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MISTI Silicone Implant is intended for the augmentation of the nasal, malar, chin, gluteal, calf and/or pectoral contour.

The MISTI Silicone Implant offers various types including Nasal, Chin, Mid-face, Forehead, Block, Temple, Gluteal, Calf and Pectoral. The Nasal, Chin, Mid-face, Forehead, Gluteal, Calf and Pectoral are used for the areas indicated in the type names. The Block type is used for various areas during plastic and reconstruction surgeries. The Temple type can be used on a juncture where four skull bones fuse together so called the temple region. It is made of implant grade silicone elastomer, and the design characteristic minimizes carving and promotes natural line.

The provided text is a 510(k) Premarket Notification from the FDA regarding the MISTI Silicone Implant. This document outlines the manufacturer's claim of substantial equivalence to existing predicate devices, primarily based on material, design, function, and performance data from non-clinical tests.

However, the document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy, which is typically what these questions relate to for AI/Software as a Medical Device (SaMD).

Therefore, I cannot provide the requested table and detailed information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these types of studies were not conducted or reported in this 510(k) submission.

This 510(k) focuses on demonstrating the physical and biological safety of the MISTI Silicone Implant by comparing its characteristics and performance in non-clinical tests (material properties, biocompatibility, sterilization) to legally marketed predicate devices, rather than on diagnostic accuracy or clinical effectiveness studies in humans with defined acceptance criteria for AI performance.

The "Performance Data (Non-Clinical)" section lists various tests performed, such as:

• Sterilization Validation
• Appearance
• Dimensional inspection
• Extraction
• Hardness (ASTM D2240 (Type A))
• Tensile strength (ASTMD412)
• Elongation (ASTM D412)
• Tear strength (ASTM D624)
• Cytotoxicity (ISO 10993-5)
• Skin Sensitization (ISO 10993-10)
• Intracutaneous Reactivity (ISO 10993-23)
• Pyrogen (ISO 10993-11)
• Acute Systemic Toxicity (ISO 10993-11)
• Subchronic Toxicity (ISO 10993-11)
• Implantation (ISO 10993-6)
• Genotoxicity (Ames) (ISO 10993-3)
• Genotoxicity (In vitro) (ISO 10993-3)

These tests are primarily focused on the safety and material properties of the implant, not on evaluating an AI algorithm's diagnostic performance.

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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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Silk Voice® is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Silk Voice® injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.

Silk Voice® is a sterile, non-pyrogenic, cohesive implant provided in a prefilled syringe and is a ready to use product. Silk Voice is comprised of porous bioabsorbable silk particles suspended in an isotonic, aqueous formulation of cross-linked, high molecular weight hyaluronic acid (HA). The crosslinked HA gel acts as a carrier for the silk particles to facilitate delivery. The main component of Silk Voice is silk particles, manufactured exclusively from regenerated silk fibroin protein, isolated from purified silk fibers. When injected, Silk Voice provides immediate volume augmentation to the vocal fold tissue. The porous particles remain at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated silk scaffold provides longterm restoration and augmentation.

Silk Voice prefilled syringes are provided in a kit with a catheter, that is designed for endoscopic delivery to the vocal fold. The catheter accessory provided in the kit is specifically designed for delivery of injectable materials into tissue during endoscopic procedures.

The provided text does not contain information about acceptance criteria or specific studies that prove the device meets acceptance criteria in the context of a clinical performance study with human readers or an AI algorithm. The document is an FDA 510(k) summary for a medical device (Silk Voice, SMI-04) and primarily focuses on demonstrating substantial equivalence to a predicate device (Silk Voice, K180631) through bench testing and shelf-life data.

Therefore, most of the requested information cannot be extracted from this document, specifically points 1, 2, 3, 4, 5, 6, 7, 8, and 9 relate to clinical or AI performance studies which are not described here.

Here's what can be extracted:

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

The document states: "All bench testing passed the acceptance criteria." However, the specific quantitative acceptance criteria for each test and the corresponding reported performance values are not detailed in the summary. For example, for "Particle size and circularity analysis", it's mentioned that it passed, but the acceptance range and the measured value are not provided.

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

Not applicable. The performance testing described is bench testing, not a clinical study on a test set of human 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, as there is no test set involving human data or expert review described.

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

Not applicable, as there is no test set involving human data or ground truth adjudication described.

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

Not applicable. No MRMC study or AI assistance is mentioned.

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

Not applicable. No AI algorithm performance is discussed.

