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BioForm's Laryngeal Augmentation Implant is indicated as a resorbable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation. The Laryngeal Augmentation Implant is a temporary implant and resorbs within a period of 3-6 months.

The Laryngeal Augmentation Implant is a flexible, resorbable implant used as a space filling material for soft tissue augmentation. The Laryngeal Augmentation Implant is placed via percutaneous injection under local anesthesia with direct visualization via nasopharyngoscope. The ability to place the implant without open surgery offers both safety and convenience to the surgeon and patient. The system is designed to resorb with eventual in-growth of surrounding tissue. Every component of the implant has a minimum of twenty years use as a biomaterial.

The provided text is a 510(k) summary for a medical device called the Laryngeal Augmentation Implant. This type of document is for regulatory submission to the FDA to demonstrate substantial equivalence to a predicate device, rather than a clinical study report proving performance against acceptance criteria in the context of AI/software device evaluation.

Therefore, the information required in the prompt (acceptance criteria, device performance, sample sizes for test/training sets, ground truth methodology, expert qualifications, adjudication, MRMC studies, standalone performance) is not present in this document. The document primarily focuses on:

• Product Description and Intended Use: Explains what the device is, how it works, and its purpose.
• Substantial Equivalence: Compares the device to existing, legally marketed predicate devices to argue that it is equally safe and effective.
• Biocompatibility and Sterilization: Details preclinical safety studies and sterilization methods.
• Summary: Reaffirms the device's safety and effectiveness.
• FDA Response: The FDA's letter granting 510(k) clearance based on substantial equivalence.

It is important to note: For a physical medical implant like this, "acceptance criteria" and "device performance" would typically refer to outcomes from non-clinical (e.g., in-vitro, animal studies) and clinical trials (human studies) measuring safety endpoints (e.g., adverse events, infection rates, rejection) and effectiveness endpoints (e.g., vocal fold medialization success, duration of effect, patient-reported outcomes). However, the 510(k) summary provided does not detail specific, quantitative acceptance criteria or corresponding clinical study results in the format requested for AI/software evaluations.

In summary, based on the provided document:

The document does not contain the information necessary to fulfill any of the requested points regarding acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth, expert qualifications, adjudication), or AI-specific evaluations (MRMC, standalone performance). This is because the nature of a 510(k) summary for an ordinary medical device submission differs significantly from a clinical study report for an AI/software as a medical device.

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BioForm's Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including:

• · Periodontal Defects
• · Ridge Augmentation
• · Extraction Sites
• · Craniofacial Augmentation
• · Cystic Defects

Calcium Hydroxylapatite Implant is a sterile, non-pyrogenic, flexible, semi-solid, cohesive paste containing calcium hydroxylapatite particles. Calcium Hydroxylapatite Implant is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects. Calcium Hydroxylapatite Implant contains calcium hydroxylapatite particles in a pasty gel of glycerin, water and sodium carboxymethylcellulose that acts as a binder for the particles. The calcium hydroxylapatite meets ASTM F1185. The gel ingredients are pharmacoutical grade excipients and are listed as GRAS materials.

Here's an analysis of the provided text regarding the Calcium Hydroxylapatite Implant, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) Premarket Notification Summary from 2003. This type of submission primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing de novo acceptance criteria through rigorous performance studies against predefined metrics. Therefore, the information provided below will reflect this regulatory context. Direct "acceptance criteria" as you might find in a performance study with specific quantitative targets and "reported device performance" against those targets are not explicitly presented in this type of submission. Instead, the "performance" is demonstrated through equivalence to predicates.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit quantitative acceptance criteria defined for the Calcium Hydroxylapatite Implant. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.

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

This document does not describe a clinical performance study with a "test set" in the traditional sense (i.e., a group of patients receiving the device for evaluation against specific clinical endpoints). The submission is based on substantial equivalence to predicate devices, which are already legally marketed.

• Sample Size: Not applicable for a traditional test set in this 510(k) submission.
• Data Provenance: The 'data' supporting equivalence comes from:
  • Descriptions and regulatory filings of the cited predicate devices (e.g., K882682, K852742, K852765, etc.).
  • General understanding of the biocompatibility and mechanism of action of calcium hydroxylapatite and similar bone graft materials, often based on "history of use in many medical devices as well as from preclinical testing and clinical experience" of the material itself.
  • Assertions about the device's characteristics and how they compare to predicates.
  • The document does not refer to prospective or retrospective clinical data collected specifically for this device's performance demonstration.

