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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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The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Indications for use also include the repair of body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

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

The LTM is a surgical mesh that is derived from porcine skin. The LTM 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 text describes a 510(k) summary for the LTM Surgical Mesh. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with specific performance metrics as one would find for a novel device or software.

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

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

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

The document does not specify a "test set" in the context of a dataset for an AI device. Instead, it refers to different types of testing:

• Biocompatibility testing: Not specified.
• Animal testing: Not specified.
• Viral inactivation testing: Not specified.
• Biomechanical testing: Not specified.

The text does not mention the country of origin of data or whether it was retrospective or prospective, as these are details commonly associated with clinical studies for AI/software devices. The studies mentioned here are performance and safety tests for a biological medical device.

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

This information is not applicable and is not provided. The ground truth for this device's performance is established through laboratory and animal testing, not expert interpretation of data points.

4. Adjudication method for the test set

This information is not applicable and is not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers or expert panels for diagnostic tasks, which is not the nature of the testing described here for a surgical mesh.

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 such study was conducted or mentioned. This type of study is relevant for AI-powered diagnostic or assistive devices, not for a surgical mesh.

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

This concept is not applicable to the LTM Surgical Mesh, which is a physical device, not an algorithm.

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

The "ground truth" for this device's performance is based on:

• Biocompatibility standards: Likely established through standardized in-vitro and in-vivo tests.
• Viral inactivation protocols: Based on validated methods to demonstrate removal or inactivation of viruses.
• Biomechanical engineering principles: Measured properties like tensile strength and suture retention, compared against established requirements for the intended application.

8. The sample size for the training set

This information is not applicable as the LTM Surgical Mesh is a physical product, not an AI/software device that requires a training set.

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

This information is not applicable.

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LTM-RC 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. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff surgery. Indications for use also 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.

The device is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and the sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair.

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

The LTM-RC is a surgical mesh that is derived from porcine skin. The LTM-RC 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 text describes the 510(k) summary for the LifeCell Tissue Matrix-Rotator Cuff (LTM-RC) Surgical Mesh. This is a medical device application, and as such, the "acceptance criteria" and "device performance" are typically framed in terms of substantial equivalence to predicate devices rather than meeting specific numerical performance targets like AI algorithms. The "study" here refers to the testing conducted to demonstrate this substantial equivalence.

Here's an analysis based on the provided document:

1. Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" is essentially demonstrating substantial equivalence to a legally marketed predicate device. This means the new device has the same intended use, similar technological characteristics, and functions equivalently.

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

The document states that the LTM-RC underwent "extensive biocompatibility testing, animal testing, viral inactivation testing, and biomechanical testing."

• Sample Size for Test Set: The specific sample sizes for these tests (e.g., number of animals, number of specimens for biomechanical testing) are not detailed in the provided 510(k) summary. This level of detail is typically found in the full technical documentation submitted to the FDA, not in the summary.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given that LifeCell Corporation is based in Branchburg, NJ, USA, it is highly probable that the testing was conducted in the USA.

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

• This device is a surgical mesh, not an AI diagnostic tool that relies on expert interpretation of images. Therefore, the concept of "experts used to establish ground truth" as it applies to medical imaging is not applicable here. The ground truth for the performance tests (biocompatibility, biomechanical strength) would be established by standardized testing protocols and analytical methods, not by human interpretation in the same way.

4. Adjudication Method for the Test Set

• Again, as this is a physical medical device and not an AI diagnostic, an "adjudication method" (like 2+1 or 3+1 for discordant reads) is not applicable. The outcome of physical and biological tests is determined by objective measurements and scientific analysis, not by subjective expert consensus on ambiguous cases.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation, sometimes aided by AI) to assess human reader performance with and without assistance. The LTM-RC is a surgical mesh; its effectiveness is evaluated through its physical and biological properties and its ability to reinforce tissue, not through diagnostic interpretation.

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

• No, a standalone performance study (algorithm only) was not done. This concept applies to AI algorithms and is not relevant for a physical surgical mesh product.

7. The Type of Ground Truth Used

The "ground truth" for the LTM-RC testing would be defined by validated scientific measurements and established standards in different fields:

• Biocompatibility: Established through standardized in vitro and in vivo tests (e.g., cytotoxicity assays, sensitization tests, implantation studies), with comparison to known safe materials.
• Viral Inactivation: Determined by analytical methods to detect viral particles or infer inactivation rates based on validated processes.
• Biomechanical Strength: Measured using material testing equipment (e.g., tensile testers) according to established engineering standards, providing objective quantifiable data like ultimate tensile strength or suture retention strength.
• Substantial Equivalence: Achieved by comparing the device's characteristics and performance to those of the predicate devices.

