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The Biodesign Otologic Butterfly Graft is intended for use as an implant material to aid in the natural healing process in myringoplasty and tympanoplasty procedures.

The Biodesign Otologic Butterfly Graft is a self-securing butterfly-style graft structure with the same underlay component as the predicate device, attached to an external stabilizing component with an absorbable knotted thread, all made from the same SIS (small intestinal submucosa) ECM material as that of the predicate device. This self-securing structure maintains the location and close tissue approximation of the underlay component across the tympanic membrane (TM) defect as an implant material to aid in the natural healing process in myringoplasty and tympanoplasty procedures.

The provided text does not describe an acceptance criteria table or a study that specifically "proves" the device meets acceptance criteria in the typical sense of a single, definitive study with a direct comparison against a set of performance metrics. Instead, it describes a Substantial Equivalence (SE) determination for a new device, the "Biodesign Otologic Butterfly Graft," by comparing it to a legally marketed predicate device (K161000).

The concept of "acceptance criteria" here is implicitly tied to demonstrating that the new device is as safe and effective as the predicate, despite some design changes. The studies conducted are largely comparative, aiming to show that the changes do not introduce new risks or diminish performance relative to the predicate.

Here's an attempt to extract the requested information based on the provided text, acknowledging that some details might be inferred or not explicitly stated as they would be in a direct performance study against a predefined acceptance criterion.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document focuses on demonstrating substantial equivalence to a predicate device rather than meeting pre-defined numerical acceptance criteria for a novel device. The "acceptance criteria" for the animal study are explicitly stated and are the closest to what was requested.

Summary of Comparative Equivalence: The overall "acceptance criterion" for the device, in the context of this 510(k) submission, is to demonstrate that its design changes do not introduce new questions of safety or effectiveness and that it performs as well as, or better than, the predicate device. The various studies and tests listed are all geared towards supporting this claim of substantial equivalence.

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

For the animal study:

• Sample Size: 14 tympanic membrane perforations implanted with the subject device.
• Data Provenance: Prospective GLP animal study in a chinchilla model. The location/country is not specified.

For bench testing (mechanical performance, usability, packaging/shelf-life): Specific sample sizes are not provided, only that "Product verification testing was performed," "Summative Usability Report which utilized simulated-use testing," and "Non-clinical bench testing was performed on accelerated-aged representative SHS conditioned packaging system samples."

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

For the animal study:

• Number of Experts: At least one "Veterinary Pathologist."
• Qualifications: "Veterinary Pathologist's review of the histologic sections of the grafted/implanted tympanic membranes." No specific years of experience are mentioned.

For other testing, specific expert numbers or qualifications for ground truth establishment are not provided.

4. Adjudication method for the test set

For the animal study:

• The text mentions a "Veterinary Pathologist's review of the histologic sections." This implies a single expert's determination for the histological ground truth. It does not describe a multi-reader adjudication method (e.g., 2+1, 3+1).
• Visual healing was determined "via endoscopy," and functional healing by "typanogram technique." It's unclear if these assessments involved multiple readers or an adjudication process.

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 was not done. This document pertains to a medical device (graft) and its biological/mechanical performance, not an AI or imaging diagnostic device where MRMC studies involving human readers and AI assistance would be relevant.

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

• Not applicable. This is a physical medical device (graft), not an algorithm or AI system.

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

For the animal study:

• Pathology: Histological assessment by a Veterinary Pathologist.
• Clinical Observation: Visual assessment (no perforation observed via endoscopy).
• Physiological/Functional Data: Tympanogram waveform analysis.

8. The sample size for the training set

• Not applicable. This document describes the evaluation of a physical medical device. There is no concept of a "training set" in the context of an animal study for a medical implant like there would be for an AI algorithm.

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

• Not applicable. As there is no training set for this type of device evaluation, no ground truth was established for one.

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The Biodesign Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The Reinforcement may be used for buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The Staple Line Reinforcement can be used for the reinforcement of the gastric staple line during bariatric surgical procedures, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The Staple Line Reinforcement may be used with anastomotic staplers or with non-anastomotic staplers.

