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Ballancer 505 is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied.

The Ballancer 505 System is indicated for:

• Simulating kneading and stroking of the tissues by use of an inflatable garment

• Temporary increase circulation in areas which the garment is applied

• Temporary relief of minor muscle aches and pains

Ballancer® 505 System, Model 1201-AC is a pneumatic massage system.

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and device performance study details. The text is a letter from the FDA regarding a 510(k) premarket notification for the Ballancer 505 System, Model 1201-AC, and includes its indications for use. It does not include a detailed study report or acceptance criteria for device performance.

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The Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L1-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograft or allograft in skeletally mature patients in the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

The Cayman Thoracolumbar Plate System is a spinal fixation system which consists of screws and plates. All of the components are available in a variety of sizes to match more closely the patient's anatomy. Materials: The devices are manufactured from CP Titanium and Ti6Al4V per ASTM and ISO standards. Function: The system functions as an adjunct to fusion to provide immobilization of the spine.

This document describes a 510(k) summary for the Cayman Thoracolumbar Plate System, Additional Sizes. This submission is for additional sizes of an existing device, and for such submissions, the primary focus is often on demonstrating that the new sizes meet the same performance criteria as the previously cleared device. Therefore, the information provided primarily pertains to mechanical testing rather than clinical studies or AI algorithm performance.

Here's an analysis of your questions based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the plates were "tested" in accordance with ASTM F1717, and are "considered substantially equivalent." It does not provide specific numerical results or predefined acceptance thresholds for these mechanical tests (e.g., a minimum strength or fatigue life). For medical devices like this, the "acceptance criteria" are often implicit in meeting a recognized standard (like ASTM F1717) and demonstrating performance comparable to predicate devices. The "reported device performance" is essentially that the tests were conducted and the device met the criteria for substantial equivalence to predicates.

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

This document describes a mechanical device (spinal plate system), not a diagnostic or AI-driven device. Therefore, a "test set" in the context of clinical data, AI algorithms, or human performance is not applicable here. The "test set" refers to the physical devices (additional sizes of the plates and screws) that underwent mechanical testing. The sample size for these mechanical tests is not specified in this summary.

Data Provenance: Not applicable in the context of clinical data. The "data" are the results of mechanical laboratory testing.

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

Not applicable. This device is cleared based on mechanical testing and substantial equivalence to predicate devices, not on human expert review of clinical data or image interpretation.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of clinical data requiring expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system, not an AI-assisted diagnostic tool or a device that impacts human reading performance.

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

No, a standalone algorithm performance study was not done. This is a mechanical surgical implant, not an algorithm.

7. The Type of Ground Truth Used

For this mechanical device, the "ground truth" implicitly refers to objective mechanical engineering standards (ASTM F1717) and comparison to the established performance of predicate devices. The "ground truth" is that the device, when subjected to specified loads and conditions, performs comparably to or within the acceptable limits defined by those standards and predicates.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI algorithm or clinical study for this mechanical device.

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

Not applicable. There is no "training set" or corresponding ground truth establishment process for this mechanical device.

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The Lympha Press Optimal is intended for the following Indications for Use: Primary lymphedema (for example, congenital lymphedema/ milroy's disease) Secondary lymphedema (for example, post-mastectomy, chronic edema, post-traumatic edema) Venous disorders (for example, venous insufficiency, varicose veins, venous stasis ulcers) Dysfunction of the muscle pump (for example, promotion of wound recovery, reduction of edema and lower limb pain following trauma and sports injuries) The device is intended to be used by the patient at home, as well as by physicians at clinics or hospitals.

Mego Afek's Lympha Press Optimal Model 1201AP Compression Therapy Device is a modification of the original Lympha Press Plus device. It utilizes a software controlled air compression pump, which sequentially inflates and deflates cells within a compression garment (sleeve) that is put around a limb. This helps to push excessive interstitial fluid in the treated limb, back into the venous and lymphatic systems; improve limb circulation; and thus treat the symptoms of a variety of lymphatic disorders, venous disorders and dysfunction of the "muscle pump". The device consists of a main console and compression garments. The main console contains an air compressor that is regulated by an electro-mechanical mechanism, including pressure sensors and a rotating disc controlling air outflow. The regulated compressed air is transferred via an air distributor through a series of hoses to the sleeve garments. In the Model 1201 device, each garment contains up to 12 overlapping pressure cells. The sleeve fits on the affected limb and can be easily adjusted to any limb size within the sleeve tolerance.

