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REVOLVE ENVI™ 600 System is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.

REVOLVE ENVI™ 600 System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrointestinal and affiliated organ surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

REVOLVE ENVI™ 600 Advanced Adipose System (REVOLVE ENVI 600 System) consists of a sterile, single-use canister and components intended to be used for harvesting, filtering and transferring of autologous adipose tissue. Such products have been classified by FDA as Class II devices under 21 CFR §878.5040. Suction Lipoplasty System. and assigned product code MUU. The subject device should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. The adipose tissue is harvested from the patient using liposuction tubing and cannula that are supplied by the user or the institution. The harvested tissue is collected inside the device which contains an inner basket with 200 um mesh filter that can process up to 600 mL of collected tissue. A manual stirring assembly allows the user to mix the tissue and Lactated Ringer's during the washing step. The processed adipose tissue is removed from the device via an extraction port located on the bottom of the device using a syringe.

The REVOLVE ENVI 600 System is comprised of the following components, intended to be used only as a system:

• Canister (including mesh filter)
• Syringe Adapter
• Temperature Strip
• Lactated Ringer's Tubing Set
• Vacuum Tubing Set

The device is offered in a single size, is packaged in a thermoformed tray and Tyvek® lidding and is sterilized via gamma irradiation. The device is a single-use device to be used in a healthcare facility.

Here's an analysis of the provided text regarding the REVOLVE ENVI 600 Advanced Adipose System, structured according to your request. However, it's important to note that this document is a 510(k) summary for a medical device and not a detailed study report for an AI/ML powered device. Therefore, many of your requested criteria, particularly those related to AI algorithm performance (like sample sizes for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies, and standalone performance metrics), are unlikely to be found. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

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

The document does not explicitly state "acceptance criteria" in the typical sense of quantitative targets for each test in a table format. Instead, it states that the tests were performed "to support substantial equivalence" and that "data demonstrate that the device is biocompatible" and "is comparable to the predicate REVOLVE System in product performance characteristics relevant to the intended use of the device."

Below is a table summarizing the types of performance tests conducted. The specific quantitative results or acceptance thresholds for each test are not provided in this summary.

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

This information is not provided in the 510(k) summary. The document describes bench testing, which typically uses laboratory samples or device units, not patient data in the context of AI.

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/provided. The performance evaluation described is for a physical medical device (lipoplasty system) through bench testing and biocompatibility assessments, not an AI/ML algorithm that requires expert-established ground truth from images or clinical data.

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

This information is not applicable/provided. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI algorithms, which is not the focus of the performance tests described 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

This information is not applicable. An MRMC study is relevant for AI-assisted diagnostic or interpretive devices. This 510(k) is for a physical surgical system for adipose tissue processing and does not involve AI assistance for human readers.

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

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

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

This information is not applicable/provided. The ground truth for this device would be established through engineering specifications, material properties, and standardized test methods (e.g., ISO standards for hose collapse, implosion, and sterilization).

8. The sample size for the training set

This information is not applicable/provided as the device is not an AI/ML algorithm.

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

This information is not applicable/provided as the device is not an AI/ML algorithm.

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REVOLVE™ ENVI 600 System is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.

REVOLVE™ ENVI 600 System is intended for use in the following surgical specialties when the aspiration of soft tissue is desired: plastic and reconstructive surgery, gastrontestinal and affiliated organ surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.

Revolve Envi 600 System consists of a sterile, single use canister and accessories intended to be used for harvesting, filtering and transferring of autologous adipose tissue. Such products have been classified by FDA as Class II devices under 21 CFR §878.5040, Suction Lipoplasty System, and assigned product code MUU. The subject device is intended to be used with a legally marketed vacuum or aspirator apparatus as a source of suction. The adipose tissue is collected from the patient using liposuction tubing and cannula that are supplied by the user or the institution. This tissue is harvested inside the canister which contains a 600ml inner basket with 200um mesh filter. A manual stirring assembly allows the user to mix the tissue and fluids during the washing step. The processed adipose tissue is removed from the device via an extraction port located on the bottom of the device using a syringe.

