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The PAL Sterilization Case is a reusable sterilization case intended to provide storage for the PAL handpiece, the PAL cable, and 4 PAL cannulas during sterilization, storage, and transportation within the hospital environment. The PAL Sterilization Case is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with FDA-cleared sterilization wraps. The PAL Sterilization Case has only been evaluated for a non-stacked configuration. The validated steam sterilization parameters are listed below:

The MicroAire PAL Sterilization Case is a non-surgical, non-patient contacting, accessory to the already existing PAL (Power-Assisted Liposuction) System (cleared for market under K212024, K171286 and K220318), designed to contain reusable surgical instruments during steam sterilization. The case is designed to contain four (4) PAL Multi-Use Cannulas, one (1) PAL Electric Handpiece, and one (1) PAL Handpiece Cable. The subject product scope only includes the sterilization case, constructed of a separable base and lid, as illustrated in Figure 11-A.

The PAL Sterilization Case (subject device) is a stainless-steel case comprised of a separable lid and base. These two components latch together via the latch mechanisms on either side of the base which mate with the flanges on either side of the lid. Inside the case there are silicone mounts for a PAL handpiece, cable, and 4 cannulas (30 cm or less in length). The sterilization case is used to steam sterilize its contents via standard gravity or dynamic air removal autoclave processes. The subject device is a non-surgical, non-patient contacting, accessory device to the MicroAire PAL System. The subject device allows a user to organize and transport PAL reusable surgical instruments before, during, and after steam sterilization. The case is provided non-sterile and contains silicon mounting brackets to keep the devices in place, and a perforated stainless-steel enclosure to allow penetration of steam. The case has an overall footprint of approximately 16" x 6" x 2". Its construction of 1mm thick stainless steel and silicone make it lightweight and easy to transport when fully loaded with instruments. The lid also has two carrying handles on its lid for easy transport.

The provided FDA 510(k) clearance letter and summary describe a "PAL Sterilization Case," which is a reusable case for sterilizing surgical instruments. This is a medical device, but it is not an AI/ML powered medical device. Therefore, the questions about acceptance criteria for AI algorithms, such as sample size for test sets, data provenance, expert adjudication, MRMC studies, and standalone algorithm performance, do not apply to this submission.

The document focuses on the performance validation of a physical sterilization case and its ability to maintain sterility under specific sterilization parameters.

Here's an analysis of the available information regarding its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sterilization Validation: The document does not explicitly state the specific sample size (e.g., number of test runs or sterilization cycles) for the gravity and pre-vacuum steam sterilization validations. However, it indicates that the tests were conducted according to recognized standards (ANSI/AAMI ST77, AAMI TIR12, ISO 17665, and FDA guidance), which would prescribe appropriate sample sizes and methodologies for achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
• Cleaning Validation: The sample size for cleaning validation is not explicitly stated. It adheres to AAMI ST98 requirements.
• Weight Verification: The document states "ANSI/AAMI ST77:2013/(R)2018 (for sample size)," implying that the sample size for weight verification was derived from this standard. The outcome states a mean weight of 5.582 lb ± 0.026 lb, which suggests multiple measurements were taken to achieve 90% confidence, but the exact number of cases or measurements isn't provided.

Data Provenance: The data is from "non-clinical testing" performed by MicroAire Surgical Instruments, LLC, the device manufacturer. The tests are laboratory-based validations rather than observational studies, so concepts like "country of origin of the data" or "retrospective/prospective" are not directly applicable in the same way they would be for patient data.

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

• This question is not applicable. For physical sterilization validation, "ground truth" is established through standardized microbiological testing (such as biological indicators and physicochemical parameters) and subsequent lab analysis to confirm the absence of viable microorganisms or the attainment of a specified Sterility Assurance Level (SAL), not by human expert interpretation in the medical imaging sense.
• For cleaning validation, "visible evidence of test soil" is typically assessed by trained personnel using visual inspection criteria.
• For weight verification, it's a direct measurement.

