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When coupled with an appropriate inflation system, compression garments are intended to increase venous return from the legs and feet as a prophylaxis for the formation of deep vein thrombosis (DVT) or subsequent pulmonary embolism (PE) in high risk and/or non-ambulatory patients. The compression garments are prescription devices intended for a single patient use only.

Compressible limb sleeves are devices that are used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb and increasing venous flow. Compression therapy is generally prescribed as a prophylaxis for deep vein thrombosis (DVT). The compression system consists of two primary pieces: an air compression pump and a soft, flexible sleeve in which the patient's extremity is placed. A hose to the pump connects to the sleeve, and when the pump is turned on, the air inflates the sleeve, applying a gentle pressure to the patient's extremity. Compression garments consist of a non-woven fabric with "hook and loop" fasteners for attaching around the leg. Air cells within the garment are molded to plastic hoses with connectors for attachment to the pump. The hoses and connectors are non-detachable and are reprocessed as part of the garment. Vanguard Reprocessed Compression Garments (Hill-Rom) contain multiple compartments and hoses that are sequentially pressurized. Vanguard receives previously used compression garments from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the garments; and returns them to a healthcare facility.

The provided text is a 510(k) summary for the Vanguard Reprocessed Compression Garments (Hill-Rom). This document describes a medical device and its substantial equivalence to predicate devices, focusing on reprocessing. It does not contain information about a study that establishes acceptance criteria for AI/ML device performance or involves human readers, experts, or ground truth establishment relevant to AI/ML device evaluation.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.

The document discusses:

• Cleaning, packaging, and sterilization validations: These demonstrate that the reprocessed devices perform as intended and are safe and effective.
• Performance and biocompatibility testing: These also support the safety and effectiveness of the reprocessed devices.
• Sterilization validation: This specifically demonstrates that sterility is achieved to a 10^-6 assurance level using ethylene oxide gas.

These are related to the physical reprocessing of the garments and ensuring they meet the same specifications and safety profiles as new, non-sterile garments. They are not related to an AI/ML device's diagnostic or predictive performance.

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Reprocessed Phacoemulsification Tips are intended to emulsify and excise cataract tissues in ophthalmic microsurgical procedures.
Reprocessed Phacoemulsification Tips are indicated for use to emulsify and excise cataract tissues in patients requiring eye surgery.

Phacoemulsification Tips are used to emulsify and excise cataract tissue in ophthalmic microsurgical procedures. When connected to the ultrasonic handpiece of a phacoemulsification system and activated, the Phacoemulsification Tip vibrates at an ultrasonic frequency that emulsifies cataract tissue. The extracted tissue is then aspirated away through the hollow tip. Irrigation of the eye with a saline solution compensates for the loss of volume in the eye when the cataract tissue is removed.

Here's a breakdown of the acceptance criteria and study information for the Alliance Medical Corporation Reprocessed Phacoemulsification Tips, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Performance testing demonstrates that Reprocessed Phacoemulsification Tips perform as originally intended." This indicates that the device met the acceptance criteria for each of these categories.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the bench and laboratory testing.

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

The provided text does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on technical performance testing rather than expert-reviewed data.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method for the test set.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The evaluation focuses on the reprocessed device's physical and functional equivalence to the predicate device, not on human reader performance.

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

The device described is a physical medical device (Phacoemulsification Tips), not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The "standalone" performance here refers to the device's own functional performance, which was demonstrated through the listed performance tests.

7. Type of Ground Truth Used

The ground truth for the performance evaluation was based on technical specifications and functional output in comparison to the original, non-reprocessed predicate devices. This includes demonstrating:

• Biocompatibility
• Successful reprocessing
• Sterility
• Appropriate function
• Packaging integrity

8. Sample Size for the Training Set

The device is a reprocessed physical medical device, not an AI or machine learning model that would require a "training set." Therefore, the concept of a training set sample size is not applicable.

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

As explained above, there is no "training set" for this type of device. The performance evaluation relies on comparing the reprocessed devices to the established performance and specifications of the original predicate devices.

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Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures.

Reprocessed Electrophysiology Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.

Diagnostic electrophysiology (EP) catheters are specially designed electrode catheters that transmit electrical impulses and can be positioned for endocardial recording or stimulation. Diagnostic EP catheters incorporate a handpiece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tips of deflectable catheters can be deflected into a curve by manipulating the handpiece; fixed curve catheters have an established distal tip shape.

