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Norian Drillable Inject and Norian Drillable Fast Set Putty are intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty are intended to be placed into bony voids either before or after final fixation.

Norian Drillable Inject and Norian Drillable Fast Set Putty are moldable, biocompatible bone void fillers with added reinforcing fibers. Norian Drillable Inject and Norian Drillable Fast Set Putty are intended to be placed into bony voids or defects of the extremities or pelvis either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during or after the setting process. When fully cured. the composition formed closely approximates the mineral phase of bone.

The product is available in two delivery forms. Norian Drillable Inject is an injectable paste that is mixed with an automatic mixer, and Norian Drillable Fast Set Putty is manually mixed with a cup and spatula.

Norian Drillable Inject is provided in a sterile pouch (the "Rotary Pouch"). The Rotary Pouch is constructed of a clear-film outer pouch and a foil laminate inner pouch with an attached delivery syringe. The Rotary Pouch contains sterile powder with fibers and is designed with an injection port for the purpose of adding the mixing solution to the pouch. The mixing solution is contained in the Solution Syringe, which is packaged separately.

The Rotary Pouch is designed to be placed in a reusable mixer (the “Rotary Mixer”) where the two components are mixed together to form a smooth, viscous paste. The paste remains injectable for approximately 5 minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Drillable Inject begins to harden after 2 minutes and sets in approximately 10 minutes. Norian Drillable Inject is slowly resorbed over a period of years and replaced with bone during the healing process.

Norian Drillable Fast Set Putty is supplied in two containers. The mixing cup holds sterile powder with fibers and the Solution Syringe holds sterile solution. When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material can be manipulated for two minutes at 18°-23°C / 64°-73°F.

At body temperature (37°C / 98.6°F), Norian Drillable Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Drillable Fast Set Putty is slowly resorbed over a period of years and replaced with bone during the healing process.

The provided text describes the Norian Drillable™ Inject and Norian Drillable™ Fast Set Putty, which are bone void fillers. The document is a 510(k) summary submitted to the FDA for market clearance. While it details the device and its intended use, it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria regarding performance metrics such as sensitivity, specificity, accuracy, or any statistical measures.

The document states that "Documentation is provided that demonstrates that Norian Drillable is substantially equivalent to other legally marketed devices." This implies that the device achieved market clearance based on its substantial equivalence to predicate devices (Norian SRS Bone Void Filler and Norian SRS Fast Set Putty, K073303), rather than through a study designed to establish specific performance acceptance criteria for the new device itself.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I provide information on sample size, ground truth establishment, expert adjudication, or comparative effectiveness studies, as these types of data are not present in the provided text for this specific device.

The FDA's 510(k) clearance process often relies on demonstrating substantial equivalence to a predicate device, meaning that the new device is as safe and effective as a legally marketed device, even if it has different technological characteristics. This process typically doesn't require a new clinical trial or performance study with defined acceptance criteria for the new device if its equivalence can be successfully demonstrated.

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Norian Reinforced and Norian Reinforced Fast Set Putty are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm '. Norian Reinforced and Norian Reinforced Fast Set Putty are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including frontoorbital areas) such as burr hole voids and other cranial defects.

Norian Reinforced and Norian Reinforced Fast Set Putty (FSP) are moldable, biocompatible bone cements with added reinforcing fibers. Norian Reinforced and Norian Reinforced FSP are intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton. The material resists cracking during the setting process. When fully cured, the composition formed closely approximates the mineral phase of bone.

The product is available in two delivery forms. Norian Reinforced is an injectable paste that is mixed with an automatic mixer, and Norian Reinforced Fast Set Putty is manually mixed with a cup and spatula.

Norian Reinforced is provided in a sterile pouch ("Rotary Pouch"). The Rotary Pouch is constructed of a clear-film outer pouch and a foil laminate inner pouch with an attached delivery syringe. The Rotary Pouch contains sterile powderpurpose of adding the mixing solution to the pouch. The mixing solution is contained in the Solution Syringe that is

The Rotary Pouch is designed to be placed in an automatic reusable mixer outside the sterile field where the two components are mixed together to form a smooth, viscous paste. The paste remains injectable for approximately 5 minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Reinforced begins to harden after 2 minutes and sets in approximately 10 minutes.