This document (K082149) describes the Lympha Press Optimal Model 1201AP Compression Therapy Device, a compressible limb sleeve, and its substantial equivalence to a predicate device.

However, the provided text does not contain acceptance criteria or detailed results from a study that proves the device meets specific performance criteria in the way typically expected for an AI/CADe device.

Instead, this 510(k) summary focuses on safety, general performance, and substantial equivalence to a predicate device for a physical medical device (a compression therapy device), rather than a diagnostic algorithm. Therefore, many of the requested categories for AI/CADe studies are not applicable.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

Analysis of Acceptance Criteria and Device Performance

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

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 applicable/Not provided. This device is a physical, mechanical system, and the testing described is engineering validation (functional, safety standards, software validation) rather than a clinical study with patient data 'test sets' in the AI sense.
• Data Provenance (country of origin, retrospective/prospective): Not applicable/Not provided. The testing relates to the device's operational characteristics, not clinical data from patients.

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)

• Number of Experts: Not applicable/Not provided. Ground truth in the context of diagnostic performance (e.g., for an AI algorithm) is not relevant here. The ground truth for this device would be established by engineering specifications and safety standards.

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

• Adjudication Method: Not applicable/Not provided. This concept is not relevant to the described testing of a physical compression therapy 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

• MRMC Study: No. This is a physical therapy device, not an AI/CADe system for interpretation.

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

• Standalone Performance: Not applicable. While there is software controlling the device, its performance is as an integrated system, not a standalone diagnostic algorithm.

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

• Type of Ground Truth: For the engineering and safety testing, the "ground truth" would be the device's functional specifications, industry standards (e.g., for electrical safety, materials), and the performance of the predicate device. These are objective engineering and regulatory benchmarks, not clinical ground truth derived from patient outcomes or expert reads.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not provided. This device does not use machine learning that requires a 'training set' of data.

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

• Ground Truth for Training Set: Not applicable/Not provided.

Summary regarding AI/CADe Relevance:

This 510(k) summary is for a physical medical device (a compressible limb sleeve) and not an AI or CADe system. The performance testing described is focused on general safety, functional specifications, software validation for device control, and demonstrating substantial equivalence to a predicate device. Therefore, the detailed questions pertaining to acceptance criteria and study designs typically used for AI/CADe devices (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not addressed in this document because they are not applicable to the type of device and regulatory submission it represents.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organs), Transvaginal, Peripheral vascular, Musculo-skeletal.

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

Here's an analysis of the provided text regarding acceptance criteria and the study:

The provided 510(k) summary for the B-K Medical Ultrasound Scanner Flex Focus 1202 (K081154) does not contain information about a diagnostic study for AI/algorithm performance against acceptance criteria.

Instead, this submission is for a traditional ultrasound system and focuses on demonstrating substantial equivalence to a predicate device (B-K Medical Ultrasound Scanner Pro Focus 2202, K043524) based on technological characteristics and intended use. The "acceptance criteria" mentioned implicitly refer to safety and performance standards for diagnostic ultrasound systems as per FDA guidelines at the time (e.g., "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997").

Let's break down the information available and what is missing, based on your requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not a submission for an AI/CAD/algorithmic device, there are no specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or acceptance criteria (e.g., "sensitivity must be >X%") against which the device performance is measured in a clinical study.

The primary "performance" discussed relates to technological characteristics and acoustic output safety.

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

This information is not provided as there is no diagnostic study with a "test set" in the context of an AI/algorithm. The submission is for an ultrasound system, and its "performance" is primarily demonstrated through engineering specifications, comparison to a predicate device, and compliance with general safety and performance standards for ultrasound equipment.

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

This information is not applicable/not provided. There is no "test set" requiring ground truth established by experts for a diagnostic algorithm in this submission.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no "test set" or adjudication process described as part of this traditional ultrasound system 510(k).

