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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.

The present document describes the reprocessing of Phacoemulsification Tips. From the provided information, we could not extract the acceptance criteria and the comprehensive details of the study for the Phacoemulsification tips.

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

2. Sample size used for the test set and the data provenance: Not specified

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified

4. Adjudication method: Not specified

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable based on the provided text. The document describes laboratory and bench testing, not a clinical study involving human readers.

6. Standalone performance: Standalone performance was conducted through bench and laboratory testing. The document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Phacoemulsification Tips." The listed tests include: Biocompatibility, Validation of reprocessing, Sterilization Validation, Function test(s), Packaging Validation.

7. Type of ground truth used: For the performance data listed in point 6, the ground truth would be established by validated test methods and specifications relevant to each testing category (e.g., specific parameters for biocompatibility, sterility assurance levels for sterilization, defined functional parameters for function tests).

8. Sample size for the training set: Not applicable and not specified. The document describes a reprocessing procedure and validation, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established: Not applicable and not specified.

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

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 hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.

Here's a breakdown of the acceptance criteria and study information for Alliance Medical Corporation's Reprocessed Electrophysiology Catheters (K061045) based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided 510(k) summary is a high-level overview. It lists the types of tests conducted but does not provide specific acceptance values or detailed results for each test. The conclusion section broadly states that the device passes.

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

• Sample Size: Not explicitly stated in the provided text. The document mentions "Bench and laboratory testing" but doesn't quantify the number of reprocessed catheters or tests performed during the performance evaluation.
• Data Provenance: The studies were retrospective in the sense that they were conducted on already reprocessed devices, comparing their performance to the "originally intended" performance of the new predicate devices. The country of origin for the data is implicitly the United States, where Alliance Medical Corporation is based and where the testing would have been overseen for FDA submission.

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

• This information is not provided in the document. The studies described are bench and laboratory tests, not clinical studies involving human observers forming a ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Adjudication methods (e.g., 2+1) are relevant for studies where multiple human readers interpret data to establish a ground truth. Since the studies described are bench and laboratory tests, an adjudication method for a test set is not applicable or mentioned.

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

• No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study typically involves human readers using a device (often an AI) to evaluate cases. The studies here are bench tests on the reprocessed physical device.

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a reprocessed physical medical device (catheter), not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate. The performance noted is that of the reprocessed physical product.

7. Type of Ground Truth Used

• The ground truth for the bench and laboratory tests would have been established by engineering and performance specifications of the original, new predicate devices. For example, a function test for electrical conductivity would compare the reprocessed catheter's performance against the expected conductivity of a new catheter. The "ground truth" is adherence to established engineering parameters and predicate device performance.

8. Sample Size for the Training Set

• Not applicable. This device is a reprocessed physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable. As stated above, there is no training set for this device.

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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.

When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

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. Only the compression sleeves are reprocessed.

Here's an analysis of the provided 510(k) summary regarding the Reprocessed Compression Sleeves, focusing on acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics in a tabular format. Instead, it makes a general statement about the testing performed and the conclusion reached.

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

• Sample Size for Test Set: Not specified. The document states that "Bench and laboratory testing was conducted," but no sample sizes for these tests are provided.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

• Number of Experts: Not applicable. This type of device (reprocessed compression sleeves) typically relies on objective physical, chemical, and functional testing rather than expert interpretation of images or clinical data for ground truth establishment in this context.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As noted above, the assessment of this device type does not typically involve human expert adjudication in the way medical imaging software might. The performance testing would likely involve standardized measurements and observations.

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

• MRMC Study Done? No. This type of study is not relevant for this device. MRMC studies are typically used to assess the impact of AI on human reader performance, especially in diagnostic imaging.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done? Not applicable. This device is not an algorithm or AI system. Its performance is assessed through physical and functional testing of the reprocessed sleeves.

7. Type of Ground Truth Used

The ground truth for this device's performance would be established through a combination of:

• Objective Measurements: Physical dimensions, material integrity tests, pressure characteristics, flow rates, etc.
• Chemical Analysis: To confirm cleanliness and absence of contaminants after reprocessing.
• Microbiological Testing: To confirm effective decontamination/sterilization.
• Functional Testing: To ensure the sleeve inflates and deflates correctly, holds pressure, and delivers compression as designed, mimicking original device performance.
• Comparison to Predicate Device Specifications: The reprocessed device is intended to perform identically to the original, so the "ground truth" implicitly references the established performance characteristics of a new, predicate device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This product does not involve machine learning or AI, and therefore no "training set" in that sense. The manufacturing process itself could be seen as "trained" through process validation, but this term is not used in the context of device performance data for this product.

