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The MacroPore Puricel Lipoplasty System is intended for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:

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

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

The MacroPore Puricel Lipoplasty System is a single use, pre-assembled, manual lipoaspirate system that relies on house vacuum for its energy supply. The MacroPore Puricel Lipoplasty System consists of a cannula, connection tubing, and a waste collection container. The cannula handle is attached to the collection canister via connection tubing. The cannula is a hollow tube with a single opening near the tip to communicate house-vacuum to the tissues and subsequently fragment. emulsify, and aspirate subcutaneous fatty tissues from the patient into the waste collection canister for purposes of aesthetic body contouring. The collection canister contains various capped / sealed ports and a filter to trap large tissue masses

The Puricel Lipoplasty cannula is provided in various sizes ranging from 15cm - 36cm in length and 3.0 ~ 4.6mm in diameter with a single opening near the tip of the cannula. The tip region of the cannula may have a single or multiple openings that range in size from 4mm to length distributed uniformly or randomly throughout the end of the cannula. The handle of the device is 20mm in diameter and may be provided in diameters ranging from 20mm in diameter. The connecting tubing is provided with an inner diameter of 9.6mm (3/8"), an outer diameter of 14.3mm (9/16"), and a wall thickness of 2.2mm. The tubing that connects the cannula handle to the waste canister is provided in a length of 4 feet and may be provided in lengths ranging from 1 - 8 feet. The bottom of the waste collection container is also provided with the same 3/8" inner diameter connection tubing of various lengths. The proximal end of the exiting connection tubing may be provided with a barbed tubing connector to assist in the attachment of like-sized tubing for purposes of connecting the MacroPore Puricel Lipoplasty System to house vacuum and / or assorted waste traps. Connection tubing leading to and from the waste collection container is provided with a stepped clamp to allow the operator to seal the connection tubing on both sides of the waste container and prevent spillage of the collected fluids / tissues.

This response is based on the provided text, which details an FDA 510(k) clearance letter for the "Macropore Puricel Lipoplasty System." This type of document focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed study with specific performance metrics and acceptance criteria for the new device as would be found in a clinical trial report or a performance study.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be fully extracted in the manner typically associated with an AI/device performance study. The document primarily describes the device and its substantial equivalence to previously cleared lipoplasty systems.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and precise performance metrics are not explicitly stated. The FDA 510(k) clearance process, as reflected here, primarily assesses "substantial equivalence" to a predicate device rather than setting new, quantitative performance benchmarks for the new device in terms of clinical outcomes or specific efficacy and safety percentages.

However, the document implies that the device "meets" its intended purpose by demonstrating substantial equivalence to predicate devices already on the market. The "performance" described is in terms of design characteristics and intended use being similar to existing cleared devices.

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

The provided document describes in vitro testing ("Mechanical testing of the MacroPore Puricel Lipoplasty System") rather than a clinical study involving a "test set" of patient data. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable in the context of this 510(k) summary. The testing appears to be primarily laboratory-based mechanical testing to demonstrate functional equivalence.

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

As there is no mention of a "test set" of patient data or a clinical study with human interpretation, this information is not applicable. The "ground truth" for this regulatory submission is established by demonstrating equivalence to existing, legally marketed devices.

4. Adjudication Method for the Test Set

Again, this information is not applicable as the document does not describe a clinical study requiring adjudication of a test set.

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. The device described is a physical medical device (lipoplasty system) and not an AI-powered diagnostic or assistive technology 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 surgical tool, not an algorithm.

7. The Type of Ground Truth Used

For this 510(k) submission, the "ground truth" for demonstrating the safety and effectiveness of the MacroPore Puricel Lipoplasty System is its substantial equivalence to predicate devices that have already been cleared by the FDA and are legally marketed. The predicate devices identified are:

• Byron Medical Lipoplasty / Liposuction and Tumescent Infusion Cannulae and Needles (cleared under K981172)
• Sound Surgical Soundvaser System (cleared under K022051)

The grounds for equivalence are based on shared indications for use, similar design principles (hollow tubular cannulas, connection tubing, waste collection container), and comparable materials.

8. The Sample Size for the Training Set

This information is not applicable. The document describes a physical medical device, not a machine learning or AI algorithm that requires a "training set."

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

This information is not applicable as the concept of a "training set" for an algorithm is not relevant to this device's submission.

