(244 days)
ABCcolla® Bone Graft 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. ABCcolla® Bone Graft resorbs and is replaced with bone during the healing process.
ABCcolla® Bone Graft is a bone mineral matrix of porcine origin. ABCcolla® Bone Graft is physically and chemically comparable to the mineralized matrix of human bone.
The provided text describes a 510(k) premarket notification for the "ABCcolla® Bone Graft" device, which is a resorbable calcium salt bone void filler. Here's an analysis of the acceptance criteria and study information, focusing on the lack of specific details regarding a "study that proves the device meets acceptance criteria" as would be expected for an AI/ML device:
Important Note: The provided document is a 510(k) summary for a bone graft medical device, not an AI/ML powered device. As such, concepts like "test set," "human readers," "AI assistance," "ground truth establishment for training set," and "adjudication method" are not applicable in their typical AI/ML context. The document describes traditional medical device testing for substantial equivalence, focusing on biocompatibility, physical properties, and pre-clinical animal performance.
Therefore, many of the requested fields will be marked as "Not Applicable" or "Not Provided" in the context of an AI/ML device. I will extract the relevant information from the document as it pertains to a traditional medical device's testing and acceptance.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ABCcolla® Bone Graft are implicitly set by demonstrating "substantial equivalence" to predicate devices and meeting established medical device standards. The "performance" in this context refers to its physical, chemical, and biological properties, as well as its ability to facilitate bone formation in animal models.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Summary from provided text) |
|---|---|
| Chemical Composition | Analyzed via X-ray diffraction (XRD). Trace element analysis by ICP/MS. Comparable to mineralized matrix of human bone. |
| Physical Properties | Particle pore size and morphology evaluated via SEM. Porosity determined by mercury intrusion porosimetry. Density evaluated via tap density analyzer. Moisture content determined by moisture analyzer. Granule and cube shape, particle size between max and min of predicate device. |
| Biocompatibility | Studies performed in accordance with ISO 10993-1, -3, -4, -5, -6, -10, -11. Passing results implied for substantial equivalence. |
| Sterilization | Validated by gamma-irradiation in accordance with ISO 11137. |
| Packing Integrity | Tested and implied passing for substantial equivalence. |
| Shelf-life | Evaluated in real-time aging study with passing results. |
| Pyrogenicity | Assessed with limulus amebocyte lysate (LAL) method, met established guidelines. |
| Pre-clinical Animal Performance | Critical-size bone defect model performed to evaluate new bone formation and healing effect. Implied positive results for substantial equivalence. |
| Functionality, Design, Materials | Substantially equivalent to predicate device. |
| Intended Use | Substantially equivalent to predicate device. Intended to fill bony voids or gaps of the skeletal system (extremities and pelvis); resorbs and replaced by bone during healing. |
Study Details (Interpreted for a non-AI/ML medical device)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- For chemical, physical, and in vitro biological tests: Not explicitly stated in terms of sample count (e.g., number of batches, units). These would typically involve multiple samples to establish consistency.
- For pre-clinical animal performance testing: A "critical-size bone defect model" was performed. The number of animals used is not specified.
- Data Provenance: The studies were performed by ACRO Biomedical Co., Ltd. (Taiwan). The document does not specify if the studies were retrospective or prospective, but animal studies are typically prospective by nature.
- Test Set Sample Size:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. For a bone graft device, "ground truth" is established through standardized laboratory analyses (e.g., chemical assays, physical measurements) and histological examination of animal tissue, performed by qualified scientists and pathologists, rather than expert clinicians rendering a diagnostic opinion. The number of such specialists is not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 are relevant for interpreting ambiguous diagnostic images or clinical scenarios, typically in studies involving human readers or AI. For the described medical device testing, results are derived from objective measurements, biochemical analyses, and histological assessments in animal models.
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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 a bone graft, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance comparison would be performed.
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If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For chemical and physical properties: Analytical measurements against established standards (e.g., hydroxyapatite content, porosity).
- For biocompatibility: Adherence to ISO 10993 series standards, which involves evaluating cellular responses, systemic toxicity, etc.
- For pre-clinical animal performance: Histological evidence of new bone formation and healing in the critical-size bone defect model, likely compared to control groups or expected healing patterns. This would involve pathology and quantitative analysis of bone growth.
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The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML model, so there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant for this device.
