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510(k) Data Aggregation
(111 days)
OsteoFlo® HydroPutty™ is indicated for bony voids or gaps of the skeletal system (i.e., 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 device provides a bone void filler that is resorbed with host bone during the healing process.
The OsteoFlo® HydroPutty™ is a resorbable bone void filler comprised of porous carbonated apatite granules and bioglass, in a synthetic polymer binder. The OsteoFlo® HydroPutty™ is intended to be easily packed into osseous defects. The single-use device is supplied sterile via gamma radiation and dry. The device requires mixing with aqueous sterile saline solution in a 1:1 ratio prior to use. The OsteoFlo® HydroPutty™ is supplied as either a pre-filled syringe or vial, in 1, 2.5, 5 and 10mL configurations.
The provided document is a 510(k) summary for the OsteoFlo® HydroPutty™ bone void filler device. It does not include acceptance criteria or a study that specifically proves the device meets such criteria in the traditional sense of a performance study with metrics like sensitivity, specificity, or accuracy, as would be typical for an AI/software device.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. The "acceptance criteria" here are effectively the successful completion of these non-clinical tests, showing that the device meets established standards for biocompatibility, sterility, packaging, shelf-life, and material characteristics, and performs comparably to the predicate in an in vivo animal study.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical Equivalence)
| Acceptance Criteria (Demonstrated through Non-Clinical Tests) | Reported Device Performance (as summarized in the document) |
|---|---|
| Biocompatibility per ISO 10993-1:2018 | Evaluation demonstrated compliance with biocompatibility standards. |
| Sterilization validation per ISO 11137-1:2006 and ISO 11137-2:2013 | Validation demonstrated effective sterilization. |
| Packaging validation per ISO 11607-1:2009 and ISO 11607-2:2006 | Validation demonstrated packaging integrity. |
| Shelf-life testing per ASTM 1980-16 | Testing confirmed the device's shelf-life. |
| Bacterial endotoxin testing per ANSI/AAMI ST72:2019 | Testing demonstrated compliance with endotoxin limits. |
| Material characterization (x-ray diffraction, particle size, porosity, surface area) | Characterization confirmed material properties. |
| In vivo evaluation in a critical-size rabbit femoral defect model | Demonstrated effectiveness in terms of device absorption and bone formation, comparable to predicate in in vivo performance. |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes an "in vivo evaluation in a critical-size rabbit femoral defect model."
- Sample Size: The exact number of rabbits used in this animal model is not specified in the provided text.
- Data Provenance: The study was an animal model (in vivo rabbit study), which is typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information (experts establishing ground truth for a test set) is typically relevant for studies evaluating the diagnostic accuracy or interpretive performance of a device (e.g., AI algorithms for image analysis). For a bone void filler device evaluated in an in vivo animal model, the "ground truth" for bone formation and absorption would likely be established through histological analysis, micro-CT imaging, and other quantitative measures performed by veterinary pathologists or researchers. The document does not provide details on the number or qualifications of such experts, as it is a summary focused on substantial equivalence.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies where human readers are interpreting data and consensus is needed for ground truth. Since this study involved an in vivo animal model and non-clinical tests, such a method would generally not be applicable or described in this context.
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. This type of study is specifically for evaluating the impact of AI assistance on human reader performance, which is not relevant for a bone void filler device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. This concept is applicable to AI/software devices, not physical medical devices like a bone void filler.
7. The Type of Ground Truth Used
For the in vivo evaluation, the ground truth would be based on direct biological observation and quantitative assessment of bone formation and device absorption in the rabbit model (e.g., histological analysis, radiographic imaging, micro-CT evaluations). The document states "Effectiveness, in terms of device absorption and bone formation, has been shown in the animal study."
8. The Sample Size for the Training Set
This concept is specific to machine learning/AI models. As this document describes a physical medical device (bone void filler) and not an AI algorithm, there is no "training set" as understood in AI development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI training set.