For user convenience, the device is supplied with the following accessories designed for use with the Revolve Envi 600 System:

• . Luer extraction tip
• . Toomey and catheter syringe extraction tip
• . Toomey/Catheter tip syringe to Luer syringe adapter
• . Temperature strip
• . Lactated Ringer's tubing set
• . Suction tubing set.

The device is offered in a single size, is packaged in a thermoformed tray and lid with Tyvek® lidding, and is sterilized via gamma irradiation. The device is a single use device to be used in a healthcare facility.

Here's an analysis of the provided text regarding acceptance criteria and the study conducted for the Revolve Envi 600 Advanced Adipose System:

This document is a 510(k) summary for a medical device (Revolve Envi 600 Advanced Adipose System). As such, it reports on studies performed to demonstrate substantial equivalence to a predicate device, rather than a clinical trial demonstrating efficacy of a novel device. Therefore, many of the typical elements of an AI-specific study focusing on metrics like sensitivity, specificity, and reader performance are not applicable or not reported in this type of submission. The 'acceptance criteria' in this context refer to engineering and performance benchmarks for the device itself, rather than diagnostic performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not explicitly stated in numerical terms for the bench testing. The document mentions "performance tests conducted on both the subject and predicate devices," implying a comparison. For biocompatibility, it refers to testing samples of the device materials.
• Data Provenance: Not applicable in the context of clinical data for a diagnostic device. The data are from laboratory bench testing of the physical medical device and its components, in-house or by contracted labs.

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

• Not Applicable. This device is a mechanical system for processing adipose tissue, not an AI or diagnostic device requiring expert interpretation for "ground truth" establishment in a diagnostic context. The "ground truth" here is the physical performance of the device and biological response to its materials.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human interpretations or diagnostic outcomes to adjudicate, this concept does not apply to the provided study summary.

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

• No, an MRMC study was not done. This is a review of a device for processing adipose tissue, not an AI-assisted diagnostic tool. Therefore, such a study 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 does not involve an algorithm or AI. It is a physical medical device.

7. The Type of Ground Truth Used

• For Biocompatibility: Laboratory testing results based on standard biological assays (cytotoxicity, sensitization, irritation, acute systemic toxicity, material mediated pyrogenicity). The "ground truth" is the biological standard for acceptable responses.
• For Sterilization: Laboratory validation demonstrating that the gamma irradiation process achieves the specified SAL. The "ground truth" is the established SAL of 10⁻⁵.
• For Bench Testing (Adipose tissue viability, simulated use testing): Laboratory measurements and observations of the device's physical performance, material integrity, and biological viability markers according to established test protocols. The "ground truth" is the direct measurement and observation of device function against predetermined design specifications or in comparison to the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve an AI algorithm that requires a training set.

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

• Not Applicable. No training set is involved for this type of device.

Summary of the Study:

The provided document describes a 510(k) premarket notification for the Revolve Envi 600 Advanced Adipose System. The "study" refers to a series of bench tests and biocompatibility assessments designed to demonstrate the device's safety and effectiveness and its substantial equivalence to a legally marketed predicate device (Revolve™ System, K120902).

The core of the "study" is:

• Biocompatibility Testing: According to ISO 10993-1 and FDA guidance, classifying the device as an "Externally Communicating Device, Tissue, Limited Contact (≤24 hours)". It passed tests for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.
• Sterilization Validation: Demonstrated a Sterility Assurance Level (SAL) of 10⁻⁵ through gamma irradiation, validated per ISO 11137-2:2013.
• Bench Testing: Included evaluation of adipose tissue viability (via Lactate Dehydrogenase assessment) and simulated use testing covering device stability, leakage, processing time, functionality under vacuum, and tubing connection tensile strength. These tests were performed on both the subject and predicate devices to show comparability.

