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Biopor® Porous Polyethylene Implants in sheet configurations are intended for the augmentation or reconstruction of the craniofacial skeleton, including the cranial skeleton, orbit, nasal bones and the zygoma.

Biopor® Porous Polyethylene Implants are manufactured of porous high-density polyethylene (PPE), a biomaterial that is contoured or carved to suit the anatomical and functional requirements of the patient. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend (AOC). Biopor® Porous Polyethylene Implants are provided STERILE and must not be resterilized.

The provided FDA 510(k) summary document for the Biopor Porous Polyethylene Implants does not describe a study involving an AI/Machine Learning device or a diagnostic device where the acceptance criteria would be related to performance metrics like sensitivity, specificity, or reader improvement.

Instead, this document is for a physical medical implant (Preformed Alterable Cranioplasty Plate). The "performance testing" described in the document refers to biocompatibility and physical/mechanical properties of the implant, not diagnostic accuracy or AI algorithm performance.

Therefore, I cannot provide the information requested in your prompt because it pertains to the performance evaluation of an AI/ML or diagnostic device, which is not what this document describes.

However, I can extract the "acceptance criteria" and "reported device performance" as they relate to the physical and biological characteristics of the implant described in this document.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

The "acceptance criteria" for this device are related to its material properties, biocompatibility, and physical performance as an implant. The "study" refers to a series of tests conducted to ensure safety and function.

1. Table of Acceptance Criteria and Reported Device Performance

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Biopor Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.

Biopor Porous Polyethylene Implants are manufactured of porous high-density polyethylene, a biomaterial that is easily contoured or carved to suit the anatomical and functional requirements of the patient. The interconnecting pores of the Porous HDPE material permits fibrovascular ingrowth into the implant. The implants are manufactured with the option of a coating with a water-soluble alkylene oxide copolymer blend and/or the option of embedded titanium mesh. AOC™ Porous Polyethylene Surgical Implants are provided STERILE and should not be resterilized.

The provided text describes a 510(k) premarket notification for a medical device (Biopor Porous Polyethylene Implants) and does not contain information about acceptance criteria for device performance in the context of a study that proves the device meets those criteria.

The document is a regulatory submission to the FDA, demonstrating substantial equivalence to predicate devices, focusing on:

• Device Description: Porous high-density polyethylene implants for maxillofacial skeleton augmentation/reconstruction.
• Intended Use: Augmentation or reconstruction of the maxillofacial skeleton.
• Substantial Equivalence: Claiming substantial equivalence to predicate devices (Ceremed Biopor K141880, Poriferous Su-Por K140437, Stryker Medpor K922489) based on similar intended use, additional shapes and sizes, material properties, and biocompatibility.
• Biocompatibility and Performance Testing: Listing various ISO 10993-compliant tests performed (e.g., Cytotoxicity, Implantation studies, Genotoxicity, Pyrogen test).

Therefore, I cannot provide the requested information, as the input does not contain a study outlining specific performance acceptance criteria, device performance results against those criteria, or details regarding test sets, expert ground truth, adjudication methods, or MRMC studies.

The "performance testing" mentioned refers to a list of standard biocompatibility and material tests (e.g., Cytotoxicity, Implantation studies) rather than a study evaluating diagnostic performance or algorithm effectiveness as might be implied by "acceptance criteria and the study that proves the device meets the acceptance criteria" in an AI/software context.

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Biopor® Porous Polyethylene Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the maxillofacial skeleton.

Porous High Density Polyethylene (HDPE) Surgical Implant

This document is a 510(k) premarket notification decision letter for the Biopor® Porous Polyethylene Implants, indicating substantial equivalence to a predicate device. It is a regulatory approval document and does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information.

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Adaptain" is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

Adaptain™ is a water-soluble, wax-like surgical implant material that will adhere to itself utilized directly and a first application of firm pressure. Adaptain " is designed to be utilized directly out of the package. The implant will soften as it is warmed. The surface of the implant becomes lubricious when wet, and the implant does not swell as it dissolves.

Adaptain™ is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend™) and contains no other additives or colorants. Adaptain is supplied in a number of forms including bars, sticks, granules and sheets of various sizes with weights ranging from 0.5 to 5 grams each.

Adaptain™ is provided sterile by irradiation and must not be resterilized.

The provided text is a 510(k) summary for a medical device (Adaptain™, Adaptain FastWrap™, Envelock™, Biowai™) and does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Specifically, the document states:
"The non-clinical evaluations used to determine substantial equivalence included indications, intended use, design, materials, sterilization, and performance. The comparison demonstrates that the device in this submission is identical in design, materials, indications, performance and sterilization to the predicate Adaptain FastWrap™ (K122561)."

