC® EASY logO Monitor (K130529), RAUMEDIC® MPR2 logO DATALOGGER (K171666), RAUMEDIC® NPS3 (K103206) or RAUMEDIC® NPS2 X (Brand name for NPS2 cleared in K103206).

The RAUMEDIC® NEUROMONITORING-SYSTEM includes components needed to facilitate the surgical implantation of NEUROVENT® catheters.

The RAUMEDIC® NEUROMONITORING-SYSTEM can be used in MR environment under specific constraints (MR conditional). Those constraints vary by device type, implantation method (bolting or tunneling), and magnetic field strength (1.5 or 3.0 Tesla).

The provided FDA 510(k) clearance letter for NEUROVENT Devices does not contain the specific details required to describe the acceptance criteria and the study that proves the device meets those criteria, particularly for performance metrics.

The document primarily focuses on:

• Device Identification: Listing all device names, regulation numbers, classification, and product codes.
• Regulatory Equivalence: Stating that the device is substantially equivalent to previously cleared predicate devices based on intended use, indications for use, and technological characteristics.
• Intended Use/Indications for Use: Detailed descriptions of what each NEUROVENT component is used for (e.g., ICP monitoring, CSF drainage, brain temperature, tissue oxygen partial pressure).
• MR Safety Testing: A list of ASTM and ISO/TS standards used to confirm the device's MR conditional status, along with the specific tests performed (magnetically induced displacement force, torque, image artifacts, heating, malfunction for various fields).

Crucially, the document explicitly states: "Based on performance testing and the available information concerning the referenced comparison devices, the RAUMEDIC® NEUROMONITORING-SYSTEM is equivalent in that: - The devices have the same intended use and indication for use. - Performance characteristics are suitable for designated indications for use."

However, it does NOT provide:

• A table of specific numerical acceptance criteria (e.g., ICP accuracy within X mmHg, temperature accuracy within Y °C, ptiO2 accuracy within Z mmHg).
• The reported device performance metrics against those criteria.
• Details about the "performance testing" beyond the MR safety tests. This implies that the performance characteristics (accuracy, precision, etc., for measuring ICP, temperature, ptiO2) were either derived from the predicate devices, established using bench testing, or considered suitable without presenting detailed clinical performance data in this 510(k) summary. Given the device type, it's highly likely a combination of bench and possibly animal/cadaveric testing, as well as reliance on the long-established performance of similar predicate devices, was used.
• Information about clinical study design. There is no mention of human subject data, test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies. The phrases "anticipated clinical performance" and "does not raise new issues of safety or effectiveness" suggest reliance on the substantial equivalence principle rather than novel clinical trial data.

Therefore, based solely on the provided text, I cannot complete the requested information for acceptance criteria and the study proving the device meets them, beyond the MR safety aspects.

I will indicate "Not provided in the document" for sections where the information is missing.

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

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

• Sample Size for test set: Not provided in the document. The document primarily refers to "performance testing" and "MR safety requirements" being "tested and confirmed" to meet standards, rather than a clinical test set from human subjects.
• Data provenance: Not provided. The MR safety tests are likely laboratory-based.

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/Not provided. The document does not describe a study involving expert-established ground truth for performance evaluation of vital sign monitoring. The evaluation methodology focuses on substantial equivalence and laboratory testing for MR compatibility.

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

• Not applicable/Not provided.

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

• Not applicable. This device is a monitoring system and a kit for surgical access, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. The performance evaluation discussed pertains to the physical and functional aspects of the hardware (catheters, sensors, and their compatibility with MR environments), not a standalone algorithm.

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

• For the MR safety testing, the "ground truth" would be established by the specifications and measurement techniques defined in the referenced ASTM and ISO/TS standards.
• For the core physiological measurements (ICP, temp, ptiO2), the "ground truth" would typically refer to the accuracy of the sensors against calibrated reference standards in laboratory or animal models. This specific detail is not provided, but it's implied compliance with recognized industry standards or internal validation that is deemed "suitable for designated indications for use" and "equivalent."

8. The sample size for the training set

• Not applicable. The document does not describe the use of machine learning or AI, and therefore, no "training set."

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

• Not applicable.