The subject device consists of a thin multi-layer strip of SIS, pre-coated with a ready-to-use contact adhesive that eliminates the need for a separate adhesive (hydrogel), or activation of the adhesive through rehydration to affix the device to surgical stapler jaws. The single-use implant device is provided to the point of use with a protective liner covering the adhesive which has been assembled onto a foam carrier which is suspended in an alignment tray sized for the jaws of a surgical stapler. The completed device, liner, carrier, and alignment tray unit is then sealed in a foil pouch with an integrated humidity control feature and terminally E-beam sterilized. In order to accommodate a variety of commercially available surgical staplers the device is available in configurations measuring from 0.05mm to 0.6mm in thickness, and in nominal (unfolded) device lengths ranging from 76 mm to 176 mm in length and up to 12 mm wide. Upon implantation, the Biodesign® Staple Line Reinforcement device will provide mechanical reinforcement of the staple line by buttressing the soft tissue and preventing the surgical staples from tearing through the affected tissue. In addition, the Biodesign® Staple Line Reinforcement device will incorporate (remodel) into the body over time such that no graft material is left behind.

This document is a 510(k) summary for the Biodesign® Staple Line Reinforcement device. It describes the device, its intended use, and compares it to a legally marketed predicate device (K170945) to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance data in terms of "Product verification testing" and "Staple line leakage testing" but does not explicitly state numerical acceptance criteria for these tests. Instead, it describes general findings.

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

The document does not provide specific sample sizes for the "Product verification testing" or "Staple line leakage testing". It states "representative SHS conditioned sterilized finished devices" and "representative SHS conditioned packaging system samples" were used.

The data provenance is not explicitly stated in terms of country of origin. The testing appears to be non-clinical bench testing conducted by the manufacturer, Cook Biotech Incorporated, which is a U.S.-based company (West Lafayette, IN). All tests mentioned are retrospective (bench tests performed on the device).

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

This information is not applicable. The device is a physical medical device (surgical mesh), and its performance is evaluated through objective physical and biological tests (mechanical performance, leakage, biocompatibility). There is no "ground truth" derived from expert interpretation of images or clinical data in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above (physical device testing, not expert-based assessment).

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 is a surgical mesh for physical reinforcement, not an AI-assisted diagnostic or clinical decision support tool.

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 product, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance claims of this device is based on objective scientific and engineering measurements in benchtop and laboratory settings:

• Mechanical performance: Measured physical properties and behaviors under simulated surgical conditions.
• Staple line leakage: Measured leakage rates or other objective indicators of buttressing effectiveness.
• Biocompatibility: Results from standardized ISO 10993 in vitro and in vivo biological tests.
• Packaging and shelf life: Measured integrity of packaging and stability of the product over time under defined conditions.

8. The Sample Size for the Training Set:

This information is not applicable because the device is a physical medical device and does not involve AI or machine learning that requires training data.

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

This information is not applicable, as there is no training set for this device.

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Biodesign Anal Fistula Plug: For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas.
Biodesign Fistula Plug: For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.
Biodesign Plastic Surgery Matrix: For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery.
Biodesign Tissue Graft: For implantation to reinforce soft tissue.

All four subject devices of this bundled submission are part of a family of devices manufactured by Cook Biotech Incorporated (CBI) consisting of processed porcine small intestinal submucosa (SIS), a three-dimensional, acellular, collagen-based extracellular matrix (ECM) material. SIS is manufactured by first removing the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer surface of the porcine small intestine. Further processing removes the cells and renders the material virally inactive. leaving behind a three- dimensional, decellularized, collagen-rich extracellular matrix.

This document does not contain an acceptance criteria table or a study proving the device meets specific performance criteria. Instead, it is a 510(k) premarket notification of intent to market for several Biodesign devices. The submission aims to demonstrate substantial equivalence to already marketed predicate devices, not to prove performance against specific acceptance criteria.

