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PRO-DENSE resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The PRO-DENSE paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

PRO-DENSE is provided sterile for single use only.

For the PRO-DENSE™ Core Decompression Procedure Kit:

The PRO-DENSE™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

For the Mixing and Delivery system:

The Mixing and Delivery syringe is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

PRO-DENSE Bone Graft Substitute is a calcium sulfate formulation consisting of a powder component and an aqueous mixing solution. When the two components are mixed according to directions, an injectable paste is formed. This paste is subsequently injected and/or digitally packed into a bone void where the graft cures and hardens via hydration reactions.

The provided text is a 510(k) summary for the PRO-DENSE™ Bone Graft Substitute. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance and does not contain information regarding acceptance criteria, device performance, or a specific study designed to prove the device meets acceptance criteria.

The document details the device's indications for use, its components, and a comparison to a predicate device. It also lists non-clinical evaluations performed to support substantial equivalence, such as injection testing, biocompatibility assessment, and pyrogenicity testing. However, these are general assessments and not performance metrics against specific acceptance criteria for "device performance" in the context you've asked (e.g., accuracy, sensitivity, specificity for an AI/diagnostic device).

Therefore, I cannot provide the requested information from the given text as it is not present in the document.

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PRO-DENSE™ resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and tumors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The PRO-DENSE™ paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

PRO-DENSE™ is provided sterile for single use only.

For the PRO-DENSE™ Core Decompression Procedure Kit:

The PRO-DENSE™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

For the Mixing and Delivery System:

The Mixing and Delivery syringe is intended to be used for the delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical site.

PRODENSE is indicated as a bone graft substitute to be injected and/or digitally packed into open bone voids/gaps that are not intrinsic to the structural stability of the skeletal system and cure in-situ. It is supplied in separate powder and liquid vials along with the instruments for mixing it into a paste and delivering it to the defect site. The triphasic resorption of PRODENSE® results in a scaffold that is osteoconductive allowing tissue infiltration and must eventually be degraded through osteoclastic action as bone remodels within the scaffold. The clinical use of calcium sulfate, calcium phosphate, and composites thereof as a bone void filler has been well established through many peer reviewed publications.

The provided text describes a 510(k) premarket notification for a bone graft substitute, and therefore, does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML powered medical device.

The document discusses the PRODENSE™ Bone Graft Substitute and its intended use, technological characteristics, and substantial equivalence to predicate devices based on non-clinical evidence. It mentions dissolution, vicat set time, diametral tensile strength (DTS) testing, biocompatibility, and pyrogenicity testing to show the new mixing and delivery systems produce a graft that meets material specifications. However, this is not a clinical study proving device performance against acceptance criteria in the manner described by the request.

Therefore, I cannot provide the requested information from the given input.

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PRO-DENSE® resultant paste is intended for use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities and pelvis) to cure in situ. These open bone voids may be the result of benign bone cysts and turnors (in adults and pediatric patients ≥ 6 years old), surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process.

The PRO-DENSE® paste cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K. Wires) to help support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

PRO-DENSE® is provided sterile for single use only.

For the PRO-DENSE® Core Decompression Procedure Kit:

The PRO-DENSE® Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE® Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

PRODENSE® is indicated as a bone graft substitute to be injected and/or digitally packed into open bone voids/gaps that are not intrinsic to the structural stability of the skeletal system and cure in-situ. It is supplied in separate powder and liquid vials along with the instruments for mixing it into a paste and delivering it to the defect site. The triphasic resorption of PRODENSE® results in a scaffold that is osteoconductive allowing tissue infiltration and must eventually be degraded through osteoclastic action as bone remodels within the scaffold. The clinical use of calcium sulfate, calcium phosphate, and composites thereof as a bone void filler has been well established through many peer reviewed publications.

PRO-DENSE® is a calcium sulfate - calcium phosphate composite bone graft substitute consisting of a powder component and an aqueous mixing solution. When the two components are mixed according to directions, an injectable paste forms and subsequently hardens via hydration reactions.