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

• Ground Truth for Training Set Established: Not applicable, as there is no "training set" for an AI algorithm. The methods used to validate the reprocessing procedure would involve standard engineering and quality control practices to ensure consistent and safe reprocessing outcomes.

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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.

When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

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. Only the compression sleeves are reprocessed.

The medical device in question is Reprocessed Compression Sleeves by Alliance Medical Corporation. The provided document is a 510(k) summary, which indicates that the device has undergone a substantial equivalence review by the FDA. This specific document primarily focuses on establishing equivalence to predicate devices and describes general performance testing, not a detailed clinical study with specific acceptance criteria and performance metrics for the reprocessed sleeves that would be typical for an AI/ML device.

Therefore, the requested information, which is highly tailored to AI/ML device studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details), cannot be fully extracted or accurately inferred from the provided 510(k) summary.

Here's an analysis based on what can be extracted and why other parts cannot be:

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

• Acceptance Criteria: The document states that "Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended." The criteria are implicitly tied to the performance of the predicate devices. However, no specific quantitative or qualitative acceptance criteria (e.g., pressure output within X% of original, no leakage above Y, durability for Z cycles) are explicitly listed in this summary.
• Reported Device Performance:
  • Bench and laboratory testing: Conducted to demonstrate "performance (safety and effectiveness)."
  • Biocompatibility: No specific results or metrics are given, only that it was tested.
  • Function Test(s): No specific results or metrics are given, only that it was tested.
  • Validation of Processing: This implies that the reprocessing steps (cleaning, decontamination, individual sleeve testing) were validated, but no specific data or metrics are provided.
  • Overall Conclusion: "Reprocessed Compression Sleeves perform as originally intended."

Without specific numerical or descriptive criteria, a table like the one requested cannot be constructed meaningfully. The document indicates that the reprocessed sleeves perform identically to the predicate devices in terms of "standard mechanical design, materials and sizes," and there are "no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." This implies the performance criteria are simply "meets the original specifications of the new device."

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

• Sample Size for Test Set: Not specified. The document mentions "individual compression sleeve is tested," but does not provide the number of sleeves tested.
• Data Provenance: Not applicable in the context of the provided information, as this refers to a reprocessed physical device, not an AI/ML algorithm's data.

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

• Not applicable. This device is a reprocessed physical medical device, not an AI/ML diagnostic or assistive tool where human expert ground truth would be established for image or data interpretation. The "ground truth" for this device would be its physical and functional specifications.

4. Adjudication method for the test set:

• Not applicable. This refers to how discrepancies in expert opinions are resolved, which is relevant for AI/ML diagnostic studies, not for the functional testing of a physical 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:

• No. This type of study is specifically for AI/ML systems that assist human readers (e.g., radiologists interpreting images). The Reprocessed Compression Sleeves are physical items.

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

• Not applicable. This refers to the performance of an AI/ML algorithm without human intervention. The device is a physical compression sleeve.

7. The type of ground truth used:

• For this physical device, the "ground truth" would be the original specifications and performance characteristics of new, unadulterated compression sleeves (the predicate devices). Each reprocessed sleeve is tested against these established functional parameters.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. See point 8.

In summary of what can be inferred for the Reprocessed Compression Sleeves:

The study proving the device meets its acceptance criteria involves bench and laboratory testing to demonstrate biocompatibility, function, and validation of processing. The inherent acceptance criterion is that the reprocessed sleeves perform identically to the new, predicate compression sleeves in all relevant aspects (design, materials, sizes, intended use, clinical applications, performance specifications, method of operation). The 510(k) summary indicates that these tests were sufficient to conclude "substantial equivalence." However, it does not provide the granular detail requested for AI/ML device studies.

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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.

When coupled with an appropriate inflation system, compression devices are intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation, and reducing wound healing time.

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. Only the compression sleeves are reprocessed.

The provided text is a 510(k) summary for Reprocessed Compression Sleeves. It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific numerical acceptance criteria, detailed study designs, or expert qualifications for ground truth establishment.