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February 1, 2018
ACRO Biomedical Co., Ltd. Dar-Jen Hsieh Chief Executive Officer 3F, No. 57, Luke 2nd Road, Lujhu District Kaohsiung City 82151 TAIWAN
Re: K171629
Trade/Device Name: ABCcolla® Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: January 10, 2018 Received: January 10, 2018
Dear Dar-Jen Hsieh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(K) Number (If Known): __K171629
Device Name: ABCcolla® Bone Graft
Indications for Use: ABCcolla® Bone Graft is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and These osseous defects are surgically created or the pelvis). result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. ABCcolla® Bone Graft resorbs and is replaced with bone during the healing process.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
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510(k) Summary
This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR 807.92. The assigned 510(k) number is_________________________________________________________________________________________________________________________________________________
| Applicant | ACRO Biomedical Co., Ltd. |
|---|---|
| 3rd Fl., No.57, Luke 2nd Rd., Lujhu Dist., Kaohsiung City 82151 | |
| Taiwan | |
| Telephone: +886-7-6955-569 | |
| Fax: +886-7-6955-069 | |
| Contact Person | DAR-JEN HSIEH |
| CEO | |
| E mail: dj@acrobiomedical.com | |
| Date of Summary | May 1st, 2017 |
| Name of Device | ABCcolla® Bone Graft |
| Common Name | Resorbable Bone Void Filler |
| Classification | Class II |
| Regulation Number | 21 CFR 888.3045 |
| Product Code | MQV |
| Advisory Panel | ORTHOPEDIC DEVICES |
| Predicate Device | • ORTHOSS® Resorbable Bone Void Filler, K090401Ed. Geistlich Soehne Ag Für Chemische Industrie• Bicera™ Resorbable Bone Substitute, K110949Wiltrom Corporation Limited |
| Reference Device | · Geistlich Bio-Oss®, K122894Geistlich Pharma Ag |
| Device Description | ABCcolla® Bone Graft is a bone mineral matrix of porcine origin.ABCcolla® Bone Graft is physically and chemically comparable tothe mineralized matrix of human bone. |
| Intended Use | ABCcolla® Bone Graft is an implant intended to fill bony voids orgaps of the skeletal system (i.e., extremities and pelvis). Theseosseous defects are surgically created or the result of traumaticinjury to the bone and are not intrinsic to the stability of the bonystructure. ABCcolla® Bone Graft resorbs and is replaced with boneduring the healing process. |
| Technological | ABCcolla® Bone Graft has been designed and manufactured to be |
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Characteristics substantially equivalent to predicate and reference device through comparison in areas including intended use, material origin, physical structure, chemical characteristics (hydroxyapatite, Ca/P ratio), principles of operation and design (user, how supplied, single use, gamma-irradiation sterilization).
ABCcolla® Bone Graft was designed in granule and cube shape similar to the predicate and reference device with different particle size which is between in the maximum and minimum size of the predicate device.
The performance of ABCcolla® Bone Graft, including chemical Performance Data composition, physical properties, biocompatibility, sterilization, packing, shelf-life, pyrogenicity and pre-clinical animal performance testing were performed to demonstrate substantial equivalence to the predicate devices.
Chemical composition (hydroxyapatite, Ca/P ratio) was analyzed via X-ray diffraction (XRD), trace element analysis was performed by inductively coupled plasma/mass spectroscopy (ICP/ MS), particle pore size and morphology was evaluated via scanning
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electron microscopy (SEM), porosity was determined by mercury intrusion porosimetry, density was evaluated via tap density analyzer, and moisture content was determined by moisture analyzer.
Biocompatibility studies were performed in accordance with ISO 10993-1, ISO10993-3, ISO10993-4, ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO10993-11. ABCcolla® Bone Graft was sterilized by gamma-irradiation and the process was validated in accordance with ISO 11137. ABCcolla® Bone Graft also has been tested for its packing integrity. The product shelf-life was evaluated in real-time aging study with passing results. Pyrogenicity was assessed with limulus amebocyte lysate (LAL) method and met the limits of established guidelines.
According to Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device, critical-size bone defect model was performed to evaluated the new bone formation and healing effect of ABCcolla® Bone Graft in pre-clinical animal performance testing.
Substantial ABCcolla® Bone Graft is substantially equivalent to the predicate Equivalence device with respect to functionality, design, materials, sterilized Summary method, package material, intended use and performance characteristics.
Conclusion Based on the 510(k) summaries and the information provided herein, we conclude that ABCcolla® Bone Graft is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act.
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.