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The MacroPore Hydrosorb Spine System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

The MacroPore Hydrosorb Spine System is a resorbable graft containment system composed of various sized porous plates / sheet, non-porous plates / sheets, and associated fixation screws manufactured from polylactic acid (PLA). The MacroPore Hydrosorb Spine System is composed of MacroPore Sheets, Plates, and Screws provided with and without USP barium sulfate beads (18mg - 20mg/bead) imbedded into the PLA polymer for radiopacity. MacroPore Sheets and Plates can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore Plates / Sheets to the desired shape or size. The MacroPore Sheet and Plates are fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. Screws range in size from 2.4mm to 6.5mm in outer diameter with lengths ranging from 4mm to 30mm. The MacroPore Sheets and Plates are provided in various sizes ranging from 1.0mm to 5.0mm in thickness according to the region to be treated. The MacroPore Sheets and Plates range in size from as small as 24mm x 18mm to as large as 100mm x 100mm. The MacroPore Sheets and Plates are provided with and without macroporous holes. The macroporous holes range in size from 500 microns to 3,000 microns in diameter. The radiopaque barium sulfate beads have an approximate nominal mass of 18mg - 20mg and range in size from 0.5mm - 2.0mm in diameter. All configurations are to be within a mass of 100 grams of polymer. Various manual instruments (screw drivers, taps, drill bit, etc.) are used in conjunction with the MacroPore Hydrosorb Spine System to assist in the installation process.

Here's a breakdown of the acceptance criteria and study information for the MacroPore Hydrosorb Spine System, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MacroPore Hydrosorb Spine System are primarily established through demonstrating substantial equivalence to predicate devices. This means the device met the performance characteristics (mechanical, material, and functional) to be considered as safe and effective as already legally marketed devices.

Study Information

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

   • The document describes in vitro testing rather than human clinical trials or a specific "test set" of patient data.
   • For the in vitro aging studies, no specific sample size (number of devices or material samples) is provided.
   • For the in vitro mechanical testing, no specific sample size is provided.
   • For crystallinity testing (DSC), "sterile and nonsterile samples" were tested; specific sample size is not given.
   • Data provenance is not provided but strongly suggests lab-based, pre-clinical testing ("in vitro").

2. 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 was an in vitro engineering and material science study, not a study requiring expert clinical assessment for ground truth. The "ground truth" was based on established scientific principles and comparison to predicate device characteristics.

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

   • Not applicable. There was no clinical ground truth requiring adjudication. The evaluation was based on objective physical and material property measurements and direct comparison to predicate device specifications and performance.

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

   • Not applicable. This is a medical device (spinal implant) clearance and not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness was involved.

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

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

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

   • The "ground truth" for this submission was based on established material science principles and engineering specifications, with direct comparison to the physical and mechanical characteristics of legally marketed predicate devices. The goal was to demonstrate "substantial equivalence" based on objective measurements rather than clinical ground truth from patient data.

7. The sample size for the training set:

   • Not applicable. This is a medical device, not a machine learning model. There was no "training set" in the context of an algorithm.

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

   • Not applicable, as there was no training set.

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The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

MacroPore Surgi-Wrap MAST Bioresorbable Sheet is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore Surgi-Wrap MAST Bioresorbable Sheet can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore Surgi-Wrap MAST Bioresorbable Sheet to the desired shape or size. MacroPore Surgi-Wrap MAST Bioresorbable Sheet is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures. which can also serve to fixate the MacroPore Surgi-Wrap MAST Bioresorbable Sheet and prevent dislocation. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet may be used in conjunction with various MacroPore manual instruments.

MacroPore Surgi-Wrap MAST Bioresorbable Sheet is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. MacroPore Surgi-Wrap MAST Bioresorbable Sheet is provided in sheets of 25mm x 25mm to 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore Surgi-Wrap MAST Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.

The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is a surgical mesh made from polylactic acid (PLA) intended for temporary wound support, soft tissue reinforcement, and repair of hernias or fascial defects.

Here's an analysis of its acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes several tests:

• In Vitro Testing (Inherent Viscosity): No specific sample size is provided, but it states "testing was performed." The data provenance is not specified, but it's an in-house lab test ("in vitro").
• In Vitro Testing (Strength): No specific sample size is provided, but it states "testing demonstrates." Data provenance is not specified.
• In Vitro Testing (Mechanical Strength): No specific sample size is provided, but it states "mechanical testing was performed." Data provenance is not specified.
• In Vivo Testing (Animal Studies): No specific species or number of animals are provided, only "Animal studies were conducted." Data provenance is typically internal to the manufacturer or a contract research organization. These are prospective studies on animals.
• Equivalence to Marketed Product: This is a comparison to previously cleared devices (K012025, K002699) and relies on their established performance, not a new test set of patients for the MacroPore Surgi-Wrap MAST Bioresorbable Sheet.

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

The document does not mention the use of human experts to establish ground truth for a test set in the context of the device's performance. The "ground truth" for material properties and animal studies would be established by the results of the scientific tests and observations themselves, as interpreted by the researchers/scientists conducting those studies.

4. Adjudication Method for the Test Set:

No adjudication method is described for any test set, as this is not a study involving human interpretation of data where consensus or adjudication would be required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No MRMC comparative effectiveness study was conducted or described. This type of study is typically done for diagnostic imaging devices where human interpretation is a key factor. This device is a surgical implant.

