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510(k) Data Aggregation
(205 days)
Orthocon MONTAGE Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e. extremities and pelvis). These defects may be surgically created, or osseous defects created as the result of traumatic injury to the bone. MONTAGE is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.
When hardened in situ, MONTAGE may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.
MONTAGE can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
MONTAGE Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The MONTAGE device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use. MONTAGE can be drilled and tapped, and hardware can be placed through it at any time during the setting process.
The provided text describes a 510(k) premarket notification for a medical device called MONTAGE Settable, Resorbable Bone Putty. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with defined acceptance criteria for device performance. Therefore, many of the requested points, particularly those related to clinical study design, expert involvement, and ground truth establishment, are not applicable or cannot be extracted from this document.
However, I can extract information related to the animal study and performance testing that was conducted.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission focused on substantial equivalence rather than explicit performance acceptance criteria for a new clinical indication, formal acceptance criteria in the traditional sense are not explicitly stated for all performance aspects. The studies aim to demonstrate that MONTAGE performs similarly to or better than the predicate device.
| Performance Metric | Acceptance Criteria (Implicit from predicate comparison) | Reported Device Performance (MONTAGE) |
|---|---|---|
| New Bone Formation (Rabbit Femoral Defect Model at 12 weeks) | Similar to or better than predicate device (HydroSet XT, 12.4%) and negative control (10%) | 16.1% |
| Implant Material Remaining (Rabbit Femoral Defect Model at 52 weeks) | Similar to predicate device (HydroSet XT) | Approximately 70% |
| Drillability without fragmenting/displacement | Device can be drilled when hardened without fragmenting or displacement | Device performed as expected, allowing for use with provisional hardware |
| Temporary Support during Complex Repair | Device provides temporary support until permanent hardware fixation | Device performed as expected, providing temporary support |
| Biocompatibility | Meets ISO 10993 recommendations (cytotoxicity, irritation, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, endotoxicity, pyrogenicity) | All tests conducted were in accordance with GLP requirements and recommendations, suggesting successful completion. Labeling adjustment regarding Vitamin E acetate based on CDER assessment. |
| Sterility | SAL of 10^-6 (Standard for medical devices) | SAL of 10^-9 (exceeds standard) |
| Bacterial Endotoxin | Lot release criteria met | Each lot is tested and meets release criteria |
2. Sample size used for the test set and the data provenance
- Animal Study: The sample size for the rabbit critical sized femoral defect model is not explicitly stated as a number of animals, but refers to "MONTAGE group," "HydroSet predicate group," and "empty defect negative control group." No specific numbers are given per group.
- Data Provenance: The animal study was conducted in a laboratory setting, likely in the country of the manufacturer or a contract research organization. The document does not specify the country. It is a prospective animal study. Other performance data are from in vitro studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Animal Study: The histopathology/histomorphometry assessments would typically be performed by veterinary pathologists or experts in bone histology. The document does not specify the number or qualifications of these experts.
- Other Performance Tests: These were likely evaluated against engineering specifications or known material properties, not by human experts establishing ground truth in the clinical sense.
4. Adjudication method for the test set
- Animal Study: Not specified. Histopathology and micro-CT assessments would likely involve independent evaluation, but no formal adjudication process like "2+1" or "3+1" is mentioned.
- Other Performance Tests: Not applicable, as these are technical performance assessments rather than interpretations requiring adjudication.
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, an MRMC comparative effectiveness study was not done. The device is a bone void filler, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (bone putty), not an algorithm.
7. The type of ground truth used
- Animal Study: The "ground truth" for the animal study was based on quantitative measurements from micro-CT and qualitative/quantitative assessments from histopathology/histomorphometry to determine new bone formation and implant resorption.
- Other Performance Tests: The "ground truth" for drillability and temporary support was established through engineering performance tests comparing the device's physical behavior against predetermined functional expectations.
- Biocompatibility: The "ground truth" was established by adherence to ISO 10993 standards and their associated endpoints.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning algorithm requiring a "training set." The development of the material involved formulation and testing, but not in the context of a "training set" for AI.
9. How the ground truth for the training set was established
- Not applicable for the reasons stated above.
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(153 days)
HBP7 Settable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
HBP7 Settable Hemostatic Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use HBP7 device contains two separate components of putty-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyetherbased polymers. When mixed together, the components of the HBP7 device form a nonabsorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. HBP7 must be mixed immediately prior to use.