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

• This question is not applicable to the non-clinical performance data presented for this physical sterilization case. Adjudication methods are typically used in clinical studies or AI/ML performance evaluations where there is subjective interpretation of findings by multiple experts.

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 question is not applicable. The PAL Sterilization Case is a physical device, not an AI/ML system, and therefore, an MRMC study related to AI assistance for human readers was not performed.

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

• This question is not applicable. The PAL Sterilization Case is a physical device, not an algorithm.

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

• Sterilization Validation: The ground truth for sterilization effectiveness is based on microbiological assay results (confirming a Sterility Assurance Level (SAL) of 10⁻⁶) and physicochemical parameters (temperature, time, pressure, and dryness) as defined by established sterilization standards (e.g., ANSI/AAMI ST77, ISO 17665). This is an objective, laboratory-derived ground truth.
• Cleaning Validation: The ground truth for cleaning effectiveness is the absence of visible test soil after cleaning, as assessed by visual inspection from a specified distance according to AAMI ST98, and potentially measured levels of residual soil.
• Weight Verification: The ground truth for weight is direct measurement using calibrated scales.

8. The sample size for the training set:

• This question is not applicable. The PAL Sterilization Case is a physical device and does not involve AI/ML algorithms that require a "training set."

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

• This question is not applicable, as there is no "training set" for this physical device.

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The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The PliaForm™ Breast Tissue Expander w/ Suture Tabs is designed for breast reconstruction, designed for thinner components and a reduction of reinforcement features and minimized insertion profile. The integrated port design consists of a plastic needle guard and a smaller magnetic element to improve MR compatibility (MR Conditional). The next generation design control technology (DCT) facilitates predictable expansion and is shape-optimized to better match the entire implant portfolio. An improved Bufferzone features a new sheeting-based self-sealing technology that offers protection from inadvertent needle punctures across the entire coverage area, and a more flexible design, which improves the overall device flexibility. An internally fixated injection port reduces device bulkiness. The injection port will incorporate a new plastic needle guard with a silicone backing and smaller magnet with reduced magnetic field strength compared to the Artoura™ breast tissue expander devices. This feature reduction improves device compatibility with MR-CT imaging, and external beam radiation (such as photon beam).

Identification of the injection port site is accomplished by use of the CENTERSCOPE™ 2.0 Magnetic Injection Port Locator, which is provided with the Tissue Expander. When the Centerscope™ 2.0 device is placed on top of the skin, the magnetic arm points to the center of the tissue expander's injection port. Injections into the injection port area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution.

The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs incorporates suture tabs to provide surgeons with the option to attach the device to surrounding tissue for enhanced device stability.

The MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs are provided sterile in three styles (Low Height, Medium Height, and Tall Height) and various sizes.

The following accessories are packaged with the MENTOR ™ PliaForm™ Breast Tissue Expander w/ Suture Tabs:

• Centerscope™ 2.0 Magnetic Injection Port Finder
• Winged Infusion Set (21G)

The provided text is a 510(k) clearance letter for the MENTOR™ PliaForm™ Breast Tissue Expander. It describes the device, its intended use, a comparison to a predicate device, and the performance data used to demonstrate substantial equivalence.

However, it does not contain any information about a study involving an AI/software device or human-in-the-loop performance. The "performance data" section exclusively details biocompatibility and mechanical testing of the physical breast tissue expander, along with MR/CT/RT qualification studies for the expander's physical properties when exposed to these imaging modalities.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria for an AI/software device or human reader performance, as this information is absent from the provided document.

The document discusses acceptance criteria and study results for the physical device's performance, which are summarized below, but these are not related to AI or human-in-the-loop studies.

Summary of Device Performance and Acceptance Criteria (for the physical device from the provided text):

1. Table of Acceptance Criteria and Reported Device Performance (for the physical device):

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

• The document refers to "samples" used for various biocompatibility and mechanical tests, but does not specify the exact sample sizes for each test. It states, "All mechanical performance testing results met their pre-determined acceptance criteria."
• The data provenance is not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. It is implied to be laboratory testing of manufactured devices.