The core of the submission, as per the snippets provided, is that the subject devices are largely identical to their predicate devices, with the only change being the inclusion of additional rehydration fluid options in the instructions for use (IFUs).

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance:
* Absent. This document does not present specific acceptance criteria with corresponding performance data. The submission focuses on demonstrating substantial equivalence to predicate devices, which implies that the device's performance is expected to be similar or equal to that of the predicates. The closest information is a comparison of characteristics between the subject devices and predicate devices (Table 5-3 on page 8).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Absent. The document mentions "Mechanical testing (burst strength, tensile strength, suture retention strength and delamination testing) performed on devices rehydrated with new rehydration fluid options" to demonstrate no negative effects on mechanical properties. However, it does not specify the sample size used for these tests, the data provenance, or whether the study was retrospective or prospective.

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 / Absent. This type of information is typically relevant for studies involving human interpretation (e.g., diagnostic imaging). This submission describes mechanical testing of a medical device (surgical mesh), not expert-based assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable / Absent. Similar to point 3, adjudication methods are usually for expert consensus on results, which is not described here for mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not applicable. This submission pertains to a surgical mesh, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness analysis is presented.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for the mechanical testing would be the measured mechanical properties (burst strength, tensile strength, suture retention strength, delamination) of the device. The aim was to show that these properties, when rehydrated with new fluid options, were comparable to those rehydrated with saline. The text states: "...demonstrate the devices still performed as expected and there were no negative effectives on the mechanical properties."

8. The sample size for the training set:
* Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:
* Not applicable. As there is no training set, this information is not relevant.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence for modifications to existing surgical mesh devices, primarily concerning rehydration fluid options. It describes mechanical testing performed to ensure the modified devices retain expected properties but does not detail acceptance criteria or study specifics in the format requested, which is typical for performance studies of AI/diagnostic devices.

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The Biodesign® Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists including the repair of diaphragmatic/hiatal hernias.

The graft is supplied sterile and is intended for one time use only.

The Biodesign® Diaphragmatic Hernia Graft, the subject device, has the same indications for use and is physically identical to the predicate device (K133011) with the same name. The only difference between the subject device and the predicate device is the rehydration fluid options described in the devices' instructions for use (IFU).

Both the subject and predicate devices are part of a family of implant devices manufactured from porcine small intestine that have been processed to remove the tunica mucosa from the inner intestinal surface and the serosa and tunica muscularis from the outer intestinal surface. After further disinfection to ensure the material is virally inactive, the resulting layer is a three dimensional, acellular, collagen-rich extracellular matrix (ECM) that is termed small intestinal submucosa (SIS). Both the subject and predicate devices are multilayered SIS sheets configured in two shapes: rectangular shape (7 x 10 cm) and the U-cut shape (7 x 10 cm with U-shaped notch). Both devices are perforated and have polyglycolic acid (PGA) suture stitched across the device and around the perimeter. The purpose of the suture stitching is to prevent delamination due to device handling during implantation. Both devices are provided in a double Tyvek® pouch and are ethylene oxide (EO) sterilized.

Prior to implantation, the Biodesign® Diaphragmatic Hernia Graft, the subject device, can be rehydrated with sterile saline or autologous body fluids (e.g., blood, bone marrow aspirate, or blood concentrates such as platelet concentrate).

Upon implantation, the Biodesign® Diaphragmatic Hernia Graft (both subject and predicate device) will provide mechanical reinforcement of soft tissue in the repair of diaphragmatic/hiatal hernias. Over time, the device will incorporate (remodel) into the body such that no graft material is left behind.

The provided document is a 510(k) summary for a medical device called the Biodesign® Diaphragmatic Hernia Graft. It describes the device, its intended use, and why it is considered substantially equivalent to a predicate device.

However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device, which is what your detailed questions are tailored to. The device in focus (a surgical mesh) is a physical implant, not a software or AI-driven diagnostic or therapeutic tool.

Therefore, I cannot answer questions 1 through 9 directly from the provided text, as they pertain to the evaluation of an AI/ML system's performance and validation.