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 a software algorithm.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria is primarily based on:

• Empirical Measurement/Laboratory Data: For inherent viscosity, strength, and mechanical properties.
• Biological Observation/Pathology: For the animal studies assessing safety and efficacy in vivo.
• Established Performance of Predicate Devices: For demonstrating substantial equivalence, relying on the known performance and clearance of the MacroPore Surgi-Wrap (TS) and Sofradim Parietex Composite Mesh.

8. The Sample Size for the Training Set:

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

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

Not applicable, as there is no training set mentioned for this type of device.

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The MacroPore Cardio-Wrap (TS) is indicated for use as a pericardium replacement device in patients that may require re-operation within six months.

MacroPore Cardio-Wrap (TS) is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore Cardio-Wrap (TS) can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore Cardio-Wrap (TS) to the desired shape or size. MacroPore Cardio-Wrap (TS) Sheet is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Cardio-Wrap (TS) can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which can also serve to fixate the MacroPore Cardio-Wrap (TS) and prevent dislocation. The MacroPore Cardio-Wrap (TS) may be used in conjunction with various MacroPore manual instruments. MacroPore Cardio-Wrap (TS) is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. MacroPore Cardio-Wrap (TS) is provided in sheets of 10mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore Cardio-Wrap (TS) ranges from 0.05 mm to 1.0 mm according to the region to be treated. The MacroPore Cardio-Wrap (TS) is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.

The provided text describes the MacroPore Cardio-Wrap (TS) device for 510(k) clearance, focusing on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study. Therefore, many of the requested elements for a study proving device meeting acceptance criteria (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not included in this type of submission.

However, I can extract the information provided regarding the testing and the basis for its equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:
  • In Vitro Testing: Not specified for each specific test (e.g., how many viscosity samples, how many mechanical tests).
  • Animal Study: Not specified how many animals were used.
• Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be conducted by the manufacturer for the 510(k) submission. These would be considered prospective tests conducted specifically for this regulatory submission.

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

• Not applicable as this is a device for surgical repair, and the "ground truth" is based on physical and biological performance rather than expert interpretation of data. The ground truth for equivalence is established by direct comparison of physical and mechanical properties and biological response in animal models.

4. Adjudication method for the test set:

• Not applicable for the types of in-vitro and in-vivo (animal) studies described, as these are objective measurements and observations rather than expert adjudication of clinical outcomes.

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 implant, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is a surgical implant; there is no "algorithm" in the sense of a software-driven process.

7. The type of ground truth used:

• In Vitro Testing: Objective physical and chemical measurements (e.g., viscosity, mechanical strength, material composition).
• In Vivo Testing (Animal Study): Safety and efficacy observations in an animal model, likely assessed by veterinarians/researchers.
• Equivalence: Direct comparison to known properties and indications of established predicate devices.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI-driven device requiring a training set. The "training" here would be the scientific and engineering principles used to design and manufacture the device.

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

• Not applicable for the reason stated in point 8.

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The MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The flat Protective Sheets with pore sizes up to 2.5mm are also indicated for cement restriction in total joint arthroplasty procedures.

Only when used in conjunction with traditional rigid fixation, the MacroPore OS Reconstruction System is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving:

• Long bones
• Flat bones
• Short bones
• · Irregular bones
• · Appendicular skeleton
• Thorax

When used alone (without traditional rigid fixation), the MacroPore OS Reconstruction System is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving:

• · Tumor resections where bone strength has not been compromised
• Iliac crest harvests
• Ribs (excluding multiple segmental defects such as those found in flail chest)

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

MacroPore OS Reconstruction System is a resorbable graft containment system composed of various sized porous sheet and sleeves, non-porous sheets and associated fixation screws and tacks manufactured from polylactic acid (PLA). The MacroPore OS Reconstruction System is composed of MacroPore OS Reconstruction System Protective Sheets, MacroPore OS Reconstruction System Protective Sleeves, and MacroPore OS Reconstruction Screws and Tacks.

The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore OS Reconstruction System to the desired shape or size. MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves are fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation.

The MacroPore OS Reconstruction System Protective Sheets can be rolled into a tube or used as a flat sheet. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves can be used either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to fixate the MacroPore OS Reconstruction System and prevent dislocation.