Alliance Medical Corporation's reprocessing of electrophysiology catheters includes removal of adherent visible soil and decontamination. Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations.

This document is a 510(k) summary for the Alliance Medical Corporation's Reprocessed Electrophysiology (EP) Catheters. As such, it describes the device and its intended use, but it does not detail specific acceptance criteria or a dedicated study that proves the device meets particular performance metrics beyond what is stated in the "Performance data" section.

However, based on the provided text, we can infer some information relating to acceptance criteria and the "study" (validation activities) performed.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it broadly states that "Performance data: Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Electrophysiology (EP) Catheters."

The reported areas of performance validation are:

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 states, "Each individual electrophysiology catheter is tested for appropriate function of its components prior to packaging and labeling operations." This implies that every reprocessed device undergoes functional testing as part of the quality control process.

For biocompatibility, reprocessing validation, and sterilization validation, the document does not specify the sample size or data provenance. These types of validations are typically prospective studies conducted in a controlled laboratory environment. The country of origin of the data is not specified, but given the company (Alliance Medical Corporation) is based in Phoenix, Arizona, USA, it's highly probable the testing was conducted in the US or by a contracted lab.

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

This information is not provided in the document. The validation activities mentioned (biocompatibility, reprocessing, sterilization, function tests) are primarily objective technical validations and would not typically involve expert "ground truth" establishment in the way it's used for AI/clinical diagnostic studies.

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

This information is not provided and is not applicable to the types of technical validations described in the document. Adjudication methods are typically used in clinical studies where subjective interpretation or classification is involved.

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, an MRMC comparative effectiveness study was not done. This document describes the reprocessing of medical devices, not an AI software device.

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 document pertains to physical reprocessed medical devices, not an algorithm.

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

For the mentioned "Function test(s)," the ground truth is against the original intended function of the new (unreprocessed) device. For biocompatibility, reprocessing, and sterilization, the "ground truth" is established by regulatory standards and industry-accepted test methods that define what constitutes a "biocompatible," "effectively reprocessed," or "sterile" device.

8. The sample size for the training set

This concept is not applicable to this document. "Training set" refers to data used to train an AI algorithm, which is not the subject of this 510(k) summary.

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

This concept is not applicable to this document.

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Reprocessed Compression Sleeves are intended to help prevent deep vein thrombosis and pulmonary embolism by supplying a measured, intermittent pressure into the compression sleeves worn on the lower extremities of a recumbent patient, resulting in a gradient, sequential, repetitive squeezing and relaxing action, simulating normal muscle contractions.

Reprocessed Compression Sleeves are indicated for use in providing external compression therapy to reduce the incidence of deep vein thrombosis and resulting pulmonary embolism in patients at risk for thrombosis formation.

Compression sleeves are part of an external compression system, in which intermittent or sequential compression is provided using a pump/controller and limb garment. The system consists of the following three main components: a control unit, inflatable limb sleeves and conduit tubing with detachable connections.

Alliance Medical Corporation's reprocessing of compression sleeves includes removal of adherent visible soil and decontamination. Each individual compression sleeve is tested for appropriate function of its components prior to packaging and labeling operations.

The provided document is a 510(k) summary for a reprocessed medical device, specifically compression sleeves, and does not contain the detailed information typically found in a study report for novel device performance or AI/software validation. Therefore, many of the requested elements for acceptance criteria and study details cannot be fully extracted.

Based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified. The document only mentions "Bench and laboratory testing was conducted." It does not provide the number of reprocessed sleeves tested.
• Data Provenance: Not specified. It's bench and laboratory testing, so it's not patient data from a specific country, nor is it explicitly stated as retrospective or prospective.

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

• Not applicable. This was bench testing, not a study requiring expert clinical assessment for ground truth.

4. Adjudication method for the test set:

• Not applicable. This was bench testing, not a study requiring adjudication of expert opinions.

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

• No. This is a 510(k) for a reprocessed physical medical device (compression sleeves), not an AI-powered diagnostic or assistive technology.

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

• No. This device is not an algorithm.

7. The type of ground truth used:

• The ground truth for the performance claim appears to be the original intended performance of the predicate device. The testing confirms that the reprocessed device performs to these established specifications.

8. The sample size for the training set:

• Not applicable. This is a reprocessed physical device, not an AI/ML algorithm requiring a training set. The "reprocessing" procedure could be considered analogous to a "training" process for maintaining device specifications, but it's not a data-driven training set in the AI sense.

