Search Results

ID® Millennium® is a personal lubricant, for penile and /or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

ID® Moments® Silicone is a personal lubricant, for penile and /or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

ID® Millennium® is non-sterile, an over-the-counter silicone based personal lubricant, formulated to be clear, non-irritating, non-greasy natural and odorless. This device is silicone soluble liquid for use as a personal lubricant. ID® Millennium® Personal Lubricant contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device. ID® Millennium® Personal Lubricant is neither a contraceptive nor a spermicide.

The device is available in the following variant personal lubricant formulas: ID® Millennium® and ID Moments® Silicone.

ID® Millennium® Personal Lubricant is provided in plastic/PET bottles with screw-on cap, flip top closure, pump dispensers, and foils.

This document is a 510(k) Premarket Notification for a personal lubricant, ID® Millennium® and ID® Moments® Silicone, classified as a Class II device under Condoms (21 CFR 884.5300). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, Wet Platinum Premium Lubricant® (K130012).

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes several tests performed to demonstrate the safety and effectiveness of the ID® Millennium® and ID® Moments® Silicone lubricants. The acceptance criteria are implicitly or explicitly stated as the desired outcome of these tests (e.g., "not cytotoxic," "non-sensitizing," "not an irritant and not systemically toxic," compatible with condoms).

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

• Sample Size: The document does not explicitly state the specific numerical sample sizes for each test (e.g., how many rabbits for irritation, how many condoms for compatibility testing, how many batches for specifications). It mentions "retains" for shelf-life testing and "major brand name" condoms, which implies a representative selection.
• Data Provenance: The studies appear to be conducted by or for Westridge Laboratories, Inc. The standards referenced (ISO, USP, ASTM) are international and national standards, but the physical location where the tests were performed is not specified. The studies are prospective in nature, as they involve testing the actual device to generate performance data.

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

This type of product does not involve "ground truth" established by human experts in the way an AI diagnostic device would. Instead, the "ground truth" or acceptance criteria are derived from:

• Standardized Test Methods: ISO, USP, and ASTM standards provide predefined methodologies and acceptable limits for chemical, biological, and physical properties.
• Scientific Principles: Biocompatibility, sterility, and material compatibility are judged against established scientific and regulatory principles for medical devices.

Therefore, the concept of "number of experts" and their "qualifications" for establishing a diagnostic ground truth is not applicable here. The expertise lies in the certified labs and personnel who conduct these tests according to the specified standards.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations where subjective expert interpretations are involved. For the objective laboratory tests described for this lubricant, such adjudication is not applicable. The results are based on objective measurements and observations according to the test protocols.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are specific to evaluating human reader performance, often in diagnostic imaging, and comparing it with or without AI assistance. This device is a personal lubricant, not a diagnostic or imaging device, so MRMC studies are not relevant.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. This device is a physical product (a personal lubricant), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The performance studies evaluate the physical and chemical properties of the lubricant itself.

7. Type of Ground Truth Used

The "ground truth" in this context refers to the defined acceptable biological, chemical, and physical properties as determined by:

• International Standards: ISO 10993 for biocompatibility.
• National Pharmacopeia: USP , , , for microbiological and certain physical properties.
• Industry Standards: ASTM 7661-10 for condom compatibility.
• Manufacturer's Internal Specifications: For viscosity, specific gravity, appearance, color, and odor, as well as for defining the shelf-life testing parameters.

8. Sample Size for the Training Set

This product is not an AI/ML device, so there is no "training set" in the computational sense. The product development would involve formulations, pilot batches, and iterative testing, but not a "training set" for an algorithm.

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

As there is no training set for an algorithm, this question is not applicable. The formulation and development of the lubricant would be based on chemical engineering principles, material science, and regulatory requirements, rather than a data-driven "ground truth" for machine learning.

Ask a specific question about this device

These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skall, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

These digital diagnostic x-ray systems consist of a tubehead and collimator assembly mounted on a U-Arm, along with a generator, generator control, and an xray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.

The provided document is a 510(k) summary for the Sedecal Millennium Plus Digital Diagnostic X-Ray System. It states that the new device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement in a study as requested.

The document primarily focuses on establishing substantial equivalence by comparing the new device's characteristics and intended use to those of its predicate devices (Sedecal Millennium Digital K042876 and Sedecal X Plus LP Plus K062335) and by stating that it passes bench and test laboratory evaluations to applicable standards (21 CFR 1020.30 and IEC 60601).