The MacroPore OS Reconstruction System Tacks range in size from 1.7mm to 2.2mm in diameter with lengths from 3.6mm to 5.6mm and the MacroPore OS Reconstruction System Screws range in size from 2.0mm to 4.75mm in diameter with lengths from 3.35mm to 30mm. The MacroPore OS Reconstruction System Protective Sheet is provided in sheets of 25 x 25 mm to 160 x 200 mm. The MacroPore OS Reconstruction System Protective Sleeves are provided in lengths of 150mm to 5mm with inner diameters that range from 5mm up to 40mm. The MacroPore Reconstruction System Protective Sleeves are provided in circular, square, trapezoidal, and parabolic shapes. The MacroPore OS Reconstruction System Protective Sleeves are provided with and without serrated edges and / or tapered end(s) for ease of surgical installation. The MacroPore OS Reconstruction System Protective Sheets and Protective Sleeves are provided with and without macroporous holes. The pore size ranges from 1.7mm to 4.0mm in diameter, with pores distributed randomly or uniformly throughout the sheet/sleeve in an offset or aligned pattern. The thickness of the MacroPore OS Reconstruction System Protective Sheets ranges from 0.5mm to 5.0mm according to the orthopedic region to be treated. The thickness of the MacroPore OS Reconstruction System Protective Sleeves ranges from 0.8mm to 5.0mm according to the orthopedic region to be treated.

The provided text describes the MacroPore OS Reconstruction System, which is a resorbable graft containment system. The document is a 510(k) summary, demonstrating "substantial equivalence" of the device to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Here's an analysis based on your requested information, acknowledging that many items are not applicable or not explicitly stated in this type of regulatory submission:

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

• Viscosity stayed within appropriate range after 120 minutes at 60℃ in saline (indicating brief heating during surgical prep not significant).
• As rigid and strong as predicate device after 6 months of exposure in aging studies.
• Substantially equivalent to mechanical strengths of predicate devices under indication for use conditions (tensile strength, rigidity).
• Amorphous and non-crystalline (confirmed by DSC). |

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

• Sample Size for Test Set: Not applicable. This submission relies on substantial equivalence to predicate devices, supported by in vitro bench testing, rather than a clinical human test set. The "test set" here refers to the samples of the device itself (MacroPore OS Reconstruction System components) used for mechanical and material characterization.
• Data Provenance: The testing was in vitro (bench testing) performed on the device components. There is no mention of country of origin for the data or whether it was retrospective or prospective, as it's not clinical data.

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

Not applicable. Ground truth, in the context of expert consensus, is relevant for diagnostic or image-based devices being evaluated by human interpretation. This document describes a surgical implantable device, and its equivalency is based on material properties, design, and mechanical performance demonstrated through objective laboratory tests.

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

Not applicable. Adjudication methods are typically used for clinical trials or studies involving human judgment (e.g., image interpretation). The "test set" here refers to physical device samples undergoing laboratory evaluation.

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.

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

Not applicable. This is not an AI/diagnostic device.

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

The "ground truth" for demonstrating equivalence was established by:

• Predicate Device Specifications: The material composition, design principles, indications for use, and mechanical properties of the legally marketed predicate devices (MacroPore OS Protective Sheet and Synthes Resorbable Meshes and Sheets) served as the reference or "ground truth" for comparison.
• Standardized Material and Mechanical Testing: In vitro tests (e.g., viscosity, aging studies, tensile strength, rigidity, DSC) were performed on the MacroPore OS Reconstruction System components, and the results were compared to the known or expected performance characteristics of the predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable. This is not a machine learning or AI device.

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The MacroPore Barrier Film is indicated for use as an orbital implant wrap to cover orbital implants used in enucleation surgery and to protect the surrounding orbital tissue from the surface of the implant.

MacroPore Surgical Barrier Film is a resorbable implant in sheet form manufactured from polylactides (PLA). MacroPore Surgical Barrier Film can be cut with scissors to the desired shape and size. MacroPore Surgical Barrier Film is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Surgical Barrier Film is provided in various shapes such as squares, rectangles, ovals, and circles. The MacroPore Surgical Barrier Film will be provided in sheets of 30mm x 30mm to 200mm x 200mm so that the surgeon may cut specific shapes and sizes. The thickness of the MacroPore Surgical Barrier Film will range from 0.05 mm to 1.0 mm. The MacroPore Surgical Barrier Film will be provided in solid sheets and in porous sheets that have pores that range in pore size from 0.5mm to 3.0mm with pores distributed randomly or uniformly throughout the film in an offset or aligned pattern. The pores are spaced at a distance of 1.5mm or greater. The MacroPore Surgical Barrier Film is fabricated from polylactide (PLA).

This document is a 510(k) premarket notification for the MacroPore Surgical Barrier Film. It's a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to prove acceptance criteria in the typical sense of a clinical trial. Therefore, many of the requested categories (like MRMC study, sample size for training set, number of experts for ground truth) are not applicable or directly derivable from this type of document.

However, I can extract the "acceptance criteria" through the lens of proving substantial equivalence, which revolves around demonstrating similar performance to predicate devices, and the "study" is the in vitro testing and comparison described.