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a standalone ultrasound system, not an AI or CAD (Computer-Aided Detection/Diagnosis) system designed to assist human readers.

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

This information is not applicable/not provided. The device itself is an ultrasound imaging system, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not applicable/not provided. "Ground truth" in the context of a diagnostic dataset is not discussed here, as this is a submission for an ultrasound imaging device itself, not an AI/algorithmic device requiring such a validation.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no "training set" for an AI algorithm discussed in this submission.

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

This information is not applicable/not provided. There is no "training set" or establishment of "ground truth" for it in this submission.

In summary:

The provided document is a 510(k) summary for a traditional diagnostic ultrasound system. It demonstrates substantial equivalence to a predicate device by comparing intended uses and technological characteristics, and by declaring compliance with relevant safety and performance standards for ultrasound (e.g., acoustic output limits). It does not involve any AI/CAD algorithms, and therefore, the specific types of studies, acceptance criteria, and ground truth methodologies relevant to AI/algorithmic performance are not present in this submission.

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Infibra is intended for use by dentists to provide reinforcement to acrylic or composite resins used for dental restorations. It can be used for the following applications: As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures, night-guards and orthodontic appliances. To repair and reinforce resin or composite prostheses including temporary and permanent bonded and removable bridges. To reinforce splints used to immobilize teeth.

InFibra is a fiber reinforcement used to reinforce dental resins. It is made of ultra-high-molecularweight polyethylene (UHMW). The fibers are braided and not leno-weave treated.

The device in question, InFibra, is a fiber reinforcement material for dental resins. The provided text is a 510(k) summary and associated FDA correspondence, not a detailed study report for a medical AI device. Therefore, much of the requested information regarding AI-specific acceptance criteria and study details (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance of an algorithm, etc.) is not applicable or available in this document.

However, I can extract the acceptance criteria and performance relevant to this material science device based on the provided FDA submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified (implied to be laboratory testing for material properties).

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

• Not applicable as this is a material science device, not an AI diagnostic device. Ground truth is established by standardized laboratory tests.

4. Adjudication method for the test set

• Not applicable. Performance is determined by quantitative measurements against ISO standards.

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 device.

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

• Not applicable. This is not an AI device.

7. The type of ground truth used

• For biocompatibility: In vitro cytotoxicity test results based on ISO 10993-5.
• For mechanical properties: Quantitative measurements (e.g., load carrying capacity) based on ISO 3597-2.
• For substantial equivalence: Comparison against the characteristics and performance of legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This is a material science device, not an AI device that requires a training set.

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

• Not applicable.

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For in vitro diagnostic use only. VITROS Chemistry Products TIBC Kit with VITROS Chemistry Products Fe Slides quantitatively measures total iron-binding capacity (TIBC) in serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.

VITROS Chemistry Products Calibrator Kit 4 is used to calibrate VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

The VITROS TIBC assay is performed using the VITROS Chemistry Products TIBC Kit, VITROS Chemistry Products Fe Slides, and the VITROS Chemistry Products Calibrator Kit 4 on VITROS Chemistry Systems.

The VITROS TIBC Kit consists of VITROS TIBC Columns (containing alumina) and VITROS Iron Saturating Reagent.

Total iron-binding capacity is determined by pretreating a sample using the method of Starr. Excess iron citrate reagent is added to the sample to saturate all available apotransferrin sites. After an incubation period of five minutes, the treated sample is applied to an alumina column where iron that is not bound to transferrin is adsorbed.

The transferrin-bound iron contained in the eluate represents the total iron-binding capacity of the sample.

A drop of eluate is deposited on the VITROS Fe Slide and is evenly distributed by the spreading layer to the underlying layers. After the addition of the eluate, the slide is incubated at 37℃. Two reflection density measurements at 600 nm are made at approximately one and five minutes. The difference in reflection density is proportional to the iron concentration in the sample.

Once a calibration has been performed for each slide lot, total iron binding capacity in unknown samples can be determined using the softwareresident two-point rate math model and the change in reflectance calculated for each unknown test slide.