The document's "Performance Data" section discusses non-clinical testing (mechanical properties, tensile strength, suture retention strength, hydration time, and simulated use/handling properties) to show that a new rehydration fluid option does not significantly change the device's properties compared to the predicate device. This is a very different type of "performance data" than what would be generated for an AI/ML medical device.

In summary, the provided text does not contain the information required to answer your specific questions.

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The Biodesign® Parastomal Hernia Repair Graft 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. It is specifically indicated for the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias.

The Biodesign® Parastomal Hernia Repair Graft is identical to the SIS Hernia Graft (i.e. same raw materials, manufacturing processes, configuration, packaging and sterilization). The devices are composed of multiple layers of porcine Small Intestinal Submucosa (SIS), a bioabsorbable, extracellular collagen matrix (ECM) that is non-crosslinked and decellularized; additionally, the device is held together with biodegradable suture to improve device handling characteristics at time of implant and is perforated to assist with fluid transfer. The single-use devices are packaged in a dried state and supplied sterile (EtO) in a sealed double pouch system.

The provided text describes the Biodesign Parastomal Hernia Repair Graft and its substantial equivalence to a predicate device (Permacol® Surgical Implant). The document details performance data through biocompatibility, mechanical testing, and clinical studies.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table for this specific device. Instead, it describes performance through various tests and clinical outcomes to demonstrate substantial equivalence to a predicate device.

Biocompatibility:

• Acceptance Criteria (Implied): Meet all biocompatibility requirements of the ISO standard for permanent implantable devices.
• Reported Device Performance: "Testing results show that the Biodesign® Parastomal Hernia Repair Graft meets all biocompatibility requirements of the ISO standard for permanent implantable devices."

Product Characterization - Mechanical:

• Acceptance Criteria (Implied): Adequate mechanical strength for use in abdominal wall defect and hernia repair.
• Reported Device Performance: "Product characterization testing shows that the Biodesign® Parastomal Hernia Repair Graft provides adequate mechanical strength for use in the repair of abdominal wall defects and hernias, including but not limited to parastomal hernias."
  • Specific mechanical tests performed: Burst strength, Ultimate tensile strength, Device stiffness, Suture retention strength, Tear strength, Delamination. (No specific quantitative results are provided in this summary).

Safety and Performance - Clinical Data (Recurrence Rate for Parastomal Hernias):

• Acceptance Criteria (Implied): Safe and effective use for repairing parastomal hernias, comparable to existing treatments or with an acceptable recurrence rate.
• Reported Device Performance:
  • Short-term (Median 18 months): 10% recurrence (2 out of 20 patients).
  • Long-term (Median 53 months): 25% recurrence (5 out of 20 patients).
  • Graft-Related Complications: 4 seromas in initial 10 patients (resolved by routine drain placement). No other complications reported long-term.

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

• Sample Size for Test Set: 20 patients for the clinical study directly referenced (Ellis A).
• Data Provenance: The primary clinical study cited is a published peer-reviewed publication by Ellis CN, titled "Short-term outcomes with the use of bioprosthetics for the management of parastomal hernias" (2010). This indicates retrospective or prospective data collection from a clinical setting, though the exact nature (e.g., country of origin) is not specified in the provided text. The document also mentions "Unpublished long term data on 19/20 patients," which suggests an extension of this initial cohort.

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

The clinical data is derived from a published peer-reviewed study. For clinical studies, the "ground truth" (e.g., diagnosis of recurrence, identification of complications) is typically established by the physicians and medical staff involved in the study. The text does not specify the number of experts, their qualifications, or the specific process they used to establish the ground truth for the clinical data. It just refers to "patients," implying clinical observation and diagnosis by healthcare professionals.

4. Adjudication Method for the Test Set

The text does not mention any specific adjudication method (e.g., 2+1, 3+1) for the clinical study's outcomes (recurrence, complications). Clinical study outcomes are generally determined by the treating physicians or study investigators.

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

No, an MRMC comparative effectiveness study is not mentioned. The clinical study cited focuses on the outcomes of the SIS-based device itself, not on comparing performance of human readers with and without AI assistance.