This indicates that the device was deemed substantially equivalent to a predicate device based on a comparison of its characteristics to the predicate, rather than through a study with defined acceptance criteria and performance metrics. Therefore, the requested information cannot be extracted from the provided text.

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Adaptain FastWrap™ is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

Adaptain FastWrap™ is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional . handling and manipulation, if so desired. Adaptain FastWrap "" is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain FastWrap " contains no other additives or colorants. Adaptain FastWrap™ is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain FastWrap is provided sterile by irradiation and must not be resterilized.

The provided text describes a 510(k) submission for the Adaptain FastWrap™ and Envelock™ devices. However, it does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily focuses on the administrative aspects of the 510(k) submission, including:

• Identification of the submitting company and contact person.
• Device names, regulation numbers, regulatory class, and product codes.
• Description of the device's composition and form.
• Intended use and indications for use.
• A declaration of substantial equivalence to a predicate device (Ceremed, Inc. Ceretene™ Soluble Implant Material (K120220)).
• Formal FDA correspondence confirming the substantial equivalence determination.

The statement regarding "non-clinical evaluations used to determine substantial equivalence included indications, intended use, design, materials, sterilization, and performance" is a general declaration, but no specific data, metrics, or study details are provided to support this. Therefore, I cannot construct the table or answer the specific questions based on the provided text.

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Adaptain™ Soluble Implant Material is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

Adaptain™ Soluble Implant Material is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. Adaptain" Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC PolymerBlend"). Adaptain" "Soluble Implant Material contains no other additives or colorants. Adaptain"" Soluble Implant Material is formed in bars and sheets of various sizes with weights ranging from 0.5 to 5 grams each. Adaptain™ Soluble Implant Material is provided sterile by irradiation and must not be resterilized.

This document describes the 510(k) submission for the Adaptain™ Soluble Implant Material, an ear, nose, and throat synthetic polymer material. The submission aims to demonstrate substantial equivalence to a predicate device, the Ceretene™ Soluble Implant Material (K081531).

Based on the provided text, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are not detailed in a quantitative, performance-based manner that would typically be seen for a diagnostic or AI-driven device. Instead, the submission relies on demonstrating substantial equivalence to an existing predicate device.

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 quantitative acceptance criteria or detailed performance metrics. The core "acceptance" is based on substantial equivalence, which implies the new device performs similarly to the predicate in all relevant aspects.

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

The document does not mention a "test set" or a specific study involving patient data (clinical or otherwise) with a defined sample size for performance evaluation. The substantial equivalence argument is based on comparing device characteristics rather than clinical outcomes. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).

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

This information is not applicable as there is no "test set" and no "ground truth" establishment in the context of device performance in a clinical setting mentioned. The evaluation is based on a comparison of the device's characteristics to its predicate.

4. Adjudication Method for the Test Set

This information is not applicable as there is no "test set" for which adjudication would be required.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence of the device itself, not on evaluating human reader performance with or without AI assistance.

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

No, a standalone "algorithm only" performance study was not done. The device is a physical implant material, not a software algorithm.

7. The Type of Ground Truth Used

This information is not applicable. The "ground truth" in this context is the established characteristics and performance of the predicate device, against which the new device is compared for "identicality." It's not a clinical "ground truth" like pathology or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reason as above – no training set for an AI/ML model.

Summary of the document's approach to "acceptance criteria" and "study":

The acceptance criteria for the Adaptain™ Soluble Implant Material appear to be qualitative: to be "identical in design, materials, indications, performance and sterilization" to its predicate, Ceretene™ Soluble Implant Material (K081531). The "study" proving this is a non-clinical evaluation that directly compares these aspects between the new device and the predicate. The FDA's 510(k) clearance signifies agreement that this comparison demonstrates substantial equivalence, allowing the new device to be marketed. This is a common pathway for medical devices that are similar to already legally marketed devices.

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Ceretene" Soluble Implant Material is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process.

Ceretene" Soluble Implant Material is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired. Ceretene" Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC). Ceretene™ Soluble Implant Material contains no other additives or colorants. Ceretene" Soluble Implant Material is formed in bars and sheets of various weights ranging from 0.5 to 5 grams each. Ceretene" Soluble Implant Material is provided sterile by irradiation and must not be resterilized.

