(173 days)
Callos® ProModel Bone Void Filler is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos ProModel is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Callos ProModel Bone Void Filler is a moldable and biocompatible calcium phosphate/calcium sulphate composite bone void filler. The single-use Callos ProModel kit contains the necessary components for mixing of the bone void filler. The Callos ProModel sterile kit contains: Calcium Phosphate/Calcium Sulfate Powder, Dilute Sodium Silicate Liquid, a Mixing System (Mixer and Syringe) and a Cannula.
The provided text describes the device "Callos ProModel Bone Void Filler" and its regulatory clearance process, including summaries of non-clinical tests. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in human patients, as would be expected for a device with a focus on AI performance or clinical efficacy against measured outcomes.
Instead, the document states:
- "Callos ProModel does not meet the criteria to require clinical testing."
- "In vitro and in vivo performance demonstrate that Callos ProModel is substantially equivalent to legally marketed predicate devices."
This indicates that clearance was based on substantial equivalence to existing devices and non-clinical data, not on a clinical effectiveness study with defined acceptance criteria for patient outcomes.
Therefore, I cannot provide the requested table and information as the document does not contain the specific details about acceptance criteria, device performance against those criteria, or a qualifying clinical study.
Based on the provided text, the following points can be addressed, but the core request for acceptance criteria and a study proving their fulfillment cannot be fully met:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics for a clinical effectiveness study in the provided text. The criteria are implied to be "substantial equivalence" to predicate devices based on non-clinical data (biocompatibility, bench testing, animal study).
- Reported Device Performance:
- "Callos ProModel met the standards set forth in ISO 10993-1. Biological Evaluation of Medical Devices."
- "radiation sterilization validation is in compliance to ANSI/A AMI/ISO 11137-2:2006."
- "Bench testing demonstrated that Callos ProModel is substantially equivalent to the marketed predicate devices. The results indicated that the device met performance criteria outlined for its intended use." (Specific numerical performance metrics are not provided).
- "The animal study provided data that Callos ProModel elicited similar biologic response in a large animal critical size defect model as compared to predicate devices for its intended use." (Specific outcome data or statistical comparisons are not provided).
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Sample size used for the test set and the data provenance: Not applicable. No clinical "test set" (human patient data) is described in the context of proving efficacy against acceptance criteria. The non-clinical studies involved bench testing (materials, mechanical properties) and an animal model. The sample size for the animal study is not specified, nor is the provenance of the animals.
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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. No human expert review of clinical cases is described for establishing ground truth, as no clinical effectiveness study requiring such review was conducted.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical "test set" requiring adjudication by multiple experts is described.
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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. The device is a bone void filler, not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to this device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a medical implant, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Adherence to ISO standards.
- For sterilization: Compliance with ANSI/AAMI/ISO standards.
- For bench testing: Comparison to predicate device performance (implied physical/mechanical properties). The "ground truth" would be objective measurements of these properties.
- For animal study: Biologic response compared to predicate devices in a large animal model. "Ground truth" would likely involve histological assessment, imaging, or gross observation of bone healing and integration in the animals, as interpreted by veterinary or pathological experts.
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The sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set. The "development" would involve material science and engineering, not machine learning.
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How the ground truth for the training set was established: Not applicable.
§ 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.