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

• Not applicable. (See #8)

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Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation aand treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.

External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.

The provided document (K012634) is a 510(k) Pre-Market Notification for "Reprocessed External Fixation Devices" by Alliance Medical Corporation. This type of submission is for "reprocessed" medical devices, meaning devices that were originally intended for single use but are being re-used after cleaning, sterilization, and sometimes repair. The testing described focuses on demonstrating that the reprocessed devices perform as intended, similar to their original, new counterparts, and that the reprocessing method is effective.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the reprocessed devices are identical in design, materials, and intended use as the predicate devices, implying that the acceptance criteria are met if these characteristics and the performance benchmarks are maintained after reprocessing. The specific quantitative acceptance criteria values (e.g., specific tensile strength, fatigue life, or sterilization sterility assurance levels) are not detailed in this summary, but are generally part of the underlying bench and laboratory testing reports.

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

The 510(k) summary does not explicitly state the sample size used for the test set in the performance, biocompatibility, or reprocessing validation studies. It only mentions "Bench and laboratory testing."

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for reprocessed devices, the data would typically be derived from controlled laboratory studies and possibly prior clinical use data of the original devices or reprocessed devices.

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

This type of submission for reprocessed devices typically relies on engineering and scientific experts to establish test protocols, analyze performance, and validate reprocessing methods, rather than clinical experts establishing a "ground truth" for a diagnostic or AI device. The document does not specify the number or qualifications of such experts involved in establishing the testing parameters or reviewing the results.

4. Adjudication Method for the Test Set

The concept of "adjudication method" (like 2+1, 3+1) is not applicable to this type of device submission. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists reading images) where disagreement needs to be resolved to establish ground truth. For reprocessed external fixation devices, performance is assessed through objective physical, mechanical, and chemical tests.

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 relevant for diagnostic imaging devices where human readers interpret medical images. External fixation devices are physical medical instruments, and their effectiveness is not assessed through human reader interpretation of cases.

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

No, a standalone (algorithm-only) performance study was not done. This concept applies to AI/ML algorithms that operate independently. The device here is a physical external fixation device.

7. The Type of Ground Truth Used

For this device, the "ground truth" is established by objective engineering specifications, material properties, and sterility standards for external fixation devices. For instance:

• Mechanical Integrity: The reprocessed devices must meet the same mechanical strength, fatigue, and other performance characteristics as new, predicate devices.
• Biocompatibility: The materials must remain biocompatible after reprocessing.
• Sterility: The reprocessing must render the devices sterile, typically validated to a Sterility Assurance Level (SAL) of 10^-6.
• Cleaning Effectiveness: The devices must be effectively cleaned to remove biological and other foreign material.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this type of device. Training sets are used in machine learning for AI algorithms. This submission is for reprocessed physical medical devices, not an AI/ML product.

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

As noted above, a "training set" is not applicable to this device.

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Reprocessed Arthroscopic Shavers are intended to resect tissue and bone found in articular body cavities during orthopedic, maxillofacial, hand, foot and plastic surgery in patients requiring arthroscopic or orthopedic surgery.

Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses.

The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a bur or blade at the end of a long rod that rotates within a long hollow stainless steel housing.

The housing has a window cut out on one side of the distal end, allowing the bur to cut one structure, while the adjacent one is still protected by the housing on the opposite side of the bur or blade. This system attaches to a motorized handpiece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue and/or bone away from the surgical site.

The provided document is limited in detail regarding specific acceptance criteria and the studies conducted. It primarily focuses on demonstrating substantial equivalence of reprocessed arthroscopic burs to predicate devices. Here's a breakdown of the information that can be extracted, and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "Bench and laboratory testing was conducted," but it does not specify the sample size for any of these tests. It also does not provide information on data provenance.

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

This information is not available in the provided document. The studies were described as "Bench and laboratory testing," which typically does not involve human expert adjudication in the same way clinical studies would.

4. Adjudication Method for the Test Set

This information is not applicable/not available as the studies described are bench and laboratory tests, not clinical studies requiring expert adjudication methods like 2+1 or 3+1.

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

No, an MRMC comparative effectiveness study was not done. The studies conducted were "Bench and laboratory testing" focused on the performance of the reprocessed burs themselves, not on human reader performance with or without AI assistance.

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

This question is not applicable. The device is an arthroscopic bur, a physical surgical tool, not an
AI algorithm. Therefore, there is no "algorithm-only" performance to assess.