VITROS Calibrator Kit 4 contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum and bovine serum albumin to which organic analytes, inorganic salts, electrolytes, stabilizers, and preservatives have been added. The diluents are prepared from processed water. Once reconstituted, the standards are used to calibrate VITROS Chemistry Systems for the quantitative measurement of total iron binding capacity in serum. Calibration of the VITROS TIBC assay requires the use of three of the four levels (bottles 1, 3 and 4). For in vitro diagnostic use only.

This prompt describes a 510(k) summary for an in vitro diagnostic device, specifically the VITROS Chemistry Products TIBC Kit and Calibrator Kit 4. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results in the typical format of an AI/ML device study.

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be directly extracted from the provided text. These concepts are primarily relevant to clinical validation studies for AI/ML-driven medical devices, which this document is not.

The provided document describes a chemistry assay, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as number of experts, adjudication method, MRMC studies, effect size with AI, standalone performance, training set data, etc.) are not applicable in this context.

However, I can extract information related to the device's performance characteristics and how its equivalence to a predicate device was demonstrated.

Here's the information that can be extracted and how it relates (or doesn't relate) to your request:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for this submission. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing various device characteristics. The "reported device performance" is essentially the modified device's characteristics, assumed to be acceptable because they are substantially equivalent to a legally marketed device.

Study Proving Substantial Equivalence:

The document states: "Equivalence was demonstrated using manufactured reagents along with quality control fluids, proficiency samples and human serum samples with measured TIBC values spanning the assay range." This is the core of the "study" for this type of submission.

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

• Sample Size for Test Set: The document mentions "human serum samples with measured TIBC values spanning the assay range," but does not provide a specific number for the sample size.
• Data Provenance: The provenance is "human serum samples." The country of origin and whether they are retrospective or prospective is not specified. Given the context of a 510(k) summary for an in-vitro diagnostic, these are typically clinical samples, likely from a diverse population or at least representative of the target user base (e.g., US patients if for US market), but this is not explicitly stated. It is implicitly retrospective as the samples would have been collected prior to the study.

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

This question is not applicable. For a chemistry assay measuring TIBC, the "ground truth" is established by a reference method or validated laboratory procedure, not by a panel of human experts in the way it is for image-based AI/ML devices. The predicate device's performance, and traceability to SRM 937 via NCCLS approved standard methods, serves as the benchmark.

4. Adjudication method

Not applicable for a chemistry assay.

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 an in vitro diagnostic chemistry assay, not an AI-assisted diagnostic tool requiring human interpretation.

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

Not applicable. This is a standalone chemistry assay, meaning it provides a quantitative result directly, rather than an "algorithm" augmenting human performance. Its performance is inherent to the assay itself.

7. The type of ground truth used

The "ground truth" for this type of assay is derived from:

• Comparison to the predicate device's performance.
• Traceability to SRM 937 (Standard Reference Material) via NCCLS approved standard methods (H17-A2 for the modified device, H17-P3 for the predicate). This essentially means the accuracy is tied to recognized international standards for iron measurement.
• "Measured TIBC values spanning the assay range" implies these values were determined by a reference method.

8. The sample size for the training set

Not applicable. This is a chemistry assay that does not usually involve a "training set" in the machine learning sense. The assay method is developed and validated through chemical principles and analytical studies, not statistical learning from a dataset.

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

Not applicable for the reasons stated above.

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The eFlow IV Fluid Warmer is indicated for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

The Enginivity cFlow™ IV Fluid Warmer consists of a warming device and a single use disposable set. The warmer can be powered by either an AC power adapter supplied by Enginivity LLC or a12-30 volt DC source meeting the requirements listed in the operators' manual. The warmer will deliver infusate to a patient at a temperature of up to 40°C at flow rates of 1 ml/min to a maximum of 200 ml/min.

The sterile disposable cartridge consists of a plastic housing and biocompatible coated aluminum extrusion which when combined form an enclosed fluid path. Heat, generated by electrical resistance, is transferred from the warmer to the fluid through the extrusion. Standard Luer fittings at the input and output allow the connection of standard hospital IV lines to the enclosed fluid path.

The document provided is a 510(k) premarket notification for the Enginivity™ eFlow IV Fluid Warmer. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical study with detailed acceptance criteria and performance data like a PMA application would.