Crucially, no clinical testing was included in this submission, and this is explicitly stated. The acceptance criteria are engineering and biological safety standards for a mechanical medical device, rather than diagnostic performance metrics (like sensitivity/specificity) typical for AI or imaging devices. Environmental or operational conditions are tested, but not in a 'diagnostic accuracy' sense.

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ARTIA Tissue Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement in plastic and reconstructive surgery.

ARTIA Tissue Matrix is intended for single patient, one time use only.

ARTIA Reconstructive Tissue Matrix Perforated (ARTIA Tissue Matrix Perforated) is a surgical mesh that is derived from porcine dermis and is processed and preserved in a patented phosphate buffered aqueous solution containing matrix stabilizers. ARTIA Tissue Matrix Perforated is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold for cellular and microvascular ingrowth. ARTIA Tissue Matrix Perforated consists of a terminally sterilized sheet of processed porcine dermal matrix provided in various geometric configurations and packaged in a plastic holder enclosed within a pouch. The device is sterilized via electron beam irradiation. The subject device has the same underlying scientific technology, principles of operation, Intended Use and Indications for Use as the cleared predicate device, ARTIA Tissue Matrix (K142326). This 510(k) premarket notification describes a new design feature of the subject device, which introduces a 3mm diameter circular pattern of perforations (holes) throughout the tissue matrix.

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested table and answer all the questions regarding acceptance criteria and a study proving device performance as it relates to an AI/ML device.

The document is a 510(k) premarket notification for a medical device called ARTIA Reconstructive Tissue Matrix Perforated, which is a surgical mesh. This process establishes substantial equivalence to a predicate device, not necessarily a study demonstrating the device meets specific acceptance criteria in the manner one would for an AI/ML product's performance metrics.

Specifically, the document discusses bench testing for the surgical mesh to demonstrate substantial equivalence to a predicate device, not clinical performance or AI/ML algorithm performance.

Here's a breakdown of why the information is not available in the provided text:

• No AI/ML Device: The device described (ARTIA Reconstructive Tissue Matrix Perforated) is a surgical mesh, not an AI/ML-driven medical device. Therefore, questions related to AI/ML performance, training sets, and expert adjudication are not applicable.
• No Acceptance Criteria for AI/ML Performance: The acceptance criteria mentioned are for mechanical properties of a surgical mesh (e.g., mesh thickness, tensile strength, burst strength), not for AI/ML algorithm outputs like sensitivity, specificity, or accuracy.
• No Performance Data in the Requested Format: While the document states that "Performance data demonstrates that ARTIA Tissue Matrix Perforated has similar mechanical properties and meets the established specifications as the predicate device," it does not provide the specific numerical results or a direct comparison table as requested for an AI/ML device.
• No Clinical Study for Effectiveness: The document explicitly states: "Clinical Testing: No clinical testing was included in this submission." This means there is no study establishing clinical effectiveness or comparative performance with human readers.
• No Ground Truth: The concept of "ground truth" as it applies to AI/ML model training and evaluation (e.g., pathology, expert consensus on imaging) is not relevant for a surgical mesh. The "ground truth" for the mesh would be its physical and chemical properties, which are evaluated by bench tests.
• No Training/Test Sets: As this is not an AI/ML device, the concepts of training sets and test sets for algorithm development and evaluation are not applicable.

Therefore, I cannot fulfill your request based on the provided text. The information requested pertains to the evaluation of AI/ML-driven medical devices, while the provided document describes a traditional surgical mesh device.

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LTM-Perforated Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and/ or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

LTM-Perforated Surgical Mesh is intended for single patient one-time use only.

LTM-Perforated Surgical Mesh is a surgical mesh that is derived from porcine dermis and then processed and preserved in a patented phosphate buffered aqueous solution containing matrix stabilizers. The device is designed to perform as a surgical mesh for soft tissue repair. The device consists of a terminally sterilized sheet of processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses. The device is packaged in a double pouch configuration, and is sterilized via electron beam irradiation. The device is considered a single use device which is to be used in a healthcare facility or hospital.