Therefore, I cannot provide the requested table and detailed information based on the content of this document. The document explicitly states:

"The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices."
and
"After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of Sedecal Inc that the Scdecal Millennium Plus Digital Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices."

This indicates that general safety and effectiveness testing was conducted, but the specific details of the acceptance criteria, study design, performance metrics, sample sizes, ground truth, or expert involvement are not disclosed in this 510(k) summary.

Ask a specific question about this device

The device is intended to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.

MILLENNIUM series are sophisticated equipments but of very friendly use, adaptable to the different demands thanks to the wide possibilities of configuration and choice of the cycles.

The equipments are able to treat in fast way every type of load through various patented systems and hi-tech solutions.

MILLENNIUM series sterilizers are equipped with a 5.5, 17 or 21 lites sterilization chamber and are characterized by an advanced fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by an effective final vacuum drying phase able to eliminate any trace of condensation from the load.

An exclusive steam generation system, combined with the advanced control system, guarantees an high process speed and high stability of the thermodynamic parameters during the whole sterilization process and consequently full safety and perfect result.

The equipment offers sterilization programmes optimized for an effective, fast sterilization of different tools and materials used in medical environment, particularly the dental one.

The sterilization program of a MILLENNIUM series sterilizer can properly be described by a sequence of phases, each with a well defined activity.

Acceptance Criteria and Study for Mocom Millennium Series Steam Sterilizers

This submission describes the Mocom Millennium series of steam sterilizers (models B, B+, B2, Bµ) and their equivalence to predicate devices (W&H Lisa and Midmark M9 UltraClave). The acceptance criteria are implicitly defined by the parameters and performance characteristics of the various sterilization programs offered by the devices, and the study demonstrates that these devices meet those criteria by being substantially equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by the operational parameters and load capacities of the predicate devices and the Millennium series sterilizers themselves. The reported device performance is presented as the various sterilization programs with their specific parameters.

The following table summarizes the typical performance characteristics, which serve as the acceptance criteria and the device's reported performance for various programs across the Millennium series. Since the document states "The new device is safe and effective as the predicate devices" and "MILLENNIUM series sterilizers are substantially equivalent to the W&H Lisa Steam Sterilizer and Midmark M9 UltraClave Steam Sterilizer," the acceptance criteria for the Millennium series are effectively the performance characteristics of these predicate devices as well as the demonstrated performance of the Millennium series devices as detailed in the "Table of the Available Programs" for each model.

Note: The document explicitly states that the "EXTRA and INTELLIGENT options" for drying and the "FAST option" for drying have not been validated. Also, the "134°C / 121°C CUSTOM program has not been validated." This indicates that these specific features, while present, are not part of the validated acceptance criteria for "safe and effective" claim and would require further validation if used as primary sterilization programs.

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

The document is a 510(k) premarket notification for substantial equivalence, not a clinical trial report. As such, it does not describe a "test set" in the context of an AI/ML device evaluating data. Instead, the "study" for this device involved engineering and performance testing to demonstrate that the sterilizers meet the specified operational parameters and effectively sterilize various loads.

• Sample Size for Testing: The document does not specify a quantitative "sample size" in terms of number of sterilization cycles or tests performed. It refers to various "programs" and their associated parameters (temperature, pressure, holding time, drying time, load types, and maximum masses). These parameters derive from general standards for steam sterilization and performance testing typical for such devices.
• Data Provenance: The data provenance is from engineering and performance testing conducted by the manufacturer (M.O.COM. s.r.l.) in Italy. This would be considered prospective testing to characterize the device's technical performance. The results are presented in the form of tables detailing the various sterilization cycles and their validated/specified parameters. While not explicitly stated, such testing would typically involve:
  • Physical Monitoring: Temperature and pressure sensors placed within the chamber and load.
  • Biological Indicators: Used to confirm sterility within various load configurations.
  • Chemical Indicators: Used to confirm exposure to sterilization conditions.
  • Bowie-Dick Test: Specifically mentioned in the tables to confirm air removal and steam penetration for porous loads.
  • Vacuum Test: Specifically mentioned to evaluate vacuum integrity.

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

In the context of a steam sterilizer, "ground truth" for a test set would pertain to the successful sterilization of items and the accurate measurement of physical parameters during a cycle.

