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510(k) Data Aggregation
(119 days)
Synthecure Synthetic Calcium Sulfate is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Synthecure Synthetic Calcium Sulfate resorbs and is replaced with bone during the healing process.
Synthecure is provided sterile for single use only. Synthecure is biodegradable and biocompatible and may be used at an infected site.
Synthecure Synthetic Calcium Sulfate is indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Synthecure is biocompatible and may be implanted at an infected site. Synthecure Synthetic Calcium Sulfate is presented as a powder and mixing solution which when mixed together forms a paste which may be injected, digitally implanted or applied to a mold provided to produce pellets.
The provided FDA 510(k) clearance letter pertains to a medical device called "Synthecure Synthetic Calcium Sulfate," a resorbable calcium salt bone void filler. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Based on the provided text, the device is a bone void filler and not a device that would typically have the acceptance criteria in the format requested. The document does not describe a study involving a "test set" with ground truth, expert adjudication, or human reader performance with or without AI assistance, as these are concepts more relevant to diagnostic or AI-powered devices.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information contained in this FDA clearance letter. The letter focuses on demonstrating the physical, chemical, and biological safety and performance of the bone void filler device through a series of non-clinical tests.
However, I can extract the acceptance criteria as described for the non-clinical tests and the reported performance based on the information provided.
Acceptance Criteria and Study for Synthecure Synthetic Calcium Sulfate
The Synthecure Synthetic Calcium Sulfate is a resorbable calcium salt bone void filler. The provided 510(k) summary outlines non-clinical testing performed to demonstrate its safety and substantial equivalence to predicate devices, rather than a clinical study with a detailed test set and ground truth as might be expected for diagnostic or AI devices.
1. A table of acceptance criteria and the reported device performance
| Performance Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Sterilization must achieve a Sterility Assurance Level (SAL) of $1 \times 10^{-6}$ for the worst-case construct, in compliance with recognized standards. | Sterilization validation has been completed on the worst-case construct to an SAL of $1 \times 10^{-6}$. |
| Bacterial Endotoxin Testing | Testing must be performed according to ANSI/AAMI ST72:2011 and demonstrate acceptable endotoxin levels. | Testing is performed according to ANSI/AAMI ST72:2011, "Bacterial endotoxins – Test methods, routine monitoring and alternatives to batch testing." (Implies acceptable levels were met). |
| Packaging Validation | Packaging performance must be validated in accordance with ISO 11607-1:2019 and ISO 11607-2:2019 to ensure product integrity and sterility throughout its shelf life. | Packaging performance validation, in accordance with ISO 11607-1:2019 and ISO 11607-2:2019, was performed on the final packaging and sterilized device. (Implies successful validation). |
| Biocompatibility | Biological safety evaluation must be completed according to ISO 10993-1 requirements and FDA Guidance Document "Use of International Standard ISO 10993-1," demonstrating all materials are biocompatible for their intended use. | A biological safety evaluation has been completed for Synthecure according to ISO 10993-1 requirements and FDA Guidance Document "Use of International Standard ISO 10993-1." All materials contained in the proposed Synthecure have been evaluated in accordance with recognized standards and are characterized as being biocompatible. |
| Performance Testing - Bench | Chemical composition and physical properties (e.g., work and setting time) must be equivalent to predicate devices and maintain performance after aging, as per current industry standards and FDA guidance. | The chemical composition and physical properties of the subject and predicate devices were evaluated and demonstrated to be equivalent. Additionally, work and setting time tests were conducted on real-time aged samples to support that the device maintains its performance after aging. |
| Performance Testing - Animal | An in-vivo implantation study must demonstrate appropriate biological response, resorption, and replacement with bone at specified endpoints (e.g., 3, 6, and 12 weeks) in an animal model, showing performance comparable to expectations for bone void fillers. | An implantation study was conducted using New Zealand White Rabbits with study endpoints at 3, 6, and 12 weeks. (Implies successful outcomes demonstrating expected performance for bone void fillers, leading to substantial equivalence). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms typically used for diagnostic or AI studies. For the animal study, the sample size is not explicitly stated number of New Zealand White Rabbits, but it's an animal model.
- Data Provenance: The document implies that all testing (bench, animal, etc.) was conducted by or for Austin Medical Ventures, Inc. in support of their 510(k) submission. It's not applicable in terms of "country of origin for human data" as these are non-clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a bone void filler, and its evaluation relies on physical, chemical, and biological testing, not on expert interpretation of diagnostic images or clinical assessments to establish ground truth in the way a diagnostic device would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This device does not involve adjudication of expert opinions or interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a software algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, "ground truth" is established through:
- Established standards and regulations: e.g., ISO 10993-1 for biocompatibility, ISO 11607 for packaging.
