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

Calcium Hydroxylapatite Vocal Fold Implant is a ready to use product. Calcium Hydroxylapatite Vocal Fold Implant is comprised of calcium hydroxylapatite particles, blended into an aqueous gel formulated from sodium carboxymethyicellulose, glycerin, and a phosphate buffer. The gel acts as a carrier for the particles to facilitate placement. The main component of Calcium Hydroxylapatite Vocal Fold Implant is synthetic calcium hydroxylapatite, a material with over thirty years of use as an implant material used in orthopedics, neurosurgery, dentistry, otolaryngology, plastic surgery and ophthalmology. Calcium hydroxylapatite is also the main mineral component found in bones and teeth so it is a major component of the body. The calcium hydroxylapatite meets the requirements of ASTM F1185. The carrier consists of glycerin (USP) sodium carboxymethylcellulose (USP) and phosphate buffer (USP). The carrier resorbs in vivo, so that the calcium hydroxylapatite remains at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated hydroxylapatite scaffold provides the longterm restoration and augmentation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Calcium Hydroxylapatite Vocal Fold Implant:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, no specific, quantifiable acceptance criteria (e.g., specific performance metrics, thresholds for success) for the device are detailed. The submission primarily focuses on establishing substantial equivalence to a predicate device rather than fulfilling pre-defined performance criteria through a separate clinical trial with specific endpoints.

The reported device performance is largely qualitative and comparative:

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

The document does not describe a clinical "test set" in the context of a performance study with human subjects for the Calcium Hydroxylapatite Vocal Fold Implant. The primary evidence presented is comparison to a predicate device and pre-clinical (in vitro and animal) studies.

• Pre-clinical tests: In vivo and in vitro tests were performed for biocompatibility. No specific sample sizes (e.g., N for animal studies or specific in-vitro replicates) are provided.
• Data Provenance: The biocompatibility studies cited are "preclinical safety studies and animal implant studies" (source not specified further, but assumed to be internal or from contract labs) and "in vivo and in vitro tests" (source not specified). There's no mention of country of origin for this data or if it was retrospective or prospective in the context of a clinical trial.

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

Not applicable. The submission does not describe a test set requiring expert-established ground truth for performance evaluation in the way a diagnostic AI would (e.g., reading images). The "ground truth" for the device's properties (biocompatibility, material composition, mechanism of action) comes from established scientific principles, ASTM standards (F1185 for the material), and laboratory testing.

4. Adjudication Method for the Test Set

Not applicable, as there is no described test set with human assessments 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

Not applicable. This device is an implantable material, not an AI-assisted diagnostic or therapeutic tool for human readers. Therefore, an MRMC study is not relevant to its regulatory submission.

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

Not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is based on:

• Material Science and Chemistry: Adherence to ASTM F1185 for calcium hydroxylapatite.
• Biocompatibility Testing: Results from in vivo and in vitro tests, as well as animal implant studies.
• Sterilization Standards: Conformance to ISO 17665.
• Risk Management Standards: Adherence to ISO 14971.
• Predicate Device Equivalence: The primary ground truth for its intended use, mechanism of action, and safety profile is implicitly the established track record and regulatory approval of the legally marketed predicate device (K070090, Radiesse Laryngeal Implant).

8. The 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. This is not an AI/ML device.

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Osteophil B-TCP is a resorbable bone void filler intended to fill bony void or gaps of the extremities, posterolateral spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Osteophil B-TCP is a porous calcium phosphate resorbable bone void filler for the repair of bony defects. The product consists of beta-Tricalcium Phosphate and is about 80% porous. The product is provided sterile and is available in granules 1-4 mm². Osteophil B-TCP has a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Osteophil B-TCP slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of Osteophil B-TCP resorbable bone filler is intended to prevent premature resorption.

The provided document describes the Osteophil B-TCP device, a resorbable bone void filler. The submission is a 510(k) premarket notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study" described are focused on proving this substantial equivalence rather than on a clinical trial to establish device performance against specific clinical acceptance criteria.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

The document states that Osteophil B-TCP has "substantially equivalent critical specifications" and "substantially equivalent technical characteristics" as its predicate device, CAMCERAM TCP (K050357). The acceptance criteria are implicitly that all listed characteristics are substantially equivalent to the predicate. The "reported device performance" is that the device met these equivalence criteria through testing.

*NA indicates 'Not Applicable', as described in the document.

Study Details

The study conducted is a bench and animal testing comparison study to demonstrate substantial equivalence to the predicate device, K050357 (CAMCERAM TCP). This is not a clinical study on human subjects but a comparison of technical and performance attributes.

