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The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

The Lipogems System is a pre-assembled device consisting of:

• . An ABS processing unit (Lipogems Processing Unit) containing 5 stainless steel spheres and 2 stainless steel sieve filters;
• An input washing line connected to the color-coded end cap of the processing unit; .
• An access port for the loading of material to be processed with a Luer-lock connection and selfoccluding valve (color-coded end-cap);
• . A drain line connected to the 'gray' end-cap of the processing unit;
• An access port for the discharge of processed material with a Luer-lock connection and self-occluding valve (gray end-cap);
• A bag for collecting waste material.

The Lipogems System Processing Unit is supplied sterile, for single use only, and manufactured in two size variants with the same functional characteristics:

• . LGD 240: Lipogems Processing Unit with 240 cc capacity and standard exit sieve;
• . LGD 60: Lipogems Processing Unit with 60 cc capacity and standard exit sieve;

The provided document is a 510(k) premarket notification for the Lipogems System. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (K161636 The Lipogems System), rather than presenting a study with specific acceptance criteria and performance data for a new device.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving those criteria are met.

Specifically, the following information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This document is a comparison to a predicate device, not a performance study against predefined criteria.
2. Sample size used for the test set and the data provenance: No performance test set is described.
3. Number of experts used to establish the ground truth... and their qualifications: No ground truth establishment is described as there's no performance study.
4. Adjudication method for the test set: Not applicable as there's no performance test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done... effect size: Not described. The device is a medical processing system, not one that involves human readers interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as there's no performance study that would require ground truth.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on demonstrating that the current Lipogems System is substantially equivalent to its predicate device by having identical indications for use, technological characteristics (e.g., closed loop system concept, sterilization method, biocompatibility), and manufacturing processes. It notes "slight modifications in end cap and outer processing unit geometry" and the addition of "color-coded end caps," but asserts these do not raise new questions of safety and efficacy. Biocompatibility testing (Cytotoxicity, Intracutaneous Reactivity, Delayed Hypersensitivity, Acute Systemic Toxicity) was performed to confirm this.

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The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

The Lipogems System is a pre-assembled device consisting of:

• An ABS processing unit (Lipogems Processing Unit) containing 5 stainless steel spheres and 2 stainless steel sieve filters;
• An input washing line connected to the 'blue' end-cap the processing unit;
• An access port for the loading of material to be processed with a Luer-lock connection and self-occluding valve (blue end-cap);
• A drain line connected to the 'gray' end-cap of the processing unit;
• An access port for the discharge of processed material with a Luer-lock connection and self-occluding valve (gray end-cap);
• A bag for collecting waste material.

The Lipogems System Processing Unit is supplied sterile, for single use only, and manufactured in two size variants with the same functional characteristics:

• LGD 240: Lipogems Processing Unit with 240 cc capacity and standard exit sieve;
• LGD 60: Lipogems Processing Unit with 60 cc capacity and standard exit sieve;

This document is a 510(k) premarket notification for the Lipogems System. It focuses on demonstrating substantial equivalence to a previously cleared device (K142682, also the Lipogems System) and a reference device (Ranfac FATS Procedure Pack, K150156). The document explicitly states that "The subject device is identical in every way to the predicate device previously cleared," and later, "The Subject and Predicate device are identical in every material and functional way, as there has been no change to the device materials, design, manufacturing, sterilization, packaging or any other feature since its prior clearance under K142682."

Therefore, the submission does not present new acceptance criteria or a new study to prove the device meets new criteria. Instead, it relies on the previous clearance and asserts that the current device is the same. The only change mentioned is a "revised language of the IFU and other labelling."

Given this, I cannot provide a table of acceptance criteria and reported device performance from this document, nor details about a new study, sample sizes, experts, adjudication methods, or MRMC studies. This information would have been part of the original K142682 submission.

However, I can extract information relevant to the current submission's claims of equivalence:

• Device Name: Lipogems System
• 510(k) Number: K161636
• Predicate Device: K142682 The Lipogems System, Lipogems International, S.p.A.
• Reference Device: K150156 Ranfac FATS Procedure Pack, Ranfac Corporation

The submission emphasizes that the current Lipogems System is identical to the predicate device K142682. The comparison table with the reference device, Ranfac FATS Procedure Pack, highlights similarities across various aspects.