The subject device shares the same underlying scientific design as a porcine derived acellular dermal matrix, and has the same Intended Use, Indications for Use, and principles of operation as the cleared predicate device, LTM-Surgical Mesh (K070560). This 510(k) premarket notification describes a new design feature of the subject device, which introduces a pre-defined pattern of perforations throughout the tissue matrix.

The document is a 510(k) premarket notification for the LTM-Perforated Surgical Mesh. It focuses on demonstrating substantial equivalence to a predicate device, LTM-Surgical Mesh (K070560), rather than providing acceptance criteria and a study proving the device meets those criteria in the traditional sense of a clinical trial for diagnostic AI.

However, based on the provided text, I can extract information related to "acceptance criteria" (in this case, performance specifications for substantial equivalence) and the "study" (bench testing) used to support the claim.

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

1. Table of acceptance criteria and the reported device performance

The document doesn't provide specific numerical acceptance criteria or performance values for the LTM-Perforated Surgical Mesh. Instead, it states that the device "maintains similar mechanical properties and meets the established specifications as the predicate device." The "acceptance criteria" are implied by the listed bench tests and the goal to be "substantially equivalent" to the predicate.

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

• Sample Size: The document does not specify the sample size for the bench testing performed. It refers to "relevant elements" of the FDA guidance for test performance.
• Data Provenance: The bench testing was performed on the "subject LTM-Perforated Surgical Mesh device." It implies in-house testing by the manufacturer (LifeCell Corporation). The type of data is physical/mechanical test results.

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

Not applicable. This is a medical device (surgical mesh), not an AI/diagnostic device where expert assessment of "ground truth" (e.g., image interpretation) would be relevant. The "ground truth" for this device's performance is established by objective physical and mechanical tests against defined standards and comparison to a predicate device.

4. Adjudication method for the test set

Not applicable. This is a medical device (surgical mesh), not an AI/diagnostic device requiring expert 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. This is a medical device (surgical mesh) and not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (surgical mesh) and not an AI algorithm.

7. The type of ground truth used

For the bench testing, the "ground truth" is established by:

• Objective physical and mechanical measurements.
• Adherence to recognized industry standards (ASTM D5735-95 for Tear Resistance, ASTM D6797-07 for Burst Strength).
• Comparison to the established performance specifications and characteristics of the legally marketed predicate device (LTM-Surgical Mesh K070560).
• Prior biocompatibility and viral inactivation data from the predicate device, which is deemed applicable due to identical raw materials and manufacturing processes (except for the perforations).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable.

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HPTM is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery.

HPTM is intended for single patient, one-time use only.

HP Tissue Matrix is a surgical mesh that is derived from porcine dermis and is processed and preserved in a phosphate buffered aqueous solution containing matrix stabilizers. This device is designed to perform as a surgical mesh for soft tissue repair. The device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses and is packaged in a double pouch configuration. The device is considered a single use device which is to be used in a healthcare facility or hospital. It is sterilized via Gamma irradiation.

The provided text describes the 510(k) premarket notification for the HPTM surgical mesh. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against defined acceptance criteria in a clinical context with human readers and ground truth.

Therefore, many of the requested sections about acceptance criteria, clinical study details, expert involvement, and reader performance cannot be extracted directly from this document. The document primarily details bench testing for material characteristics.

Here's an analysis of what can be extracted and what cannot:

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

The document provides a list of bench tests performed but does not explicitly state acceptance criteria or the specific numerical results of the device's performance for each test. It only states that "The results of the tests performed demonstrated that the modifications did not affect safety and efficacy of the device or raise any new questions of safety or efficacy."

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

• Sample Size: Not specified for the bench tests.
• Data Provenance: Not applicable as this is bench testing on materials, not human data. There is no mention of country of origin.