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

• Not applicable as no human-in-the-loop or AI study is described. The ground truth for the physical device performance is established through standardized engineering and materials science testing methods (e.g., ASTM standards) and comparisons to established safe profiles for biocompatibility.

4. Adjudication Method:

• Not applicable as no human-in-the-loop or AI study is described.

5. MRMC Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done, as this is a physical medical device, not an AI or imaging diagnostic tool.

6. Standalone Performance (Algorithm Only):

• Not applicable as this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• For biocompatibility: Analytical characterization and comparison to established safe materials and predicate device.
• For mechanical testing: Engineering specifications, ASTM standards (e.g., ASTM F1441-03), and internal "pre-determined acceptance criteria."
• For MR/CT/RT qualification: Physical measurements (induced force, torque, heating), post-exposure device integrity checks against ASTM standards, and dosimetry measurements in a preclinical phantom model compared to sham controls.

8. Sample Size for the Training Set:

• Not applicable as this is a physical medical device, not an AI system that requires a "training set."

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

• Not applicable as this is a physical medical device, not an AI system.

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Aesthetic body contouring

The MicroAire PAL® Aspiration System provides an adjustable vacuum source that drives the suction of tissue during suction-assisted aesthetic body contouring procedures. The PAL Aspiration System features a modular style PAL® Aspiration Pump (ASP-PUMP-120/240) unit with a separate, stackable PAL® Aspiration Pump Console (ASP-UI) which provides organizational modularity and ease of transport within the medical facility. Communication between the units is achieved via the Aspiration Pump Cable (ASP-CBL). The PAL Aspiration Pump utilizes a dual-piston pump as a vacuum source that delivers 0-29 inHg and drives the suction of tissue. The PAL Aspiration Pump also features a multi-socket outlet (MSO) to provide power to up to four devices using the AC Power Cord Jumper Cable (ASP-CORD), eliminating extra power cords for better cable organization. The PAL Aspiration Pump Console is an electronic control system which allows the operator to digitally set and visualize the vacuum level. It also provides the status of basic pump operations, sends the Pump's ON/OFF signal, and provides receptacles for the connection of the Aspiration Pump Cable and optional accessories. The Aspiration Foot Switch (ASP-FOOT) and the 5020 to Aspiration Pump Cable (5020-ASP) are optional accessories which provide the operator with additional Aspiration Pump ON/OFF control options. The PAL Aspiration Pump requires a Biofilter (ASP-FLTR2), which prevents the ingress of vapor particulate into the motor. The Biofilter is a non-sterile filter assembly with vacuum tubing placed on the vacuum inlet. Connection to a system of generic collection canisters (sold separately) is expected for the PAL Aspiration System to function as intended. Additional Vacuum Tubing (ASP-TUBING) can be used to replace existing Biofilter tubing as needed.

The provided text is a 510(k) summary for the MicroAire PAL® Aspiration System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm validation study would for AI/ML devices.

Therefore, much of the requested information cannot be found in this type of regulatory submission. The device is a physical suction system, not an AI/ML device, which explains the absence of data related to AI/ML specific criteria.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document does not explicitly present a table of acceptance criteria alongside reported device performance in a quantitative manner for specific benchmarks. Instead, it states that "The PAL Aspiration System passed all non-clinical bench testing, supporting its safety and effectiveness, and its substantial equivalence to the predicate device."

It lists several voluntary consensus standards and FDA Guidance documents that the device complies with, which implicitly define the acceptance criteria for various aspects:

Note on "Maximum Vacuum" and "Maximum Flow Rate": While these are reported as characteristics in Table A, they are presented as comparative figures to the predicate device, not necessarily as acceptance criteria that were quantitatively "met" against a pre-defined threshold.

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

This information is not applicable and not provided. The testing described is non-clinical bench testing of a physical device, not a study involving patient data or a "test set" in the context of AI/ML or clinical trials.

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 applicable and not provided. As above, there is no "test set" requiring expert-established ground truth in the context of this device's non-clinical bench testing.