• Number of Experts: The document does not specify a number of experts. The data presented (e.g., total cycle time, water/energy consumption, max load mass) would be derived from standard engineering and microbiological validation protocols.
• Qualifications of Experts: The "experts" involved in verifying the sterilizer's performance would primarily be:
  • Engineers: Responsible for designing, building, and testing the device to meet specified physical parameters (temperature accuracy, pressure control, vacuum levels, timing).
  • Microbiologists/Sterilization Scientists: Responsible for validating the sterilization efficacy using biological indicators and ensuring the device achieves a sterility assurance level (SAL) appropriate for medical devices.
  • Regulatory Affairs Personnel: To ensure compliance with relevant standards and regulations (e.g., ISO, AAMI, FDA).

These are implied roles based on the nature of the device and regulatory submission, rather than explicitly stated individuals in this document.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving expert consensus on subjective evaluations (e.g., medical image interpretation). For a device like a steam sterilizer, "adjudication" is not directly applicable in this sense.

Instead, the "adjudication" for the performance of a steam sterilizer involves:

• Conformance to Standards: Ensuring the device operates within the parameters set by recognized national and international standards for steam sterilization (e.g., EN 13060 for small steam sterilizers).
• Successful Sterilization Endpoints: Confirming the inactivation of biological indicators, meeting specific physical parameter thresholds (temperature, pressure, time), and passing routine tests like the Bowie & Dick test and Vacuum test.
• Engineering Validation: Verification and validation activities by the manufacturer's R&D, Quality Assurance, and Engineering teams to ensure the device performs as designed and meets its specifications.

The document implies that these standard industry practices for validation were followed, leading to the reported performance characteristics for each program.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic or AI-assisted interpretation devices where multiple human readers evaluate multiple cases, often with and without AI assistance, to measure changes in diagnostic performance.

This document is a 510(k) submission for a medical device (steam sterilizer), which is an entirely different class of device and does not involve human interpretation of cases or AI assistance in that sense. The comparison provided in the submission is purely based on the technological characteristics and intended use of the sterilizer against predicate devices, establishing "substantial equivalence."

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

No, this question is not applicable to a steam sterilizer. The Millennium series of sterilizers are electromechanical devices that perform a physical process of sterilization. They do not involve algorithms in the sense of AI/ML interpretation where a "standalone" or "human-in-the-loop" performance would be evaluated. The sterilizer operates autonomously based on its programmed cycles, with human interaction limited to loading/unloading and program selection.

7. The Type of Ground Truth Used

The "ground truth" for a steam sterilizer is:

• Physical Parameters: Accurate measurements of temperature, pressure, and time achieved within the sterilization chamber and the load.
• Sterility Assurance: The confirmed inactivation of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) as demonstrated by biological indicators (BIs) placed within test loads, achieving a specified sterility assurance level (SAL).
• Process Indicators: Successful change in color/state of chemical indicators (CIs) to confirm exposure to sterilization conditions.
• Test Pack Results: Successful passing of Bowie-Dick tests (for air removal and steam penetration) and Vacuum tests (for chamber integrity).

These are established through rigorous engineering and microbiological validation during the development and testing phases of the sterilizer. The tables in the document reflect the parameters of cycles that have demonstrated these ground truths.

8. The Sample Size for the Training Set

This question is not applicable. Training sets are relevant for AI/ML algorithms. The Mocom Millennium series sterilizers are not described as incorporating AI/ML, and therefore, there is no "training set." The device's operation is based on pre-programmed, validated sterilization cycles and control systems.

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

This question is not applicable, as there is no training set for an AI/ML algorithm. The "ground truth" for the device's efficacy is established through the validation of its physical and biological performance against accepted sterilization standards, as explained in point 7.

Ask a specific question about this device

The Varian Millennium 120 Multi-leaf Collimator (MLC) is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either Clinac dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution.

Millennium Multi-Leaf Collimator (MLC) Release v7.0 is a modification of the present MLC device (K990085) to include the following:

• 1. Large Field IMRT treatments
• Smooth motion control 2.
• 3. Faster patient plan downloads via ethernet
     The Varian Millennium Multileaf Collimator (MLC) is an x-ray collimator designed to be mounted on a Varian Clinac® radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac® dose fraction or gantry angle.