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

Not applicable. This document describes bench testing of a physical medical device, not an AI or diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. There is no human interpretation or adjudication involved in the described bench testing.

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. The document explicitly states: "No clinical testing was included in this submission." This is a 510(k) submission for a surgical mesh, not a diagnostic AI device, so such a study would not be expected or relevant here.

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

Not applicable. This is not an algorithm or AI device. The "device" is a physical surgical mesh.

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

Not applicable. For the bench tests, the "ground truth" would be the measured physical properties of the material, compared to established material standards (like ASTM or ISO) or the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI or algorithm device requiring a training set.

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

Not applicable.

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LTM-Laparoscopic Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome during open or laparoscopic procedures.

LTM-Laparoscopic Surgical Mesh is intended for single patient one-time use only.

L TM-Laparoscopic Surgical Mesh is a surgical mesh that is derived from porcine dermis and is processed and preserved in a phosphate buffered aqueous solution containing matrix stabilizers. This device is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold to the patient. The device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses and is packaged in a double pouch configuration. The proposed device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, LTM-Laparoscopic Surgical Mesh (K121289).

The only change described in this submission is a minor modification to the Instructions for Use. There have been no changes made to the physical LTM-Laparoscopic Surgical Mesh device. The Instructions for Use have been modified to describe fixation of the device by sutures and surgical tacks, according to surgeon preference. The Instructions for Use previously provided as part of the cleared predicate device (K121289) described suturing LTM-Laparoscopic Surgical Mesh into position.

The provided text describes a 510(k) premarket notification for a medical device called LTM-Laparoscopic Surgical Mesh. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets acceptance criteria in the typical sense of measuring performance against predefined metrics (e.g., sensitivity, specificity, accuracy for an AI/diagnostic device).

Here's an analysis based on the provided text, addressing your points where applicable, and noting where information is not present for this type of submission:

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

For this type of device (surgical mesh) and submission (510(k) for a minor modification), acceptance criteria are primarily related to safety and efficacy not being negatively impacted by the change, and the device continuing to perform its intended use. The "performance" reported is less about statistical metrics and more about confirming functionality under the new condition.

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

The text describes "testing included laparoscopic fixation of LTM-Laparoscopic Surgical Mesh by surgical tacks under simulated conditions." However, it does not specify:

• The sample size of the test set (e.g., number of meshes tested, number of fixation points).
• Data provenance (country of origin), although it's a submission to the US FDA.
• Whether the study was retrospective or prospective, but "simulated conditions" implies a controlled experimental setup.

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 type of information is not applicable to the study described. The study involves a physical device and its fixation method, not an AI or diagnostic tool requiring expert interpretation for ground truth establishment.

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

Not applicable. This is not an observational study requiring adjudication of expert opinions. The "results have demonstrated" implies objective measurements or observations in the simulated conditions, rather than subjective interpretation that would need 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. This is not an AI/diagnostic device, and no MRMC study was performed.

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

Not applicable. This is a physical surgical mesh, not an algorithm.

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

The "ground truth" here is implied to be the successful and safe fixation of the mesh under simulated conditions, and the maintenance of the device's intended function. It's based on technical assessment and potentially engineering testing rather than medical "ground truth" like pathology or clinical outcomes in patients for this specific modification.

8. The sample size for the training set

Not applicable. There is no training set for this type of device modification.

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

Not applicable. There is no training set.

Summary of the Study:

The study described is a design validation testing for a minor modification to the Instructions for Use of LTM-Laparoscopic Surgical Mesh. The modification allows for fixation of the mesh using surgical tacks in addition to sutures.

• Objective: To ensure that using surgical tacks for fixation does not negatively impact the safety and efficacy of the device.
• Methodology: Laparoscopic fixation of the mesh using surgical tacks was performed under "simulated conditions."
• Findings: The results "demonstrated that this method of fixation did not affect safety and efficacy of the device or raise any new questions of safety or efficacy."
• Conclusion: The device continues to perform its intended use and is substantially equivalent to the predicate device.

