(96 days)
ALLOMATRIX® Custom is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. ALLOMATRIX® Custom is intended to be gently packed into bony voids or gaps of the skeletal system as a bone graft extender (spine) and as a bone void filler in the extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
ALLOMATRIX® Custom Putty is provided in the form of a kit with a premeasured powder and CBM chips, premeasured mixing solution, and the tools necessary to mix the components. After the powder is hydrated using all the mixing solution supplied in the kit (or BMA and local bone when used in the spine), the resultant putty can then be handled and placed in the appropriate bone voids. This product is supplied sterile for single patient use.
The provided text describes a medical device, ALLOMATRIX® Custom Putty, and its substantial equivalence to predicate devices, but not a study that establishes acceptance criteria and proves the device meets those criteria in the way typically associated with AI/software devices (e.g., performance metrics like sensitivity, specificity, AUC).
Instead, the document focuses on:
- Substantial Equivalence: The primary assertion is that ALLOMATRIX® Custom Putty is substantially equivalent to predicate devices.
- Osteoinductivity Potential: This is assessed via in vitro bioassays or immunoassays for the Demineralized Bone Matrix (DBM) component, correlating results to athymic rat models and clinical results of DBM alone.
- Viral Inactivation Validation: The processing method for DBM and CBM is evaluated for its ability to inactivate viruses.
- Product Performance Testing (Clinical): Clinical performance involved a comparison of radiographic outcomes, subjective questionnaires (SF-36, Oswestry, VAS), and adverse events between the subject device (mixed with BMA and local bone) and autograft iliac crest bone for lumbosacral fusion. This study "demonstrated equivalency."
Therefore, I cannot populate the table and answer all the questions directly, as the nature of the evaluation presented is for a physical medical device (bone void filler) and not a software/AI device. There are no "acceptance criteria" in terms of performance metrics like sensitivity/specificity, nor an "AI algorithm" involved.
However, I can extract the relevant information regarding the clinical performance study for the physical device based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit for equivalence) | Reported Device Performance (Equivalency) |
|---|---|
| Clinical Equivalence to Autograft Iliac Crest Bone: | "This study demonstrated equivalency between the subject device and predicate autologous iliac crest bone where lumbosacral fusion is indicated." |
| * Radiographic Outcomes (Lenke fusion score) | * Not explicitly stated beyond "demonstrated equivalency." |
| * SF-36 subjective questionnaire | * Not explicitly stated beyond "demonstrated equivalency." |
| * Oswestry disability questionnaire | * Not explicitly stated beyond "demonstrated equivalency." |
| * Visual Analog Scale (VAS) for back and leg pain | * Not explicitly stated beyond "demonstrated equivalency." |
| * Adverse event profile | * Not explicitly stated beyond "demonstrated equivalency." |
| Osteoinductivity Potential (DBM component): | Each lot of DBM is evaluated in vitro using a cell-based assay (Saos human osteosarcoma cell proliferation) or immunoassay for a native protein, correlated to athymic rat model and clinical results of DBM alone. |
| Viral Inactivation: | The processing method demonstrated "suitable viral inactivation potential" for a wide spectrum of potential human viruses. (No specific log reduction or success rate is provided). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the clinical performance study. "[A] comparison of radiographic outcomes... compared to autograft iliac crest bone" implies a clinical trial with a patient cohort, but the text does not give the number of patients.
- Data Provenance: The document does not specify the country of origin. The study is a "clinical performance" evaluation, suggesting it is prospective (a clinical trial), but it is not explicitly called out as such.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept (experts establishing ground truth for a test set) is not applicable to this physical device evaluation. Radiographic outcomes would have been interpreted by clinicians as part of standard medical practice for the clinical trial endpoints.
4. Adjudication method for the test set:
- Not applicable in the context of this device evaluation. Clinical trial endpoints would typically have pre-defined criteria for assessment.
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/software device. The clinical study compared the device to autograft, not human readers with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/algorithm.
7. The type of ground truth used:
- For the clinical performance study, the "ground truth" would be clinical outcomes data (radiographic fusion scores, patient-reported outcomes like SF-36, Oswestry, VAS) and adverse event profiles, measured during the clinical evaluation in comparison to a predicate treatment (autograft iliac crest bone).
- For osteoinductivity, the "ground truth" for correlation was results from athymic rat models and clinical results of DBM alone as referenced in the provided studies.
- For viral inactivation, the "ground truth" involved demonstrating inactivation of model potential human viruses.
8. The sample size for the training set:
- Not applicable. This is not a machine learning/AI device requiring a training set.
9. 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.