7. The Type of Ground Truth Used

The ground truth for the "Bench and laboratory testing" would have been established by engineering and quality control standards for medical device performance. For example:

• Biocompatibility: Likely relies on standardized tests showing no adverse biological reactions.
• Reprocessing Validation: Involves demonstrating the sterilization and cleanliness of the reprocessed device meets required standards.
• Function Tests: Involves objective measurements of the device's cutting ability, rotational speed, durability, etc., against predefined specifications derived from new devices or industry standards.

8. The Sample Size for the Training Set

This information is not applicable. The device is a reprocessed physical medical tool, not a machine learning algorithm that requires a "training set."

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

This information is not applicable, as there is no training set for this type of device.

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Reprocessed Arthroscopic Shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses.

The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a burr or blade at the end of a long rod that rotates within a long hollow stain- less steel housing. The housing has a window cut out on one side of the distal end, allowing the burr to cut one structure while the adjacent one is still protected by the housing on the opposite side of the burr or blade. This system attaches to a motorized handpiece that drives the internal burr or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site.

The provided document is a 510(k) summary for the Alliance Medical Corporation's Reprocessed Arthroscopic Shavers. It doesn't describe the acceptance criteria and study for a software-as-a-medical-device (SaMD) or an AI/ML device. Instead, it focuses on the substantial equivalence of a reprocessed medical device (arthroscopic shavers) to predicate devices.

Therefore, the information requested in the prompt regarding acceptance criteria, device performance, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance for an AI/ML device is not available in the provided text.

The document discusses:

• Device Description: Arthroscopic shavers used to abrade, cut, and excise tissue and bone, remove loose fragments, and shave debris in arthroscopic surgeries.
• Intended Use: Resecting tissue and bone in articular body cavities during various surgeries (orthopedic, maxillofacial, hand, foot, plastic surgery).
• Indications Statement: Cutting and removal of soft and hard tissue or bone in orthopedic surgical procedures of joints, jaw, or sinuses.
• Technological Characteristics: States that the design, materials, and intended use of the reprocessed shavers are identical to predicate devices.
• Performance Data: Mentions that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Arthroscopic Shavers." It also states "Biocompatibility Validation of reprocessing Functionality Test(s)" was done and "Performance testing demonstrates that Reprocessed Arthroscopic Shavers perform as originally intended."

However, it does not provide specific acceptance criteria or detailed results of these tests in a quantitative manner as requested for an AI/ML device. The focus is on demonstrating that the reprocessed device performs as originally intended by the predicate devices, not on proving a novel algorithm's performance.

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The reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw, or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses.

The arthroscopic shaver components reprocessed by Alliance Medical Corporation include a bur or blade at the end of a long rod that rotates within a long hollow stainless steel housing. The housing has a window cut out on one side of the distal end, allowing the bur to cut one structure while the adjacent one is still protected by the housing on the opposite side of the bur or blade. This system attaches to a motorized handpiece that drives the internal bur or blade inside the outer housing and provides suction to pull the cut tissue away from the surgical site.

The provided text describes the 510(k) summary for "Reprocessed Arthroscopic Shavers" by Alliance Medical Corporation. This pertains to the reprocessing of existing medical devices, not a new device with its own specific performance criteria derived from a study comparing it to an AI or human system.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of submission. This document focuses on demonstrating substantial equivalence to predicate devices for reprocessed medical instruments.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Performance testing demonstrates that Reprocessed Arthroscopic Shavers perform as originally intended." However, it does not provide specific quantitative acceptance criteria or detailed reported performance metrics (e.g., cutting force, sharpness retention, etc.) for the reprocessed devices. The acceptance criteria described are largely qualitative, focusing on equivalence to the original devices and successful reprocessing.

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

Not applicable. This is not a study evaluating a diagnostic or AI device with a test set of data. The "test set" in this context refers to the reprocessed devices themselves.

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

Not applicable. Ground truth as typically understood for AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the reprocessed devices is that they perform as originally intended, which would be validated through engineering and functional testing.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable. This is not an AI-assisted diagnostic or classification device.

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

Not applicable. This is a reprocessed physical medical device, not a standalone algorithm.