Here's the information formatted to the best extent possible given the document type:

Acceptance Criteria and Device Performance for MacroPore Surgical Barrier Film

Note: This document is a 510(k) for substantial equivalence, not a clinical trial report. "Acceptance criteria" are inferred from the requirements for substantial equivalence, and "reported device performance" refers to the results of the described in vitro tests and comparisons to predicate devices. A "study" in this context refers to the non-clinical testing performed to support the 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated as this is non-clinical testing. The "test set" would refer to the samples of the MacroPore Surgical Barrier Film subjected to in vitro heating, aging, and mechanical tests. The number of samples tested for each specific test (e.g., viscosity, tensile strength) is not quantified in this summary.
• Data Provenance: The data is from in vitro laboratory testing performed by MacroPore Biosurgery, Inc. It is considered prospective in the sense that the tests were specifically conducted for this 510(k) submission. Country of origin for data generation is likely the USA, implicitly where the manufacturer is located (San Diego, CA).

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

• Not applicable / not provided. This is an in vitro device and a 510(k) submission. It does not involve human subjects or expert assessment for establishing "ground truth" in a clinical sense. The "ground truth" for the material properties would be established by standard engineering and materials science principles and testing protocols.

4. Adjudication Method for the Test Set

• Not applicable / none. Since the "test set" refers to in vitro measurements against established material science parameters and comparisons to predicate device specifications, there is no need for expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is a type of clinical comparative effectiveness study involving multiple human readers evaluating diagnostic cases. This document describes an in vitro device and a 510(k) submission for substantial equivalence based on material properties and design, not diagnostic accuracy requiring human reader performance.

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

• Partially applicable, but in a non-AI context. The "standalone" performance here refers to the intrinsic material and mechanical properties of the device itself (e.g., its viscosity retention, strength, malleability, dimensions) as measured in laboratory tests, without human interaction beyond the initial setup and measurement. There is no AI algorithm involved in this device.

7. The Type of Ground Truth Used

• Engineering and Material Science Standards / Predicate Device Specifications. The "ground truth" for the in vitro tests is derived from:
  • Established scientific principles for material behavior (e.g., viscosity, mechanical strength).
  • Comparison to the known performance and specifications of legally marketed predicate devices (Bio-Vascular Ocu-Guard and Bio-Eye II Orbital Implant).
  • The assumption that the predicate devices are safe and effective for their intended use.

8. The Sample Size for the Training Set

• Not applicable / No training set in the AI sense. This is not an AI/machine learning device. The "training" for the device itself would refer to its manufacturing and design process, informed by polymer science and surgical needs, not a data-driven training set.

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

• Not applicable. As there is no AI training set, this question is not relevant. The device's design and material selection are based on established engineering principles, material properties of polylactides, and the functional requirements for an orbital implant wrap, with reference to predicate devices.

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The MacroPore OS Trauma System is intended to maintain the relative position of weak bony tissue such as bone graft substitutes, or bone fragments from comminuted fractures. The MacroPore OS Trauma System is also indicated for cement restriction in total joint arthroplasty procedures.

Only when used in conjunction with traditional rigid fixation, the MacroPore OS Trauma System is intended to maintain the relative position weak bony tissue in trauma and reconstructive orthopedic procedures involving:

• Long bones
• Flat bones
• Short bones
• Irregular bones
• Appendicular skeleton
• Thorax

When used alone (without traditional rigid fixation), the MacroPore OS Trauma System is intended to maintain the relative position of bone graft substitutes in reconstructive orthopedic procedures involving:

• Tumor resections where bone strength has not been compromised
• Iliac crest harvests
• Ribs

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

MacroPore OS Trauma System is a resorbable graft containment system composed of various sized porous sheet and sleeves, non-porous sheets and associated fixation screws manufactured from poly (L-lactide) 70:30 (PLA). The MacroPore OS Trauma System is composed of MacroPore OS Trauma Protective Sheets, MacroPore OS Trauma Protective Sleeves, and MacroPore OS Trauma Screws.

The MacroPore OS Trauma Protective Sheets and Protective Sleeves can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore OS Trauma to the desired shape or size. MacroPore OS Trauma Protective Sheets and Protective Sleeves are fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Power Pen can also be used to cut or shape the MacroPore OS Trauma Protective Sheets and Protective Sleeves to the desired shape or size.

The MacroPore OS Trauma Protective Sheets can be rolled into a tube or used as a flat sheet. The MacroPore OS Trauma Protective Sheets and Protective Sleeves can be used either alone or in conjunction with internal bone fixation devices such as plates and screws, which also can serve to fixate the MacroPore OS Trauma and prevent dislocation.

The MacroPore OS Trauma Screws range in size from 2.0mm to 4.8mm in diameter. The MacroPore OS Trauma Protective Sheet is provided in sheets of 20 x 20 mm to 120 x 120 mm and will be provided in other sizes as needed for particular surgical procedures. The MacroPore OS Trauma Protective Sleeves are provided in lengths of 150mm to 5mm with diameters that range from 10mm up to 25mm. The MacroPore OS Trauma Protective Sheets and Protective Sleeves are provided with and without macroporous holes. The pore size ranges from 500 microns to 3000 microns in diameter, with pores distributed randomly or uniformly throughout the sheet/sleeve in an offset or aligned pattern. The thickness of the MacroPore OS Trauma Protective Sheets and Protective Sleeves ranges from 0.75 mm to 3.0 mm according to the orthopedic region to be treated.