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

   • Test set sample size: Not explicitly stated as a single "sample size" number in terms of human subjects or distinct clinical cases, as this is primarily a bench and animal study. For the specific technical characteristics, standard laboratory test methods were used, implying internal samples sizes as required for those tests (e.g., multiple samples for chemical analysis, dissolution testing). The document mentions "Animal testing to determine bone in-growth and resorption of the implant over time," which would involve an animal cohort, but its size is not specified.
   • Data provenance: Not explicitly stated. Given it's a 510(k) submission for a medical device manufacturer (Cytophil, Inc. in East Troy, WI, USA), the testing would likely have been conducted in a laboratory setting, potentially internal or outsourced, presumably in the USA. The data is retrospective in the sense that it evaluates pre-existing device characteristics against a predicate rather than prospective clinical outcomes.

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

   • Not applicable in the context of this 510(k) submission. "Ground truth" in this context refers to the established standards and properties of the predicate device and the new device as determined by laboratory analyses and animal studies, not by expert human interpretation of images or clinical data.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical trials or diagnostic studies involving human interpretations, where conflicts in expert opinions need resolution. Here, the "truth" is determined by scientific measurement and comparison.

4. 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 a diagnostic imaging device or an AI-assisted device. Therefore, no MRMC study was conducted, and there's no concept of human readers improving with or without AI assistance.

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

   • Not applicable. This device is a physical resorbable bone void filler, not an algorithm or AI system.

6. The type of ground truth used:

   • The "ground truth" for demonstrating substantial equivalence was established through standardized laboratory test methods for chemical composition, physical properties, pH, in vitro dissolution rate, and animal testing for bone in-growth and resorption. The predicate device's established characteristics serve as the benchmark for comparison.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such a device would be the R&D and manufacturing process to ensure it consistently meets its specifications.

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

   • Not applicable, as there is no "training set" in the context of this device and submission type.

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Periophil ß -TCP is indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil ß -TCP can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.

Periophil 8 -TCP is a bone graft substitute. Periophil 3 -TCP is a microporous and macroporous calcium phosphate ceramic consisting of beta tricalcium phosphate (6-TCP). Periophil ß -TCP is available as granules and is provided sterile for single patient use.

Periophil B -TCP is a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Periophil ß -TCP slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. There is progressive resorption for 4 to 12 months (may vary patient to patient) of Periophil B -TCP resorbable bone filler.

The provided document is a 510(k) summary for a medical device called Periophil β -TCP, a synthetic bone graft material. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, many of the requested details about acceptance criteria, device performance, study design, and ground truth establishment are not explicitly present in this type of regulatory submission. This document highlights biocompatibility, sterilization, and material conformance to standards, which are aspects of safety and effectiveness, but not in the format of a clinical or standalone performance study as typically expected for diagnostic devices.

Here's a breakdown of the information that can be extracted or deduced, and what is absent:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance targets. The "acceptance criteria" for this 510(k) submission are primarily based on demonstrating substantial equivalence to predicate devices regarding intended use, technological characteristics, safety, and effectiveness. The report indicates compliance with the ASTM F1088 "Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation" for chemical safety (heavy metal trace element levels).
• Reported Device Performance:
  • Biocompatibility: "non-toxic, non-allergenic, biocompatible, and elicit no inflammation. No adverse effects or foreign body reactions have been reported." This is based on documented history of β-TCP and identical materials to a predicate device (K063634).
  • Sterilization: "Sterilized using gamma radiation," validated to "10 SAL" (Sterility Assurance Level).
  • Resorption: "slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. There is progressive resorption for 4 to 12 months (may vary patient to patient)." This is a general characteristic, not a reported performance metric from a specific study within this document.
  • Chemical Safety: Conforms to ASTM F1088 for heavy metal trace element levels.

Table (based on available information):

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

• Not Applicable / Not Explicitly Stated: This document does not describe a clinical performance study with a "test set" in the context of device performance as one might expect for a diagnostic or AI-driven device. The pre-clinical tests performed relate to material specifications (ASTM F1088) and biocompatibility, which typically don't involve "test sets" of patient data in the same way. The biocompatibility claim references "well documented" evidence for β-TCP, implying existing literature, but no specific study with sample size, provenance, or retrospectivity/prospectivity is detailed within this submission.

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

• Not Applicable / Not Stated: Since there is no described clinical "test set" requiring ground truth establishment, this information is not provided.

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

• Not Applicable / Not Stated: As there's no clinical test set described, no adjudication method is mentioned.