7. The Type of Ground Truth Used:

For the reprocessed devices, the "ground truth" is that they retain the performance characteristics (e.g., physical dimensions, material integrity, sharpness, cutting efficiency) and safety profiles of the original, new devices. This would be established through a combination of:

• Biocompatibility Validation: Ensuring no harmful residuals or material degradation from reprocessing.
• Reprocessing Function Test(s): Verifying the effectiveness of sterilization and cleaning protocols.
• Performance Testing: Bench and laboratory testing to confirm that the reprocessed shavers perform equivalently to new shavers as "originally intended." This likely involves mechanical testing, cutting force measurements, and visual inspection for integrity.

8. The Sample Size for the Training Set:

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

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

Not applicable.

Summary of available information regarding acceptance criteria and "study":

• Acceptance Criteria (Implicit):

  • Substantial Equivalence: The reprocessed devices must be substantially equivalent to the predicate (original, new) devices in terms of design, materials, intended use, mechanism of action, performance specifications, and safety.
  • Biocompatibility: The reprocessing process must ensure the device remains biocompatible.
  • Functional Performance: The reprocessed device must "perform as originally intended," implying retained cutting ability, structural integrity, and proper function.
  • Sterility: The reprocessing must achieve appropriate sterility.

• Study/Evidence Provided:

  • "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Arthroscopic Shavers."
  • "Biocompatibility Validation of reprocessing Function test(s)"
  • "Performance testing demonstrates that Reprocessed Arthroscopic Shavers perform as originally intended."

The document generally asserts equivalence and adequate testing without providing granular details about the specific tests performed, the quantitative acceptance thresholds, or the exact results of those tests. This level of detail is typical for a 510(k) summary for reprocessed devices, where the focus is often on demonstrating that the reprocessing does not alter the fundamental characteristics or performance of the device relative to its original, legally marketed form.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Musculo-skeletal Conventional.

The AMB7 is compact, lightweight and completely self-contained (w12" x h10" x 120") portable multipurpose ultrasound scanning system as are the predicate devices. The device can be carried anywhere for diagnostic purposes. The unit may operate from either a power source of 110vac / 220vac or from its' internal battery. A fully charged battery is able to provide the unit with approximately 1.5 hours of continuous operation. The predicate devices do not provide a means for battery operation. The AMIB7 uses a multi-frequency probe technology to produce high quality images (256 grey scale). The operator can select the best frequency, depending on the probe in use, to optimize near field imaging resolution and far field imaging penetration. The operator can move the focal point deeper through the image to reach the complex focus zone, to provide a better image resolution. The system features several operating modes, as do the predicate devices, and offers the following exam capabilities: B-mode. It is designed to perform Abdominal, Cardiac, and peripheral vascular, Pediatric, Obstetrical/Gynecological, Musculo-skeletal and small parts. The AMIB7 also enables the user to print reports viewed on screen. The AMIB7 allows the user to set up a wide variety of default parameters for easy operation like the predicate devices mentioned above. A sophisticated package of measurements and calculations ( Distance, Area, Circumference, Volume, Heart Rate, Ejection Fraction) are available B and M modes. In obstetric measurements for example, one can use the system equations and pre-programmed comparison tables or can set-up the unit and apply his own tables. The operator of the AMB7 unit can adjust the deplayed echo The system master gain allows the operator to uniformly control the gain level for all parts of the displayed image. The system Time Gain Compensation (TGC) allows for level adjustment of the echo amplification in near and far field (upper and the lower part of the echographic image).

The provided text is a 510(k) summary for the AMIB7 Ultrasound Diagnostic System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a specific study proving device performance against such criteria.

The document states that the AMIB7 ultrasound system "does not in any way raise new questions of safety or effectiveness, when used as labeled, in comparison to the predicate devices." It also mentions that the "AMIB7s are tested for compliance according to the Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices." This indicates compliance with a standard, but not a specific study with defined acceptance criteria and performance results directly linked to clinical outcomes or imaging quality metrics in the way a clinical trial or performance study would.

The FDA's response letter also primarily focuses on the determination of substantial equivalence and regulatory compliance, and requires a post-clearance special report for acoustic output measurements, but this is a condition of clearance, not a pre-market performance study outlined in the initial submission.

Therefore, for your request, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not applicable as a formal performance study against acceptance criteria is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an ultrasound imaging device, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on establishing substantial equivalence to predicate devices (Hitachi EUB-405, Aloka SSD-500, Fukuda UE-4500) based on similar technological characteristics and intended use, rather than presenting a detailed performance study with acceptance criteria for a novel device.

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