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(472 days)
NovoGen Wound Matrix is indicated for the management of wounds including:
· Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- · Diabetic ulcers
- · Chronic vascular ulcers
- · Tunneled/undermined wounds
- · Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- · Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
- · Draining wounds
NovoGen Wound Matrix is a an absorbable, non-pyrogenic, sterile, single use device intended for use in local management of cutaneous wounds. It is manufactured from bovine type I collagen and 45S5 bioactive glass. When hydrated with wound exudate or sterile water, this product transforms into a soft conforming layer which is naturally incorporated into the wound over time.
The provided text describes the NovoGen Wound Matrix, a medical device, and its substantial equivalence determination by the FDA. However, it does not contain a study that proves the device meets specific acceptance criteria in the way described in the prompt (e.g., performance metrics, sample sizes, expert adjudication, MRMC studies, or standalone algorithm performance).
Instead, it outlines the device's characteristics, its comparison to a predicate device, and a summary of non-clinical performance testing. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a predicate device based on similar intended use, technological characteristics, and safety and performance testing.
Here's a breakdown of the information provided, formatted to address your request as much as possible, with explicit notes where the requested information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Since there are no explicitly stated numerical acceptance criteria or thresholds in the document, this table will reflect the types of performance tests conducted and their qualitative results as stated in the submission.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Absorption Capacity (demonstrates appropriate fluid handling) | Testing performed. (Specific values or ranges not provided, but implies satisfactory performance given the conclusion of substantial equivalence). |
| Compression Recovery (demonstrates material integrity/shape retention) | Testing performed. (Specific values or ranges not provided). |
| Degradation Potential via Collagenase (demonstrates appropriate bio-resorption) | Testing performed. (Specific values or rates not provided). |
| Hydration Time (demonstrates proper hydration characteristics) | Testing performed. (Specific values or ranges not provided). |
| Tensile Strength (demonstrates mechanical integrity) | Testing performed. (Specific values or ranges not provided). |
| Viral Inactivation (demonstrates safety from viral contaminants) | Testing performed. (Specific methods or quantitative reduction not provided, but implies successful inactivation). |
| Wound Healing Performance (demonstrates effectiveness in promoting wound healing) | A full-thickness porcine wound healing study found equivalent wound healing performance for the NovoGen Wound Matrix when compared to the primary predicate device and untreated control sites. |
| Biocompatibility (demonstrates non-toxic, non-irritating, non-sensitizing properties) | Found to be biocompatible for its intended use when tested in compliance with ISO 10993-1. Cytotoxicity, sensitization, acute systemic toxicity, material mediated pyrogenicity, subacute systemic toxicity, implantation, genotoxicity, and endotoxin endpoints were addressed via testing. Chronic toxicity and carcinogenicity were addressed via a toxicological risk assessment. The Human Repeat Insult Patch Test (HRIPT) found no potential for eliciting dermal irritation or inducing sensitization. |
| Sterilization (demonstrates sterility assurance) | Gamma, 10^-6 SAL. (Implies successful sterilization). |
| Non-Pyrogenic (demonstrates absence of fever-inducing substances) | Yes. (Implies successful testing). |
2. Sample size used for the test set and the data provenance
- Porcine Wound Healing Study: "A full thickness porcine wound healing study" - Sample size (number of animals or wounds) is not specified. Data provenance is animal study (porcine).
- Biocompatibility (ISO 10993-1): Sample size not specified. Provenance is in vitro and in vivo (e.g., animal tests for systemic toxicity, implantation).
- Human Repeat Insult Patch Test (HRIPT): "Based on the test population who completed the study" - Sample size (number of human subjects) is not specified. Provenance is prospective human study. Specific country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not provided in the document. The studies performed (animal, biocompatibility, HRIPT) would typically involve trained personnel, but the specific number and qualifications of "experts" to establish a ground truth in the sense of clinical interpretation are not mentioned, as these are primarily laboratory and animal studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided. The studies described are not of a diagnostic nature requiring expert adjudication of results.
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
An MRMC study was not done. This device is a wound matrix, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical wound matrix, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Porcine Wound Healing Study: The "ground truth" for wound healing would be based on direct observation and measurement of wound closure, tissue regeneration, and potentially histopathology in the porcine model. It's compared to a predicate device and untreated controls for equivalence.