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

This device is a physical medical implant (a surgical graft), not an algorithm or AI. Therefore, the concept of a "standalone study" for an algorithm's performance without a human-in-the-loop is not applicable to this device. The studies performed directly assess the device's physical and biological performance in a clinical setting.

7. The Type of Ground Truth Used

• Biocompatibility and Mechanical Testing: The "ground truth" for these tests are the established ISO standards and FDA guidance documents, which define acceptable physical and biological characteristics. The results directly measure these characteristics.
• Clinical Data: The "ground truth" for the clinical study outcomes (recurrence, complications) is based on expert clinical diagnosis (e.g., physical examination, radiological (CT) examination) and patient outcomes data collected during follow-up.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is a physical graft, not a machine learning model. The biocompatibility and mechanical tests are performed on the device itself, and the clinical study provides evidence of its performance in patients.

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

As noted above, a "training set" is not relevant for this type of medical device. The "ground truth" for the device's safety and performance is established through adherence to regulatory standards (biocompatibility, mechanical testing) and clinical observations/diagnoses in patient studies.

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The Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.

The Biodesign® Fistula Plug is a fistula repair device made from porcine SIS, a collagen rich, bioresorbable, extracellular matrix (ECM)-based biomaterial. The device design consists of a tapered SIS cylinder (plug body) and an SIS flange/button connected together using biodegradable polyglycolic acid (PGA) surgical suture. The function of the plug body is to fill the fistula tract and the function of the flange/button is to anchor the device at the internal fistula opening. Three different size offerings (2mm, 5mm and 7mm) are available based on the diameter of the primary end of the plug.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving device meets acceptance criteria. Therefore, most of the requested information cannot be fully extracted or is not applicable in this context.

Here's what can be inferred or directly stated from the provided document:

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

The document describes non-clinical testing performed to demonstrate substantial equivalence but does not explicitly list acceptance criteria values for each test. Instead, it states that "The results of the testing confirm that the subject device does not pose new or different biocompatibility risks and can withstand the expected mechanical forces on the device."

Specific tests performed:

• Biocompatibility testing: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation (on SIS and PGA suture).
• Performance Testing Bench: Extrusion resistance testing, Tensile strength testing, Plug suture retention strength.

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

The document does not provide details on sample sizes for the non-clinical tests (e.g., number of samples for extrusion resistance, number of animals for biocompatibility). It also does not discuss data provenance for these tests (country of origin, retrospective/prospective), as these are typically laboratory bench and animal studies, not human clinical trials.

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

Not applicable. This is a non-clinical submission, not an image-based diagnostic device or one involving human expert interpretation for ground truth.

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

Not applicable for a non-clinical 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 is a physical medical device (fistula plug), not an AI-based diagnostic system.

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

Not applicable, as it is not an algorithm/AI device.

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

For biocompatibility, the "ground truth" would be established by standard biological assays and observation for adverse reactions in animal models, comparing to established safety profiles of materials. For mechanical tests, the "ground truth" is based on engineering specifications and physical test methods.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device.

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

Not applicable, as this is not an AI/machine learning device.

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The Biodesign® Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers. The device may be used for buttressing and reinforcing staple lines during lung resection (e.g. wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy, pneumonectomy/pneumectomy, pneumoreduction) and other incisions and excisions of the lung and bronchus. The device can be used for the reinforcement of the gastric staple line during bariatric surgical procedures of gastric bypass and gastric banding, and for reinforcement of staple lines during small bowel, mesentery, colon and colorectal procedures. The device may be used with anastomotic staplers or with non-anastomotic staplers.