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

This information is not applicable and not provided.

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

This information is not applicable and not provided. The device is a suction lipoplasty system, not an AI-assisted diagnostic or treatment system.

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

This information is not applicable and not provided. The device is a physical system, not an algorithm.

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

This information is not applicable and not provided. For non-clinical bench testing, the "ground truth" would be established by validated measurement equipment and adherence to engineering specifications and international standards.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for this type of device.

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

This information is not applicable and not provided.

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The PAL® Infiltration System is indicated for the purpose of aesthetic body contouring.

The MicroAire® Power Assisted Liposuction (PAL®) Infiltration System is a medical device intended for aesthetic body contouring. The PAL Infiltration System is a stand-alone peristaltic Infiltration Pump, with the ability to control ON/OFF function to the PAL Handpiece (sold separately), the Infiltration Pump, or a Foot Switch (INF-FOOT-1) depending on the doctor's preference.

The PAL® Infiltration System is comprised of the following components that are subject to this 510K:

• INF-PUMP PAL Infiltration Pump
• Accessories
  • o PAL-INF-1600 Infiltration Tubing
  • o PAL-INF-XXXXX Single-Use Infiltration Cannulas
  • o PAL-INF-RXXXXX Multi-Use Infiltration Cannula
  • o INF-CBL-5020, Infiltration Pump to 5020 Console Connector Cable
  • o INF-FOOT-1, Infiltration Foot Switch

The provided document is a 510(k) Pre-Market Notification for a medical device (MicroAire PAL Infiltration System). This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel safety and effectiveness through clinical trials or performance studies with acceptance criteria in the typical sense of AI/algorithm performance.

Therefore, the requested information regarding acceptance criteria, study design for proving device performance (especially related to AI/algorithms), sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this type of regulatory submission.

The document describes engineering and biocompatibility testing, primarily against established standards, to demonstrate that the new device performs similarly and is as safe as its predicate. It does not involve AI, image analysis, or diagnostic/prognostic output that would require the typical performance study elements you've listed.

Here's a breakdown based on the document's content, explaining why your specific questions are not directly answerable in this context:

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

• Not Applicable in the AI/algorithmic sense. The "acceptance criteria" here are met through demonstrating compliance with recognized standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety) and internal specifications for functional parameters (e.g., flow rate). The document states: "Results confirm that the design inputs and performance specifications for the device are met. The PAL Infiltration System passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device."
• Reported Performance (Functional, not diagnostic):
  • Infiltration Pump Flow Rate: "meets internal specifications" (No specific numerical target or range is given in the public summary, only that it passed).
  • Biocompatibility: Passed Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute Systemic Toxicity per ISO 10993-5, -10, -11, and USP <151>.
  • Electrical Safety: Passed per IEC 60601-1.
  • Electromagnetic Disturbance (EMD) testing: Passed per IEC 60601-1-2.
  • Transportation Testing: "Demonstrates package integrity maintained" per ASTM D4169.

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

• Not Applicable. This device is a mechanical pump and associated cannulas/tubing. Performance testing refers to engineering tests on a limited number of manufactured units or materials, not a "test set" of patient data for an algorithm. There is no patient data involved in these performance tests.

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

• Not Applicable. No "ground truth" in the clinical/interpretive sense is established as there's no AI or diagnostic component.

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

• Not Applicable. No clinical/interpretive test set or adjudication is relevant here.

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

• Not Applicable. This is not an AI-assisted device.

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

• Not Applicable. This is not an AI device.

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

• Not Applicable. No ground truth for clinical outcomes in this context. Performance is measured against engineering specifications and international standards.

8. The sample size for the training set:

• Not Applicable. No training set, as there is no AI/machine learning component.

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

• Not Applicable. No training set or associated ground truth.

In summary: The provided document is a direct FDA 510(k) submission that demonstrates substantial equivalence for a physical medical device (an infiltration pump) through engineering and biocompatibility testing against established standards, not through AI/algorithm performance studies or clinical trials involving patient data analysis. Your questions are tailored for AI/ML device submissions, which is a different regulatory pathway and type of evidence.