- Bench testing methodologies: Measuring physical and chemical properties.
- In-vivo animal models: Observing biological response, resorption rates, and bone ingrowth over time (e.g., 3, 6, and 12 weeks endpoints). The "truth" here is the biological reaction within the animal model.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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(62 days)
The paste made with OsteoCure is intended to be injected, digitally packed into bone voids or gaps; or molded into solid pellets that are gently packed into bone voids or gaps that are not intrinsic to the stability of the bony structure of the skeletal system (i.e. long bones, extremities, spine and pelvis). The bone voids or gaps may be either surgically created or result from traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process.
OsteoCure paste cured in-situ provides a bone void or gap filler that can augment provisional hardware (e.g. K-Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary scaffold and is not intended to provide support during the healing process.
OsteoCure Kits are provided sterile for single use only. Because the device is biodegradable and biocompatible, it may be used at an infected site.
OsteoCure Resorbable Bead Kit and OsteoCure Injectable Graft Kit consist of premeasured surgical grade calcium sulfate, pre-measured mixing solution, and the tools necessary to mix the components into a paste. These products are provided sterile for single patient use. When mixed according to directions, the OsteoCure Kits produce biodegradable, radiopaque paste/molded beads that resorb in approximately 30-60 days, when used according to labeling.
After the powder is hydrated using all of the mixing solution supplied in each kit, the resultant paste can be injected, digitally packed into the bone void to cure in-situ; or molded into solid implants that are gently packed into non-load bearing voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis). These bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The implants provide a bone void filler that resorbs and is replaced with bone during the healing process.
The provided document, K051406, is a 510(k) premarket notification for the OsteoCure Resorbable Bead Kit and OsteoCure Injectable Graft Kit. A 510(k) notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific, quantitative acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the document does not contain the specific information requested about acceptance criteria and a dedicated study to prove the device meets these criteria in the way one might find for a novel diagnostic or AI device.
However, based on the information provided, here's a breakdown of what can be inferred and what is not available:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly stated in the provided 510(k) summary. The submission focuses on demonstrating substantial equivalence to predicate devices (Biogeneration, ProFusion Bone Graft Substitute Kits and Wright Medical OsteoSet) in terms of:
- Intended Use: The OsteoCure Kits are intended for filling non-load bearing bone voids/gaps, which may be surgically created or due to traumatic injury. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The paste also augments provisional hardware for temporary support.
- Material Composition: "The OsteoCure Kits have the equivalent chemical composition...as the predicate device."
- Technological Characteristics: "The OsteoCure Kits have...the technological characteristics as the predicate device."
- Performance Data: "Testing demonstrated that the performance of the OsteoCure Kits are substantially equivalent to the performance of the predicate device."
Without specific acceptance criteria for a new clinical outcome or performance benchmark, it's impossible to create a table of acceptance criteria and reported device performance. The "performance data" mentioned is not detailed, but broadly states "substantially equivalent."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available in the provided document. The 510(k) summary does not describe a clinical study in the traditional sense with a "test set" of patients. The performance data mentioned likely refers to non-clinical (e.g., in-vitro, mechanical, animal) testing to support material and characteristic equivalence.
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):
This information is not applicable/not available. As there is no described clinical study with a "test set" and a need for "ground truth" establishment by experts (e.g., for diagnostic accuracy), this detail is not present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/not available for the same reasons as point 3.
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 information is not applicable/not available. The OsteoCure devices are bone void fillers, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/not available. The OsteoCure devices are not algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable/not available. Since there is no detailed clinical study described requiring ground truth for performance evaluation (e.g., diagnostic accuracy), this information is not present. For device performance in equivalence, the "ground truth" would be the known and accepted performance characteristics of the predicate device, which is established through its own regulatory history and performance data.
8. The sample size for the training set:
This information is not applicable/not available. The OsteoCure devices are not AI models requiring training sets.
9. How the ground truth for the training set was established:
This information is not applicable/not available for the same reason as point 8.
In summary:
The provided document is a 510(k) summary demonstrating substantial equivalence to predicate devices, primarily through comparison of materials, indications for use, and general performance. It does not detail a study designed to prove the device meets specific, quantitative acceptance criteria through a clinical trial with human subjects and associated performance metrics, as would be expected for a novel device or an AI/diagnostic product. The "acceptance criteria" here are implicitly meeting the standards of the predicate device to establish substantial equivalence.
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