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The Jumao JM-P50A Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients (ages 22 and older) requiring respiratory therapy on a prescriptive basis. It may be used in the home or in professional healthcare facility.

Portable Oxygen Concentrator, model: JM-P50A is a portable oxygen generator that is intended to release oxygen for respiratory therapy by physical means (a molecular sieve). It supplies a pulsed high concentration of oxygen and is used with a nasal cannula (supplied separately) to channel oxygen from the concentrator to the patient. The JM-P50A is small, portable and may be used in the home or in a professional healthcare facility.

Portable Oxygen Concentrator, model: JM-P50A, uses molecular sieve/pressure swing adsorption technology. Ambient air is drawn through particle filters by a compressor and forced through molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed, and nitrogen is desorbed from the molecular sieve, allowing it to adsorb again during the next cycle. Oxygen is collected in an air tank. Waste nitrogen is exhausted back into the room. A series of sieve beds, manifolds and precision valves, sensors and embedded software are used to control the cycle to make the system function.

Portable Oxygen Concentrator, model: JM-P50A, can be used in the home or in a professional healthcare facility. Power options include 100 – 240 V (50- 60Hz) AC power supply, rechargeable battery packs.

Oxygen is delivered to the patient on a pulse dose basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Portable Oxygen Concentrator, model: JM-P50A, senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, through a final filter, into the connected nasal cannula and on to the patient.

The portable oxygen concentrator consists of main unit, battery, power adapter and carry case. The main gas pathway of oxygen concentrator is composed of particle filter, particle filters, air compressor, molecular sieve beds, manifold valve, sensors, air tank.

This is a 510(k) clearance letter for a Portable Oxygen Concentrator (JM-P50A). The document primarily focuses on demonstrating substantial equivalence to a predicate device (Inogen Rove 6 Portable Oxygen Concentrator) through bench testing and compliance with recognized consensus standards. It explicitly states that "There was no clinical testing performed."

Therefore, the provided document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or human-in-the-loop assessment. The information you're asking for, particularly points 1-7 from your prompt, typically applies to studies proving clinical effectiveness or diagnostic accuracy of AI/software as a medical device (SaMD), which is not the case here.

However, I can extract information related to the device's technical specifications and how its performance was evaluated against standards, which serve as a form of acceptance criteria for this type of device.

Here's an interpretation based on the provided document, addressing what can be extracted and noting what cannot be:

Acceptance Criteria and Device Performance for Portable Oxygen Concentrator (JM-P50A)

Based on the provided 510(k) clearance letter, the acceptance criteria and the "study" (bench testing and standards compliance) focus on demonstrating substantial equivalence to a predicate device and adherence to recognized performance and safety standards. There was no clinical testing performed for this device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the performance specifications of the predicate device and the requirements of various international standards. The "reported device performance" refers to the JM-P50A's demonstrated capability to meet these criteria through bench testing.

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Geistlich Bio-Gide® is intended for the following uses:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects; and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Shape is indicated for:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth; and
• guided bone regeneration in dehiscence defects.

Geistlich Bio-Gide® Compressed is indicated for:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Forte is indicated for:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Gide® Perio is intended for the following uses:

• augmentation around implants placed in immediate extraction sockets;
• augmentation around implants placed in delayed extraction sockets;
• localized ridge augmentation for later implantation;
• alveolar ridge reconstruction for prosthetic treatment;
• filling of bone defects after root resection, cystectomy, removal of retained teeth;
• guided bone regeneration in dehiscence defects, and
• guided tissue regeneration procedures in periodontal defects.

Geistlich Bio-Oss Collagen® is intended for the following uses:

• augmentation or reconstructive treatment of the alveolar ridge;
• filling of periodontal defects;
• filling of defects after root resection, apicoectomy, and cystectomy;
• filling of extraction sockets to enhance preservation of the alveolar ridge;
• elevation of the maxillary sinus floor;
• filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
• filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation.
Geistlich Bio-Gide® is provided in the following sizes: 13 x 25 mm, 25 x 25 mm, 30 x 40 mm, 40 x 50 mm.

Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.

Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.

Geistlich Bio-Gide® Forte is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Forte membrane is available in five different sizes, 13 x 25 mm, 25 x 25 mm, 20 x 30 mm, 30 x 40 mm, and 40 x 50 mm.

Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Pre-formed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.

Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.

The provided FDA 510(k) clearance letter and associated S510(k) summary documents describe a class II medical device, Geistlich Bio-Gide and its variants, which are resorbable bilayer membranes and bone grafting materials. This submission is for a determination of substantially equivalent to a predicate device.

Crucially, this document is focused on demonstrating substantial equivalence based on material characteristics, manufacturing processes, and performance data for the device itself (a physical membrane and bone grafting material), not on the performance of an AI/ML powered device.

Therefore, most of the requested information regarding acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and effect sizes for AI assistance are not applicable to this type of medical device submission. The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance testing conducted to confirm the physical and biochemical properties of the new device are equivalent to the predicate device, especially after changes to supplier and manufacturing processes.

Here's an attempt to extract relevant information and note the inapplicable sections based on your request:

Acceptance Criteria and Device Performance (for a physical medical device)

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

Since this is not an AI/ML device, the acceptance criteria are not typically expressed in terms of accuracy, sensitivity, or specificity. Instead, they are based on physical, chemical, and biological properties demonstrating equivalence to a predicate device. The performance data provided is primarily comparative to the predicate.

The "analysis" column in the provided tables consistently states "The material of construction is identical," "The sizes offered are identical/similar," etc., implying the acceptance criterion is indeed identity or substantial similarity to the predicate.

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

• Sample Size for Test Set: Not explicitly stated as a single "test set" in the context of an AI/ML model. The performance data consists of various physical, biochemical, and experimental tests. The number of samples for each specific test (e.g., number of membranes for tensile strength testing) is not provided.
• Data Provenance: Not specified regarding country of origin. The studies are described as "in vitro and in vivo biocompatibility," "sterilization," "shelf-life," "bench," and "clinical performance studies" leveraged from previous predicate device submissions (e.g., K212463, K171643). These are likely a mix of lab-based and potentially historical clinical data. It is not specified if these are prospective or retrospective studies; however, given they are leveraged from previous clearances, they would be historical for this specific submission.

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. This is not an AI/ML diagnostic device requiring expert interpretation or ground truth establishment in that manner. The "ground truth" for a resorbable membrane involves objective physical, chemical, and biological measurements, and comparison to established standards and predicate device characteristics, not expert consensus on image interpretation.

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

• Not Applicable. No human adjudication method is described or relevant for the physical and chemical performance tests conducted on this medical device.

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

• Not Applicable. This is not an AI-assisted device, so MRMC studies are not relevant.

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

• Not Applicable. This is not an AI algorithm. Its "standalone" performance refers to its intrinsic physical and chemical properties.

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

• Not Applicable / Different Context. The "ground truth" for this device's performance is established by:
  • Objective Measurements: Results of standardized physical and biochemical tests (e.g., SEM, porosity, tensile strength, DSC, solubility, degradation, molecular weight, hydration capacity, suture pull-out force).
  • Regulatory Standards: Compliance with ISO and ASTM standards (e.g., ISO 10993-1, ISO 11137 series, ISO 22442-3, ASTM F2450-18, ASTM F2150-19, ASTM F2212-20).
  • Predicate Device Data: Comparison and leveraging of performance data (biocompatibility, sterilization, shelf-life, bench, clinical) from previously cleared predicate devices. The claim is substantial equivalence, meaning it performs as safely and effectively as the legally marketed predicate.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML model, this question does not apply.

Summary of the Study Proving Device Meets Acceptance Criteria (in this context):

The "study" conducted for the Geistlich Bio-Gide product family in this 510(k) submission primarily consists of a comprehensive battery of non-clinical performance tests combined with the leveraging of existing performance data from previously cleared predicate devices. The purpose of these tests was to demonstrate that modifications (e.g., new slaughterhouse, non-significant manufacturing changes) did not alter the fundamental safety and effectiveness of the device, making it substantially equivalent to its predicates.

The non-clinical tests included:

• Physical and Biochemical Testing: SEM (surface morphology), porosity, tensile strength, DSC (onset temperature), suture pull-out force, solubility, enzymatic degradation, SDS-PAGE (molecular weight distribution), and hydration capacity. For Geistlich Bio-Gide Forte and Compressed, handling properties were also evaluated.
• Other Experimental Testing: Viral safety according to ISO 22442-3:2007.