Based on the provided text, here's a breakdown of the requested information:

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

The document references ASTM F 2172-02 Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers as the performance standard. This standard would contain specific acceptance criteria for fluid warmers. However, the document does not explicitly list the acceptance criteria from this standard or the detailed results of the Enginivity eFlow™ IV Fluid Warmer against them in a table format.

The document states:

• "performance data demonstrate the temperature accuracy of the device at different flow rates."
• "Laboratory evaluations have been conducted to evaluate the hemolytic effect of the eFlow IV Fluid warmer during flows ranging from 10 to 200 ml/min and stopped flow."

Without access to the full submission or the ASTM standard, the specific numerical acceptance criteria and reported performance values cannot be extracted from this document.

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

The document mentions "studies conducted on sterilized eFlow™ Disposable Carticiges" and "Laboratory evaluations." These are non-clinical studies.

• Sample Size for Test Set: Not specified. The document does not provide a number of devices or disposable cartridges tested.
• Data Provenance: The studies were described as "Laboratory evaluations," implying they were conducted in a controlled environment, likely in the US where the company is based. The data would be prospective as it involves testing the device, not analyzing existing patient data.

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

This device is an IV fluid warmer, a piece of hardware, not an AI/imaging device requiring expert interpretation for ground truth. Therefore, this question is not applicable to the context of this 510(k) submission.

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

Not applicable. This is not an imaging or diagnostic device requiring human adjudication of results. The testing would involve objective measurements (e.g., temperature sensors, blood analysis for hemolysis).

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 an IV fluid warmer, not a diagnostic device involving human readers or AI assistance in interpretation.

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

This question is geared towards AI/software devices. For this hardware device, the closest equivalent is the standalone performance of the device itself as evaluated in the laboratory studies mentioned (temperature accuracy, hemolytic effect). The document does indicate that such standalone performance (without human input beyond operating it) was assessed.

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

For this device, the "ground truth" refers to objective physical and biological measurements obtained through laboratory testing.

• Temperature: Measured by calibrated sensors.
• Hemolysis: Measured through laboratory assays (e.g., spectrophotometry) to quantify free hemoglobin in the blood after passing through the device.

8. The sample size for the training set

Not applicable. This is a hardware device, not 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 training set for this hardware device.

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3M™ Liquid Bandage is intended to cover minor cuts, scrapes, and skin irritations.

3M™ Liquid Bandage is a sterile, clear, n-2-butyl cyanoacrylate liquid used to cover minor cuts, scrapes, and minor skin irritations. The device is packaged in an aluminum tube with a reusable cap.

The provided text describes a 510(k) premarket notification for the 3M™ Liquid Bandage. This is a medical device submission seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to prove the device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested elements about acceptance criteria, detailed study design, and performance metrics (like sensitivity, specificity, or reader improvement with AI) are not applicable to this type of regulatory submission as they are typically associated with performance studies for devices where such metrics are relevant.

However, I can extract information related to the safety tests conducted and the comparison to the predicate device.

Here's the information that can be extracted from the provided text, structured as requested where applicable, with an explanation of why certain items are not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for AI or diagnostic accuracy. Instead, the "acceptance criteria" in the context of this 510(k) are related to safety and substantial equivalence to a predicate device.
• Reported Device Performance: The "performance" in this context refers to safety test results.

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

• Test Set Sample Size:
  • In-Vitro Cytotoxicity Test: Sample size not specified.
  • HRIPT: Not explicitly stated, but implies "subjects" were used. "A small number of subjects" for the irritation observation.
  • HCIPT: Not applicable (not performed).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Human tests would generally be prospective.

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

• Not applicable. This device is a liquid bandage, and the tests involve laboratory cytotoxicity and human skin reactions, not diagnostic imaging or clinical interpretation requiring expert readers for ground truth.

4. Adjudication Method for the Test Set

• Not applicable. The tests conducted (cytotoxicity, patch tests) do not involve adjudication by multiple experts in the way clinical diagnostic studies might.

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

• No. This is a medical device for wound covering, not an AI or diagnostic tool that involves human readers interpreting cases. Therefore, an MRMC study and effects of AI assistance are not applicable.