This submission is a 510(k), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical trials, especially for minor modifications like this one. The "study" here is a targeted engineering/performance test to address the specific change.

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The LifeCell Tissue Expanders are intended for use in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The LifeCell Tissue Expanders are intended for temporary subdermal implantation and are not intended for use beyond six months.

The LifeCell Tissue Expander is composed primarily of silicone elastomers. The predicate device and the LifeCell Tissue Expander utilize the same fundamental technology:

• A silicone expansion shell with a smooth or textured surface which expands with t sequential injections of sterile saline
• An injection site, a magnetic locating system, a titanium needle guard, and suture tabs .
  The LifeCell Tissue Expander is provided sterile and its packaging consists of an inner polycarbonate thermoform tray, containing a tissue expander, sealed with Tyvek® lidstock. The sealed inner tray is placed inside a sterile barrier system which is composed of an outer polycarbonate tray that is then sealed with a Tyvek® lid. The LifeCell Tissue Expander is available in multiple styles and sizes, and each product is labeled accordingly.

The provided text describes the 510(k) summary for the LifeCell Tissue Expander, and states a substantial equivalence claim to a predicate device, rather than providing specific acceptance criteria and detailed performance data from a clinical study for this device. Therefore, a direct answer to all points of your request based solely on the provided input is not possible.

However, I can extract the information that is present and explain based on the common practices for 510(k) submissions focusing on substantial equivalence.

Here's a breakdown of what the document does provide:

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

   • The document does not provide a table of acceptance criteria for clinical performance. Instead, it states: "The LifeCell Tissue Expander has undergone biocompatibility and preclinical testing including tensile strength, percent elongation, tensile set, joint strength testing, overexpansion testing, injection port testing and tissue expander injection port competency over time testing. The data demonstrates the LifeCell Tissue Expander possesses sufficient material and functional properties for the intended use."
   • It also states in the substantial equivalence section: "Performance data demonstrate that the LifeCell Tissue Expander functions equivalently to the predicate device."
   • Therefore, the primary "acceptance criterion" demonstrated is that its material and functional properties are sufficient for intent and are equivalent to the predicate device. Specific numerical acceptance criteria were likely part of the internal testing protocols, but are not disclosed in this summary.

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

   • The document does not specify a sample size for a clinical test set. The testing described is preclinical (biocompatibility, mechanical properties) and not human clinical data. Therefore, provenance in terms of country of origin or retrospective/prospective is not applicable for this type of submission.

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

   • Not applicable. This submission focuses on preclinical testing and substantial equivalence, not a study requiring expert readers to establish ground truth on clinical images or patient outcomes.

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

   • Not applicable. This is a preclinical submission.

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 device is a physical tissue expander, not an AI-powered diagnostic or assistive tool.

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

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

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

   • For the preclinical tests, the "ground truth" would be established by the specifications and standards for each material and functional test (e.g., a specific tensile strength value that must be met, or a specific range for percent elongation). For biocompatibility, it would be validated according to ISO standards.

8. The sample size for the training set:

   • Not applicable. This refers to a physical device submitted under the 510(k) pathway for substantial equivalence, not a machine learning model requiring a training set.

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

   • Not applicable.

In summary, for the LifeCell Tissue Expander 510(k) submission, the "study that proves the device meets the acceptance criteria" is outlined as preclinical (biocompatibility, tensile strength, elongation, joint strength, overexpansion, injection port competency) testing. The acceptance criteria themselves are not explicitly detailed in the provided summary beyond the general statement that "The data demonstrates the LifeCell Tissue Expander possesses sufficient material and functional properties for the intended use" and that its "Performance data demonstrate that the LifeCell Tissue Expander functions equivalently to the predicate device."