These tests, performed on the modified devices, aimed to show that their properties were consistent with a product that would continue to perform as intended and as safely and effectively as the predicate devices. The acceptance criteria were implicitly that the new devices exhibit equivalent performance characteristics to the cleared predicate devices, as supported by these various in vitro and experimental studies and referencing past clinical data from the predicates.

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Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user

Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user

I apologize, but the provided FDA 510(k) clearance letter for the "Wearable Breast Pump" does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The letter is a standard clearance notification that states the device is substantially equivalent to legally marketed predicate devices. It covers:

• The device name and model numbers.
• The regulation number and name.
• The regulatory class and product code.
• Dates of submission and clearance.
• General controls provisions of the Act that apply to the device.
• Links to FDA guidance documents and regulations (e.g., QS regulation, UDI rule, MDR).
• Contact information for FDA resources.
• The Indications for Use statement for the device.

There is no mention of performance studies, clinical trials, specific acceptance criteria, or data related to the device's functional performance (e.g., milk expression efficiency, comfort, battery life, etc.). The FDA's substantial equivalence determination for this type of device typically relies on demonstrating that the new device has the same intended use and similar technological characteristics to a predicate device, and does not raise different questions of safety and effectiveness. This often involves engineering bench tests and comparisons of specifications rather than detailed clinical performance studies, especially for well-established device types like breast pumps.

Therefore, I cannot fulfill your request for the specific points about acceptance criteria and study details because that information is not present in the provided document.

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The portable x-ray system may be used for diagnostic imaging of body extremities.

• Not for mammography use
• This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.

This device is a battery-powered portable X-ray System, designed and manufactured by H&abyz. This portable radiographic system (Model: HnX-P1, HnX-PB) consists of an LCD display with up and down soft-keys for controlling kV, an X-ray generator (line-powered transformer), an X-ray tube assembly, a collimator and a cart. It can also use a stand instead of a cart. The HnX-P1 is used with a film-cassette or flat-panel detector. (The film-cassette or flat-panel detector, cart, and stand are not included in the basic components of the product.)

The major components of the X-ray main unit include handle, enclosure, main control panel, system control board, high-voltage tank, inverter, collimator (beam limiter), and system control software running on the system control board. The system control software is for real-time interaction and control with various circuit modules inside the X-ray generator. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator, and monitor the working status of the device, and control the display of the status indicators.

The system is for X-ray imaging and diagnosis in facilities with portable or fixing sites. The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. This portable X-ray System is designed for handheld or stand-mounted imaging.

It appears there may be a misunderstanding or a gap in the provided document regarding acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter for a portable X-ray system (HnX-P1, HnX-PB), and it does not contain information about acceptance criteria for AI/software performance or a study proving the device meets such criteria.

The document explicitly states several times that "Clinical studies were not performed." (Page 10, Section 8 on "Clinical studies"). This means there was no clinical evaluation of diagnostic accuracy or comparative effectiveness with human readers using this specific device.

The "Non-Clinical Test summary" (Page 9, Section 7) mentions:

• "A total of 30 clinical image samples, including elbows, hands, knees, ankles, and feet, were reviewed by qualified clinicians and determined to be of good quality and clinically useful." This sounds like an image quality assessment, not a performance study of an AI algorithm.
• "Software validation and risk analysis was performed." This refers to internal software quality assurance processes.

Therefore, many of the requested points related to AI performance, ground truth, expert adjudication, and MRMC studies cannot be answered from the provided text, as the device described is a hardware X-ray system, not an AI diagnostic algorithm.

However, I can still extract information based on the typical requirements for a 510(k) clearance for a hardware device like an X-ray system. The "acceptance criteria" here would typically relate to meeting performance standards for X-ray output, safety, electrical compatibility, and image quality demonstrations, rather than diagnostic accuracy of an AI algorithm.