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

Not applicable. The "ground truth" in this context would be the design specifications and regulatory requirements for the bench tests.

8. The sample size for the training set

Not applicable. No training set for an AI algorithm is mentioned.

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

Not applicable. No training set for an AI algorithm is mentioned.

Summary of available information related to performance testing:

The device's performance was evaluated through bench testing and shelf-life testing.

• Bench Testing:
  • Tests Performed: Particle size and circularity analysis, Rheometry, Extrusion force, HA fragment test, Particle concentration, Residual Crosslinker Content, pH, Endotoxin, Catheter leak test, Catheter tensile strength.
  • Outcome: "All bench testing passed the acceptance criteria," demonstrating that the delivery system meets pre-established design input requirements.
  • Biocompatibility: Relied on "Biocompatibility test results of the predicate device submitted as part of the original submission (K180631)," which are stated to "continue to support that Silk Voice® meets the requirements of ISO 10993 for its intended use."
• Shelf-Life Testing: Performed to support labeled expiration dating.
• Sterilization Validation: Conducted for steam and EtO sterilization cycles, demonstrating a Sterility Assurance Level (SAL) of 10-6.

The primary purpose of this submission is to demonstrate substantial equivalence to an existing predicate device (Sofregen's Silk Voice K180631), highlighting that a change in silk particle size ($250 \pm 50 \mu m$ in the subject device vs. $380 \pm 46 \mu m$ in the predicate) "does not affect the safety or effectiveness assessment."

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SeptAlign is used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

The Spirair SeptAlign implant is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. SeptAlign is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. SeptAlign is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle to enable attachment to the tissue which is trimmed off affer use. SeptAlignis provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.

The SeptAlign implantis provided preloaded into a disposable delivery tool comprised of a non-patient contacting handle assembly and a medical grade stainless steel delivery cannula and trocar. The delivery tool enables placement of the distal portion of the implant in a minimally invasive manner. The SeptAlign implant and accessory delivery tool are provided sterile and are intended for single-use only.

I am sorry, but the provided text from the FDA 510(k) notification for the SeptAlign device does not specify acceptance criteria for device performance or describe a study that proves the device meets such criteria in terms of accuracy, sensitivity, or specificity for any diagnostic or prognostic task.

The document primarily focuses on the device's mechanical and material performance, biocompatibility, packaging, and shelf-life. It states that "No animal or clinical performance testing was required to support substantial equivalence." This indicates that the substantial equivalence determination for this device (SeptAlign) was not based on clinical performance studies measuring diagnostic accuracy or reader improvement.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to diagnostic/prognostic metrics.
2. Sample size, data provenance, expert ground truth establishment, adjudication, MRMC studies, standalone performance, or ground truth types. These are typically associated with studies evaluating AI/diagnostic device performance, which were not required or reported for this submission.

The "Performance Data" section (Pages 4-5) lists the following performance elements:

• Biocompatibility Testing: Confirms materials do not pose a risk of negative interaction. This is about safety, not diagnostic performance.
• Distribution, Packaging and Shelf-Life Testing: Demonstrates integrity of sterile barrier and preservation of performance, related to product stability and safety.
• Performance Testing – Bench: Focuses on the accessory delivery tool's functionality, mechanical integrity, and cannula joint strength. This is about the physical device and its delivery mechanism working as intended, not its ability to detect or diagnose anything.

The acceptance criteria implicitly met are related to these physical and material properties (e.g., passing biocompatibility tests, maintaining sterility, successful mechanical deployment).

In summary, the provided document does not contain the type of information needed to answer your questions regarding acceptance criteria for diagnostic performance or studies proving such performance, as the device is a physical implant (a bioabsorbable ribbon) rather than a diagnostic or AI-powered device.

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The Spirair Nasal Septal Strap is used to support and straighten in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

The Spirair Nasal Septal Strap is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. The Nasal Septal Strap is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. The Nasal Septal Strap is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle attachment to the tissue which is trimmed off after use. The Nasal Septal Strap is provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.

This document is a 510(k) summary for the Spirair Nasal Septal Strap, detailing its regulatory review and substantial equivalence to a predicate device. It primarily focuses on the device's technological characteristics, indications for use, and performance data required for regulatory clearance. It does not describe a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device, as the Spirair Nasal Septal Strap is a physical medical device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance as it pertains to an AI/ML medical device, because the provided text is for a physical medical device and lacks any mention of AI, algorithms, or complex performance metrics typical of AI/ML systems.