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

• No. This is a liquid bandage, entirely a physical product, not an algorithm.

7. Type of Ground Truth Used

• In-Vitro Cytotoxicity Test: Ground truth is the cellular response observed in lab conditions.
• Human Repeat Insult Patch Test (HRIPT): Ground truth is the observed human skin reaction (e.g., presence/absence of sensitization or irritation), typically assessed by trained dermatologists or clinicians.
• Substantial Equivalence: Ground truth for comparison is the documented characteristics and performance of the predicate device (Johnson & Johnson BAND-AID® Liquid Bandage).

8. Sample Size for the Training Set

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

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

• Not applicable. This is not a machine learning or AI device that requires a training set or ground truth establishment for training.

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• 1. Fetal Surveillance
     A Corometrics 120 Maternal/Fetal Monitoring System is used for non-invasive and invasive monitoring of the fetus during the antepartum period as well as throughout labor and delivery (i.e. fetal heart rate and uterine activity monitoring). Fetal movement detection and fetal heart rate alarm options (user selectable high/low and poor signal quality alarms) are available.

ll Maternal Monitoring

A Corometrics 120 Maternal/Fetal Monitoring System is intended for monitoring maternal vital signs to help assess maternal well-being. The vital signs which can be measured with these monitor configurations are summarized as follows:

NOTE: Maternal vital signs provided by the monitor should only be used as an adjunct in patient assessment in conjunction with clinical signs and symptoms.

Blood Pressure: The monitor is intended for use in the non-invasive monitoring of maternal blood pressure (NBP). This monitor is not intended for use in the neonatal or pediatric blood pressure monitoring.

Pulse Oximetry. The monitor is intended for use in the non-invasive monitoring of maternal functional oxygen saturation of arterial hemoglobin (MSpO2).

Heart/Pulse Rate. The monitor is intended for use in the non-invasive monitoring of the maternal heart/pulse rate. Additionally, an MECG waveform "snapshot" may be displayed and printed.

NOTE: Only the maximum configuration provides both maternal heart rate and pulse rate data.

The 120 Maternal/Fetal Monitoring System consists of the following features/options that can be available in multiple configurations:

• fetal heart rate (via Doppler Ultrasound of FECG)
• maternal uterine activity (via intrauterine pressure catheter or tocotransducer
• fetal movement detection
• maternal non-invasive blood pressure (clinician prompted or automatic)
• maternal pulse oximetry
• maternal heart/pulse rate (MECG) and ECG waveform "snapshot"

The provided text is a 510(k) Summary of Safety and Effectiveness for the Corometrics Model 120 Maternal/Fetal Monitor. It details the device, its intended use, and states that it employs the same fundamental scientific technology as predicate devices. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria.

The "Test Summary" section lists general quality assurance measures applied to the development, such as:

• Requirements specification review
• Code inspections
• Software and hardware testing
• Safety testing
• Environmental testing
• Final validation

The "Conclusion" states that "The results of these measurements demonstrated that the Model 120 Maternal/Fetal Monitor (with Masimo SET Pulse Oximetry) is as safe, as effective, and performs as well as the predicate device."

Without further documentation, it is not possible to complete the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies. The 510(k) summary typically references a more detailed technical file that would contain this information.

Therefore, based solely on the provided text, I cannot describe the acceptance criteria or a detailed study that proves the device meets specific performance metrics.

However, I can extract the information that is present:

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

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

• Not specified. The document mentions "Software and hardware testing," "Safety testing," "Environmental testing," and "Final validation" but does not detail the datasets used for these tests.

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 specified.

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

• Not specified.

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 device is a physical monitor, not an AI diagnostic tool. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable. The comparison is against predicate devices, not human performance.

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

• This device is a physical monitor, not a standalone algorithm. Performance demonstrated was likely the integrated system's performance.

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

• Not specified. For a maternal/fetal monitor, ground truth would typically refer to the accuracy of physiological measurements (e.g., actual fetal heart rate, uterine pressure, maternal SpO2 measured by a gold standard), but the document does not detail this.

8. The sample size for the training set:

• Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense. The "development" process included reviews and various forms of testing.

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

• Not applicable as this is not an AI/machine learning device.

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