Based on the provided FDA 510(k) clearance letter, here's an analysis tailored to what is present and what is absent:

Summary of Device Performance and Acceptance Criteria (as implied for a hardware X-ray system)

The acceptance criteria for a portable X-ray system like the HnX-P1/HnX-PB are primarily focused on safety, technical performance, and image quality adequacy for diagnostic use, rather than the diagnostic accuracy of an AI. The studies proving the device meets these criteria are primarily non-clinical tests and demonstrations of substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (for "Image Quality" evaluation): 30 clinical image samples.
• Data Provenance: Not explicitly stated regarding country of origin or whether retrospective/prospective. However, the use of "clinical image samples" suggests real patient data, likely retrospective given the lack of a formal clinical study.

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

• For the "image quality" assessment of the 30 samples: "qualified clinicians" reviewed the images. The exact number of clinicians or their specific qualifications (e.g., "Radiologist with 10 years of experience") are not specified in this document.

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

• Not applicable/Not specified for this type of hardware evaluation. The document implies a qualitative assessment ("determined to be of good quality and clinically useful") rather than a diagnostic performance 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 MRMC study was performed or required. The device is a portable X-ray system, not an AI diagnostic aid for human readers.
• The document explicitly states: "Clinical studies were not performed." (Page 10, Section 8).

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

• Not applicable. This device is a hardware X-ray imager, not a standalone AI algorithm. It produces images, but does not autonomously interpret them.

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

• For the "image quality" assessment, the "ground truth" was effectively the qualitative judgment of "qualified clinicians" that the images were "good quality and clinically useful." This isn't diagnostic "ground truth" (e.g., presence/absence of a disease).

8. The sample size for the training set:

• Not applicable. This document describes a hardware device, not an AI algorithm that requires a training set.

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

• Not applicable. As above, no AI training set is described or relevant to this hardware device clearance.

In conclusion, the provided FDA 510(k) clearance letter details the regulatory review for a medical device hardware (portable X-ray system), not an AI or software as a medical device (SaMD) with diagnostic capabilities that underwent a performance study against specific diagnostic acceptance criteria. The "acceptance criteria" discussed are largely compliance with electrical, safety, and performance standards, and a qualitative assessment of image utility.

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P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) for daily wear are spherical lenses indicated for the correction of refractive error in not-aphakic persons with otherwise non-diseased eyes with myopia ranging from -0.00 diopters to -10.00 diopters.

The lenses may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. The lenses are intended for daily wear and are to be replaced every three months (quarterly). When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

The P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in 0.9% saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).

The P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is available clear or tinted for visibility using phthalocyanine blue, tinted in unique pattern to enhance or alter the apparent color of the eye. Each unique patterns may be distributed under unique or "private label" trade names. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: C.I Reactive Black 5, Titanium Dioxide (TiO2), Carbazole Violet (i.e.,C.I Pigment Violet 23), Phthalocyanine green (i.e.,C.I PIgment Green 7), D&C Yellow No. 10, D&C Red No. 17, [Phthalocyaninato (2-)] Copper (i.e.,C.I PIgment Blue 15).

When producing the color lenses, the manufacturing process changes the specifications of the clear lens by pad-printing the color pigment(s)—entrapping the colorants in the interpenetrating network of the contact lens material—in a location that corresponds to the iris. The color pigments used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the clear, pre-tinted lens.

Eye care practitioners may prescribe the lenses in a frequent/planned replacement program with cleaning, disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

The provided text is a 510(k) clearance letter for contact lenses. While it details the device, its intended use, and substantial equivalence to a predicate device, crucial information regarding acceptance criteria for AI/algorithm performance and the study that proves the device meets the acceptance criteria (specifically in the context of AI/algorithm evaluation) is not present.

The document focuses on the physical and biological properties of contact lenses and manufacturing processes, not on an AI or algorithmic component that would require a study with an AI-specific acceptance criterion, ground truth establishment, or MRMC studies. The "Non-Clinical Test Conclusion" section primarily refers to biocompatibility, shelf life, and physicochemical/mechanical properties testing, all of which are standard for contact lenses and do not involve AI performance evaluation.

Therefore, I cannot fulfill the request as the input document does not contain the necessary information about AI/algorithm performance.

If this were a document for an AI-powered medical device, the information would typically be found in dedicated sections detailing "Clinical Performance Study," "Software Verification and Validation," or similar.

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The software supports image guidance by overlaying vessel anatomy onto live fluoroscopic images in order to navigate guidewires, catheters, stents and other endovascular devices.