Here's a breakdown of the available information and where details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Device Performance: The document states, "Performance testing demonstrates that Reprocessed Compression Sleeves perform as originally intended." It also mentions, "Each individual compression sleeve is tested for appropriate function of its components prior to packaging, labeling, and EO exposure operations." However, specific numerical targets or detailed metrics for "appropriate function" are not provided.

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

The document does not specify the sample size used for the test set in the performance studies (biocompatibility, function tests, validation of processing). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature). The studies appear to be bench and laboratory tests, implying they were conducted in a controlled environment rather than involving patient data.

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

This information is not applicable and not provided. The studies described are bench and laboratory tests, not clinical studies requiring expert interpretation of medical images or patient outcomes to establish ground truth. The "ground truth" here would likely be defined by engineering specifications and objective measurements of device function and material properties.

4. Adjudication Method for the Test Set

This information is not applicable and not provided as the tests are not observational studies requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating the performance of the reprocessed sleeves itself and its substantial equivalence to the predicate, not on human-in-the-loop performance or the effect of AI assistance.

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

Yes, the studies described are standalone performance tests of the device itself (biocompatibility, function, and processing validation). There is no "algorithm" in the context of this device; it is a physical medical device. The "standalone" performance refers to the device's inherent functional and material characteristics without human intervention during the test aside from operating the test equipment.

7. The Type of Ground Truth Used

For the performance studies (biocompatibility, function tests, validation of processing), the ground truth would be established based on:

• Engineering Specifications/Standards: Performance metrics likely compared against established design specifications for new compression sleeves and relevant industry standards.
• Material Science Properties: For biocompatibility, adherence to material safety standards.
• Functional Parameters: Objective measurements of pressure, inflation/deflation cycles, integrity of components, etc., compared against the predicate device's known performance or design criteria.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical medical device, not an AI/machine learning algorithm, so there is no "training set" in the computational sense. The studies focused on verifying the reprocessing methods and the resulting device's performance.

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 external fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bory 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 is a 510(k) summary for the Alliance Medical Corporation's Reprocessed External Fixation Devices. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical or performance study for a novel AI/medical imaging device would.

Instead, the submission for these reprocessed devices focuses on demonstrating that they perform "as originally intended" and are substantially equivalent to the original predicate devices. This is a crucial distinction. For reprocessed devices, the "acceptance criteria" are primarily centered around ensuring the reprocessing does not compromise the device's functional integrity, sterility, and material properties compared to new devices.

Therefore, the information for some of your requested points is not present in this type of submission. I will answer based on the information provided and note when information is not available due to the nature of this 510(k) for reprocessed external fixation devices.

Description of Acceptance Criteria and Study

The acceptance criteria for the Reprocessed External Fixation Devices are implicit in demonstrating that the reprocessed devices are safe, effective, and substantially equivalent to the predicate devices and perform "as originally intended." The study conducted was a series of bench and laboratory tests designed to validate the reprocessing methods and ensure the device's original performance characteristics are maintained.

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 in the provided document. The 510(k) summary only states "Bench and laboratory testing was conducted," implying that a sample of reprocessed devices would have been tested, but the exact number is not disclosed.
• Data Provenance: The document does not specify the country of origin of the data. Given it's a US submission, it's highly probable the testing occurred in the USA. The tests were likely conducted prospectively as part of the reprocessing validation process.

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

• This information is not applicable and not provided. The "ground truth" for proving substantial equivalence of reprocessed mechanical devices primarily relies on objective engineering and scientific measurements from bench and laboratory tests, rather than expert clinical assessment of images or patient outcomes. The "ground truth" would be the engineering specifications and performance characteristics of the original predicate devices.

4. Adjudication method for the test set:

• This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation (e.g., radiologists, pathologists) where there might be inter-reader variability. For bench testing of mechanical properties, results are generally objective measurements that do not require clinical adjudication.

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

• This information is not applicable and not provided. This device is a reprocessed external fixation device, not an AI-powered diagnostic or therapeutic tool that would involve human readers or AI assistance.

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

• This information is not applicable and not provided. This device is a mechanical medical device, not an algorithm or AI system.

7. The type of ground truth used:

• The ground truth used for these tests would be the original manufacturer's specifications and performance data for the predicate (new) external fixation devices. The reprocessed devices are demonstrated to be substantially equivalent if their performance in the bench and lab tests meet these established specifications.