Below are the details that can be extracted or inferred from this specific document, primarily regarding the assertion of equivalence rather than new performance data:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not provide a new table of acceptance criteria or performance data for the K161636 submission because it claims the device is identical to a previously cleared predicate. Performance was presumably established during the K142682 submission process. The table provided in the document focuses on comparing the subject device (K161636 Lipogems System) to its predicate (K142682 Lipogems System) and a reference device (Ranfac FATS Procedure Pack) to establish substantial equivalence based on device characteristics and indications for use, rather than new performance metrics.

   Implicit Acceptance Criterion (for Equivalence): The device (K161636) should be identical in material, functional aspects, design, manufacturing, sterilization, and packaging to the predicate device (K142682) and have similar technological characteristics and indications for use to the predicate and reference devices.

   Characteristic	Predicate Device (K142682)	Subject Device (K161636)	Reference Device (K150156)	Similarity
   Device Name	The Lipogems System	The Lipogems System	Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack	Identical to predicate, different from reference
   Device Manufacturer	Lipogems International SpA	Lipogems International SpA	Ranfac Corporation	Identical to predicate, different from reference
   510(k) Reference	K142682	K161636	K150156	N/A (unique to each submission)
   FDA Product Code	MUU	MUU	MUU	Identical
   FDA Classification Name	System, Suction, Lipoplasty	System, Suction, Lipoplasty	System, Suction, Lipoplasty	Identical
   FDA Regulation Number	878.5040	878.5040	878.5040	Identical
   System concept	Closed loop	Closed loop	Closed Loop	Identical
   Device Size Variations	Two: LGD 60, LGD 240	Two: LGD 60, LGD 240	None	Identical to predicate, different from reference
   Fill Volumes	Up to 30 or 120 ml of fat	Up to 30 or 120 ml of fat	5ml to 25ml of fat	Identical to predicate, different from reference
   Construction	Preassembled	Preassembled	Preassembled	Identical
   Sterility	Supplied sterile for single use	Supplied sterile for single use	Supplied sterile for single use	Identical
   Sterilization method	Ethylene oxide Gas	Ethylene oxide Gas	Ethylene oxide Gas	Identical
   Sterility Assurance Level (SAL)	SAL = 10-6	SAL = 10-6	SAL = 10-6	Identical to predicate
   Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Identical
   Indications for Use / Intended Use	Similar (for processing and transfer of autologous adipose tissue in various surgical specialties)	Similar (expanded list of surgical specialties, but core function is processing and transferring autologous adipose tissue)	Similar (for harvesting, concentrating, and transferring autologous adipose tissue in various surgical specialties)	Similar (The subject device's Indications for Use language is slightly different/expanded compared to its own predicate, but still asserts overall similarity, especially compared to the Ranfac reference device for the core function of processing and transferring autologous adipose tissue.)

2. Sample size used for the test set and the data provenance: Not applicable to this filing. This submission relies on substantial equivalence to a previously cleared device (K142632) that is stated to be "identical in every way." Any performance testing data would have been part of the original K142632 filing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a new study requiring expert ground truth establishment for performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This document does not describe a new study or test set 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: Not applicable. The Lipogems System is a physical medical device for processing adipose tissue, not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The Lipogems System is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this filing. As this is a substantial equivalence claim for an identical device, new performance data and corresponding ground truth are not presented.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

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The Lipogems System is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue for the purpose of transferring autologous adipose tissue for aesthetic body contouring (lipofilling) in applications including plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, qynecological surgery, thoracic surgery, and laparoscopic surgery. Only legally marketed accessory items. such as syringes, should be used with the system. If harvested fat is to be reimplanted. the harvested fat is only to be used without any additional manipulation.

The Lipogems System is a pre-assembled device consisting of:

• An ABS processing unit (Lipogems Processing Unit) containing 5 stainless steel spheres and . 2 stainless steel sieve filters;
• . An input washing line connected to the 'blue' side the processing unit;
• An access port for the loading of material to be processed with a Luer-lock connection and self-. occluding valve (blue side);
• . A drain line connected to the gray side of the processing unit;
• An access port for the discharge of processed material with a Luer-lock connection and selfoccluding valve (gray side);
• . A bag for collecting waste material.

