Search Results

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.

Ask a specific question about this device

The Cook® Biodesign® Otologic Repair Graft is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.

The Cook® Biodesign® Otologic Repair Graft is a porous, absorbable, multi-layer biomaterial composed of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). SIS is obtained from the intestine using a process that retains the natural composition of matrix molecules such as collagen (Types I, III, VI), glycosaminoglycans (hyaluronic acid, chondroitin sulfate A and B, heparin, and heparin sulfate), proteoglycans, and fibronectin. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.

This document describes a 510(k) premarket notification for the Biodesign Otologic Repair Graft (K161000). The key information revolves around a packaging change and the demonstration of substantial equivalence to a predicate device (K150594).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state specific sample sizes for the "sterilization adoption," "package performance testing," or "cytotoxicity testing." It only mentions that these tests were "performed to demonstrate substantial equivalence."

• Data Provenance: The studies were conducted by Cook Biotech Incorporated, as part of their 510(k) submission. The data is retrospective in the sense that these tests were performed on the device and its new packaging configuration to demonstrate equivalence, rather than being part of a prospective clinical trial. The country of origin of the data is implied to be the USA, where Cook Biotech Incorporated is located.

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

This document does not pertain to studies requiring expert adjudication for ground truth (e.g., medical image interpretation). The testing described here is related to device engineering, materials science, and packaging performance. The "ground truth" for these tests would be established through defined scientific methodologies and standards (e.g., ISO standards for biocompatibility or ASTM standards for package testing), rather than expert consensus on a clinical outcome or image.

4. Adjudication Method for the Test Set

Not applicable as this is not a study involving human reader interpretation or clinical outcomes that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a material and packaging change, not an AI or diagnostic device that would involve human readers.

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

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

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests would be based on:

• Scientific Standards: For sterilization adoption, it would be demonstration of sterility in accordance with established standards (e.g., ISO 11135 for ethylene oxide sterilization).
• Engineering Standards: For package performance, it would be meeting pre-defined physical and barrier property requirements based on industry standards (e.g., ASTM F1980 for accelerated aging, various ASTM standards for package integrity like peel strength, burst tests, etc.).
• Biological Standards: For cytotoxicity, it would be meeting the requirements of recognized biocompatibility standards (e.g., ISO 10993-5 for in vitro cytotoxicity).

8. The Sample Size for the Training Set

Not applicable. This device 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

Not applicable for the same reason as above.

Ask a specific question about this device

The Biodesign Otologic Repair Graft is intended for use as an implant to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.

The Biodesign Otologic Repair Graft is an absorbable multi-layer biomaterial composed of four layers of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). The SIS material is lyophilized and then punched into the desired shape. The device is available in 4 mm, 6 mm and 9 mm diameter discs, as well as 2.5 x 2.5 cm and 5 x 5 cm square sheets. Upon implantation, the Biodesign Otologic Repair Graft is infiltrated by the host cells and acts as a scaffold for these cells during the body's natural repair process.

Additionally, the circular configurations of the device are packaged in a dried state and supplied sterile in a tray inside a sealed Tyvek® pouch. The square configurations of the device are also packaged sterile in a dried state inside a sealed Tyvek® pouch.

The provided text describes the Biodesign Otologic Repair Graft and its substantial equivalence to predicate devices, but it does not contain the specific information required to complete the detailed table about acceptance criteria and study design for a device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing devices rather than defining and proving acceptance criteria with specific performance metrics and a detailed study design as might be seen for a novel device or PMA.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Cannot be extracted:

The document focuses on substantial equivalence based on material properties, biocompatibility, and clinical outcomes, rather than specific, quantified acceptance criteria for novel performance claims. For example, while mechanical strength was tested, the acceptance criterion (e.g., "burst strength must exceed X MPa") is not provided, only the qualitative statement that it was "adequate." Similarly, for efficacy, there's no explicitly stated acceptance criteria (e.g., "myringoplasty success rate must be >90%") before the study results are presented.