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For aesthetic body contouring

The MicroAire® Power Assisted Liposuction (PAL) System is a medical device intended to be used for the aspiration of autologous adipose tissue in lipoplasty procedures. The PAL system consists of three components: electric instrument console, handpiece, and cable. The PAL-650 handpiece is powered by the MicroAire 5020 Electric Instrument Control console via the 5006 PAL cable and connected to an independent aspiration source. The PAL-650 handpiece reciprocates a cannula used in liposuction procedures for aspiration of fat tissue.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of AI/ML performance.

The document is a 510(k) premarket notification for a medical device called the "PAL System" (Power Assisted Liposuction System) manufactured by MicroAire Surgical Instruments, LLC. It details the device's substantial equivalence to a predicate device, the Vibrasat® Power, for the indication of aesthetic body contouring.

The information provided focuses on:

• Regulatory information: FDA clearance, product codes, regulation numbers.
• Device description: Components (console, handpiece, cable), mechanism of action, physical characteristics.
• Comparison to a predicate device: Highlighting similarities and differences in intended use, technology, user, physical characteristics, performance (e.g., strokes/min), electrical safety, and reuse (cleaning/sterilization).
• Non-clinical performance data: Listing various bench tests performed (biocompatibility, electrical safety, EMD, software verification/validation, mechanical tensile testing, sterilization validation, transportation testing).
• Clinical performance data: Stating that no human clinical testing was required because the indications for use are equivalent to the predicate device and the device type has a long history of safe and effective use.

Therefore, the document does not include:

1. A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
2. Sample sizes or provenance of a test set for AI/ML.
3. Information about experts establishing ground truth for AI/ML.
4. Adjudication methods for AI/ML test sets.
5. MRMC studies for AI assistance.
6. Standalone performance of an algorithm.
7. Type of ground truth (beyond "proven safety and efficacy" for a mechanical device).
8. Sample size for a training set or how its ground truth was established, as this is not an AI/ML device submission.

The document describes the regulatory pathway for a conventional medical device, not an AI/ML model.

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The MicroAire PAL Manual Wand and Multi Use Cannulas are indicated for the removal of tissue or fluid from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.

The MicroAire® PAL liposuction family of instruments is indicated for use for the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty for the purpose of aesthetic body contouring. The MicroAire® PAL Multi-Use Cannula consists of a stainless steel cannula with a plastic hub which attaches to the MicroAire® PAL-730 Manual Wand and has a connection for standard vacuum (suction) tubing.

The MicroAire® Multi-Use Cannula is supplied non-sterilized by the user, and may be steam sterilized for use on subsequent patients. The Multi-Use Cannula are offered in various diameters (2.4mm, 4.0mm and 5.0mm diameters), lengths (15cm, 30cm and 40 cm) and with various types of distal fenestrations (Mercedes, Flared Mercedes, Double Mercedes, Offset Double Mercedes, Tri-Port II, Mirrored Tri-Port III, Tri-Port III, Helixed Tri-Port III, Multi-Hole, Del Vecchio Track-12).

The MicroAire® PAL Manual Wand (PAL-730) is indicated for use in the removal of tissue or fluid from the body during general surgical procedures, including suction Lipoplasty for the purpose of aesthetic body contouring. The MicroAire® PAL Multi-Use Cannulas are supplied non-sterilized by the user prior to use, and may be steam sterilized for use on subsequent patients

The provided document is a 510(k) Premarket Notification from the FDA for the MicroAire PAL Multi-Use Cannula and PAL Manual Wand. It asserts substantial equivalence to legally marketed predicate devices rather than proving independent acceptance criteria through a standalone study with human data.

Therefore, the study design and results typically associated with AI/ML-driven medical devices (e.g., test set sample size, expert ground truth, MRMC studies, effect sizes) are not applicable to this submission. This device is a traditional mechanical surgical instrument, not an AI/ML device.