When applied to surgically cut or traumatically broken bone. HBP7 Settable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
This document describes the HBP7 Settable Hemostatic Bone Putty, a medical device indicated for controlling bleeding from cut or damaged bone by acting as a mechanical barrier. The device's substantial equivalence to predicate devices is established through a series of performance tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for HBP7 Settable Hemostatic Bone Putty in the format of a table with specific thresholds. Instead, it describes various performance tests conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is largely qualitative, indicating that the device "demonstrates" or "verifies" certain properties or functions similar to the predicates.
| Acceptance Criteria Category | Description of Performance/Test Conducted | Reported Device Performance |
|---|---|---|
| Bench Testing | Handlings properties, performance over a range of temperatures, dissolution properties. Includes: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution, and swelling. | "Bench testing was conducted to verify the device's handling properties, to characterize the device's performance over a range of temperatures and to evaluate the device's dissolution properties." The specific results meeting acceptance for each sub-test are implied by the statement: "demonstrate that the device is substantially equivalent to the predicate devices in intended use, technological characteristics, and performance." |
| Biocompatibility | Evaluated in accordance with ISO 10993 recommendations. Includes: cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, local tissue toxicity, hemolysis, endotoxicity, and pyrogenicity. | "Biocompatibility Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993." The tests were conducted on the "final, finished, gamma-irradiated sterile device in accordance with the GLP requirements." Implied successful outcome as part of demonstrating substantial equivalence. |
| Animal Functionality | In vivo hemostasis and resistance to irrigation. | "Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis and resistance to irrigation." Implied successful outcome in demonstrating substantial equivalence. |
| Intended Use | Control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. | "HBP7 Settable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade." This aligns with the predicate devices' intended use for bone hemostasis through mechanical tamponade. Its mechanism of action is identical to the predicates (mechanical tamponade occluding vascular openings). |
| Sterility | Provided sterile. | "Provided sterile for single use by gamma irradiation." This is consistent with the predicate devices. |
| Set Time | Ability to set (harden) within minutes of application. | "Sets (hardens) within minutes of application." This is a characteristic shared with the MONTAGE predicate device (K141502 and K152005), which also "Sets (hardens) within minutes of application." CP Medical Bone Wax (K024372) is "N/A" for set time because it hardens after application through kneading, not a chemical set. |
| Form of Device | Two-part putty/putty device that forms a settable (hardening) putty when manually mixed. | HBP7 "is formulated as a two-part putty/putty device that forms a 'settable' (hardening) putty when manually mixed at the time of surgery." This is analogous to MONTAGE, which is also a "two-part putty/putty device that forms a 'settable' (hardening) putty when manually mixed." CP Medical Bone Wax is a single component to be kneaded. |
| Materials | Sterile mixture of two components of putty-like consistency: granular calcium phosphate (hydroxyapatite and β-tricalcium phosphate), paraffin, vitamin E acetate, triacetin, and a mixture of nonabsorbable polymers. Primarily comprised of calcium phosphate. | The materials described are consistent with the device description and the comparison to predicates, particularly MONTAGE, which also contains granular calcium phosphate, vitamin E acetate, and polymers, differing primarily in the absorbability of its polymers. The HBP7 device's composition is stated to be primarily comprised (>60% by weight) of calcium phosphate. |
| Absorbability | Nonabsorbable. | "No" (nonabsorbable). In vivo residence time is a "Permanent Implant." This differs from MONTAGE (absorbable) but is consistent with CP Medical Bone Wax (nonabsorbable). |
| Degradation Process | Nonabsorbable in the body; permanent implant. | "Nonabsorbable in the body - permanent implant." This is identical to CP Medical Bone Wax. MONTAGE has a degradation process involving dissolution and hydrolysis. |
| Radiopacity | Contains hydroxyapatite and β-tricalcium phosphate resulting in radiopacity. | "Radiopaque - Contains hydroxyapatite and β-tricalcium phosphate." This is similar to MONTAGE (also radiopaque due to these components) but differs from CP Medical Bone Wax (not radiopaque). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the "test set" in terms of how many devices, animals, or specimens were used for the bench, biocompatibility, or animal studies. It states that tests were "conducted" and "demonstrate" substantial equivalence.
The data provenance (country of origin, retrospective/prospective) is not mentioned.
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 provided in the document. The studies performed (bench, biocompatibility, animal) do not typically rely on expert consensus for "ground truth" in the way an AI diagnostic device would. Instead, their "ground truth" comes from established scientific methods, laboratory observations, and medical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and is not provided. Adjudication methods like "2+1" are relevant for expert review of images or data, typically in diagnostic AI studies. The tests described here are physical, chemical, and biological evaluations, not requiring such adjudication.
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
A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The HBP7 is a physical medical device (bone putty) and not an AI-powered diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of an algorithm was not done. The HBP7 is a physical medical device, not an algorithm, so this concept does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing, the "ground truth" would be objective measurements and observations against pre-defined engineering and material science standards (e.g., stiffness measurements, dissolution rates).
For biocompatibility testing, the "ground truth" is derived from established biological assays and observation protocols outlined in ISO 10993, assessed by scientists/toxicologists.
For animal testing, the "ground truth" for hemostasis is direct observation of bleeding control and resistance to irrigation in a live animal model, assessed by veterinary surgical staff and researchers.
There is no "expert consensus" or "pathology" in the typical sense of diagnostic ground truth. Outcomes data for patients is not mentioned, as this is a premarket notification, not a large-scale clinical trial.
8. The sample size for the training set
This information is not applicable and is not provided. The HBP7 is a physical medical device, not an AI model, therefore it does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this physical device.
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