2. Sample Size for the Test Set and Data Provenance

• Biocompatibility Tests: The exact number of samples used for each test (genotoxicity, cytotoxicity, etc.) is not specified. The tests were performed on "sterilized SIS devices," which are identical in composition to the Biodesign Otologic Repair Graft.
• Mechanical Testing (Burst Strength): The sample size is not specified.
• Animal Testing:
  • Efficacy study: Chinchilla model (number of animals not specified).
  • Implant study: Mouse model (number of animals not specified).
• Clinical Testing (Prospective Data):
  • Primary Study: 404 patients (217 SIS repairs, 215 temporalis fascia (PTF) repairs).
  • Data Provenance: The study was conducted by D'Eredita, but the country of origin is not explicitly stated. The material was labeled as "Surgisis." The comparison was made against "temporalis fascia (PTF) repairs performed by the same surgeon," implying a clinical setting. The follow-up was 2-11 years (average 7.7 years).
  • Additional Unpublished Data:
    • a) 18 patients (Hsu, DuPage Medical Group, 2015)
    • b) 19 patients (Toh C. et al., Birmingham Heartland Hospital, UK, 2003) - UK origin.
    • c) 32 patients (Ofo E. et al., North West London Hospital, UK, 2009) - UK origin.
    • d) 8 patients (Lalwani A. San Francisco, CA, COSM 2003) - USA origin.
  • Retrospective/Prospective: The 404-patient study is explicitly called "Prospective data." The additional data are referred to as "unpublished data" but their specific prospective/retrospective nature is not detailed.

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

• This information is not provided. Clinical outcomes (e.g., stable tympanic membrane closures, adverse events) would have been assessed by treating physicians, but the document does not detail a specific expert panel/adjudication process for establishing ground truth for the clinical studies mentioned.

4. Adjudication Method for the Test Set

• This information is not provided. For clinical outcomes, the treating surgeon or independent clinicians would typically assess post-operative results, but no specific adjudication method (like 2+1 consensus) is outlined.

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

• No, an MRMC comparative effectiveness study was not done. The clinical studies reported involved a comparison of the device material (SIS) with autologous tissue repair (temporalis fascia) or comparison to a predicate in an animal model, and observations of patient outcomes. These are not MRMC studies as typically understood for AI device assessments involving multiple readers evaluating cases with and without AI assistance to measure reader improvement.

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

• This is not applicable. The Biodesign Otologic Repair Graft is a physical medical device (implantable biomaterial), not an AI algorithm or software device. Therefore, a "standalone algorithm performance" study is not relevant to this product.

7. The Type of Ground Truth Used

• Biocompatibility: In vitro and in vivo test results against ISO 10993-1 standards.
• Mechanical Testing: Measured burst strength.
• Animal Testing: Histological assessment of cellular response and device degradation (observations by researchers), and efficacy observations in chinchilla tympanic membrane repair.
• Clinical Testing: Clinical outcomes data (e.g., stable tympanic membrane closures, occurrence/absence of adverse reactions/events) observed post-operatively by treating physicians or study investigators. This would be considered outcomes data or clinical expert observation.

8. The Sample Size for the Training Set

• This is not applicable. The Biodesign Otologic Repair Graft is a physical medical device (biomaterial), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device itself is manufactured using a specific process and its properties are inherently defined by its material and design, not by being "trained" on data.

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

• This is not applicable for the reasons stated in point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

The Biodesign® ENT Repair Graft is intended to separate tissue or structures compromised by surgical trauma, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. The device is indicated for use where an open wound dressing material is required in the nasal and/or sinus cavities following nasal and/or sinus surgery where separation of tissues or structures is desired. The device is supplied sterile and is intended for one-time use.