The provided 510(k) summary for the Millennium Multi-leaf Collimator (K050442) outlines a modification to an existing device, primarily focusing on engineering enhancements rather than a new AI-powered diagnostic or predictive tool. Therefore, many standard acceptance criteria and study design elements typically associated with AI/ML medical devices are not explicitly detailed in this document.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary does not contain a quantitative table of acceptance criteria and reported device performance in the way one would expect for a diagnostic AI device (e.g., sensitivity, specificity, AUC). Instead, the improvements are described qualitatively:

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

The document does not describe a "test set" in the context of data for an AI/ML algorithm. This 510(k) is for a physical device modification, not a software algorithm evaluated against a dataset of patient images or outcomes. Therefore, there is no mention of sample size for a test set or data provenance (country of origin, retrospective/prospective). The evaluations would likely involve engineering testing, performance verification, and possibly clinical use data from the previous version of the device, but these details are not provided in this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This is not an AI/ML device requiring expert-established ground truth from medical images or patient data. The "ground truth" for this device would be its ability to perform its mechanical and electronic functions (e.g., accurately shaping radiation fields, smooth movement).

4. Adjudication Method:

Not applicable. There is no adjudication method described as this is not a study involving human-expert consensus on medical data.

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

Not applicable. This device is a physical component of a radiation therapy system, not an AI software intended to assist human readers in interpretation. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical device, not an algorithm. Its performance is intrinsically linked to its operation within the linear accelerator system.

7. Type of Ground Truth Used:

The "ground truth" for this medical device would be based on engineering specifications, physical measurements, and performance benchmarks for radiation field shaping, motion control, and data transfer speeds. It would also implicitly rely on the established safety and efficacy of the predicate device (K990085). The document does not specify the exact methods for defining or verifying this "ground truth."

8. Sample Size for the Training Set:

Not applicable. This device is a hardware modification, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable. As there is no AI/ML training set, there's no ground truth established for it.

Ask a specific question about this device

The Millennium M10 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life support nor life sustaining.

The Millennium M10 Oxygen Concentrator is a medical device that produces concentrated oxygen from room air for delivery to a patient requiring oxygen therapy. It uses molecular sieve and a pressure swing adsorption process to concentrate oxygen from air. The device is capable of providing oxygen flow up to 10 LPM and is offered with an optional Oxygen Percentage Indicator.

This submission focuses on the substantial equivalence of the Millennium M10 Oxygen Concentrator to existing predicate devices rather than providing a detailed performance study with specific acceptance criteria and ground truth analysis. Therefore, much of the requested information regarding sample sizes, expert qualifications, and specific statistical performance metrics is not available in the provided text.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

The document states that "Performance, environmental, electrical, mechanical and electromagnetic compatibility testing was performed to prove the safety and effectiveness of the Millennium M10." However, it does not explicitly list specific numerical acceptance criteria or the reported performance data against those criteria. The conclusion is a general statement of substantial equivalence.

Study Information

Due to the nature of this 510(k) summary, which focuses on substantial equivalence to predicate devices, comprehensive study details typically found in a clinical trial report are not present.

1. Sample size used for the test set and the data provenance: Not explicitly stated. The testing mentioned ("Performance, environmental, electrical, mechanical and electromagnetic compatibility testing") likely involved a series of engineering and bench tests rather than a patient-based test set with a defined sample size for performance evaluation in the context of diagnostic accuracy.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not stated. As this is not a diagnostic device with "ground truth" established by human interpretation, there's no mention of experts for ground truth.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not stated.
4. 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 oxygen concentrator, not an AI-assisted diagnostic device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not a standalone AI algorithm. The performance evaluation would be of the device itself.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly defined as "ground truth" in the diagnostic sense. The "ground truth" for an oxygen concentrator would be its physical output and functional parameters measured against engineering specifications and industry standards for safety and performance (e.g., oxygen concentration, flow rate, purity, noise levels, power consumption, etc.).
7. The sample size for the training set: Not applicable. This is a hardware device, not a machine learning model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document is an Abbreviated 510(k) summary for an oxygen concentrator, primarily demonstrating substantial equivalence to existing devices. It outlines that various engineering and performance tests were conducted to confirm safety and effectiveness, but it does not detail specific acceptance criteria or results in the way a diagnostic device study would.

Ask a specific question about this device

The Sedecal URS LP/Millennium/RadPro Xray Units with Detector are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

URS LP/Millennium/RadPro X-ray Units with Detector are stationery units which operate from 120 or 220 V 50-60~ AC. The units utilize high frequency inverters. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G. The new units offer additional mounting options for the tube head and other components.

The provided text describes a 510(k) summary for the SEDECAL URS LP/Millennium/RadPro X-ray Units with Detector. This submission appears to be for a combination device, integrating two previously cleared devices.