8. The sample size for the training set:

• This information is not applicable and not provided. There is no concept of a "training set" for a reprocessed mechanical device as there would be for an AI algorithm.

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

• This information is not applicable and not provided. As explained above, there is no training set for this type of device submission.

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

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.

Alliance Medical Corporation's Reprocessed Electrophysiology Catheters are designed to be substantially equivalent to predicate devices. The submission focuses on demonstrating that the reprocessing method does not alter the device's original performance, safety, or effectiveness.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed EP Catheter."

• Sample Size for Test Set: The exact sample size used for performance testing (functional, biocompatibility, reprocessing, sterilization, packaging) is not specified in the provided text.
• Data Provenance: The detailed provenance (e.g., country of origin of data, retrospective or prospective) is not specified. The testing was conducted internally by Alliance Medical Corporation, as implied by statements like "Alliance Medical Corporation's reprocessing... includes... testing..."

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

This type of information is not applicable to this submission. The "ground truth" here is based on objective scientific/engineering standards and measurements (e.g., cleanliness levels, sterility, electrical conductivity, mechanical deflection forces, material integrity after reprocessing, standard biocompatibility assays) rather than expert interpretation of images or clinical outcomes that require human assessment for ground truth determination.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable to the type of bench and laboratory testing described in this submission. Adjudication processes are typically used in clinical studies involving human interpretation or subjective clinical endpoints, where disagreements between evaluators need to be resolved.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance, typically in image-based diagnostics. The Reprocessed Electrophysiology Catheter is a medical device, and its evaluation focuses on its physical and functional integrity after reprocessing, not on diagnostic interpretive tasks.

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

Not applicable. This submission does not involve an AI algorithm with standalone performance. The device is a reprocessed physical medical instrument.

7. Type of Ground Truth Used

The ground truth used for this device evaluation is based on objective scientific and engineering metrics and standards. This includes:

• Physical/Functional Measurements: To confirm "appropriate function of its components" and "perform as originally intended," likely involving electrical conductivity tests, mechanical integrity tests (e.g., for shaft flexibility, deflection in deflectable catheters, electrode integrity), and dimensional analysis.
• Chemical Analysis/Microbiology: For "Biocompatibility," "Validation of reprocessing" (e.g., residual protein, bioburden, endotoxin levels), and "Sterilization Validation" (e.g., sterility testing, often using Biological Indicators).
• Packaging Integrity: For "Packaging Validation."
• Reference Standards: Comparison against the performance specifications of the original, new predicate devices.

8. Sample Size for the Training Set

Not applicable. This submission does not involve an AI algorithm that requires a training set.

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

Not applicable. As no AI algorithm requiring a training set is involved, this question does not apply.

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Reprocessed Diagnostic Electrophysiology Catheters are indicated for temporary intracardiac sensing, recording, stimulation, and electrophysiology mapping of cardiac structures.

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 hand piece, a flexible shaft and a distal tip section containing diagnostic electrodes. The distal tip of deflectable catheters can be deflected into a curve by manipulating the hand piece.

This document describes the 510(k) submission for Reprocessed Electrophysiology Catheters by Alliance Medical Corporation. The focus is on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for novel performance features. Therefore, many of the requested data points related to clinical study design and ground truth are not applicable or not provided in the typical sense for an AI/CAD device.

Given the information provided, here's a breakdown of the acceptance criteria and the "study" that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are primarily related to proving that the reprocessed device performs identically and as originally intended compared to new, predicate devices. The performance data focuses on demonstrating that the reprocessing does not negatively impact the catheter's function and safety.

Overall Conclusion regarding "Acceptance Criteria"

The overall acceptance criterion is: "Reprocessed Electrophysiology (EP) Catheters perform as originally intended" and are "safe, effective and substantially equivalent to the predicate devices." The "study" (bench and laboratory testing) aimed to demonstrate this equivalence across the listed categories.

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

• Sample Size for Test Set: The document does not specify the sample size for the bench and laboratory testing. It merely states that such testing was conducted.
• Data Provenance: Not applicable in the context of patient data provenance, as this is bench/laboratory testing on devices, not a clinical study involving patients.