The document discusses performance data related to:

• Biocompatibility Testing: According to ISO 10993-1 and FDA Guidance, assessing cytotoxicity, sensitization, irritation, implantation, and chemical characterization.
• Distribution, Packaging, and Shelf-Life Testing: Successful completion of accelerated aging and integrity of sterile barrier.
• Performance Testing - Bench: Demonstrating physical and functional requirements, including mechanical properties, material properties, migration of implant, and in vitro degradation.
• Performance Testing - Animal: A GLP animal study for safety, degradation, and biocompatibility.
• Performance Testing - Clinical: Interim safety data from a prospective, multi-center, multi-cohort, early feasibility clinical study in the US.

These tests are designed to demonstrate the safety and effectiveness of a physical implantable device, not an AI/ML algorithm.

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The Pre-Formed Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.

The Pre-Formed Silicone Block is an implant intended to be used in the aesthetic (cosmetic) correction of soft tissue deformities. The Pre-Formed Silicone Block comes in multiple shapes and sizes (cup-shaped in small, medium and large; crescent-shaped, and rectangular block) and one durometer to accommodate a variety of surgical techniques and implantation sites. All implants are made from medical grade silicone and can be trimmed with a knife or scissors. The trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable implant for a specific surgical indication. The implants are provided either sterile or non-sterile. Devices that are provided non-sterile must be sterilized prior to use.

The provided text is a 510(k) Summary for a medical device (Pre-Formed Silicone Block). This document describes the device, its indications for use, and a comparison to predicate devices to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria through performance evaluation.

Therefore, the information required to answer the prompt (acceptance criteria, device performance results, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided text. The document states:

• "No additional testing was provided in this submission in order to demonstrate substantial equivalence."
• "Previous testing (i.e., biocompatibility, sterilization, and non-clinical performance testing) was leveraged to support a demonstration of substantial equivalence." (This implies that this specific submission did not include new performance studies comparing the device to acceptance criteria, but rather relied on comparisons to previously cleared devices and existing safety/biocompatibility data.)

In summary, the provided FDA 510(k) summary does not contain the information requested about performance studies, acceptance criteria, or their results. It primarily focuses on demonstrating substantial equivalence to predicate devices based on shared characteristics.

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ShiNeo Silicone Implant is intended for the augmentation of the nasal and/or chin contour

ShiNeo Silicone Implant is intended for the augmentation or reconstruction of the nasal and/or chin contour.

ShiNeo Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The ShiNeo Silicone Implant offers two major shapes to meet the needs in nasal and chin locations. The devices are also provided in various sizes and can be carved or cut to fit each patient. The ShiNeo Silicone Implant is individually packaged and sterilized by gamma radiation and is labeled for single use. ShiNeo Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.

This document is a 510(k) summary for the ShiNeo Silicone Implant. It asserts that the device is "identical/substantially equivalent" to a predicate device, the BioSiCar Silicone Implant (K193392).

Because the submission claims identity between the proposed device and the predicate device, it explicitly states:

• No performance data was submitted, and no new testing was provided.
• No acceptance criteria were established or studies conducted to demonstrate performance against such criteria for the ShiNeo Silicone Implant.

Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance simply does not exist within this 510(k) summary, as it wasn't required given the claim of identity. The regulatory strategy relies on showing the new device is the same as an already cleared device, not that it independently meets specific performance metrics through new testing.

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The Augmenta Penile Implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant.

The Augmenta Penile Implant is an implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant. The Augmenta Penile Implant is made of silicone. The Augmenta Penile Implant comes in 175 sizes with a range of dimensions. The proximal end of the device may be trimmed by the physician to further customize the fit. The device is provided sterile and is intended for single-use only.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria, as typically seen for AI/ML-based medical devices or diagnostic tools. Instead, it is an FDA 510(k) clearance letter for a physical medical device, the "Augmenta Penile Implant," which is a silicone implant for cosmetic correction of soft tissue deformities.

The document focuses on demonstrating substantial equivalence to a predicate device (Pre-Formed Penile Silicone Block, K181387) rather than proving performance against specific acceptance criteria for an AI/ML algorithm.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These concepts are not applicable to the type of device and clearance described in the provided text.

The closest analogue to "acceptance criteria" in this document are the non-clinical performance data listed on page 5, which are primarily related to biocompatibility, material integrity, and sterilization for an implantable device, usually demonstrated through adherence to recognized standards like ISO 10993 and ASTM standards.

