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Optecure and Optecure +CCC are intended for use in combination with autogenous bone as a bone graft extender (extremities, spine and pelvis) and as bone void fillers (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Optecure and Optecure + CCC can be used with autogenous bone marrow. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Optecure and Optecure +CCC may be used with rigid fixation systems.

Optecure and Optecure + CCC are aseptically processed, single use, ready-to-mix devices intended for use as bone graft extenders (extremities, spine and pelvis) and as bone void fillers (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

Optecure products are provided in the form of a kit with pre-measured polymer powder, demineralized bone matrix (DBM), corticocancellous bone chips (CCC), pre-measured mixing solution and all the tools necessary to mix the components. After the powder is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids or gaps.

Optecure products gradually resorb and are replaced with new bone during the healing process.

The purpose of this 510(k) submission is to expand the current Indications for Use so that Optecure and Optecure + CCC may be used in combination with autogenous bone marrow as a bone graft extender.

Here's an analysis of the provided text regarding the Exactech® Optecure® and Optecure® + CCC Traditional 510(k), focusing on acceptance criteria and supporting studies.

It's important to note that this document is a 510(k) summary, which by design provides a high-level overview. Therefore, specific details about acceptance criteria, numerical performance metrics, and detailed study methodologies are generally not present as they would be in a full study report or detailed submission.

Description of Acceptance Criteria and Proving Device Meets Criteria

The document describes the Exactech® Optecure® and Optecure® + CCC as bone void fillers and bone graft extenders. The primary purpose of this 510(k) submission is to expand the Indications for Use for Optecure and Optecure + CCC to include combination with autogenous bone marrow as a bone graft extender.

The "acceptance criteria" here are not explicitly stated as quantitative thresholds for performance (e.g., "device must achieve X% success rate"). Instead, acceptance is determined by demonstrating substantial equivalence to legally marketed predicate devices. This means that the device must be shown to have the same or similar intended use, design, material composition, and functions as existing devices. The studies conducted are used to support this claim of substantial equivalence.

The "study that proves the device meets the acceptance criteria" refers to the preclinical testing mentioned, which aims to demonstrate that the new indications for use or the device itself perform comparably to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for a bone void filler/graft extender, specific quantitative acceptance criteria and performance metrics (like sensitivity, specificity, etc., common in AI/diagnostic devices) are not provided. The acceptance criterion is "substantial equivalence" to predicate devices.

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

The document describes preclinical testing using animal models, specifically an in vivo athymic mouse assay for osteoinduction and "tibial defect and spinal fusion animal models" for bone healing effectiveness.

• Sample Size for Test Set: Not specified. The document states "Samples from each lot of donor demineralized bone matrix (DBM)" for the osteoinduction assay, and "animal models" without specifying the number of animals or defects.
• Data Provenance: The studies are preclinical (in vivo animal models). The country of origin for the studies is not explicitly stated. They are retrospective in the sense that they were conducted prior to this 510(k) submission to support it, but they are not clinical human data (prospective or retrospective).

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

This section is not applicable to this type of device and submission. The "ground truth" for bone void fillers and graft extenders in preclinical animal studies is typically established through direct observation, histology, imaging, and biomechanical testing by trained researchers/veterinarians, not by human expert readers adjudicating diagnostic outputs. The assessment criteria are objective biological and physical measurements, not subjective expert interpretations in the same way an AI diagnostic algorithm would be evaluated.

4. Adjudication Method for the Test Set

This section is not applicable. The preclinical studies described (animal models, in vivo assays) involve objective measurements and observations of biological responses (e.g., bone formation, healing rates) rather than human interpretation that requires adjudication (like reading medical images).

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant to diagnostic devices, particularly those involving human interpretation of images, sometimes with AI assistance. The device in question (bone void filler) is a therapeutic implantable material, not a diagnostic tool requiring human reader interpretation in clinical practice in the way an MRMC study would assess.

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

No, a standalone performance study (algorithm only) was not done, and is not relevant. The device is a physical bone void filler, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used in the preclinical studies would be based on:

• Histology: Microscopic examination of tissue samples for evidence of new bone formation.
• Imaging: X-rays, CT scans, or other imaging modalities to assess bone bridging, density, and defect filling in animal models.
• Biomechanical Testing: Measuring the mechanical strength of the healed bone.
• Direct Observation: Gross assessment of healing in animal models.
• Biochemical markers: Where applicable for specific aspects of bone regeneration.

For the osteoinduction assay, the ground truth would be the observation of ectopic bone formation in the athymic mouse.

8. The Sample Size for the Training Set

This section is not applicable. The device is a medical product (bone void filler), not an AI algorithm that requires a training set in the machine learning sense. The "training" for such devices would be the iterative development and testing of the material formulation itself by the manufacturer.

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

This section is not applicable for the same reasons as point 8.

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OpteCure + CCC is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. Thesper of ent may be surgically created osseous defects or osseous defects created from to autonatic injury to the bone.

OpteCure may be used with rigid fixation systems.

Optecure™ + CCC is packaged in the form of a kit with pre-measured polymer powder, corticocancellous bone chips (CCC), demineralized bone matrix (DBM), premeasured mixing solution and all the tools necessary to mix the components. After the powder is hydrated, the resultant putty can then be handled and placed in the appropriate bone voids.

Optecure™ + CCC gradually resorbs and is replaced with new bone during the healing process.