- Biocompatibility Studies: Ground truth is established by standardized laboratory test results against established safety thresholds (e.g., cell viability in cytotoxicity, immune response in sensitization, absence of fever in pyrogenicity).
- HRIPT: Ground truth is clinical observation of skin reactions (irritation/sensitization) in human subjects.
8. The sample size for the training set
This is not applicable as the device is not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/machine learning algorithm.
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(212 days)
NanoFUSE® is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (i.e. the posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NanoFUSE® must be used with autograft as a bone graft extender in the posterolateral spine and pelvis. The product provides a bone graft substitute that remodels into the recipient's skeletal system.
NanoFUSE® is a malleable, putty-like, bone-void filler. The product is comprised of a synthetic calcium phosphor-silicate particulate material particles (45S5 bioactive glass), both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, medical grade polymer syringe, double-wrapped in peel-back pouches, in a dust cover paperboard carton. An empty sterile syringe for addition of the hydration fluid of choice is also included in the sterile barrier packaging. NanoFUSE® is intended for single patient use only and is non-pyrogenic. Instructions for use are provided by way of a package insert in the paperboard carton.
At point of use, the surgeon reconstitutes the product with an appropriate sterile solution of choice (sterile saline, water for injection, or autologous whole blood). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then mixed with autograft and gently extruded by the surgeon into the bone void. NanoFUSE® is progressively resorbed and replaced by host bone during the osteo-remodeling process.
This document is a 510(k) premarket notification decision letter from the FDA for the NanoFUSE® line of resorbable calcium salt bone void filler devices. As such, it describes the device and its intended use, and compares it to predicate devices. It does not present a study with acceptance criteria and device performance results in the way a clinical study or a software algorithm study would.
Therefore, I cannot extract the information required in your prompt's format from the provided text. The document focuses on showing substantial equivalence to existing devices based on material composition, packaging, intended use, and in vivo animal studies, rather than clinical performance metrics and acceptance criteria for a diagnostic or AI device.
Specifically, the document contains:
- A product description: NanoFUSE® is a bone void filler made of synthetic calcium phosphor-silicate particulate material (45S5 bioactive glass) coated with gelatin derived from porcine skin. It's provided dry and reconstituted at the point of use.
- Indications for Use: To be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to its stability (e.g., posterolateral spine and pelvis). It must be used with autograft as a bone graft extender.
- Predicate Devices: NanoFUSE® DBM (primary predicate, K142104) and NovaBone Putty – Bioactive Synthetic Bone Graft (reference predicate, K110368).
- Safety and Effectiveness Data: Mentions biocompatibility data adoption from the primary predicate (NanoFUSE® DBM) due to shared materials. It also states that in vivo rabbit model studies (24 weeks and 52 weeks) were conducted to evaluate posterolateral spine use and demonstrated substantial equivalence to the comparative control (NanoFUSE® DBM).
However, it lacks the following information for a study proving device meets acceptance criteria:
- A table of acceptance criteria and reported device performance: This document does not provide quantitative performance metrics or a table comparing them to pre-defined acceptance criteria. The "substantial equivalence" claim is qualitative based on material and animal study findings.
- Sample size used for the test set and data provenance: It mentions "two studies (24 weeks and 52 weeks)" in the rabbit model, but no specific sample sizes for the test set are given, nor details about data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts and their qualifications for ground truth: Not applicable, as this is an animal study for substantial equivalence, not a human reader or AI performance study.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study, effect size: Not applicable, as this is not an AI-assisted human reader study.
- Standalone (algorithm only) performance: Not applicable, as this is a medical device (bone void filler), not a software algorithm.
- Type of ground truth used: For the animal studies, the "ground truth" would be histological examination or other biological markers of bone remodeling/fusion, but this is not explicitly detailed.
- Sample size for the training set: Not applicable, as this is not a machine learning/AI device.
- How ground truth for the training set was established: Not applicable.
In conclusion, the provided text describes a traditional 510(k) submission for a physical medical device, focusing on substantial equivalence to predicates rather than a performance study with acceptance criteria as one would find for a diagnostic test or an AI/ML device.
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