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

• This is not applicable to this type of submission. "Ground truth" in the context of device reprocessing is typically established through established engineering standards, material science, microbiology (for sterility validation), and performance specifications for the original device. There isn't a need for "expert consensus" on diagnostic findings or clinical outcomes in the same way as an AI/CAD device.

4. Adjudication Method for the Test Set

• Not applicable as this is bench and laboratory testing against predetermined specifications and scientific principles, not a clinical trial requiring adjudicators for patient outcomes or diagnostic interpretations.

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 is a 510(k) for a reprocessed medical device (a catheter), not an AI/CAD system. Therefore, the concept of "human readers improving with AI" is not relevant to this submission.

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

• Not applicable. This device is a reprocessed physical medical instrument, not an algorithm or software. Its performance is inherent to its physical properties and functionality.

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

• The "ground truth" for this submission is based on the original performance specifications and safety profiles of the new, predicate electrophysiology catheters, coupled with established engineering, material science, and sterilization validation standards. For example:
  • Biocompatibility: Demonstrated against ISO standards for medical devices.
  • Sterilization: Validated to achieve a specific Sterility Assurance Level (SAL), often 10^-6, through established microbiological methods.
  • Functionality: Measured against the mechanical and electrical specifications of the original device (e.g., impedance range, signal-to-noise ratio, deflection force, physical integrity).

8. The Sample Size for the Training Set

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

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

• Not applicable. As there is no training set for an AI/ML model, there is no corresponding ground truth to establish for it.

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Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and 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 text describes an FDA 510(k) summary for Reprocessed External Fixation Devices. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or conducting a study to prove performance against specific metrics for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable or present in this type of submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The "acceptance criteria" for a reprocessed device in a 510(k) submission are primarily centered around demonstrating that the reprocessed device is substantially equivalent to the original, legally marketed predicate device(s) and performs "as originally intended" after reprocessing. Specific quantitative, measurable acceptance criteria in the sense of an algorithm performance are not typically included in such submissions for mechanical devices.

Missing Information/Not Applicable to this Device/Submission Type:

• 2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device undergoing a diagnostic performance test. The "test set" here refers to the actual reprocessed devices that underwent bench and laboratory testing. The submission does not specify the number of individual reprocessed units tested. Data provenance is also not relevant in the context of device reprocessing.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/software devices (e.g., expert consensus on medical images) does not apply here. The "ground truth" for a reprocessed device's performance is its original specifications and how untouched, new versions of the device perform.
• 4. Adjudication method for the test set: Not applicable for a reprocessed mechanical device.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this reprocessed device is its performance against the original device's specifications and intended function. The benchmark is the performance of the new, original (predicate) fixation devices.
• 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

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Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and 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 text describes the 510(k) summary for a reprocessed external fixation device (K052064). This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and functional testing rather than clinical trials with human subjects. Therefore, many of the typical elements of an AI/ML device study (like sample size for test sets, expert consensus for ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context.

Here's an analysis of the provided information in relation to the requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The acceptance criteria for a reprocessed device primarily revolve around demonstrating that the reprocessing does not degrade the device's original performance characteristics or safety. The performance data provided is high-level, stating that testing was conducted and that the reprocessed devices perform as originally intended. Specific pass/fail thresholds for individual tests are not detailed in this summary.

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

This is not applicable to this 510(k) submission. No test set involving human data or images was used. The evaluation was based on bench and laboratory testing of the reprocessed devices themselves.

The data provenance is from laboratory and bench testing, presumably conducted by Alliance Medical Corporation.

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

This is not applicable. The "ground truth" for a reprocessed medical device in this context is its ability to perform identically to virgin devices according to established mechanical and functional standards. This is determined through engineering tests directly on the devices, not by expert interpretation of data.

4. Adjudication Method for the Test Set

This is not applicable. There was no "test set" in the sense of clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. This submission is for a reprocessed physical medical device, not an AI/ML-powered diagnostic tool. Therefore, no MRMC studies or human reader performance analyses were conducted.

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

This is not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For this device, the "ground truth" for performance is established by the original design specifications and performance characteristics of the predicate (virgin) external fixation devices. The reprocessed devices are compared against these established standards through defined bench and laboratory tests to ensure they function equivalently. The "ground truth" is therefore established through engineering specifications and validated testing methods.

8. The Sample Size for the Training Set

This is not applicable. There is no AI/ML algorithm that requires a "training set" in this submission.

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

This is not applicable as there is no training set.

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