(143 days)
NovoGro Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis). NovoGro must be used with autograft as a bone extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The device resorbs and is replaced with bone during the healing process.
NovoGro Putty is provided to the end-user as two components (dry powder and aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a moldable cohesive putty-like graft. The dry powder component of NovoGro Putty contains spherical particles that are composed primarily of a co-precipitate of dicalcium phosphate anhydrite Imonetite. CaHPO4], magnesium phosphate trihydrate [newberyite, Mg(PO2OH)+3(H2O)] and sodium hydrogen phosphate [NaH2PO4]. Small amounts of silica (SiO2) and magnesium oxide (MgO) are combined with this co-precipitate during manufacturing. These spherical particles are mixed heterogeneously with dry sodium carboxymethyl cellulose (CMC) powder to enhance the handling properties of the final mixed graft. The aqueous component of NovoGro is ultrapure reverse osmosis deionized water (DI H2O). NovoGro Putty is provided sterile for single use in volumes ranging from 1 cc to 20 cc. NovoGro Putty is provided in a kit with a mixing system, a vial of ultrapure water for mixing, and a graduated syringe to measure the correct volume of the supplied ultrapure water to add to the dry component.
The provided text is a 510(k) summary for the medical device NovoGro Putty. It describes the device, its intended use, and substantial equivalence to legally marketed predicate devices. This document does not describe an acceptance criteria table or present a study that proves the device meets specific performance criteria in the context of an AI/ML-based medical device evaluation for diagnostic accuracy.
The "Performance Data" section details pre-clinical testing, chemical characterization, physical characterization, biocompatibility, sterilization validation, and limited comparative animal testing to demonstrate substantial equivalence to a predicate device, not to meet specific diagnostic accuracy thresholds.
Therefore, many of the requested details, particularly those pertaining to AI/ML device performance evaluation (e.g., sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details), are not applicable to this document as it concerns a bone void filler and its substantial equivalence based on material and structural properties, and in vivo integration/resorption in an animal model, rather than an AI/ML diagnostic or prognostic algorithm.
However, I can extract the information that is present and explain why other information is not available in this type of submission.
Acceptance Criteria and Study for NovoGro Putty (Based on Provided 510(k) Summary)
This 510(k) summary evaluates a bone void filler (NovoGro Putty), not an AI/ML device. Therefore, the concepts of "acceptance criteria" and "study proving the device meets acceptance criteria" are framed in terms of "substantial equivalence" to a predicate device, focusing on material properties, performance characteristics, and biological response, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are typical for AI/ML devices.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, the "acceptance criteria" are implicitly met if the device demonstrates substantial equivalence to the predicate device across various non-clinical tests. The "performance" is the demonstration of similarity or comparable outcomes to the predicate device in these tests.
| Acceptance Criterion (Implicitly "Substantial Equivalence to Predicate") | Reported Device Performance (as demonstrated in the study) |
|---|---|
| Chemical Composition (Identification of crystalline/non-crystalline components, elemental composition, heavy metal content, calcium dissolution, pH) | Performed using PXRD, FTIR, ICP-MS, and methods described in ASTM F2024, ASTM F1185, ASTM F1926/F1926M. (Details of specific values for equivalence against predicate not explicitly quantified in this summary, but implied to be comparable). |
| Physical Characterization (SEM, particle size, mass, volume, density, surface area, porosity) | Performed using SEM, gas displacement pycnometry, gas adsorption, mercury intrusion porosimetry. NovoGro Putty: Granule Size 1-2 mm, Porosity 31.3%. (Comparison table shows predicate granules 0.5-1.6 mm, 80% porosity for granules - note the porosity comparison is not directly comparable as predicate's is for granules, not the overall mixed product.) Implied to be within acceptable range for substantial equivalence. |
| Biocompatibility (Cytotoxicity, sensitization, irritation, genotoxicity, material mediated pyrogenicity, bacterial endotoxin) | Performed using methods described in AAMI/ANSI/ISO 10993-1, -3, -5, -10, -12, -18, ISO 10993-11, and AAMI/ANSI ST72. (Implied to meet necessary safety standards; specific results indicating equivalence or passing scores are not detailed but are accepted by FDA). |
| Sterilization Validation & Shelf Life (Sterility, sterile barrier, product shelf life) | Performed according to AAMI/ANSI/ISO 11137-1, 11137-2, ASTM D4169, ASTM F1980, ASTM F1886/F1886M, ASTM F2096, ASTM F88/F88M. (Implied to meet necessary standards; specific results not detailed but accepted). Device is "Provided sterile for single use in volumes ranging from 1 cc to 20 cc." Sterilization: Gamma irradiation (similar to predicate). |
| In vivo Performance (Radiographic, histologic, histomorphometric characteristics in a bone fusion model) | Rabbit Posterolateral Spine Fusion Model Study: "The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate device K140375." Evaluation endpoints included manual palpation, range of motion/flexibility testing, plain and high-resolution radiography, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis. Histology sections graded per AAMI/ANSI/ISO 10993-6 (Annex E). No specific quantitative metrics of equivalence are provided in this summary. |
| Bioactivity (Apatitic calcium phosphate formation in simulated body fluid) | In vitro study comparing NovoGro, positive control (bioactive glass), and negative control (polyethylene). Apatitic calcium phosphate formation observed on NovoGro and positive control, but not negative control. (Implied to show desired bioactive properties). |
2. Sample size used for the test set and the data provenance
- Test Set (Animal Study): A "rabbit posterolateral spine fusion model" was used. The specific sample size (number of rabbits) is not provided in this 510(k) summary.
- Data Provenance: The study was an animal study (rabbit model), which is generally considered pre-clinical rather than human retrospective or prospective clinical data. The summary does not specify the country of origin, but given the FDA submission, it's typically conducted in a controlled environment compliant with US or international standards for animal research.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable in the context of an AI/ML-based diagnostic device. The "ground truth" in this study was established through objective measurements and evaluations in an animal model:
- Manual palpation
- Range of motion/flexibility testing
- Plain and high-resolution radiography
- Micro-CT imaging
- Undecalcified histologic evaluation
- Histomorphometric analysis
- Histology sections graded according to AAMI/ANSI/ISO 10993-6 (Annex E).
- Experts (e.g., pathologists, radiologists) would have been involved in the interpretation of these results, but their number and specific qualifications are not detailed as this is not an AI/ML diagnostic accuracy study requiring human consensus for "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are used in consensus reading for establishing ground truth in human imaging studies, particularly for AI/ML performance evaluation. The animal study involved objective measurements and standard histological/radiographic 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
- No, not done. This is a non-clinical evaluation of a bone filler, not an AI/ML diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/No. This device is a physical bone void filler, not an algorithm. Standalone performance refers to the accuracy of an AI algorithm without human input.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the animal study: The ground truth was established through a combination of radiographic imaging, micro-CT imaging, and histological/histomorphometric analysis in a rabbit model. These methods provide direct evidence of bone formation, integration, and resorption. It's essentially biological/pathological assessment in an animal model.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. The "training" for this product would be its manufacturing process and quality control.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, there is no corresponding ground truth establishment process.
§ 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.