The device is indicated for use by physicians for patients undergoing endovascular PAD interventions of the lower limbs including iliac vessels.

The device is intended to be used in adults.

There is no other demographic, ethnic or cultural limitation for patients.

The information provided by the software or system is in no way intended to substitute for, in whole or in part, the physician's judgment and analysis of the patient's condition.

The Subject Device is a standalone medical device software supporting image guidance in endovascular procedures of peripheral artery disease (PAD) in the lower limbs, including the iliac vessels. Running on a suitable platform and connected to an angiographic system, the Subject Device receives and displays the images acquired with the angiographic system as a video stream. It provides the ability to save and process single images out of that video stream and is able to create a vessel tree consisting of angiographic images. This allows to enrich the video stream with the saved vessel tree to continuously localize endovascular devices with respect to the vessel anatomy.

The medical device is intended for use with compatible hardware and software and must be connected to a compatible angiographic system via video connection.

Here's a breakdown of the acceptance criteria and study information for the Vascular Navigation PAD 2.0, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance for Vascular Navigation PAD 2.0

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a single number.
  • For Latency Tests: Data from Siemens Cios Spin and Ziehm Vision RFD 3D.
  • For Level Selection and Overlay Alignment: Images acquired with Siemens Cios Spin, Ziehm Vision RFD 3D, and GE OEC Elite CFD.
  • For Modality Detection: Image data from Siemens Cios Spin, GE OEC Elite CFD, Philips Zenition, and Ziehm Vision RFD 3D.
  • For Roadmapping Accuracy: Image data from Siemens Cios Spin.
  • For Stitching Algorithm: Image data from Philips Azurion, Siemens Cios Spin, GE OEC Elite CFD, and Ziehm Vision RFD 3D.
• Data Provenance:
  • Retrospective/Prospective: Not explicitly stated for all tests. However, the Level Selection and Overlay Alignment and Roadmapping Accuracy tests mention using "cadaveric image data" which implies a controlled, likely prospective, acquisition for testing purposes rather than retrospective clinical data. Other tests reference "independent image data" or data "acquired using" specific devices, suggesting a dedicated test set acquisition.
  • Country of Origin: Not specified.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The document mentions "manually achieved gold standard registrations" for Level Selection and Overlay Alignment and "manually comparing achieved gold standard (GS) stitches" for the Stitching Algorithm, implying human expert involvement in establishing ground truth, but specific details on the number or qualifications of these "manual" reviewers are absent. The phrase "if a human would consider the image pairs matchable" in the stitching section further supports human-determined ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly described. The ground truth seems to be established through "manually achieved gold standard" or "manual comparison," implying a single expert or a common understanding rather than a formal adjudication process between multiple conflicting expert opinions (e.g., 2+1 or 3+1).

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

• Was it done? No. The submission focuses on standalone technical performance measures and accuracy metrics of the algorithm rather than comparing human reader performance with and without AI assistance.

6. Standalone Performance Study

• Was it done? Yes. The entire "Performance Data" section details the algorithm's performance in various standalone tests, such as latency, stress/load, level selection and overlay alignment, modality detection, roadmapping accuracy, and stitching algorithm performance. The results are quantitative metrics of the device itself.

7. Type of Ground Truth Used

• Type of Ground Truth:
  • Expert Consensus / Manual Gold Standard: For Level Selection and Overlay Alignment ("manually achieved gold standard registrations") and for the Stitching Algorithm ("manually comparing achieved gold standard (GS) stitches"). This implies human experts defined the correct alignment or stitch.
  • Technical Metrics: For Latency, Capture Process, Stitching Timespan, Roadmap/Overlay Display Timespan, and System Stability, the ground truth is based on objective technical measurements against defined criteria.
  • True Modality: For Modality Detection, the ground truth is simply the actual modality of the image (fluoroscopy vs. angiography) as known during test data creation or acquisition.

8. Sample Size for the Training Set

• Sample Size: Not provided. The submission focuses solely on the performance characteristics of the tested device and its algorithms, without detailing the training data or methods used to develop those algorithms.

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

• How Established: Not provided. As with the training set size, the information about the training process and ground truth for training is outside the scope of the clearance letter's performance data section.