The Biodesign® Staple Line Reinforcement device is part of a family of implant devices manufactured from porcine small intestine that are disinfected and processed to remove the tunica mucosa from the inner intestinal surface and tunica muscularis from the outer intestinal surface. The resulting membrane is a three dimensional, acellular, collagen-rich extracellular matrix (ECM) that is termed small intestinal submucosa (SIS). Biodesign® Staple Line Reinforcement consists of a thin multi-layer strip of SIS, pre-coated with an adhesive that eliminates the need for a separate adhesive (e.g. hydrogel) to affix the device to surgical stapler jaws. The single-use device is provided on a foam applicator and suspended in a form-fitting tray before being sealed in a foil pouch and sterilized (E-beam). The material composition, general manufacturing processes, packaging configuration and sterilization method of the subject device are identical to the predicate, SURGISIS® SLRTM Staple Line Reinforcement (K070405).

Upon implantation, the Biodesign® Staple Line Reinforcement device will provide mechanical reinforcement of the staple line by buttressing the soft tissue and preventing the surgical staples from tearing through the affected tissue. In addition, the Biodesign® Staple Line Reinforcement device will incorporate (remodel) into the body over time such that no graft material is left behind.

This document is a 510(k) premarket notification decision letter and summary for a medical device called "Biodesign® Staple Line Reinforcement." It focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report with specific performance metrics for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, performance data with specific metrics (e.g., sensitivity, specificity, AUC), sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in the provided text.

The document discusses:

• Device: Biodesign® Staple Line Reinforcement (a surgical mesh).
• Purpose: Buttressing and reinforcing staple lines during various surgical procedures (lung, gastric, small bowel, colon/colorectal).
• Comparison to Predicate: The core of the submission is to show the device is substantially equivalent to the SURGISIS® SLRTM Staple Line Reinforcement (K070405). The key point is that the subject device is identical to the predicate in materials, manufacturing, intended use, and mode of action, with the only modification being the addition of thinner configurations.
• Performance Data Mentioned:
  • Biocompatibility testing: Leveraged from the predicate device as materials and manufacturing are identical.
  • Non-Clinical testing: "Product verification testing was performed on sterilized finished devices to evaluate the mechanical performance of the subject device for its intended use. Staple line leakage testing confirms that the Biodesign® Staple Line Reinforcement provides adequate staple line buttressing..."

In summary, this document does not contain the information needed to answer your request about acceptance criteria and study details for an AI-driven medical device, as it describes a traditional surgical mesh device seeking 510(k) clearance based on substantial equivalence to an existing product, primarily through material and mechanical performance validation rather than clinical or AI algorithm performance.

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DynaMatrix is intended for use in guided tissue regeneration and bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to enhance alveolar ridges, or to contain or prevent migration of graft material. The device is supplied sterile and intended for one-time use.

DynaMatrix consists of layered sheets of bioabsorbable extracellular collagen membrane matrix derived from porcine Small Intestinal Submucosa (SIS). These sheets are lyophilized, packaged in a Tyvek pouch, and sterilized using ethylene oxide to an SAL of 10°. The device is available in sheets ranging from 2 cm to 12 cm2, and can be trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane maintains suture tear resistance. It is considered to be a permanent contact implanted device, and is fully biocompatible.

DynaMatrix is available by prescription only and is intended for use in an oral surgery setting for guided tissue regeneration and bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain or prevent migration of graft material. Dynamatrix achieves its intended use by providing a passive, resorbable scaffold to guide epithelial tissue ingrowth and angiogenesis of the epithelial layer in order to maintain space around the bony defect, prevent epithelial down-growth, and allow for new bone formation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the DynaMatrix/DynaMatrix Plus device.

Based on the provided text, this document is a 510(k) Summary for a medical device (DynaMatrix/DynaMatrix Plus) seeking substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than performing clinical studies to prove new efficacy.

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the traditional sense of a clinical or performance study. Instead, it relies on demonstrating substantial equivalence to a predicate device (DynaMatrix, K082058) and a reference device (Surgisis Periodontal Membrane, K010952).

The key "acceptance criterion" in this context is that the subject device (DynaMatrix/DynaMatrix Plus) is substantially equivalent to the predicate device, meaning it has the same intended use, fundamental scientific technology, and comparable safety and effectiveness.

The "device performance" is primarily presented as being identical to the predicate in all critical aspects except for a dimensional change (additional sizes).