Based on the provided information, the 510(k) summary does not contain details about specific acceptance criteria or a study designed to prove the device meets those criteria in terms of clinical performance or detection accuracy. Instead, the summary focuses on demonstrating substantial equivalence to existing predicate devices.

Here's an analysis based on the information available:

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

No specific acceptance criteria related to a performance study (e.g., sensitivity, specificity, accuracy) are mentioned. The "Performance Standard" in the Substantial Equivalence Chart refers to 21 CFR 1020.30, which is a regulatory performance standard for diagnostic X-ray systems and their major components, not a clinical performance metric. This standard typically covers aspects like radiation safety, image quality characteristics (e.g., resolution, contrast, noise), and operational parameters.

The reported device performance is implicitly covered by the "SAME" statements in the Substantial Equivalence Chart, indicating that the new device's characteristics are the same as the predicate devices in terms of energy source, digital resolution (160 x 160 microns pixel pitch, approximately 6 million pixels and 4,096 gray scale contrast), and relevant safety/performance standards.

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

Not applicable. No clinical or performance test set data is provided. The evaluation was based on "bench, user, and standards testing" and a comparison of technical characteristics to predicate devices.

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. No ground truth establishment by experts is mentioned, as there was no study involving medical image interpretation.

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

Not applicable. No adjudication method is mentioned.

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 such study was conducted or reported. This device is an X-ray unit, not an AI-powered diagnostic tool. The focus is on the hardware and its integration.

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

Not applicable. This is not an algorithmic diagnostic device.

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

Not applicable. No clinical ground truth was established, as the submission relies on demonstrating substantial equivalence of the hardware's technical characteristics and adherence to regulatory standards.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning model.

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

Not applicable.

Summary of Acceptance Criteria and Performance (Based on provided text):

Since the submission is a 510(k) for a combination device based on substantial equivalence, the "acceptance criteria" are implied by the characteristics of the predicate devices and adherence to relevant regulatory standards.

In essence, the "study" demonstrating that the device meets acceptance criteria is the comparison to predicate devices and the assertion that "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." No specific details of these "bench, user, and standards testing" are provided in the 510(k) summary itself, but they would collectively serve to confirm that the combined device meets the functional and safety requirements established by regulatory standards and the performance of its cleared components.

Ask a specific question about this device

The MB 105 Millennium blade is intended to be used as a replacement blade for the Moria M2 Non-Disposable Microkeratome.

The MB 105 Millennium Blade is a replacement blade designed to be used with the Moria M2 Non Disposable Microkeratome. The MB 105 Millennium Blade is a single-use only, disposable device. The Blade material is similar to that used in predicate devices (stainless steel).

The provided document is a 510(k) Premarket Notification for the Millennium Biomedical Inc. MB 105 Millennium Blades. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical studies with detailed acceptance criteria and performance data like those found in a PMA (Premarket Approval) application.

Therefore, the document does not contain the requested information regarding specific acceptance criteria for device performance, or a study proving the device meets said criteria in the way a clinical trial report would.

Here's why and what can be inferred from the document:

• Type of Device: The MB 105 Millennium Blade is a replacement blade for a microkeratome, a Class I device (regulated under 21 CFR 886.4370 as a Keratome). Class I devices typically have lower risk and do not require extensive clinical data for market clearance.
• 510(k) Process: The 510(k) pathway demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing device characteristics (design, materials, intended use, performance testing, etc.) rather than conducting de novo clinical trials to establish safety and effectiveness against explicit performance criteria.
• Content of the Document: The summary focuses on:
  • Identifying the submitter and device.
  • Listing predicate devices.
  • Describing basic physical and performance characteristics (blade material is stainless steel, similar to predicates).
  • Stating the intended use (replacement blade for a specific microkeratome).
  • The FDA's decision letter confirming substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions as the required information is not present in the provided text. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Types of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

The absence of this information is typical for a 510(k) submission for a Class I device where substantial equivalence is demonstrated through non-clinical means (e.g., material testing, mechanical testing) rather than extensive clinical efficacy or diagnostic performance studies.

Ask a specific question about this device

The Millennium III 3T 8-Channel Neurovascular Coil is designed to provide magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The Millennium III 3T 8-Channel Neurovascular Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.

The indications for use are the same as for standard imaging:

The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon parameters (proton density, spin lattice relaxation time T1, and spin spin relaxation time T2) and (3) display the soft tissue structure of the body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Millennium III 3T 8-Channel Neurovascular Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the head and spine and has been designed to maximize comfort and ease of use. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.