The Biodesign ENT Repair Graft is composed of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS). The Biodesign ENT Repair Graft is similar to its predicate MeroGel™ Control Gel ENT Surgical Dressing (K002972) which is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of extracellular matrix. The device is available in multilayered sheets with sizes from 1 cm by 2 cm to 20 cm x 40 cm. The Biodesign ENT Repair Graft is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The Biodesign ENT Repair Graft can be shaped by the physician to the appropriate size for the desired indication. The Biodesign ENT Repair Graft is similar to its MeroGel predicate in its technology in that it has the ability to be incorporated into the body. The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.

Here's an analysis of the provided text regarding the Biodesign ENT Repair Graft, focusing on acceptance criteria and supporting studies:

This submission is for a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving efficacy against a set of predefined performance endpoints. Therefore, the "acceptance criteria" here are primarily about demonstrating that the new device is as safe and effective as the predicate, based on similar intended use, materials, and technological characteristics. There isn't a conventional "device performance" described in terms of specific metrics like sensitivity or accuracy in the way it would be for a diagnostic AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Direct numerical "device performance" metrics (e.g., specific tensile strength values, degradation rates, quantitative clinical outcomes) are not provided in this summary. The focus is on qualitative equivalence ("adequate," "substantially similar," "evidence that...").

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

• Biocompatibility Testing: The text states "sterilized SIS devices (which have already been cleared in multiple applications)" were used. The specific number of devices tested for each biocompatibility test is not mentioned.
• Mechanical Testing: Specific sample sizes for suture retention strength and ultimate tensile strength tests are not mentioned.
• Preclinical Testing (Mouse Study): The number of mice used in the subcutaneous study is not mentioned.
• Clinical Testing: The number of patients included in the clinical study for nasal septal perforation repair is not mentioned. The provenance (e.g., country of origin, retrospective/prospective) of the clinical data is not mentioned, though the study was performed using SIS material (Surgisis), implying it could have been a previously conducted study.

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

This type of information is not applicable to this 510(k) submission. For this medical device (a surgical graft), "ground truth" is not established by expert consensus on interpretations as it would be for an AI diagnostic device. Instead, the "truth" is determined by established scientific/engineering test methods (e.g., ISO standards for biocompatibility) and clinical observation of outcomes, which are assessed by medical professionals in the context of a clinical study. The document does not specify the number or qualifications of experts who interpreted the results of the biocompatibility, mechanical, or preclinical tests. For the clinical study, the results would typically be analyzed by clinical researchers and physicians, but their specific roles or number establishing "ground truth" (e.g., pathology confirmation of repair) are not detailed.

4. Adjudication Method for the Test Set

This is not applicable in the context of this device and testing. Adjudication methods (like 2+1 or 3+1) are typically used in studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved to establish a robust ground truth. Here, the "test sets" involve physical, chemical, and biological measurements or clinical outcomes, not interpretations requiring adjudication.

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

This is not applicable. This submission is for a surgical graft, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.

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

This is not applicable. This device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for demonstrating substantial equivalence for this device is based on a combination of:

• Standardized Biocompatibility Test Results: Adherence to ISO 10993-1 standards for various biological responses, with results indicating "meets biocompatibility requirements."
• Mechanical Testing Results: Measurements of physical properties like suture retention and tensile strength, deemed "adequate."
• Preclinical (Animal) Observations: Post-implant observations in a mouse model regarding tissue separation, cellular ingrowth, and degradation.
• Clinical Outcomes Data: The clinical study on nasal septal perforation repair using SIS material implies evaluation of patient outcomes such as healing, complication rates, and efficacy in achieving the intended purpose. The specific endpoints or type of data forming this "ground truth" are not detailed (e.g., surgical success rate, re-perforation rate, symptomatic improvement).

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is intended for use during and after ENT surgeries for the control of minimal to moderate bleeding by tamponande effect, blood absorption and platelet aggregation.