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 bone graft material, not an AI-driven diagnostic device, so an MRMC study and AI assistance effect size are not relevant or discussed.

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

• Not Applicable: This is a physical bone graft material, not an algorithm.

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

• Not Explicitly Stated in a clinical context: For the material properties, the "ground truth" is provided by compliance with the ASTM F1088 standard. For biocompatibility, it relies on "well documented" evidence for β-TCP and comparison to the predicate device's materials. No clinical outcomes data or pathology as "ground truth" for a specific performance study is detailed here.

8. The sample size for the training set

• Not Applicable: This is not an AI/algorithm-based device and does not involve a training set.

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

• Not Applicable: As above, no training set for an algorithm is involved.

Summary of what the document does provide regarding "proof":

The "study that proves the device meets the acceptance criteria" in this 510(k) submission primarily relies on:

• Predicate Device Comparison: Demonstrating substantial equivalence to existing legally marketed devices (K063634, K051885, K082917) in terms of Indications for Use, technological characteristics, safety, and effectiveness.
• Compliance with Standards: Conformance to recognized consensus standards like ASTM F1088 for chemical safety.
• Material Biocompatibility Documentation: Referencing existing knowledge and safety history of β-TCP as a biomaterial.
• Validated Manufacturing Processes: Sterilization validation to a specific SAL.
• Risk Assessment: Adherence to standards like ISO 14971 for risk identification.

In essence, this is a regulatory filing focused on establishing substantial equivalence rather than presenting a novel clinical performance study with defined acceptance criteria and performance metrics in the way a new diagnostic or AI device might.

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Periophil Biphasic is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil Biphasic can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.

Periophil Biphasic is a bone graft substitute. Periophil Biphasic is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% hydroxyapatite (HA) and 40% beta tricalcium phosphate (B-TCP). Periophil Biphasic is available as granules and is provided sterile for single patient use.

Periophil Biphasic is a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Periophil Biphasic slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of Periophil Biphasic resorbable bone filler is intended to prevent premature resorption.

The provided text does not contain information about acceptance criteria, device performance metrics, or a study demonstrating the device meets such criteria. The document is a 510(k) summary for a synthetic bone graft material called "Periophil Biphasic," focusing on its indication for use, product description, and substantial equivalence to a predicate device.

Therefore, I cannot provide the requested table and study details.

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Vocalis Gel is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication. The product is intended to be durable for a minimum of one month.

Sterile, latex free, non-pyrogenic, high yield strength, isotonic, clear gel injectable implant. The gel consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The high yield strength is created by small amounts of carbomer (USP). The gel carrier allows tissue infiltration over time. All components are listed as GRAS (Generally Recognized as Safe 21 CFR 182). The character of the gel allows it to be very thick and cohesive but sheer to be easily injected through very fine needles with minimal force.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Vocalis Gel device.

Acceptance Criteria and Device Performance for Vocalis Gel

Unfortunately, the provided document does not explicitly state specific acceptance criteria (e.g., numerical targets for performance metrics) for Vocalis Gel.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices and fulfilling general regulatory requirements for medical devices. The primary "performance" is implicitly demonstrated through biocompatibility, sterilization, and pre-clinical safety assessments.

The device's intended effect, "vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent...to meet the opposing fold at the midline for improved phonation" and being "durable for a minimum of one month," are clinical outcomes rather than quantifiable device performance metrics presented in this 510(k) summary.

Based on the available information, the closest approximation to "acceptance criteria" and "reported device performance" are as follows:

Study Details Proving Device Meets Acceptance Criteria:

The provided document describes pre-clinical tests rather than a study with a defined "test set" or "ground truth" as might be seen for diagnostic AI devices.

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

   • Test Set Sample Size: Not specified in terms of number of subjects or samples. The document refers to "in vivo and in vitro tests" and "animal implant studies" but does not give specific numbers for these.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based pre-clinical (in vitro and in vivo animal) rather than human clinical data. They are retrospective in the sense that they were conducted before the 510(k) submission.

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

   • This concept is not applicable to the type of pre-clinical studies described. Ground truth, in this context, would be established by scientific methods and validated assays (e.g., cytotoxicity assays, irritation tests, histological analysis for biocompatibility in animal models) performed by trained laboratory personnel or specialists in relevant fields (e.g., toxicology, pathology). There is no mention of "experts" in the sense of clinical reviewers adjudicating results for the pre-clinical tests.

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

   • Not applicable. This concept pertains to human review of data, typically in diagnostic or qualitative assessment studies. The pre-clinical tests described would be evaluated based on objective scientific measurements and established criteria for toxicity, irritation, etc.