However, I can extract information about the non-clinical performance data which serves as the "proof" that the device meets its acceptance criteria for substantial equivalence.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria (Non-Clinical Performance) and Reported Device Performance:

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

• Test set sample size: Not applicable in the context of clinical data for this 510(k) submission. For the non-clinical performance tests, specific sample sizes are not explicitly stated in the summary, but standard engineering and quality control practices would apply to each test (e.g., number of units tested for bending strength, fatigue, etc.).
• Data provenance: Not explicitly stated for each non-clinical test, but implied to be internal laboratory testing performed by MicroAire Surgical Instruments, LLC.

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 not an AI/ML diagnostic device requiring expert interpretation of results. The "ground truth" for the non-clinical tests is established by engineering specifications and objective measurements against those specifications.

4. Adjudication method for the test set:

• Not applicable. (See #3)

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 not an AI-assisted device.

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

• No. This is not an AI/ML device.

7. The type of ground truth used:

• For the non-clinical performance data, the ground truth is based on engineering specifications, material science properties, and adherence to recognized national and international standards related to medical device safety and performance (e.g., ISO 10993-1 for biocompatibility, AAMI standards for sterilization).

8. The sample size for the training set:

• Not applicable. There is no AI/ML training set for this device.

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

• Not applicable. (See #8)

Summary on Substantial Equivalence Justification:

The core of this 510(k) submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices (MicroAire® PAD System Cannula, K981922, and Black&Black Surgical Inc., Aspiration and Infiltration Cannulas, K113795). The applicant asserts that the device has the same intended use, similar technological characteristics, and that the non-clinical testing confirms it does not raise any new safety or effectiveness concerns compared to the predicates. The FDA concurred with this assessment in the 510(k) clearance letter. This approach is standard for many traditional medical devices.

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The MicroAire LipoFilter System is used in the aspiration, filtering and transferring of autologous adipose tissue for aesthetic body contouring. If the harvested fat is to be re-implanted fat is only to be used without any additional manipulation.

The MicroAire LipoFilter System consists of a single use, closed loop tissue collection system comprised of a medical grade canister, vacuum port, collection port, tissue port and lid intended to be used with a standard liposuction aspiration system pump to collect fatty tissue for aesthetic body contouring. As the tissue is harvested from the patient, it enters the canister via the collection port in the canister lid. The physician removes unwanted waste materials from the collection system via the vacuum port by closing a valve. This process leaves fatty tissue that can be transferred to syringes via the tissue port for autologous fat re-injection.

The provided text describes the MicroAire LipoFilter System, a device for aspirating, filtering, and transferring autologous adipose tissue for aesthetic body contouring. The document is a 510(k) premarket notification from the FDA, aiming to establish substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information provided, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or target performance metric format with corresponding reported values. Instead, it describes various tests and validations that demonstrate the device meets certain standards. These can be inferred as the "acceptance criteria" for demonstrating substantial equivalence.

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

The document does not specify sample sizes for any of the tests conducted (e.g., how many units were tested for sterility, shelf life, or biocompatibility). It only states that various tests were performed.

The data provenance is not explicitly mentioned in terms of country of origin or whether the studies were retrospective or prospective. All testing appears to be pre-clinical (bench testing, lab validation), not involving human subjects.

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 tests described (sterility, shelf life, biocompatibility, performance) are objective validations against international standards (ISO) and internal specifications. They do not typically involve experts establishing a "ground truth" in the way a clinical study might for diagnostic accuracy, where interpretations are made.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data (e.g., imaging, pathology) by multiple reviewers to resolve discrepancies and establish a consensus "ground truth." Since the studies described are pre-clinical validation tests (sterility, shelf life, biocompatibility, mechanical performance), an adjudication method is not applicable and therefore not 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 MRMC comparative effectiveness study was done or is applicable. This device is a surgical instrument system for fat processing, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no discussion of human readers, AI, or effect sizes related to AI assistance.