Norian Reinforced is slowly resorbed over a period of years and replaced with bone during the healing process.

Norian Reinforced Fast Set Putty is supplied in two containers. The mixing cup holds sterile powder with fibers and the solution syringe holds sterile solution. When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material can be manipulated for two minutes at 18°-23°C / 64°-73°F.

At body temperature (37°C / 98.6°F), Norian Reinforced Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Reinforced Fast Set Putty is slowly resorbed over a period of years and replaced with bone during the healing process.

Here's an analysis based on the provided 510(k) summary for Norian Reinforced and Norian Reinforced Fast Set Putty:

Key Takeaway: This 510(k) summary is for a medical device (bone cement), not an AI/ML powered device. Therefore, many of the requested sections related to AI/ML specific evaluation criteria (e.g., sample sizes for test and training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this document. The "study" here refers to a comparative non-clinical study against predicate devices, focusing on material properties and biocompatibility.

Acceptance Criteria and Study Details (Non-AI/ML Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a bone cement, the "acceptance criteria" are related to its physical properties, biocompatibility, and intended use as compared to predicate devices. The document doesn't provide specific quantitative tables for acceptance criteria and performance values in the way one would for an AI model. Instead, it states that the device meets the requirements through comparative testing.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided summary. This would refer to the number of material samples tested for mechanical, in-vitro, and biocompatibility assessments.
• Data Provenance: Not specified, but generally, such tests are conducted in laboratories following specific standards (e.g., ISO, ASTM). The data would be from controlled laboratory experiments, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. This is a medical device (bone cement) undergoing non-clinical testing for material properties and biocompatibility, not an AI/ML system requiring expert-based ground truth on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this doesn't involve subjective human interpretation or diagnostic agreement typical of AI/ML evaluation. Performance is based on objective measurements against established material standards and comparisons to predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. This is a bone cement, not an imaging AI diagnostic aid. MRMC studies are not relevant for this type of 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 cement), not an algorithm.

7. The Type of Ground Truth Used

• Objective Material Science and Biocompatibility Standards: The "ground truth" for this device's performance is based on established scientific and engineering principles for material properties (e.g., strength, setting time), chemical composition, and biological response as defined by recognized standards (e.g., ISO 10993 for biocompatibility). The comparison point is often the performance of the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is a medical device, not an AI/ML model that requires a training set. The device formulation and manufacturing process are developed through R&D and engineering, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As with point 8, there is no "training set" in the context of an AI/ML model for this type of device.

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Norian CRS Fast Set Putty is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2.
Norian CRS Fast Set Putty is not intended for use in the spine and should not be used in the presence of active or suspected infection.

Norian CRS Fast Set Putty is a moldable, thermally activated, biocompatible bone cement. Norian CRS Fast Set Putty is supplied in two containers: one container holds sterile powder (calcium phosphate) and the second container holds sterile solution (dilute sodium phosphate). When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material is suitable for augmentation and restoration of the craniofacial skeleton. When fully cured, the composition formed closely approximates the mineral phase of bone. Norian CRS Fast Set Putty is gradually remodeled over time. This material is provided sterile and is for single use only.

The provided document, K060443, is a 510(k) summary for the Norian CRS Fast Set Putty, a medical device, and therefore does not contain information about acceptance criteria or a study proving its performance in the manner typically described for AI/ML-driven devices.

This document serves as a regulatory submission demonstrating substantial equivalence to a predicate device, which is a different type of assessment than proving performance against predefined acceptance criteria through clinical or scientific studies involving data analysis, as would be common for AI/ML devices.

Therefore, I cannot provide the requested information for the following reasons:

1. No Acceptance Criteria or Performance Metrics: The document does not specify any quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, F1-score) or reported device performance metrics in the context of an AI/ML system.
2. No Study Details: There is no mention of a study involving a test set, training set, ground truth establishment, expert adjudication, or MRMC comparative effectiveness study, as these are not relevant to a 510(k) submission for this type of device.
3. Nature of the Device: The Norian CRS Fast Set Putty is a biocompatible bone cement, not an AI/ML-driven device that would typically undergo the kind of performance validation outlined in your request. Its regulatory pathway (510(k)) relies on demonstrating substantial equivalence in material composition, physical properties, and performance characteristics to a legally marketed predicate device, rather than proving diagnostic or prognostic accuracy with data-driven metrics.