This is typical for a 510(k) submission asserting substantial equivalence, especially for a device like a tissue expander. The FDA determined that based on this preclinical data and the comparison to the predicate, the device is substantially equivalent and thus safe and effective for its intended use. Clinical studies with human subjects are often not required for this type of device if substantial equivalence to a well-understood predicate can be demonstrated through material and functional testing.

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LTM-Laparoscopic Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome during open or laparoscopic procedures.

LTM-Laparoscopic Surgical Mesh is intended for single patient one-time use only.

The LTM-Laparoscopic Surgical Mesh is a surgical mesh that is derived from porcine dermal tissue. The LTM-Laparoscopic Surgical Mesh device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and sizes ranging from 10 cm x 16 cm to 20 cm x 20 cm, with future sizes planned ranging from 2 cm x 2 cm to 20 cm x 30 cm. It will be packaged in double pouch configuration.

The document describes the LTM-Laparoscopic Surgical Mesh, a device intended for surgical repair of hernias and body wall defects. The submission focuses on demonstrating substantial equivalence to a predicate device, LTM Surgical Mesh (K070560), and discusses its performance relative to established specifications.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "extensive biocompatibility testing, animal testing, viral inactivation testing, and biomechanical testing" of the predicate device (K070560). For the LTM-Laparoscopic Surgical Mesh itself, it states that it "went through the same biomechanical testing after laparoscopic handling (Attachment 1)."

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 study primarily relies on physical and manufacturing consistency with a previously cleared device and biomechanical testing, rather than expert evaluation of the device in a clinical or diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the study focuses on physical and mechanical properties rather than subjective assessments 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

An MRMC study was not done. This device is a surgical mesh, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

A standalone performance study of an algorithm was not done. This is a physical surgical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through biomechanical specifications and performance data derived from the predicate device (LTM Surgical Mesh K070560) and further confirmed through specific tests on the LTM-Laparoscopic Surgical Mesh after simulated laparoscopic handling. This includes:

• Tensile Strength
• Tear Resistance
• Suture Pull-out Strength
• Burst Strength
• Biocompatibility data (from predicate)
• Viral inactivation data (from predicate)

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this submission, as it concerns a physical surgical device, not a machine learning algorithm.

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

This information is not applicable as there is no training set for a machine learning algorithm.

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LTM-BPS Surgical Mesh is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissues in plastic and reconstructive surgery.

LTM-BPS is intended for single patient, one time use only.

The LTM-BPS is a surgical mesh that is derived from porcine skin. The LTM-BPS device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses, and packaged in double pouch configuration.

The provided document is a 510(k) premarket notification for a medical device called "LTM-BPS Surgical Mesh." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a traditional acceptance criteria study. Therefore, the information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not typically found in a 510(k) summary for this type of device.

Instead, the document highlights biocompatibility, viral inactivation, and biomechanical testing to support the safety and technological characteristics of the device.

Here's a breakdown of why specific information is missing and what is provided:

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

• This information is not explicitly provided in the 510(k) summary. For device approvals based on substantial equivalence, the "acceptance criteria" are implicitly met if the device demonstrates equivalent performance characteristics (e.g., strength, biocompatibility) to predicate devices.
• The document states: "The biomechanical data show that the LTM-BPS matrix possesses sufficient strength and suture retention for the intended use." This is an overall statement of performance but does not list specific numerical criteria or outcomes.

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

• Not applicable for a 510(k) demonstrating substantial equivalence through non-clinical testing. The "test set" would refer to samples used for biocompatibility, animal, viral inactivation, and biomechanical testing. The exact number of samples for each of these tests is not quantified in the summary.
• The document states: "The LTM-BPS has undergone extensive biocompatibility testing, animal testing, viral inactivation testing and biomechanical testing." This indicates the types of tests performed.

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

• Not applicable. Ground truth as typically understood in a clinical study (e.g., disease presence/absence based on expert review) is not established here. The assessment of test results (e.g., biocompatibility) would be performed by qualified laboratory personnel following established protocols.