Acceptance Criteria and Study for Ceretene™ Soluble Implant Material (K103047)

The provided documentation, K103047, describes Ceremed, Inc.'s Ceretene™ Soluble Implant Material. This submission focuses on regulatory clearance via the 510(k) pathway, asserting substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results. Therefore, the information provided below is derived from the absence of certain elements in the 510(k) summary and the nature of this regulatory pathway.

The 510(k) submission for Ceretene™ Soluble Implant Material does not contain a specific study designed to prove the device meets acceptance criteria in the manner typically seen for novel or significantly modified devices. Instead, the submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that the "acceptance criteria" are implicitly met by demonstrating that the new device has the same fundamental scientific technology, indications, intended use, and performance as equivalent predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" and quantifiable "reported device performance" from a dedicated clinical study are not provided in the document. The acceptance criteria are broadly focused on demonstrating equivalency in various aspects as outlined below:

• Reported Performance (from submission): "Ceretene™ Soluble Implant Material is indicated for use as a water-soluble implant material and as a water-soluble space occupying material as an adjunct during the natural healing process." This is presented as equivalent to the predicates without explicit comparative performance data. |
  | Intended Use | * Acceptance: The intended use is substantially equivalent to the predicate devices.
• Reported Performance (from submission): "The non-clinical evaluations used to determine substantial equivalence included indications, intended use, design, materials, sterilization, and performance. The comparison demonstrates that the device in this submission has the same fundamental scientific technology as the legally marketed predicate Ceretene™ (K081531) and is substantially equivalent in indications, intended use, and performance..." (No further specific performance data on intended use provided for the new device beyond this statement). |
  | Design | * Acceptance: The design is identical or substantially equivalent to the predicate devices.
• Reported Performance (from submission): "is identical in design, materials, and sterilization to the predicate Ostene®CT (K091636)." "Ceretene™ Soluble Implant Material is comprised of a sterile mixture of water-soluble alkylene oxide copolymers (AOC)." Specific design parameters (e.g., bar/sheet weights: 0.5 to 5 grams) are described, intending to show similarity to predicates without specific performance metrics against those parameters. |
  | Materials | * Acceptance: The materials are identical or substantially equivalent to the predicate devices.
• Reported Performance (from submission): "is identical in design, materials, and sterilization to the predicate Ostene®CT (K091636)." "Ceretene™ Soluble Implant Material contains no other additives or colorants." The core material (water-soluble alkylene oxide copolymers) is implicitly accepted as equivalent in biocompatibility and functional properties to the predicates, as no new material testing data is presented. |
  | Sterilization | * Acceptance: The sterilization method and resulting sterility are identical or substantially equivalent to the predicate devices.
• Reported Performance (from submission): "is identical in design, materials, and sterilization to the predicate Ostene®CT (K091636)." "Ceretene™ Soluble Implant Material is provided sterile by irradiation and must not be resterilized." The presumption is that this method achieves a sterility assurance level (SAL) equivalent to that of the predicate, without specific SAL data for this particular device appearing in the provided text. |
  | Fundamental Scientific Technology | * Acceptance: The device shares the same fundamental scientific technology as legally marketed predicates.
• Reported Performance (from submission): "The comparison demonstrates that the device in this submission has the same fundamental scientific technology as the legally marketed predicate Ceretene™ (K081531) and is substantially equivalent in indications, intended use, and performance..." This is a foundational claim of the 510(k) submission. |
  | Performance | * Acceptance: The device's overall performance (efficacy, safety, functionality) is substantially equivalent to predicate devices.
• Reported Performance (from submission): "The comparison demonstrates that the device in this submission has the same fundamental scientific technology as the legally marketed predicate Ceretene™ (K081531) and is substantially equivalent in indications, intended use, and performance..." This is a general statement. The document does not describe a specific performance study with quantitative outcomes, sample sizes, or specific acceptance criteria for attributes like dissolution rate, space-occupying effectiveness, or biological response. The "performance" assessment is based on the equivalency argument rather than new primary data. |

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

The provided document does not describe a specific test set or clinical study with human or animal subjects with a defined sample size for performance evaluation of the Ceretene™ Soluble Implant Material. The 510(k) submission relies on non-clinical evaluations to establish substantial equivalence. These non-clinical evaluations typically refer to bench testing, material characterization, and comparison to predicate device specifications, not a test set in the sense of a clinical trial. Therefore, there is no reported sample size or data provenance (e.g., country of origin, retrospective/prospective) for a performance test set.