The provided text describes a 510(k) summary for the MacroPore OS Trauma System, focusing on its substantial equivalence to predicate devices rather than adherence to a specific set of acceptance criteria with quantified performance metrics. Therefore, many of the requested categories for a study proving adherence to acceptance criteria cannot be extracted directly from this document.

Here's an attempt to populate the table and answer the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes in vitro testing but does not specify sample sizes for mechanical or material tests. It also does not mention any clinical test sets or data provenance (e.g., country of origin, retrospective/prospective). The study is entirely focused on in vitro engineering and material characterization.

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

Not applicable. The ground truth for in vitro mechanical and material properties is established through standardized engineering and material science testing methods (e.g., viscosity measurements, mechanical testing, DSC), not through expert consensus on qualitative observations.

4. Adjudication method for the test set

Not applicable. This was in vitro testing, not a clinical study requiring adjudication of expert interpretations.

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

Not applicable. This is a medical device for bone fixation, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device does not involve algorithms or AI.

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

For the in vitro testing, the "ground truth" was based on objective measurements and established scientific principles related to material properties (viscosity, crystallinity) and mechanical performance (rigidity, strength, tensile strength). The comparison was made against predicate device characteristics.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no training set. All testing described is analytical or comparative to predicate devices.

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

Not applicable. There is no training set.

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The MacroPore Surgi-Wrap (TS) is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.

MacroPore Surgi-Wrap (TS) is a resorbable implant in sheet form manufactured from polylactic acid (PLA). MacroPore Surgi-Wrap (TS) can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or weld the MacroPore Surgi-Wrap (TS) to the desired shape or size. MacroPore Surgi-Wrap (TS) is fully malleable when heated to approximately 55°C (for example, by the use of warm water), and thus can be conformed to anatomic structures. MacroPore Surgi-Wrap (TS) can be rolled into a tube or used as a flat sheet. It can be fixated with tissue fixation devices such as resorbable sutures, which also can serve to fixate the MacroPore tissue fixation devices such as resorbable sutures. MacroPore Surgi-Wrap (TS) may be used in conjunction with various MacroPore manual instruments.

MacroPore Surgi-Wrap (TS) is provided in sheets of 10mm to 120mm x 120mm and will be provided in other shapes and sizes in accordance to the region to be treated. The thickness of the MacroPore Surgi-Wrap (TS) is provided with and without macroporous holes from 0.02 mm to 2.0 mm according to the region to be treated. The macroporous holes range in size from 50 microns to 3,000 microns in diameter and the sheets may be aligned with holes to attach suture material.

The provided document is a 510(k) summary for the MacroPore Surgi-Wrap (TS), seeking substantial equivalence to existing surgical meshes. This type of regulatory submission (from 2001) primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed acceptance criteria and standalone clinical study results for novel device performance.

Therefore, much of the requested information regarding acceptance criteria, specific study designs (like MRMC), expert consensus, and ground truth establishment, which are common in de novo or PMA submissions for novel or high-risk devices, is not present in this 510(k) summary.

The document primarily focuses on establishing substantial equivalence based on:

1. Indications for Use: Demonstrating the same intended use as predicate devices.
2. Design and Materials: Showing comparable physical characteristics and material composition.
3. Performance Data: Presenting in-vitro and in-vivo non-clinical testing to support the functional equivalence and safety.

Here's an attempt to answer the questions based on the provided text, explicitly stating when information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission focused on substantial equivalence to predicate devices, explicit quantitative acceptance criteria with specific thresholds for device performance are not detailed in the provided summary in the manner usually seen for new device or algorithm performance evaluations. Instead, the document reports that the device "meets" or is "substantially equivalent" to the predicate devices based on various tests.

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

• Sample Size for Test Set:
  • In Vitro Testing: Not explicitly stated (e.g., number of samples for viscosity, aging, or mechanical strength tests).
  • In Vivo (Animal) Testing: Not explicitly stated (e.g., number of animals, number of implants).
• Data Provenance: The document does not specify the country of origin of the data. The studies appear to be non-clinical (in vitro and animal), not human clinical data, and there's no indication of the studies being retrospective or prospective in the human clinical sense.

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

This information is not available in the provided 510(k) summary. Given the non-clinical nature of the studies discussed (in vitro and animal), expert consensus in the form of radiologists or other clinicians establishing ground truth for a test set (as would be relevant for an AI/CAD device) is not applicable here. Ground truth for the animal studies would likely come from histopathological analysis and macroscopic observation by veterinarians or pathologists, but specifics are not provided.

4. Adjudication Method for the Test Set

This information is not available and not applicable to the non-clinical studies described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or assessments to resolve discrepancies, which are not detailed here.