The Gel-Sponge ENT is a sterile, absorbable gelatin sponge, USP available in sizes ranging from a 1.5 cm disk to a 100 cm rectangular size. It is able to absorb and hold within its interstices, many times its weight of blood and other fluids. The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. Hemostasis is achieved by the physiological coagulation-inducing properties of the absorbable gelatin sponge. USP, The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is applied dry or is wetted before use with sterile water for injection or saline (not provided),

The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP, as described in the provided 510(k) summary, did not involve specific acceptance criteria in the typical sense of quantitative performance thresholds for a clinical study. Instead, the device's suitability for its intended use was established through a demonstration of substantial equivalence to existing predicate devices (Gelita-Spon Absorbable Gelatin Sponge, USP and ThrombiGel® thrombin/gelatin foam hemostat). This means the device was shown to be as safe and effective as a legally marketed device for which a PMA was not required.

The study that "proves" the device meets the acceptance criteria is implicitly the demonstration of substantial equivalence through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a substantially equivalent device, the "acceptance criteria" are primarily implied by the predicate device's performance and the successful completion of specific non-clinical tests to demonstrate that the new device shares similar characteristics and performs as expected. No specific quantitative performance metrics like sensitivity, specificity, or reduction in bleeding time were reported with acceptance thresholds.

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

• Sample Size for Test Set: Not applicable. No clinical test set involving human subjects was used. The "test set" for non-clinical testing refers to samples of the device itself. The specific quantities of samples used for each bench and biocompatibility test are not provided in this summary.
• Data Provenance: Not applicable, as no human data was collected. The testing was laboratory-based.

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

• Not applicable. As no human clinical data was collected, there was no need for experts to establish ground truth for a test set of patient cases. The "ground truth" for the non-clinical tests would be established by standard laboratory methods and validated testing protocols.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring expert adjudication.

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

• No. A MRMC comparative effectiveness study was not performed. The 510(k) summary explicitly states: "No human clinical testing was required for this device."

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

• Not applicable. This device is a physical medical device (absorbable gelatin sponge), not an AI algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

• Bench Testing: Ground truth established by validated laboratory standards and measurements for physical properties (e.g., pH, absorption capacity, formaldehyde residual).
• Biocompatibility Testing: Ground truth established by in-vitro and in-vivo (animal model, for some tests like pyrogen and sensitization) toxicology and biocompatibility standards (e.g., ISO 10993 series).
• For the overall product, the "ground truth" for its safety and effectiveness was assessed against the predicate devices through substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm, so there is no "training set" in the machine learning sense. The manufacturing process of the device itself can be seen as a form of "training" to achieve consistent product characteristics, but this is not reported as a data set for an algorithm.

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

• Not applicable, as there is no training set for an AI algorithm.

Ask a specific question about this device

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

AOC" -L 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.

AOC" -L Soluble Implant Material is comprised of a sterile aqueous mixture of watersoluble alkylene oxide copolymers, derived from ethylene oxide and propylene oxide. AOC" -L Soluble Implant Material contains no other additives or colorants. AOC" -L Soluble Implant Material is formed of various weights ranging from 0.5 to 5 grams each.

AOC" -L Soluble Implant Material is provided sterile by irradiation and must not be resterilized.

This document does not describe an AI/ML-powered medical device and therefore the requested information regarding acceptance criteria and study proving device efficacy cannot be extracted in the context of AI/ML performance.

The document pertains to a 510(k) premarket notification for a medical device called "AOC™-L Soluble Implant Material." This device is a water-soluble implant material used as a space-occupying material during natural healing. The entire submission focuses on establishing substantial equivalence to a predicate device (AOC™ Soluble Implant Material, K081531) based on having the same intended use, fundamental scientific technology, and indication for use. The only stated difference is the addition of water to alter handling properties.

The document does not mention any AI or machine learning components, nor does it describe any performance metrics that would be relevant to an AI/ML device such as sensitivity, specificity, accuracy, or reader study outcomes. Therefore, it is impossible to provide the requested information.

Ask a specific question about this device