8. The Sample Size for the Training Set

• This concept is not applicable to a physical surgical mesh. A "training set" refers to data used to train machine learning models. The LTM-RC is a manufactured product; it doesn't have a "training set" in the AI sense.

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

• As the concept of a "training set" is not applicable, the establishment of ground truth for a training set is also not applicable.

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LTM Surgical Mesh (LTM) 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 is intended for single patient use only.

The LTM is a surgical mesh that is derived from porcine skin. The LTM 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 text describes a 510(k) premarket notification for the LTM Surgical Mesh. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical efficacy through a detailed study with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the kind of detailed information about acceptance criteria and a study proving device performance as typically expected for an AI/device performance study.

Here's a breakdown of why this information is not present and what is stated instead:

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

• Not Applicable in this context. The 510(k) summary focuses on demonstrating substantial equivalence, not on meeting specific, quantifiable acceptance criteria for a novel performance characteristic.
• What is reported: "The biomechanical data show that the LTM matrix possesses sufficient strength and suture retention for the intended use." This is a general statement, not a table of specific criteria and results.

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

• Not discussed. There is no mention of a "test set" in the context of clinical or performance data for software or AI. The performance data mentioned refers to lab-based biocompatibility, animal testing, viral inactivation, and biomechanical testing.

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 in the context of expert consensus is not a component of this submission. The device is a surgical mesh, not a diagnostic tool requiring expert interpretation for performance validation.

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

• Not Applicable. Adjudication methods are relevant for studies where human interpretation of results (e.g., medical images) is involved to establish ground truth or resolve discrepancies. This is not the case for a surgical mesh.

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. MRMC studies and the concept of "human readers improving with AI" are specific to AI-powered diagnostic or assistive devices. The LTM Surgical Mesh is a physical implant.

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

• Not Applicable. This refers to AI algorithm performance, which is not relevant to a surgical mesh.

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

• Not Applicable in the typical sense. For the performance data cited (biocompatibility, animal testing, viral inactivation, biomechanical testing), the "ground truth" would be established by scientific and laboratory standards, validated assays, and accepted engineering principles for material strength. It's not a diagnostic "ground truth" as you'd define for an AI system.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this device is not an AI/machine learning algorithm.

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

• Not Applicable. As there's no training set, there's no ground truth to establish for it.

Summary of Device Performance as Stated in the 510(k) Document:

The LTM Surgical Mesh's performance is demonstrated through:

• Extensive biocompatibility testing: Indicates the device is safe for biological interaction.
• Animal testing: Used to assess in-vivo performance and safety.
• Viral inactivation testing: Proves the manufacturing process effectively eliminates viral components from the porcine source material.
• Biomechanical testing: Shows the LTM matrix has "sufficient strength and suture retention for the intended use."

The entire submission hinges on demonstrating substantial equivalence to existing predicate devices (Permacol® Implant and Surgisis®) based on:

• Same intended uses and similar indications.
• Same or similar technological characteristics (derived from porcine skin, terminally sterilized sheet of processed dermal matrix).
• Similar principles of operation.

The statement explicitly says: "Performance data demonstrate that LTM functions equivalently to the predicate devices. Thus, LTM is substantially equivalent." This is the core "proof" in a 510(k) for this type of device, rather than meeting specific, numerical acceptance criteria for novel performance claims.

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LifeCell Dural Substitute Matrix is indicated as a dural substitute for the repair of dura mater.

The LifeCell Dural Substitute Matrix, like the predicate devices made from a biological material, is made from donated human cadaver skin. The donated allograft human dermis is processed to remove cells and freeze-dried to remove moisture while preserving the general structure of the dermal matrix. The LifeCell Dural Substitute Matrix is terminally sterilized using e-beam irradiation and packaged in a double-pouch configuration. The freeze-dried matrix is rehydrated prior to implantation. After implantation, the graft is revascularized and repopulated with cells. The LifeCell Dural Substitute Matrix is packaged in a double-pouch configuration - an inner (Tyvek) peel-pouch and an outer foil pouch.

The provided text describes a 510(k) premarket notification for the "LifeCell Dural Substitute Matrix." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive, de novo clinical trials with predefined acceptance criteria.

Therefore, the concept of specific "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a new clinical trial with statistical endpoints is not explicitly detailed in this document. The submission focuses on showing that the new device is as safe and effective as existing, legally marketed predicate devices.

However, based on the provided information, we can infer how performance was assessed for equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) based on substantial equivalence, there are no specific numerical acceptance criteria like sensitivity/specificity thresholds. Instead, the acceptance is based on demonstrating that the device performs similarly to the predicate devices in terms of its intended function and safety.