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 assesses how human readers perform with and without AI assistance and is irrelevant for this device (surgical mesh), which is not an AI/CAD system.

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

No, a standalone algorithm performance study was not done. This device is a physical surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

• For In Vitro Testing: The "ground truth" implicitly refers to the quantifiable physical and chemical properties of the material (e.g., viscosity, mechanical strength, material composition) measured against established scientific standards or the performance of predicate devices.
• For In Vivo (Animal) Testing: The "ground truth" for biocompatibility and appropriateness for use would typically be established through histological analysis, gross pathological examination, and possibly functional observation by trained veterinarians and pathologists. The summary only states that studies "demonstrated that the MacroPore Surgi-Wrap (TS) materials are biocompatible and appropriate for the indications for use."

8. The Sample Size for the Training Set

This information is not applicable and not available. This device is not an AI/ML algorithm that requires a training set. The data described comes from laboratory and animal testing.

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

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

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The MacroPore ENT Reconstruction Film is indicated for the following surgical applications:

• 1). Tympanic membrane repair.
• 2). Tympanoplasty in the middle ear.
• 3). Nasal splinting and surgical repair of nasal septum.
• 4). Guided tissue regeneration of the external ear.
• 5). Prevents adhesions between the septum and the nasal cavity.

MacroPore ENT Reconstruction Film is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore ENT Reconstruction Film can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore ENT Reconstruction Film to the desired shape or size.

MacroPore ENT Reconstruction Film Sheet is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore ENT Reconstruction Film can be rolled into a tube or used as a flat sheet. It can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which also can serve to fixate the MacroPore ENT Reconstruction Film and prevent dislocation. The MacroPore ENT Reconstruction Film may be used in conjunction with various MacroPore manual instruments.

MacroPore ENT Reconstruction Film is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. MacroPore ENT Reconstruction Film is provided in sheets of 10mm x 10mm to 120mm x 120mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore ENT Reconstruction Film ranges from 0.02 mm to 2.0 mm according to the region to be treated. The MacroPore ENT Reconstruction Film is provided with and without macroporous holes. The macroporous holes range in size from 50 microns to 3,000 microns in diameter and may be in aligned, offset, or random patterns. The borders of the sheets may be aligned with holes to attach suture material

The provided 510(k) summary for the MacroPore ENT Reconstruction Film outlines the device's characteristics and its equivalence to predicate devices, but it does not contain details about specific acceptance criteria, a study proving those criteria were met, or the metrics involved in such a study.

Instead, the document details physical and material properties, in vitro and in vivo testing for safety and efficacy, and a comparison with existing devices to establish "substantial equivalence." The "acceptance criteria" presented below are inferred from the types of tests and comparisons mentioned in the document, as the 510(k) process focuses on demonstrating equivalence rather than meeting pre-defined performance criteria like those found in a clinical trial for a novel device.

Here's an attempt to structure the information based on your request, highlighting the limitations due to the nature of the provided document:

Acceptance Criteria and Device Performance (Inferred from 510(k) Submission)

Study Details:

The provided document describes neither a specific "test set" nor "training set" in the context of an algorithm or AI model, nor does it detail a study proving specific acceptance criteria in the way a clinical trial would. Instead, it refers to pre-clinical (in vitro and in vivo animal) testing and a substantial equivalence comparison to predicate devices.

1. 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 "Test Set" as defined for AI/Algorithm performance. The document refers to "in vitro testing" and an "animal study."
   • In vitro testing: No sample sizes are explicitly stated for the in vitro tests (viscosity, aging, mechanical testing). The provenance is not stated, but it would typically be conducted by the manufacturer (MacroPore, Inc.) in their labs in San Diego, CA, USA.
   • Animal study: The document states "An animal study was conducted," but no details on the number of animals, species, or study design are provided. The provenance is not stated.

2. 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 this context would implicitly be established through standard scientific and pre-clinical methodologies for evaluating material properties and biological response in animal models. No expert panel for "ground truth" adjudication in the context of a dataset evaluation is mentioned.

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

   • Not applicable. This concept pertains to expert review of data for AI/algorithm validation, which is not described.

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

   • No, an MRMC comparative effectiveness study was not done. This is a medical device (reconstruction film), not an AI algorithm intended to assist human readers.

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

   • No, this is not an algorithm, so standalone performance is not applicable.

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

   • For the in vitro testing: The "ground truth" would be the objective measurements obtained from the laboratory tests (e.g., viscosity readings, tensile strength, elongation).
   • For the animal study: The "ground truth" for safety and efficacy would be based on histological analysis, clinical observations, potential pathology, and biocompatibility assessments in the animal model.

7. The sample size for the training set

   • Not applicable. This is not an AI/algorithm submission.

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

   • Not applicable. This is not an AI/algorithm submission.