4. 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. Vocalis Gel is an injectable medical device, not a diagnostic imaging or AI-assisted system for human readers. Therefore, an MRMC study is not relevant to its evaluation.

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

   • Not applicable. This refers to AI algorithm performance. Vocalis Gel is a physical medical device.

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

   • For biocompatibility: Histological analysis from animal implants, and various laboratory assays (e.g., cytotoxicity, hemocompatibility).
   • For irritation, sensitization, acute and sub-chronic toxicity, genotoxicity, and hemolysis: Standardized in vivo (animal) and in vitro (cell culture, biochemical) assays with pre-defined endpoints and controls.
   • For sterility: Biological indicators and physical parameters measured during the sterilization cycle to confirm a 10⁻⁶ SAL.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

   • Not applicable. See point 7.

In summary, the provided document for Vocalis Gel focuses on demonstrating the device's safety, biocompatibility, and manufacturing quality through pre-clinical laboratory and animal studies, rather than clinical performance metrics with specific numerical acceptance criteria typically seen for diagnostic devices or those with direct, quantifiable output. The acceptance is based on demonstrating substantial equivalence to predicate devices and fulfilling these fundamental safety and sterilization requirements.

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Vocalis and Vocalis SM are indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication. The product is intended to be durable for a period of one month.

Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principle durable component is synthetic calcium hydroxylapatite. The semi-sold nature is created by suspending the calcium hydroxylapatite particles in a durable high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the Carbopol 974P NF (USP).

The provided text is a 510(k) summary for the Vocalis and Vocalis SM vocal fold implants. It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document focuses on:

• Intended Use: Vocal fold medialization and vocal fold insufficiency to improve phonation, with a durability of one month.
• Product Description: Sterile, latex-free, non-pyrogenic, semi-solid, cohesive subdermal implant with synthetic calcium hydroxylapatite suspended in a thixotropic gel.
• Substantial Equivalence: Lists several predicate devices (K013243, K070090, K071663, K080956).
• Pre-Clinical Tests: Biocompatibility, sterilization, and general in vivo/in vitro tests for irritation, sensitization, cytotoxicity, toxicity, genotoxicity, and hemolysis. These tests concluded the device is non-irritant, non-toxic, and has no long-term safety concerns.
• Risk Assessment: Identified primary risks associated with nasopharyngoscopy and injection laryngoplasty.
• Summary: Concludes the device is safe and effective as a space-filling material for soft tissue augmentation in laryngeal procedures.

Therefore, I cannot extract the requested information, as the document does not contain details about acceptance criteria, specific performance studies with sample sizes, expert involvement, or ground truth establishment for clinical effectiveness. The review is a premarket notification centered on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices.

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

Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principle durable component is synthetic calcium hydroxylapatite. The semi-sold nature is created by suspending the calcium hydroxylapatite particles in a durable high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the Carbopol 974P NF (USP). Cytophil 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 of the Cytophil Tissue Marker.

The provided document pertains to a 510(k) premarket notification for the Cytophil Tissue Marker. This type of filing demonstrates substantial equivalence to a legally marketed predicate device, rather than proving effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size of human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document focuses on:

• Intended Use: To radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
• Product Description: Sterile, latex-free, non-pyrogenic, semi-solid, cohesive subdermal implant made primarily of synthetic calcium hydroxylapatite in a thixotropic gel.
• Substantial Equivalence: Claimed equivalence to BioForm Medical, Inc.'s Coaptite Tissue Marker and Coaptite FN Tissue Marker (K012955).
• Biocompatibility Evaluations: Preclinical safety and animal implant studies indicating biocompatibility when injected into soft tissues.
• Sterilization: Sterilized using steam by a contract sterilization company, validated to 10⁻⁶ SAL.
• Pre-Clinical Tests: In vivo and in vitro tests for irritation, sensitization, cytotoxicity, acute and sub-chronic toxicity, genotoxicity, and hemolysis, concluding the device is non-irritant, non-toxic, with no long-term safety concerns.
• Risk Assessment: Performed in accordance with EN 1441.

The FDA's review in the provided letter acknowledges the substantial equivalence claim based on the information submitted, allowing the device to be marketed. It specifically states that "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

In summary, the provided text describes the regulatory pathway and pre-clinical safety assessments for a medical device (Cytophil Tissue Marker) based on substantial equivalence, and therefore, does not include a study or data on specific performance acceptance criteria as would be found for a device requiring a higher level of clinical evidence (e.g., a PMA or certain de novo applications).

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