Study Information (Inferring from "Performance Data"):

The document mentions "Performance Data" which includes "mechanical," "preclinical animal testing," and "clinical data." This suggests a combination of studies were conducted, but specific details about each study are limited.

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

• Mechanical and Preclinical Animal Testing: The specific sample sizes are not provided in this summary.
• Clinical Data: The specific sample size for the clinical data is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The term "clinical data has shown" suggests some form of observational or compiled data, but details are not given.

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

This information is not provided in the 510(k) summary. For devices of this nature, "ground truth" often refers to histological analysis or clinical outcomes adjudicated by physicians, but no specifics are mentioned here.

4. Adjudication method for the test set:

This information is 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:

• No. An MRMC comparative effectiveness study is not applicable to this device. This device is a dural substitute (a physical implant), not an AI-powered diagnostic tool that assists human readers.

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

• No. This question is not applicable to this device, as it is a physical implant, not an algorithm.

7. The type of ground truth used:

Based on the nature of the device (dural substitute), the "ground truth" would likely involve:

• Histology/Pathology: For preclinical animal studies (e.g., tissue integration, inflammatory response, dural regeneration, presence/absence of cells).
• Clinical Outcomes Data: For human application (e.g., absence of CSF leak, infection, adverse reactions, successful dural repair as observed surgically or symptomatically).
• Mechanical Testing Results: For physical properties.
• The exact methods for establishing "ground truth" are not detailed in the summary.

8. The sample size for the training set:

• Not applicable/Not provided. This device is a biologic implant, not an AI algorithm that requires a training set. The "clinical data" and "preclinical animal testing" are likely related to validation/performance assessment rather than training a model.

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

• Not applicable/Not provided. As above, there is no "training set" for this type of device.

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AlloCraft is intended for use as bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. AlloCraft can be used to fill bone voids in the posterolateral spine. It is in licated for use in the treatment of surgically created osseous defects or oss :ous defects created from traumatic injury.

AlloCraft is intended for single patient use only.

AlloCraft, like all bone graft materials c >ntaining demineralized bone matrix, is a bone vold finer mallinary of paring structures. AlloCraft is packaged in two Separate Syringes, one contaming tresus pended in sterile saline. When mixed, the containing acchuiar dermal maxxture that can be molded or handled by the surgeon, or placed directly into the osse >us defect site.

The provided text is a 510(k) summary for the AlloCraft™ DBM device, seeking clearance as a medical device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in a human clinical setting with defined metrics like sensitivity, specificity, or accuracy.

The performance data mentioned in the document is limited to preclinical assessments:

Performance Data Section Analysis:

• Study Description: "LifeCell has assessed the osteoconductive and osteoinductive properties of AlloCraft in valid animal models. The Company also establishes the AlloCraft in valid anniala nivach lot of the DBM component of AlloCraft in ostcomadel. In all instances, /11loCraft functioned as intended and the bone formation observed was as expected."
• Acceptance Criteria & Device Performance: This section does not define specific, quantifiable acceptance criteria (e.g., "X% bone formation at Y weeks"). Instead, it broadly states that the device "functioned as intended" and "bone formation observed was as expected." This is a qualitative statement rather than a measurable metric.
• Sample Size (Test Set) and Data Provenance: The document states "valid animal models" and "each lot of the DBM component" but does not specify the number of animals or lots used in these studies. The data provenance is animal models, not human data.
• Experts and Ground Truth: The document does not mention the use of experts to establish a ground truth. Bone formation would likely be assessed histologically or radiographically in animal models, but the specific method, number of observers, or their qualifications are not provided.
• Adjudication Method: Not applicable, as there's no mention of expert review or consensus.
• MRMC Comparative Effectiveness Study: No MRMC study was conducted or mentioned. The performance data is solely on the device's material properties in animal models, not its comparative effectiveness with human readers.
• Standalone Performance: The described "performance data" is focused on the material properties and biological response of the device in animal models. It does not measure a "standalone" algorithmic performance as typically understood for AI/software devices.
• Type of Ground Truth: The ground truth used was observed bone formation in animal models, likely through methods like histological analysis.
• Training Set Sample Size: Not applicable, as this is not an AI/ML device that requires a training set.
• Training Set Ground Truth Establishment: Not applicable.

Summary Table (Based on available information from the document):

Additional Information Not Present in the Document:

• No specific quantifiable acceptance criteria (e.g., minimum percentage of bone formation, specific strength values).
• No human clinical study data.
• No detail on the methodology for assessing "bone formation as expected" (e.g., specific assays, histological grading scales).
• No information regarding blinding or independent review of animal study results.
• No information on the statistical significance or confidence intervals of the findings.

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