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Orthocon MONTAGE Settable. Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or 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., kwires, 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.

Orthocon Montage-QS Settable, Resorbable Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. Montage-QS 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-QS 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-QS can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Orthocon MONTAGE Flowable Settable, Resorbable Bone Paste is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. Montage Flowable 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 Flowable may be used to augment provisional hardware (e.g., kwires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened paste acts only as a temporary support medium and is not intended to provide structural support during the healing process.

Montage Flowable can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Orthocon Montage-XT Settable. Resorbable Hemostatic Bone Putty is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), are surgically created or the result of traumatic injury to the bone. Montage-XT 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-XT 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-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

The devices are sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. Each device comprises two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohol(s) and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of each device form a cohesive material that adheres to the bone surface and remains in place following application. The resulting hardened is primarily calcium phosphate. The 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.

This document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. Unfortunately, it does not contain the detailed acceptance criteria and study results you would find in a clinical study report or a more comprehensive premarket submission (like a PMA).

This document focuses on demonstrating substantial equivalence to existing predicate devices, particularly for an expanded indication for use. It highlights the addition of "benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old)" to the current Indications for Use statement for four Orthocon MONTAGE products.

Therefore, I cannot provide the specific details about acceptance criteria or a study that proves the device meets those criteria, as requested in your prompt. The information related to sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets is simply not present in this type of FDA clearance letter and 510(k) summary.

The document explicitly states: "Any difference between the subject device and the predicate and reference devices have been addressed through risk assessment, and no new verification testing was required to mitigate the potential risks. All the pre-clinical, and clinical testing conducted to support the previous 510(k) clearances are applicable to the subject device." This indicates that the current submission relies on previously conducted studies for the original clearances of these products, and no new studies were performed specifically for this expanded indication to generate new performance data against specific acceptance criteria.

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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.

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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Orthocon MONTAGE Settable, Resorbable Bone Putty is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm². MONTAGE Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

MONTAGE Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The MONTAGE device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, 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 putty-like material. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use.

The provided document does not describe the acceptance criteria and a study proving a digital health device meets acceptance criteria. Instead, it is a 510(k) premarket notification for a medical device called "MONTAGE Settable, Resorbable Bone Putty."

Therefore, I cannot provide the information requested in points 1-9 as they pertain to the evaluation of a digital health device, specifically looking for metrics like human reader improvement with AI assistance, standalone algorithm performance, and details about training/test sets for AI models.

Instead, the document details the substantial equivalence of the MONTAGE Settable, Resorbable Bone Putty to a predicate device (Stryker Injectable Cement) based on technological characteristics and performance data.

Here's a summary of what the document does provide regarding the MONTAGE device's performance evaluation:

1. Acceptance Criteria and Reported Device Performance (Bench Testing):
   The document lists several bench tests with their conclusions, implying that the "met specification" or "acceptable" status indicates the device met its acceptance criteria for these specific properties.

   Test	Acceptance Criteria (implied by "met specification" or "acceptable")	Reported Device Performance
   Visual Inspection	Putty color and handling met specification	Putty color and handling met specification
   Putty Handling	Putty stickiness met specification	Putty stickiness met specification
   Putty Stiffness	Putty stiffness met specification	Putty stiffness met specification
   Putty Vitamin E Acetate Concentration	Putty vitamin E acetate concentration met specification	Putty vitamin E acetate concentration met specification
   Hand Mixing Time	Mixing time met specification	Mixing time met specification
   Hand Mixing Stickiness	Stickiness met specification	Stickiness met specification
   Mixability	Mixability met specification	Mixability met specification
   Device Stiffness	Device stiffness met specification	Device stiffness met specification
   Package Gross Leak	All test articles passed leak test	All test articles passed
   Temperature Sensitivity	Acceptable maximum temperature increase following hand-mixing	Acceptable maximum temperature increase following hand-mixing
   Water Uptake, Swelling, and Dissolution	Acceptable water uptake, swelling and dissolution	Acceptable water uptake, swelling and dissolution

2. Sample size used for the test set and the data provenance: Not applicable for a medical device without AI components. However, biocompatibility testing was conducted on the "final, finished, gamma-irradiation sterilized device," and in-vivo animal testing was performed using "New Zealand White rabbits."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as it's a physical medical device.

7. The type of ground truth used:

   • Biocompatibility: In accordance with ISO 10993 recommendations and GLP requirements.
   • Bench Testing: Internal specifications derived from engineering and material science principles.
   • In-Vivo Testing: Histopathologic evaluation and histomorphometric measurements of implant absorption over time from animal study, compared to the predicate device.

8. The sample size for the training set: Not applicable for this type of medical device.

9. How the ground truth for the training set was established: Not applicable.

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