Non-Clinical Performance Data (related to material and sterilization safety, not algorithmic performance):

• Biocompatibility Assessments (in accordance with ISO 10993-1):
  • Cytotoxicity
  • Sensitization
  • Irritation/intracutaneous reactivity
  • Acute Systemic Toxicity
  • Material-Mediated Pyrogenicity
  • Implantation
  • Genotoxicity
  • Extractables and Leachables
  • Toxicology Risk Assessment
• Product and Packaging Integrity Assessments (in accordance with recognized standards):
  • Visual integrity
  • Seal strength
  • Shipping
  • Burst test
  • Sterilization validation (ISO 111135: 2014)
  • EO residual (ISO 10993-7: 2008)
  • Image artifact evaluations (F2119-07 (2013))
  • ASTM D4169-16
  • ASTM F88/F88M-15
  • ASTM F1140/F1140M-13
• Conclusion: The claim is that these assessments provide evidence that the Augmenta Penile Implant "performs comparable to the legally marketed predicate device."

In summary, none of the requested information regarding AI/ML device performance and validation can be provided from this document.

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The Pre-Formed Penile Silicone Block is intended for use in augmentation, reconstructive and cosmetic surgery, and is contoured at the surgeon's discretion to create a custom implant. When used in augmentation procedures, the device provides cosmetic augmentation of the penis and is intended for aesthetic purposes.

The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in visual augmentation, reconstructive and cosmetic surgery for the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.

The device in question is the Pre-Formed Penile Silicone Block.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative format for the clinical study. Instead, it describes observed outcomes and improvements. Based on the "Clinical effectiveness" section, we can infer the measures of performance.

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PosiSep® EAR Fragmentable Ear Dressing is indicated for use in patients undergoing outer ear surgery:
As a space occupying stent to separate and prevent adhesions between mucosal surfaces; and
To help control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation.
PosiSep® Ear is intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep® EAR Fragmentable Ear Dressing is a sterile dressing comprised of modified Chitosan particles and polysaccharide binder. Chitosan has well known hemostasis properties and when combined with hydroxyethyl cellulose binder, forms a foam-type dressing that has an affinity to absorb and hold water. PosiSep® EAR Fragmentable Ear Dressing is used in patients undergoing outer ear surgery as a space occupying stent and to help control minimal bleeding. The dressing quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema.
PosiSep® EAR is fragmentable and eliminated from the site of application by natural excretion via the ear canal.

This document describes the PosiSep® EAR Fragmentable Ear Dressing, a medical device, and its acceptance criteria as demonstrated through a substantial equivalence submission to the FDA. The information provided focuses on comparing the device to a predicate device (NasoPore® Ear) and reference devices (PosiSep/PosiSep X) rather than detailing a specific clinical study with granular data on acceptance criteria and performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with numerical targets and corresponding reported device performance. Instead, substantial equivalence is claimed based on comparable characteristics to predicate devices. The key "acceptance criteria" are implied through the comparison parameters.

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

The document primarily relies on non-clinical performance data, specifically biocompatibility testing and performance bench testing. It does not mention a "test set" in the context of clinical data or patient samples for evaluating device performance against the specified indications. The evaluation appears to be based on:

• Biocompatibility testing: Performed internally, demonstrating compliance with ISO 10993 and FDA guidelines.
• Performance bench testing: Performed internally to demonstrate physical and functional requirements were met.
• Comparison to predicate devices: The primary data provenance is the established safety and effectiveness of the legally marketed predicate devices (NasoPore® Ear, PosiSep/PosiSep X).

The document does not specify a sample size for these non-clinical tests. As it's a 510(k) submission, the focus is on demonstrating "substantial equivalence" rather than conducting a de novo clinical trial with a large patient sample.

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

This information is not provided because the submission primarily relies on non-clinical data and comparisons to predicate devices for demonstrating substantial equivalence, not on a clinical test set with human expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with expert adjudication is described.

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

Not applicable. The device described is a physical ear dressing, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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

Not applicable, as the device is a physical medical dressing, not an algorithm.

7. The Type of Ground Truth Used

For biocompatibility, the ground truth is established by standardized biological tests (e.g., cytotoxicity, irritation, sensitization) following ISO 10993 guidelines, where "ground truth" means the objective results of these tests (e.g., non-cytotoxic). For performance, the "ground truth" relates to the physical and functional properties of the device meeting predetermined engineering specifications during bench testing.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm requiring a training set.

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

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

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