The Lipogems System Processing Unit is manufactured in two size variants with the same functional characteristics:
LGD 240: Lipogems Processing Unit with 240 cc capacity and standard exit sieve; LGD 60: Lipogems Processing Unit with 60 cc capacity and standard exit sieve;

The intrinsic characteristics of the Lipogems fat treatment can be summarized as follows:

• . Minimal handling of adipose tissue (only via mechanical action);
• Maintenance of the vascular-stromal niches; ●
• . Reduction of fat clusters to allow injection with fine needles, up to 27G;
• . Removal of impurities, such as oil residues and blood.

The result of processing with the Lipogens System is a homogeneous and micronized fraction of adjpose tissue, which allows a patient's subcutaneous fat to be processed for autologous reinjection within the operative procedure time.

There is no direct interaction of the device with the patient, although the adipose tissue that is processed in the device comes from the patient and is returned to the same patient after processing.

Interaction with other devices is necessary for operation of the Lipogems System, in particular, standard FDA cleared syringes are needed for the initial injection of adipose tissue into the processing unit, and for receiving the processed tissue upon completion of the processing steps.

The steps of operation of the Lipogems System are:

• The Lipogems processing unit receives a constant gravity feed of physiological saline through the 1. upper port. After first filling the processing unit with saline, adipose tissue is injected into the processing unit, where it undergoes a first reduction treatment and micronization of lipidic cluster as it passes through the input sieve.
• 2. The processing unit is then shaken manually, causing the spheres contained within the processing unit to exert mechanical action on the tissue/saline emulsion and further reduce the lipidic clusters, preserving the vascular-stromal niches, while the continuous flow of saline eliminates oil and blood component residuals from the emulsion. The used saline is collected in the waste bag. Conducting the mechanical reduction while fully immersed in saline minimizes any traumatic action on the cells.
• 3. After completion of the shaking/washing step, the solution appears clear (at the top of the processing unit) and the lipoaspirate is yellow (at the bottom). The saline flow is then stopped and the device is inverted. A second adipose cluster reduction takes place by pushing the floating adipose clusters through the second sieve, pushing fluid from below with a svringe. The reduced clusters pass out of the (now) top of the unit into a collecting syringe.

The provided text is a 510(k) summary for the Lipogems System, a medical device intended for processing lipoaspirate tissue. It does not describe a study proving the device meets specific acceptance criteria in terms of clinical or technical performance metrics beyond basic device functionality and safety. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from studies directly measuring the device's efficacy or outcomes.

Therefore, the following information cannot be extracted from the provided text: acceptance criteria related to device performance (e.g., accuracy, sensitivity, specificity, or outcome measures), a study proving the device meets such criteria, sample size for test sets or training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth for performance evaluation of the device's intended use.

The document discusses "Performance data" in a section, but explicitly states: "The performance of the device is entirely controlled by the user and is not predetermined by the device itself." This indicates that the regulatory submission does not include studies for clinical performance or efficacy.

What is described are non-clinical tests performed to ensure the device's safety, sterility, and biocompatibility, which are necessary for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Since clinical or technical performance metrics for the device's intended use (processing lipoaspirate tissue for re-implantation) are not provided in the context of an acceptance criteria table, this table focuses on the non-clinical tests and their "performance."

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

• For non-clinical tests (sterility, shelf-life, biocompatibility, patency/leakage), the sample sizes are not explicitly stated. These are typically performed on a representative number of devices or materials according to the respective standards.
• Data provenance: Not applicable in the context of device performance related to its intended use as no clinical performance studies are presented. The non-clinical tests are conducted by the manufacturer as part of the device validation.

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

• Not applicable, as no clinical performance or ground truth for diagnostic accuracy is being established in this document. The "ground truth" for non-clinical tests is defined by the standards and validated methodologies for those tests.

4. Adjudication method for the test set:

• Not applicable, as no clinical performance or ground truth for diagnostic accuracy is being established.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, an MRMC comparative effectiveness study was not done. The document does not describe any clinical studies comparing the device's effectiveness.

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

• This device is a mechanical processing system, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device's "performance" is described as user-controlled.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" is based on established scientific and regulatory standards (e.g., ISO, ASTM) for demonstrating sterility, biocompatibility, and physical integrity. There is no clinical or pathology-based ground truth related to the device's efficacy on tissue processing outcomes discussed.

8. The sample size for the training set:

• Not applicable, as this is not an AI/algorithm-based device and no training set is mentioned or implied.

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

• Not applicable.

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