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

Not applicable. There was no "test set" in a clinical study sense where expert adjudication of ground truth was required for the Calcium Hydroxylapatite Implant.

4. Adjudication Method for the Test Set

Not applicable. No "test set" and no adjudication of ground truth for performance.

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

No. An MRMC comparative effectiveness study was not performed or described in this document. This submission is for a material implant, not an imaging AI diagnostic device. The concept of "human readers" and "AI assistance" improving performance is not relevant to this type of medical device submission.

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

Not applicable. This device is a bone graft material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in the context of this 510(k) is the established safety and effectiveness profile of the predicate devices and the general scientific understanding of calcium hydroxylapatite as a bone graft material. The submission argues that the Calcium Hydroxylapatite Implant shares fundamental characteristics with these predicates, making it equally safe and effective.

• Ground Truth Sources (Implied):
  • Regulatory history and approvals of predicate devices.
  • Preclinical and clinical experience with similar materials (calcium hydroxylapatite, calcium phosphate glasses) cited indirectly.
  • ASTM standard F1185 for the calcium hydroxylapatite.

8. Sample Size for the Training Set

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

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

Not applicable. No training set for an AI/ML device.

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Coaptite™ Laryngeal Augmentation System is intended as an injectable, space-occupying implant for vocal fold medialization and augmentation.

The Coaptite™ Laryngeal Augmentation System consists of a single use, nonpyrogenic, space-occupying implant contained in a prefilled syringe with an injection needle for laryngeal vocal fold augmentation and medialization.

Coaptite™ is available in 1.0cc syringes that are filled with either 1.0cc or a 0.5 cc volume. Coaptite™ contains calcium hydroxylapatite (Cas(PO4)3OH)2 particles (75-125 microns) suspended in a gel of USP glycerin, sterile water for injection and sodium carboxymethylcellulose (NaCMC). The calcium hydroxylapatite meets ASTM F1185. The excipients glycerin, sterile water, and NaCMC are both pharmaceutical USP grade and listed as GRAS. Calcium hydroxylapatite is radiopaque.

The properties of Coaptite™ facilitate ingrowth of surrounding tissue-over time. The implantation procedure uses direct injection to the laryngeal augmentation site with direct visualization via nasopharyngoscope.

The provided text does not contain information about specific acceptance criteria or a study that directly proves the device meets those criteria for the Coaptite™ Laryngeal Augmentation System. Instead, the document is a 510(k) Premarket Notification Submission, which focuses on demonstrating substantial equivalence to predicate devices already on the market.

Therefore, I cannot populate the table or answer the questions regarding acceptance criteria and performance study details based on the provided text.

Here's why the information is not present:

• 510(k) vs. Clinical Trial Reports: A 510(k) submission primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive new clinical trials with predefined acceptance criteria for efficacy and safety. While some submissions may include limited performance data, a comprehensive clinical study report with detailed acceptance criteria is generally not a core component of a 510(k) unless specifically requested by the FDA or if the device introduces significantly different technology or indications.
• Focus on Substantial Equivalence: The document explicitly states its purpose is to demonstrate substantial equivalence (section 4.3). This involves comparing the new device's technological characteristics, materials, and intended use to those of predicate devices.

What the document does provide:

• Intended Use: "Coaptite™ Laryngeal Augmentation System is intended as an injectable, space-occupying implant for vocal fold medialization and augmentation."
• Product Description: Details on its composition (calcium hydroxylapatite particles in a gel), form (injectable), and mechanism ("facilitate ingrowth of surrounding tissue").
• Predicate Devices: Lists several predicate devices (Smith & Nephew VoCoM, Gore ReVox Thyroplasty Implant, Xomed Silicone Pre-form Blocks) and explains why Coaptite™ is considered substantially equivalent to them based on material, form, and biological action.

Without specific performance data from a clinical study, providing information on acceptance criteria, sample sizes, expert qualifications, or comparative effectiveness studies is not possible from the given text.