The document's purpose is to establish that the Norian CRS Fast Set Putty is substantially equivalent to a predicate device based on its intended use, material, and physical properties. It does not involve "acceptance criteria" and "device performance" in the context of diagnostic or predictive capabilities, which are central to your query.

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Norian SRS Fast Set Putty is intended only for bony voids or defects that are not intrinsic to the stability of the bony structure. Norian SRS Fast Set Putty is intended to be placed into bony voids or gaps of the skeletal system (the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Norian SRS Fast Set Putty is a self-setting calcium phosphate cement. SRS Fast Set Putty components are supplied sterile in two separate containers. It is prepared for use by manually mixing two components within a cup using a spatula. The mixing cup and spatula are included in the device packaging. Once combined into a uniform consistency, the product can be shaped and contoured by hand. Norian SRS Fast Set Putty is gradually resorbed over time. This material is provided sterile and is for single use only.

Based on the provided text, the document is a 510(k) Summary for a medical device (Norian SRS Fast Set Putty) and the FDA's clearance letter. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It does not contain information about acceptance criteria for device performance studies, nor does it describe any specific study that proves the device meets such criteria.

The document primarily focuses on:

• Device classification and description.
• Indications for Use and Contraindications.
• Identification of a predicate device (Norian SRS Fast Set Putty, K041842).
• A statement of substantial equivalence to the predicate in terms of material composition, physical properties, and performance characteristics.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as this information is not present in the provided text.

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Norian SRS Fast Set Putty is indicated only for filling bony voids or gaps that are not intrinsic to the stability of the bony structure. The putty is to be gently packed into bony voids or gaps of the skeletal system including the extremities, spine, and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SRS Fast Set Putty provides a bone void filler that resorbs and is replaced with bone during the healing process.

Norian SRS Fast Set Putty is a self-setting calcium phosphate cement characterized by a rapid in situ setting time. The Fast Set Putty components are supplied sterile in two separate containers. The putty is intraoperatively prepared by manually mixing the components within a cup using a spatula. Once complete, the putty can be shaped and contoured by hand.

The provided text is a 510(k) summary for the Norian SRS® Fast Set Putty, a medical device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically described for AI/ML devices or diagnostic accuracy studies.

The document is a premarket notification to the FDA, demonstrating substantial equivalence to previously marketed devices. It confirms the device's classification, describes its components and indications for use, and states that documentation was provided to show substantial equivalence. There is no information regarding a study with a test set, ground truth, expert review, or statistical performance metrics.

Therefore, I cannot provide the requested information in the table format or specific details about a study, as such a study is not described or referenced in the provided text. The context of this document is a regulatory submission for a physical medical device (bone void filler) based on substantial equivalence, not an AI/ML algorithm or a diagnostic test with performance criteria.

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Fast Set Putty is indicated for repairing or filling craniofacial defects and craniotomy cuts with a surface area no larger than 25cm². Fast Set Putty is also indicated for the restoration or augmentation of bony contours of the craniofacial skeleton, including the fronto-orbital, malar and mental areas.

Fast Set Putty is a putty-like calcium phosphate bone cement characterized by a rapid in situ setting time. The Fast Set Putty components are supplied sterile in two separate containers. The putty is intraoperatively prepared by manually mixing the components within a cup using a spatula. Once complete, the putty can be shaped and contoured by hand.

This document is a 510(k) summary for the Synthes (USA) Fast Set Putty, a calcium phosphate bone cement. It addresses the substantial equivalence to a predicate device and provides details on its intended use and material. However, it does not contain information regarding an acceptance criteria table, a study proving device meets acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information from the provided text. The document is primarily a regulatory submission for market clearance, focusing on safety and efficacy based on substantial equivalence, rather than a detailed performance study report.

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