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

• Not applicable. Adjudication methods are relevant for studies involving human interpretation or multi-reader scenarios, which is not the case for the testing described.

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 device is a surgical mesh, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

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

• Not applicable. This device is a physical surgical mesh, not an algorithm.

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

• Not applicable in the traditional sense of a clinical study. For the non-clinical tests conducted, the "ground truth" would be established by validated testing methodologies and standards (e.g., ISO standards for biocompatibility).

8. The sample size for the training set:

• Not applicable. No training set is used as this is not an AI/machine learning device.

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

• Not applicable. No training set is used.

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The LTM Wound Dressing is intended for the management of wounds including:

• Partial and full thickness wounds; -
• Pressure ulcers; -
• Venous ulcers: -
• Diabetic ulcers; -
• Chronic vascular ulcers; -
• Tunneled/undermined wounds; -
• Surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence);
• Trauma wounds (abrasions, lacerations, second-degree burns and skin tears); +
• Draining wounds -
• And other bleeding surface wounds.

The LTM Wound Dressing provides an environment that supports wound healing and control of minor bleeding.

The device is intended for single patient, one time use only.

The LTM Wound Dressing device is identical in materials and construction to the Company's rno DTM Wound Droomigical Mesh (K070560). Like the LTM Surgical Mesh, LTM Wound Dressing consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thickness, and packaged in a double pouch configuration.

The provided 510(k) summary for the LTM Wound Dressing does not describe a study that uses acceptance criteria in the way typically seen for AI/ML device performance. Instead, it relies on a Substantial Equivalence argument based on a predicate device.

Here's an analysis of the provided information in the context of your request:

1. Table of Acceptance Criteria and the Reported Device Performance

Not applicable in the traditional sense for this submission. The "acceptance criteria" for this 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. The performance is deemed acceptable if it is comparable to the predicate.

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

Not applicable. There was no specific "test set" for the LTM Wound Dressing itself. The submission leverages data from the LTM Surgical Mesh (K070560), which previously underwent testing. The document does not specify the sample sizes or data provenance for that historical testing.

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 establishment by experts for a test set is described. The assessment is based on the previously established safety and effectiveness of the predicate device (LTM Surgical Mesh) and the new device being technologically identical.

4. Adjudication Method for the Test Set

Not applicable. No test set or associated adjudication method is described.

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 a medical device submission for a physical wound dressing, not an AI/ML-driven diagnostic or assistive device. Therefore, no MRMC study or AI assistance is relevant.

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

Not applicable. This is not an algorithmic device.

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

Not explicitly stated for the LTM Wound Dressing as it relies on substantial equivalence. For the predicate LTM Surgical Mesh, the "performance data" included "biocompatibility testing, animal implantation testing, and biomechanical testing." These types of tests likely relied on:

• Biocompatibility: Standardized assay results.
• Animal Implantation: Histopathological analysis, clinical observation, and potentially outcomes data from animal models.
• Biomechanical Testing: Quantitative measurements of physical properties.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set or associated ground truth establishment.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" that proves the LTM Wound Dressing meets the acceptance criteria is a demonstration of technological identity and substantial equivalence to a previously cleared device, the LTM Surgical Mesh (K070560).

The key arguments are:

• Technological Identity: The LTM Wound Dressing is "identical in materials and construction" to the LTM Surgical Mesh.
• Leveraging Prior Data: The LTM Surgical Mesh "has undergone extensive biocompatibility testing, animal implantation testing, and biomechanical testing."
• Equivalence of Data: Because the devices are technologically identical, the "testing conducted on the LTM Surgical Mesh is equally applicable to the LTM Wound Dressing."
• Conclusion: This similarity allows the conclusion that the LTM Wound Dressing is "as safe and as effective" as its predicate devices.

Therefore, the "proof" is based on the direct transferability of established safety and performance data from a predicate device due to their identical nature. There was no new clinical or performance study specifically for the LTM Wound Dressing described in this 510(k) submission.

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