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Coaptite™ Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

Coaptite™ Tissue Marker is a sterile, nonpyrogenic, flexible, semi-solid, cohesive implant used as a single use tissue marker. The principle component of the Coaptite™ Tissue Marker is synthetic calcium hydroxylapatite, a radiopaque biomaterial with over twenty years of use in orthopedics, neurosurgery, dentistry, otolaryngology, and ophthalmology. The product is available in two particle size ranges to allow different needle sizes for percutaneous placement. Coaptite™ Tissue Marker (0008025-1 and 0008026-1) has a size range of 75-125 microns. Coaptite™ FN Tissue Marker (0008027-1 and 0008028-1) has a size range of 25-45 microns. The calcium hydroxylapatite beads are clearly visible on standard radiographs as well as CT scan, MRI, and ultrasound. The cohesive semi-solid, elastic nature of the Coaptite™ Tissue Marker is created by physical bonds formed with sodium carboxymethylcellulose (NaCMC). NaCMC has also been used safely as a biomaterial for over twenty years. Coaptite™ Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. There is no ferrous material used in the formulation for Coaptite™ Tissue Marker and therefore it is MRI compatible.

This 510(k) submission for the Coaptite™ Tissue Marker (K012955) does not include a study with acceptance criteria and reported device performance in the way a typical AI/ML device submission would. The document is for a physical implantable tissue marker, not an AI/ML software device.

Therefore, many of the requested categories in your prompt are not applicable to this submission. I will address the relevant sections of your prompt based on the provided text, and explicitly state when information is not available or not applicable for this type of medical device submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information (e.g., sensitivity, specificity, accuracy) is not applicable to this physical device submission. The acceptance criteria for the Coaptite™ Tissue Marker are inherent in its design, materials, and manufacturing processes, aiming for safety and effectiveness through biocompatibility, sterilization, and visible radiographic marking.

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

• Sample Size (Pre-clinical): The document mentions "in vivo tests" for sensitization, tissue reaction, systemic reactions, and long-term safety issues, conducted under GLP guidelines. However, the exact sample size (number of animals or test subjects) for these in vivo tests is not specified.
• Sample Size (Clinical): "Subjects from the clinical study by Robert Mayer, M.D." are mentioned, but the exact number of subjects is not provided.
• Data Provenance: The preclinical tests were "in vitro and in vivo" based on Tripartite and Biocompatibility guidelines and ISO10993, using historically accepted test methods. These tests were conducted under GLP (Good Laboratory Practice) guidelines, suggesting a controlled experimental environment. The clinical study by Dr. Robert Mayer would inherently be prospective in nature for assessing long-term outcomes, but the original study design details are not in this 510(k) summary. The country of origin for these studies is not specified, though BioForm, Inc. is located in Wisconsin, USA.

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

This concept is not directly applicable to this physical device submission. "Ground truth" in the context of material biocompatibility and radiographic visibility is established through objective scientific testing (e.g., chemical analysis, imaging studies) and established medical understanding of materials, rather than expert consensus on diagnostic interpretations. The document refers to "pre-clinical and clinical experience" and Dr. Robert Mayer's clinical study, implying medical expertise in evaluating outcomes, but no specific number or qualification of "experts establishing ground truth for a test set" on device performance in the AI sense is provided.

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

Not applicable to this device type. Adjudication methods are typically used in clinical studies for diagnostic devices where subjective interpretation (e.g., by radiologists) needs to be reconciled to establish a consensus ground truth. For a physical tissue marker, its presence and visibility are objectively verifiable.

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

Not applicable. This is a physical tissue marker, not an AI or diagnostic imaging device that assists human readers.

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

Not applicable. This is a physical tissue marker.

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

The "ground truth" for the performance of the Coaptite™ Tissue Marker is based on:

• Biomaterial Science and Standards: Compliance with ASTM-1185 for calcium hydroxylapatite, and established safe use records for excipients (USP grade glycerin and sodium carboxymethylcellulose).
• Pre-clinical In Vivo Testing: Direct measurement and observation of tissue reactions (sensitization, irritation, toxicity) in animal models, and long-term safety assessments (36-month data).
• Radiographic Visibility: Objective imaging (X-ray, CT, MRI, ultrasound) to confirm the marker's presence and clarity.
• Clinical Outcomes Data: "Long-term concerns" from subjects in a clinical study (Robert Mayer, M.D.) are considered. This refers to the real-world performance and safety in human subjects over an extended period.

8. The sample size for the training set

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

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

Not applicable. Refer to point 8.

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