Here's an interpretation based on the provided text:

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

The primary "test set" mentioned for evaluation of the dimensional change is a swine pilot study.

• Sample Size: Not explicitly stated as a numerical count beyond "a swine pilot study."
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Likely prospective, as it was conducted for verification activities related to the new device sizes.

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)

The text does not specify the number of experts or their qualifications for evaluating the swine pilot study or establishing any specific "ground truth" through expert consensus. The assessment seems to be based on observed "successful incorporation and no foreign body response."

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

No information is provided regarding an adjudication method for the swine pilot study results. It's implied that the findings of "successful incorporation and no foreign body response" were straightforward and did not require complex 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a biomaterial (bone grafting material), not an AI-assisted diagnostic or therapeutic device. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

No, this is not an algorithm-only device. It is a physical biomaterial.

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

For the swine pilot study, the "ground truth" appears to be based on histopathological evaluation or direct observation of biological response, specifically "successful incorporation and no foreign body response."

8. The sample size for the training set

This is not applicable as the device is a biomaterial and does not involve AI/machine learning requiring a training set in the conventional sense.

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

Not applicable for the reasons mentioned in point 8.

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The Nerve Cuff is intended for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. The device is supplied sterile and is intended for one-time use.

The Nerve Cuff is composed of a bioabsorbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Nerve Cuff is identical to that of its predicate (Surgisis Nerve Cuff, K031069), and reference device (Nerve Cuff, K132660). Both the predicate and reference devices are also manufactured by Cook Biotech Incorporated. The Nerve Cuff is implanted around an injured nerve to provide a scaffold which becomes infiltrated by the patient's cells and is remodeled into native tissue. In addition, the Nerve Cuff protects the damaged or severed nerve while the nerve heals. The device is packaged in a dried state and supplied sterile in a clamshell container inside a sealed pouch.

This document describes the AxoGuard Nerve Connector (K162741), a Class II medical device intended for the repair of peripheral nerve discontinuities. The submission is a Special 510(k) focusing on a size change for shorter lengths and one narrower diameter of the existing Nerve Cuff.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a single, overarching table with specific numerical targets for the device's main function (nerve repair success). Instead, it presents various tests with their respective acceptance criteria for different aspects of the device's material, handling, and sterility. The reported device performance indicates that these criteria were met.

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

The document does not explicitly state distinct "test sets" with specific sample sizes for this submission (K162741) in the context of evaluating algorithm performance or clinical outcomes. Instead, it leverages data from the predicate device (K031069) and reference device (K132660) due to identical material and manufacturing processes.

• User handling validation: "representative final product" was used. Specific sample size not given.
• Pre-clinical study discussion/evaluation: "representative final product" was used. Specific sample size not given.
• Bench Testing:
  • Ultimate tensile strength: Not specified.
  • Suture retention strength: "All samples met acceptance criteria." Specific sample size not given.
  • Compression and rebound: "All samples met acceptance criteria." Specific sample size not given.
• Biocompatibility Testing:
  • Cytotoxicity: Not specified.
  • Sensitization: Guinea pigs (sample size not given).
  • Intracutaneous reactivity: Rabbits (sample size not given).
  • Acute systemic toxicity: Mice (sample size not given).
  • Subchronic and chronic toxicity: Rats for 4 weeks (subchronic) and 18 weeks (chronic) (sample size not given).
  • Genotoxicity: Not specified.
  • Implantation: Rabbits for 4, 12, and 24 weeks (sample size not given).
• Sterilization validation: Not specified.

Data Provenance: The studies cited (bench, biocompatibility, sterilization) relate to the material and manufacturing process, which are stated to be identical to the predicate device (Surgisis Nerve Cuff, K031069). Therefore, the data provenance is indirectly tied to the studies performed for that predicate, which would have been conducted to support its clearance. There is no information regarding country of origin or whether these original studies were retrospective or prospective in this document.