Here's an analysis of the provided text regarding the PRODENSE® Bone Graft Substitute, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state quantitative (e.g., numerical thresholds for strength, resorption rate) acceptance criteria in the way one might expect for a typical medical device performance study, nor does it present a direct alongside comparison of such criteria with the device's reported performance. Instead, the document focuses on substantial equivalence to predicate devices. The "performance" assessment is based on demonstrating that the modified PRODENSE® is equivalent to its original form and established predicate devices.

   The key "acceptance criteria" appear to be:

   • Equivalence of Characteristics: The modified device's characteristics, especially set-time, should be equivalent or adequately managed compared to the original product.
   • No New Questions of Safety or Effectiveness: The design changes should not introduce new safety or effectiveness concerns.
   • Adequate Risk Mitigation: All risks associated with the product line must remain adequately mitigated.

   Acceptance Criterion	Reported Device Performance
   Equivalence of Characteristics (specifically set-time)	"The components of PRODENSE® were slightly adjusted to decrease its set-time. The characteristics of this PRODENSE® modification were analyzed according to design control testing and found to be equivalent to the original product." (This implies the new set-time is acceptable).
   No New Questions of Safety or Effectiveness	"The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness."
   Adequate Risk Mitigation	"a risk analysis indicated all risks associated with the PRODENSE® product line remain adequately mitigated."
   Indications for Use unchanged as a result of modification	"The indications for use of the subject device were not changed as a result of the modification..."
   Fundamental scientific technology/mechanism of action remains identical	"...and the fundamental scientific technology of the device, including the bone void filler's mechanism of action, remain identical to the original product."
   Performance at least as well as predicate systems	"From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems." (This is the overarching conclusion of a substantial equivalence submission, effectively serving as the ultimate acceptance criterion for this type of submission).

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

   The document does not specify a distinct "test set" in the context of human subjects or clinical data. The evaluation was primarily based on design control testing for the modified device. No sample size for a test set (e.g., number of patients or bone voids) is provided, as the submission did not involve new clinical studies for this specific modification. The provenance of any underlying data from the original PRODENSE® or predicate devices is also not mentioned, as the focus is on the equivalence of the modified product. The study is non-clinical in nature, focusing on engineering and material characteristics.

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

   Not applicable. This was a non-clinical submission based on design control testing and comparison of material properties, not on interpretation of clinical images or patient outcomes requiring expert ground truth in that sense. The FDA regulatory review process itself involves experts (e.g., Mark N. Melkerson, Director, Division of Orthopedic Devices, and Laurence D. Coyne, Division Sign-Off) but they are evaluating the submission, not establishing ground truth for a test set within the submission.

4. Adjudication Method:

   Not applicable. There was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   No, a MRMC comparative effectiveness study was not done. The submission explicitly states "Substantial Equivalence - Clinical Evidence N/A". The evaluation was based on non-clinical design control testing.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   Yes, in a conceptual sense, the "standalone" performance was assessed through design control testing. This testing evaluated the material properties and characteristics of the PRODENSE® modification itself, independent of human interaction beyond the mixing and application steps as intended. The "set-time" was a key characteristic evaluated. This isn't an algorithm, but the concept of evaluating the device's intrinsic properties applies.

7. Type of Ground Truth Used:

   The "ground truth" for the non-clinical evaluation was based on engineering and material specifications of the original PRODENSE® device and the established expectations for bone void fillers as outlined in FDA's special control guidance for resorbable calcium salt bone void filler devices. The comparison was to the original product's known characteristics and regulatory standards, rather than pathology, outcomes data, or expert consensus in a clinical trial setting.

8. Sample Size for the Training Set:

   Not applicable. This device is a bone graft substitute, not an AI/ML algorithm that requires a training set. The term "training set" doesn't apply to the evaluation described in this 510(k) submission.

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

   Not applicable, as there was no training set in the context of an AI/ML algorithm.

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