The provided document is a 510(k) premarket notification for a medical device (Millennium III 3T 8-Channel Neurovascular Coil). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

This document describes a new MRI accessory and demonstrates its substantial equivalence to previously cleared predicate devices. The focus is on comparing the physical characteristics, intended use, indications for use, and safety features (like RF burn prevention and RF absorption) of the new coil to existing, cleared coils.

Therefore, I cannot provide the requested information. The document is not a study report for an AI/ML device that would establish performance metrics against acceptance criteria.

Ask a specific question about this device

The Bausch & Lomb (B&L) Millennium Peristaltic Pump System is intended for the introduction of Balanced Salt Solution (BSS) into the eye, as well as, the aspiration of fluid/tissue from the eye during ophthalmic anterior surgery. The Millennium Peristaltic Pump System consists of the B&L CX4100 module to be used with the B&L Millennium Microsurgical System and the B&L Peristaltic Phaco Pack, CX5310 sterile single-use accessory pack which consists of the various components/accessories necessary to enable the use of B&L Anterior Handpieces with the Millennium Microsurgical System.

The Peristaltic Pump System consists of a new module and will fit into the existing base of Millennium Microsurgical Systems. It is an anterior only module designed to be used with phacoemulsification. The module is flow based in that it will provide aspiration by means of a peristaltic pump. A peristaltic pump is a positive displacement type of pump which controls flow rate by the rotational speed of the pump head. The module will contain an interface for the disposable Peristaltic Pump Cartridge and one pneumatic output. The interface for the peristaltic pump cartridge ensures the peristaltic tubing is properly positioned for engagement by the pump head and the pressure sensor and integral pinch valves are properly aligned. The pneumatic connection delivers air pressure sufficient to drive a vitrectomy cutter. The Peristaltic Pump Cartridge will be provided as a sterile, single use product. The cartridge consists of a molded housing with pre-connected irrigation tubing which acts as a conduit for instilling balanced salt solution (BSS). The tubing interfaces with the rotating peristaltic roller pump head. In addition, the cartridge contains a pressure transducer that interfaces with the transducer PCB on the peristaltic module to measure the vacuum within the aspiration path of the cartridge.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the Millennium™ Peristaltic Pump System, focusing on its description, indications for use, and a comparison to predicate devices to establish substantial equivalence.

It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts, adjudication methods, or ground truth for a test set.
• Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
• Information about training set size or how its ground truth was established.

The 510(k) process primarily assesses substantial equivalence to legally marketed predicate devices, rather than requiring extensive de novo clinical studies with predefined acceptance criteria for novel performance claims.

Ask a specific question about this device

• To measure bilateral differences in surface EMG along the spine
• To measure surface EMG along the spine during functional tasks
• To measure bilateral differences in skin temperature along the spine
• To measure Range of Motion of the three spinal regions
• To measure patient self-reported pressure sensitivity in joints and muscles
• To measure Heart Rate
• To chart patient progress during the course of treatment

The Insight Millennium III is a non-invasive, multi-modality physiologic monitoring device. The Insight Millennium III contains the following five sensor types: (1) surface EMG used to measure muscle activity, (2) infrared temperature sensor used to measure skin temperature, (3) inclinometer used to measure end-point range of motion, (4) algometer used to measure patient self-reported pressure sensitivity, and (5) heart rate sensor to measure heart rate.

The provided text describes the Insight Millennium III, a non-invasive, multi-modality physiologic monitoring device. However, it does not include information about specific acceptance criteria for its performance (beyond general accuracy specifications) or the studies conducted to prove the device meets these criteria in the context of clinical efficacy or diagnostic accuracy.

The document is a 510(k) Summary, which focuses on establishing substantial equivalence to predicate devices rather than proving new clinical efficacy or diagnostic performance through specific studies with acceptance criteria.

Therefore, the following information is not present in the provided document:

• A table of acceptance criteria and reported device performance related to a clinical study (only general performance specifications are given).
• Sample size used for a test set or data provenance in a study for performance validation.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone performance study.
• Type of ground truth used (beyond implying the device measures physiological parameters).
• Sample size for training set.
• How ground truth for the training set was established.

What is available in the document regarding "performance" are the device's technical specifications:

1. Table of Acceptance Criteria (Technical Specifications) and Reported Device Performance

Ask a specific question about this device