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The MicroScan Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16-20 hours at 35°C ± 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial aztreonam at concentrations of 0.5-64 µg/mL to the test panel. Testing is indicated for Enterobacterales and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) has demonstrated acceptable performance with the following organisms:

Enterobacterales (Citrobacter freundii complex, Citrobacter koseri, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii, Yersinia enterocolitica)

Pseudomonas aeruginosa

MicroScan Dried Gram-Negative MIC/Combo Panels are designed for use in determining quantitative and qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.

The principle of MicroScan panels with antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

This product is single-use and intended for laboratory professional use.

The provided FDA 510(k) clearance letter pertains to an Antimicrobial Susceptibility Test (AST) system, specifically the MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam. It is not an AI/ML medical device. Therefore, many of the requested criteria regarding AI-specific study design (like MRMC studies, number of experts for AI ground truth, training set details) are not applicable to this type of device and study.

However, I can extract the relevant acceptance criteria and performance data for this AST device based on the provided document.

Acceptance Criteria and Device Performance (for an AST System)

The study proves the device's performance through comparison with a CLSI (Clinical and Laboratory Standards Institute) frozen Reference Panel. The criteria primarily revolve around "Essential Agreement (EA)" and "Categorical Agreement (CA)" between the new device and the reference method.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implicitly refers to the "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009. This guidance typically defines the statistical acceptance criteria for EA and CA for AST systems. The document states the device "demonstrated substantially equivalent performance when compared with a CLSI frozen Reference Panel, as defined in the FDA document..." meeting "acceptable performance."

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

• The document mentions "external evaluations were conducted with contemporary and stock Efficacy isolates and stock Challenge strains."
• Specific numerical sample sizes for the test set (number of isolates/strains) are not explicitly stated in the provided text.
• Data Provenance: The document does not specify the country of origin. It indicates the use of "contemporary and stock Efficacy isolates and stock Challenge strains," which suggests a mix of clinical and laboratory strains. The study appears to be prospective in nature, as new data was generated for this specific submission to demonstrate performance against a reference standard.

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

• This is an AST system, not an AI/ML device requiring expert radiological annotation.
• Ground Truth Establishment: The ground truth (reference MIC values and categorical interpretations) for the test set was established by a CLSI frozen Reference panel. This is a recognized standard method for AST device validation. The "experts" in this context are the established CLSI methodologies and laboratories that produce these reference panels, not individual human readers or annotators in the typical AI/ML sense.

4. Adjudication Method for the Test Set

• Adjudication, as typically described (e.g., 2+1, 3+1), is not applicable here because the ground truth is established by a standardized laboratory method (CLSI frozen Reference panel), not by consensus among human experts annotating medical images. The comparison is objective, based on measured MIC values.

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 specific to diagnostic imaging devices where human readers interpret medical images with and without AI assistance.
• This device is an in vitro diagnostic (IVD) antimicrobial susceptibility test system, where the output is a MIC value and a categorical interpretation for a bacterial isolate, not an image interpretation by a human observer.

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

• This question is framed for AI/ML algorithms. While the device automation ("MicroScan instrumentation," "WalkAway instrument") is a component, the "standalone performance" here refers to the device's ability to accurately determine MIC and categorize susceptibility when compared to the CLSI reference method.
• The study did evaluate the device's performance independently of human interpretation, as it explicitly states panels can be "read either visually or with MicroScan instrumentation." The reported EA and CA numbers reflect the system's performance, including automated reading where applicable.

7. The Type of Ground Truth Used

• Reference Standard: The ground truth used was a CLSI frozen Reference Panel. This is considered the gold standard for comparing the performance of new antimicrobial susceptibility test devices. It provides "true" Minimum Inhibitory Concentration (MIC) values for the bacterial isolates against the antimicrobial agent.

8. The Sample Size for the Training Set

• This is an IVD device, not an AI/ML system that undergoes a separate "training" phase with a large dataset in the sense of machine learning. The device's underlying "knowledge" is built into its design, chemistry, and reading algorithms (for automated methods).
• Therefore, the concept of a "training set" as understood in AI/ML is not applicable to this device.

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

• As the concept of a "training set" as in AI/ML does not apply here, this point is not applicable. The device's development involved standard microbiological and analytical chemistry principles, validated against established reference methods.

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