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

No standalone algorithm performance study was done or is applicable. As mentioned, this is a physical medical device, not a software algorithm or AI.

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

For the pre-clinical tests, the "ground truth" is established by:

• International Standards: e.g., ISO 11137-1:2006, ISO 11137-2:2006 for sterility; ISO 11607-1:2006, ISO 11607-2:2006 for packaging/shelf life; ISO 10993-1:2009 for biocompatibility; ISO 10079-1 for specific performance aspects.
• Predetermined Internal Specifications: "MicroAire LipoFilter System was tested for performance in accordance with its predetermined specifications on file at MicroAire."
• Direct Measurement/Observation for Functionality: Testing for tubing connection strength, vacuum leaks, and adipocyte viability would involve direct objective measurements against predefined pass/fail criteria.

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these pre-clinical validations.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and 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 above, there is no training set for this type of device.

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The MicroAire LipoTower System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

• Neurosurgery
• Gastrointestinal and Affiliated Organ Surgery
• Urological Surgery
• Plastic and Reconstructive Surgery
• General Surgery
• Orthopedic Surgery
• Gynecological Surgery
• Thoracic Surgery
• Laparoscopic Surgery

The MicroAire LipoTower System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.

The MicroAire LipoTower System is a modular wheeled cart that contains an adjustable vacuum source and a tumescent pump (110/120 VAC, 60 Hz). The vacuum source is a rotary vane type pump that delivers 0-29 inHG vacuum and drives the suction of tissue. The tumescent pump is a peristaltic type that delivers 50-600 ml/min of fluid as required. The system includes a control module with an LCD touch screen for control and status of the system and foot controls for controlling the vacuum pump and tumescent pump. Accessories include a bag holding pole, canister rack and shelves with are included. The system requires a biofilter (non-sterile) on the vacuum inlet and collection canisters (non-sterile - 1200ml and 2000ml) which are available separately.

This FDA 510(k) summary for the MicroAire LipoTower System (K113128) does not describe a study to prove the device meets specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Sound Surgical Technologies LLC - SoundVaser System, K022051) by comparing technical characteristics, indications for use, and compliance with recognized standards.

Therefore, many of the requested details about acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC/standalone studies are not applicable or not provided in this type of regulatory document.

However, I can extract information related to the technical characteristics and standards compliance, which serve as a form of "acceptance criteria" for electro-mechanical medical devices like the MicroAire LipoTower System.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this type of device are primarily related to its technical specifications matching or being comparable to the predicate device, and its compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards.

Table of Acceptance Criteria (Technical/Compliance) and Reported Device Performance:

Study Information (as applicable to this type of device submission):

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

   • N/A. This submission does not describe a clinical performance study with a "test set" in the diagnostic sense. The testing performed would have been laboratory-based verification and validation against engineering specifications and regulatory standards. The provenance of such lab data is typically internal to the manufacturer or from accredited testing laboratories, not clinical patient data.

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

   • N/A. No ground truth established by experts for a diagnostic test set is mentioned.

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

   • N/A. No adjudication method for a diagnostic test set is mentioned.

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:

   • N/A. This device is a surgical instrument (suction lipoplasty system), not an AI-powered diagnostic imaging device. No MRMC study was conducted or is relevant.

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

   • N/A. This device is not an algorithm; it is an electro-mechanical surgical system.

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

   • N/A. For this device, "ground truth" would relate to engineering specifications, safety standards, and functional performance metrics (e.g., vacuum pressure, flow rates) validated through bench testing, not clinical diagnostic ground truth.

7. The sample size for the training set:

   • N/A. This device does not use machine learning algorithms that require a "training set."

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

   • N/A. Not applicable, as no training set is used.

Conclusion from the Document:

The document states in section 8, "Conclusion: The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials, design and tested methods." This means the product's compliance with electrical safety, EMC standards, and its technical specifications, along with its intended use, were deemed sufficient to demonstrate substantial equivalence to the predicate device, not that it met a specific clinical performance acceptance criteria in terms of diagnostic accuracy.

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