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

As there is no clinical "test set" described in the document, there is no mention of experts used to establish ground truth. The substantial equivalence argument relies on regulatory and scientific review of the device's characteristics against predicate devices, which would involve internal experts at Ceremed and eventually FDA reviewers.

4. Adjudication Method for the Test Set

Since no clinical "test set" and no experts establishing ground truth are described, there is no adjudication method mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic devices involving human interpretation of images, which is not applicable to an implant material.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable to the Ceretene™ Soluble Implant Material. This is a physical implant, not an algorithm or AI-driven diagnostic tool. Therefore, no standalone "algorithm only" performance study was conducted or is relevant.

7. Type of Ground Truth Used

Given the nature of the 510(k) submission, the "ground truth" for the Ceretene™ Soluble Implant Material is primarily based on demonstrated equivalence to legally marketed predicate devices. This involves:

• Predicate Device Performance and Safety: The established safety and effectiveness profile of the predicate devices (Ceretene™ K081531 and Ostene®CT K091636) serves as the "ground truth" for how a similar device should perform.
• Material Characterization: Ground truth for material properties (e.g., sterility, composition) is established through standard laboratory testing and adherence to recognized standards.
• Regulatory Standards: Compliance with relevant FDA regulations (e.g., 21 CFR 874.3620, general controls) forms part of the "ground truth."

There is no stated ground truth based on expert consensus, pathology, or outcomes data from a specific study of the new device in this document; rather, these would have informed the original clearance of the predicate devices.

8. Sample Size for the Training Set

This question is not applicable. The Ceretene™ Soluble Implant Material is a physical medical device, not an AI or machine learning model that requires a training set.

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

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

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OSTENE®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces in cardiothoracic surgery surgery following sternotomy .

Ostene® CT is a water-soluble surgical implant material for use in cardiothoracic surgery. Ostene CT is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired.

Ostene CT is comprised of a sterile mixture of water-soluble alkylene oxide copolymers. Ostene®CT contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.

As a bone hemostasis agent, Ostene®CT stops bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. Ostene CT, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.

Ostene CT is provided sterile by irradiation and must not be resterilized.

The provided text is a 510(k) summary for the Ostene®CT Soluble Bone Hemostasis Implant Material. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance. As such, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, or standalone algorithm performance) is not available in the provided document.

However, I can extract the following:

1. Acceptance Criteria and Reported Device Performance:

The document states: "The non-clinical evaluations used to determine substantial equivalence included indications, intended use, design, materials, sterilization, and performance. The comparison demonstrates that the device in this substantially equivalent in indications and intended use; and is identical in design, materials, sterilization, and performance to the predicate Ostene®CT (K091636)."

This indicates that the acceptance criterion was "identical performance" to the predicate device. Specific quantitative performance metrics are not provided in this summary.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. The evaluations were "non-clinical."

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

• Not applicable/Not specified, as this appears to be a non-clinical evaluation comparing device characteristics to a predicate, not an evaluation against a clinical ground truth established by experts.

4. Adjudication method for the test set:

• Not applicable/Not specified.

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/software device.

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

• Not applicable. This is not an AI/software device.

7. The type of ground truth used:

• For the non-clinical evaluation, the "ground truth" was essentially the established characteristics and performance of the predicate device (Ostene®CT, K091636).

8. The sample size for the training set:

• Not applicable. This is not a study involving a training set in the context of machine learning or AI.

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

• Not applicable.

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OSTENE®CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Ostene®CT is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired.

Ostene®CT is comprised of a sterile mixture of water-soluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. * Ostene® CT contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.

As a bone hemostasis agent, Ostene®CT stops bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. Ostene CT, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.

Ostene®CT is provided sterile by irradiation and must not be resterilized. * A substitution has been made in a neutral excipient copolymer.

This submission describes a medical device, Ostene®CT, which is a bone hemostasis implant material. The document provided is primarily a 510(k) summary for a Special 510(k) submission, indicating a modification to an already legally marketed device. Therefore, the focus is on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and a comprehensive study report typical for novel devices.

Given the nature of a Special 510(k) and the provided text, there is no specific performance study with defined acceptance criteria in the way one might expect for a new, high-risk device requiring detailed clinical trial data. The device is for bone hemostasis and is classified as "Unclassified," which typically means less stringent performance study requirements for demonstrating substantial equivalence, especially when it's a modification of a predicate.

The primary "study" is the demonstration that a "substitution has been made in a neutral excipient copolymer" and that the modified Ostene®CT "has the same intended use and fundamental scientific technology as the legally marketed Ostene®CT Soluble Bone Hemostasis Implant."