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

Acceptance Criteria and Device Performance Study for Optecure™ + CCC

The provided document is a Traditional 510(k) Summary for Optecure™ + CCC, primarily focusing on establishing substantial equivalence to predicate devices rather than presenting a performance study with explicit acceptance criteria. As such, the information you've requested regarding specific acceptance criteria and a detailed study proving the device meets them is largely absent.

The document describes the device and its intended use, and briefly touches on safety and effectiveness information, but it does not detail a specific performance study with quantitative acceptance criteria, sample sizes, expert involvement, or adjudication methods for demonstrating clinical performance.

Here's what can be inferred and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The document's primary argument for safety and effectiveness lies in its substantial equivalence to already cleared predicate devices regarding design, material composition, and function. The "Safety & Effectiveness Information" section describes the tests performed to ensure the safety of the DBM component (osteoinductivity and viral inactivation) but does not present these as acceptance criteria for the entire device's clinical performance or a comparative study.

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

• Test Set Sample Size: Not applicable/Not provided. The document does not describe a clinical "test set" for evaluating device performance against pre-defined acceptance criteria.
• Data Provenance:
  • Osteoinductive Potential: In-vivo athymic mouse assay (animal model data).
  • Viral Inactivation Validation: Conducted by a CLIA certified testing laboratory (likely in vitro or ex vivo testing of the DBM component).

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

• Not applicable/Not provided. No human expert review or "ground truth" establishment for a clinical test set is described.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. No adjudication method for a clinical test set is described.

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

• No. An MRMC comparative effectiveness study is not mentioned or described in the provided summary. This type of study is more common for diagnostic imaging AI systems, not typically for bone void fillers that primarily demonstrate bioactivity and safety.

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

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

7. The Type of Ground Truth Used

• For Osteoinductive Potential: The "ground truth" is based on the biological response observed in the in-vivo athymic mouse assay (formation of new bone).
• For Viral Inactivation: The "ground truth" is based on the measured reduction of specific model viruses in laboratory testing.
• For overall device effectiveness for its indications: The "ground truth" (or basis of approval) for the device's intended use as a bone graft extender/filler is its substantial equivalence to predicate devices, which implies that their established safety and effectiveness apply.

8. The Sample Size for the Training Set

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

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

• Not applicable/Not provided. This device is not an AI/ML algorithm.

Summary of what the document does convey regarding "proving" the device:

The document leverages the concept of substantial equivalence to predicate devices. This means that instead of conducting new, large-scale clinical trials with specific acceptance criteria, the manufacturer argues that Optecure™ + CCC is as safe and effective as other legally marketed devices because it shares similar design, material composition, and function, and undergoes standard safety testing for its components (like osteoinductivity and viral inactivation validation for the donor bone matrix). The FDA's 510(k) clearance (K061668) confirms this assessment of substantial equivalence.

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OpteCure is intended for use as a bone graft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

OpteCure may be used with rigid fixation systems.

OpteCure comes in the form of a kit with pre-measured powder and demineralized bone matrix (DBM), pre-measured mixing solution and all the tools necessary to mix the components. After the powder is hydrated the resultant putty can then be handled and placed in the appropriate bone voids. Supplied as aseptic manufacture, single use, ready to mix implantable device derived from a single donor.

OpteCure gradually resorbs and is replaced with new bone during the healing process.

The provided text is a 510(k) summary for a medical device called OpteCure, which is a bone void filler. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving clinical efficacy of a novel device through a detailed study with acceptance criteria in the way an AI/ML device might be evaluated.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and human-AI comparative effectiveness studies is not applicable to this document. The 510(k) summary focuses on demonstrating that OpteCure is substantially equivalent to existing legally marketed devices, primarily through comparison of its design, materials, and intended use, and by showing safety data (like viral inactivation and osteoinductive potential) and performance data (like resorption).

Here's an explanation based on the provided text, outlining why the requested AI/ML-specific details are not present:

1. A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria in the context of a performance study as would be seen for an AI/ML device. Instead, it states that "OpteCure is the substantially equivalent to the predicate devices." The device's "performance" is implicitly demonstrated through its similarity to predicate devices and results from tests such as osteoinductive potential and viral inactivation.

   • Osteoinductive Potential: "Samples from each lot of donor demineralized bone matrix (DBM) are formulated with the carrier and tested for osteoinductivity in an in-vivo athymic mouse assay." The findings are not necessarily predictive of human clinical results. This is a biological characteristic test, not a performance metric against clinical acceptance criteria.
   • Viral Inactivation Validation: "A viral reduction study was conducted... This study demonstrates the demineralization process... significantly diminishes these model viruses..." This is a safety validation, not a performance metric for the device's main function as a bone void filler in humans.

2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation. The document mentions an "in-vivo athymic mouse assay" for osteoinductive potential and a "viral reduction study," but does not specify sample sizes for these, nor provenance of test data in a clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, test set, or expert evaluation in the AI/ML context mentioned in the document.

4. Adjudication method: Not applicable. No adjudication method is mentioned for any clinical or performance study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This document does not concern an AI system or human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used: Not applicable. The "ground truth" for this device's efficacy is its substantial equivalence to predicate devices and results from non-clinical tests (like osteoinductivity and viral inactivation) which evaluate biological properties and safety, respectively.

8. The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a traditional 510(k) submission for a physical medical device (bone void filler), where the primary goal is to demonstrate substantial equivalence to existing legally marketed predicate devices. It does not involve AI/ML technology, and therefore, the requested information pertaining to AI/ML device evaluation criteria, study design, and performance metrics is irrelevant to this specific submission.

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