Summary of the Study that "Proves" Equivalence:

The "study" or rather the evidence provided to the FDA for 510(k) clearance consists of:

• In vitro testing: This included viscosity testing (after heating at 60°C for 120 minutes, showing it stayed in an "appropriate range"), aging testing (demonstrating sufficient strength), and mechanical testing (demonstrating substantial equivalence to predicate devices). The details of these tests (e.g., number of samples tested, specific methods, raw data) are not provided in this summary.
• In vivo animal study: Conducted to demonstrate "safety and efficacy" and that the materials are "appropriate for the indications for use." No details on the study design, species, number of animals, or specific outcomes are included in this summary.
• Substantial Equivalence Comparison: A detailed comparison of the MacroPore ENT Reconstruction Film's indications for use, design characteristics (material composition, malleability, thickness range, dimensions, mechanical characteristics, ability to be cut), and general performance with a list of predicate devices (Pillar Prolastic Sheeting, SupraFOIL, Seare Silicone Sheeting, Durasil I and Durasil II, Specialty Surgery Silicone Elastomer, Lactosorb Ethmoid Stent, and MacroPore Protego System). The core argument for clearance is that the MacroPore device is sufficiently similar to these legally marketed devices that it can be considered safe and effective.

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A. General Indications: Trauma procedures of the midface or craniofacial skeleton. Specific Indications: 1). Comminuted fractures of the naso-ethmoidal infraorbital areas. 2). Comminuted fractures of the frontal sinus wall. 3). Pediatric midface or craniofacial trauma 4). Lefort (I, II, III) fractures. 5). Orbital floor fractures. 6). Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones. 7). Trauma of the craniofacial skeleton including: frontal, parietal, temporal , sphenoid, and occipital bones. B. General Indications: Reconstructive procedures of the midface or craniofacial skeleton.. Specific Indications: 1). Infant craniofacial surgery (i.e., craniosynostosis, congentital malformations, trauma, etc.). 2). Lefort (I, II, III) osteotomies. 3). Tumor reconstruction in midface or craniofacial procedures. 4). Bone graft procedures in the midface or craniofacial skeleton. 5). Pediatric reconstructive procedures. 6). Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones. 7). Craniotomy flap fixation.

MacroPore FX, PS, NS, LP is a resorbable bone fixation system composed of various sized porous sheets, non-porous sheets, and associated fixation tacks and screws manufactured from poly lactic acid. The MacroPore FX, PS, NS, LP are composed of MacroPore FX, PS, NS, LP Protective Sheets and MacroPore FX and LP Screws and Tacks. MacroPore Protective Sheets can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore Plates and Protective Sheets to the desired shape or size. The MacroPore Plate and Protective Sheets are fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore FX, PS, NS, LP bone fixation system includes a selection of resorbable screws, tacks, and associated manual instruments. Tacks range in size from 1.5mm to 2.0mm in outer diameter. Screws range in size from 2.0mm in outer diameter. The MacroPore Plates and Protective Sheets come in various sizes ranging from 0.5mm in thickness according to the region to be treated. The MacroPore Protective Sheets range in size from as small as 20mm x 20mm to as large as 120mm x 120mm. The MacroPore Protective Sheet is provided with and without macroporous holes. The macroporous holes range in size from 500 microns to 3,000 microns in diameter. All configurations are to be within a mass of 18 grams of polymer. Various manual instruments (PowerTack Driver, StarBurst Screw drivers, Tack Pusher, taps, drill bit, etc.) are used in conjunction with the MacroPore FX, PS, NS, LP bone fixation system to assist in the installation process.

This document describes the MacroPore FX, PS, NS, LP bone fixation system, which is a medical device. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study establishing acceptance criteria and device performance in the way typically seen for a new AI/software-based medical device.

Therefore, many of the requested categories related to clinical study design and results for acceptance criteria cannot be directly answered from this document. This document details in vitro testing for mechanical properties and a comparison to predicate devices to establish substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of performance metrics for a clinical study. Instead, it focuses on demonstrating substantial equivalence to predicate devices in terms of:

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

• Sample Size for Test Set: The document describes in vitro mechanical testing but does not specify the sample size (number of devices or tests performed) for this testing.
• Data Provenance: The testing appears to be conducted by the manufacturer ("MacroPore, Inc."). The document does not specify the country of origin of the data beyond implying it's part of the manufacturer's submission for FDA clearance in the USA. It is in vitro data, not human patient data (retrospective or prospective).

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

This is not applicable as the study involved in vitro mechanical testing comparing device properties, not a clinical assessment requiring expert interpretation of patient data or establishment of a clinical ground truth.

4. Adjudication Method for the Test Set

Not applicable, as it involved in vitro mechanical testing, not a clinical assessment requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI

Not applicable. This is not an AI/software-based device, and no MRMC study was conducted.

6. If a Standalone (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

The "ground truth" in this context refers to the established mechanical properties and design characteristics of the predicate devices. The new device's performance was measured in vitro and compared against these established characteristics to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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