Here's an attempt to answer your questions based on the provided text, noting where specific information is absent due to the type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a Special 510(k) for a modified device, the "acceptance criteria" are generally that the modified device remains substantially equivalent to the predicate device and that the change (a neutral excipient copolymer substitution) does not adversely affect safety or effectiveness. Specific numerical performance targets are not provided in the document for the new Ostene®CT against the predicate.

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

• Sample Size: Not specified. Clinical trial data with defined sample sizes and test sets are not presented in this 510(k) summary. The submission focuses on the modification of an excipient in an already cleared device.
• Data Provenance: Not applicable in the context of a performance study; the submission details the device composition and its mechanism of action, emphasizing its similarity to the predicate.

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

• Not applicable. There is no mention of a clinical "test set" requiring ground truth established by experts in this 510(k) summary.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication is described.

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

• Not applicable. This device is a bone hemostasis implant material, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

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

7. The Type of Ground Truth Used

• Not applicable in the context of a typical performance study for diagnostic AI or imaging devices. For a medical device like this, "ground truth" often relates to established scientific principles of material compatibility and physiological function, as well as pre-clinical testing (e.g., biocompatibility, hemostatic efficacy in animal models), which are standard for medical device development but not detailed in this 510(k) summary. The primary "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.

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. There is no "training set."

Summary based on the document:

This 510(k) submission for Ostene®CT is for a modified version of an already cleared device. The "study" proving it meets acceptance criteria is primarily the demonstration of substantial equivalence to the predicate device (Ceremed, Inc. Ostene® Soluble Bone Hemostasis Implant Material, K082491), especially considering a "substitution has been made in a neutral excipient copolymer." The acceptance criteria are implicitly met if the FDA determines that the modified device has the same intended use, fundamental scientific technology, and does not raise new questions of safety or effectiveness compared to the predicate. Details on specific performance metrics, sample sizes, or expert adjudication for clinical performance studies are not provided in this regulatory summary.

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OSTENE® CT is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.

Ostene is an odorless, opaque wax-like material designed to be utilized directly out of the package. It is best used immediately following removal from the package, and can be softened and increased in stickiness by warming and by additional handling and manipulation, if so desired.

Ostene is comprised of a sterile mixture of water-soluble alkylene oxide copolymers. derived from ethylene oxide and propylene oxide. Ostene contains no other additives or colorants. The wax-like material is formed into sticks of various weights ranging from .5 to 5 grams each.

As a bone hemostasis agent, Ostene stops bone bleeding by the creation of a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. Ostene, when placed on bone under moderate pressure, plugs the vascular openings in the bone. This plug prevents further bleeding.

Ostene is provided sterile by irradiation and must not be resterilized.

This appears to be a 510(k) summary for a medical device (Ostene®CT Soluble Bone Hemostasis Implant Material) that claims substantial equivalence to a predicate device (Ostene® Soluble Bone Hemostasis Implant Material). The provided text describes the device, its intended use, and indicates that it is substantially equivalent to a legally marketed device.

However, the document is a regulatory submission for substantial equivalence, not a study report demonstrating the device meets specific acceptance criteria through clinical trial or performance testing with quantitative results. Therefore, the information needed to answer the questions about acceptance criteria, study details, sample sizes, ground truth establishment, and multi-reader effectiveness is not present in this document.

The document mainly focuses on establishing that the modified Ostene®CT has the "same intended use fundamental scientific technology as the legally marketed Ostene® Soluble Bone Hemostasis Implant." This implies that extensive new studies to prove performance against novel acceptance criteria may not have been required for this specific 510(k) submission, as it relies on the predicate device's established safety and effectiveness.

Based on the provided text, the requested information cannot be fully extracted for the following reasons:

• No specific acceptance criteria are stated. The document asserts substantial equivalence to a predicate device, implying that the predicate's established performance is the benchmark.
• No new study data is presented to prove specific acceptance criteria. The submission is about modifications to an already cleared device and proving its equivalence, not a new device requiring a de novo clinical trial with defined performance metrics.
• Details on sample size, data provenance, expert ground truth, adjudication, or MRMC studies are absent. These elements would typically be found in a clinical study report or a 510(k) submission for a device requiring performance data.
• No standalone algorithm performance or training set details are relevant as this is a physical medical device (bone hemostasis material), not an AI/software device.

Therefore, I cannot populate the table or answer the specific questions based solely on the provided text. The document describes a regulatory pathway (510(k) Special) rather than a detailed performance study with quantifiable results against acceptance criteria.

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