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

• Key Opinion Leaders / Surgeons: For the "User handling validation" and "Pre-clinical study discussion/evaluation," surgeons and "key opinion leaders" were involved. The exact number of experts and their specific qualifications (e.g., years of experience or specialty beyond "surgeon") are not detailed. Their role was to assess handling characteristics and provide feedback on pre-clinical data.
• For other tests (bench, biocompatibility, sterilization), the "ground truth" is established by adherence to recognized standards (e.g., ISO, EN ISO) and objective measurements, not by expert consensus in the same way clinical ground truth is established.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for a "test set" in the context of clinical outcomes or diagnostic accuracy. For the "User handling validation" and "Pre-clinical study discussion/evaluation," it states "acceptability to the end user" and "No concerns regarding pre-clinical data," implying a consensus or agreement among the participating experts/surgeons, but no specific adjudication method (e.g., 2+1, 3+1) is mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document is for a medical device (nerve cuff), not an AI or imaging diagnostic algorithm. Therefore, the concept of human readers improving with or without AI assistance is not applicable. The device's performance is assessed through material properties, biocompatibility, and handling, mainly by comparison to a predicate device.

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

No, a standalone performance study in the context of an algorithm has not been done. This is a hardware medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for various tests is primarily objective measurements and established scientific/biological standards:

• Functional Performance (User handling, Pre-clinical discussion): Subjective assessment by surgeons/key opinion leaders (qualitative "ground truth" on handling and acceptability).
• Bench Testing (Tensile strength, Suture retention, Compression/rebound): Direct physical measurements and comparison to performance of the predicate device, against engineering specifications and the device's intended function.
• Biocompatibility Testing: Biological responses observed in animal models (mice, guinea pigs, rabbits) and in vitro tests, evaluated against established safety profiles and ISO standards. This is akin to pathology/biological response data.
• Sterilization Validation: Microbiological testing to achieve a specific Sterility Assurance Level (SAL), based on established sterilization protocols (EN ISO 11135).

There is no mention of pathology, clinical outcomes data from human trials, or expert consensus on disease diagnosis as ground truth, as the submission focuses on safety and performance characteristics for a device that provides a physical structure for nerve repair, rather than a diagnostic tool.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is not an AI/machine learning device. The device's characteristics are established through various physical, chemical, and biological tests, not through training on a dataset.

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

Not applicable, as there is no "training set" for this type of medical device submission.

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The Flowable Wound Matrix 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, 2nd degree burns, skin tears) and draining wounds.

The Flowable Wound Matrix is a wound management device consisting of particulate Porcine Small Intestinal Submucosa (SIS) and fructose, a natural carrier. The device is an addition to the family of SIS-based wound management devices (Oasis Wound Matrix (K061711) and Cook ECM Powder (K152033)) already manufactured by Cook Biotech Incorporated. The device is supplied dry, rehydrated with saline at the time of application, and delivered topically to the wound through a pre-supplied syringe. SIS, which composes the majority of the device, is the same base material as that of the predicate device Oasis Wound Matrix (K061711) and reference device Cook ECM Powder (K152033). In addition to SIS, the device also contains fructose, a carrier added only to facilitate the preparation and delivery of the device. Fructose is a sugar naturally found in the body and is readily metabolized. The Flowable Wound Matrix is meant to be employed by the user to manage wounds of the types outlined in the intended use of the device. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.

I am sorry, but the provided text only contains a 510(k) summary for the "Flowable Wound Matrix" device. It outlines the device description, its intended use, comparison to predicate/reference devices, and a summary of non-clinical tests conducted for substantial equivalence.

However, the document does not contain the specific details required to answer your request regarding acceptance criteria and a study proving the device meets them. Specifically, it lacks:

1. A table of acceptance criteria and reported device performance. It only lists performed tests (biocompatibility, rehydration and deployment, package integrity, shelf life, collagen characterization).
2. Sample sizes used for a test set, data provenance, or details about ground truth establishment.
3. Information on the number of experts or adjudication methods.
4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
5. Sample size for a training set or how ground truth for a training set was established.

This document is focused on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing and comparison of features, rather than presenting a clinical study with detailed performance metrics against specific acceptance criteria.

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