Search Results

ROP Bone Hemostasis Material is a water-soluble material indicated for use to control bleeding from bone surfaces.

The ROP Bone Hemostasis Material is a blend of water-soluble alkylene oxide copolymers. It contains no additives or colorants. The product is provided in a stick-like form, contained in a capped delivery tube. Each tube contains approximately 6.0 grams of the material. It is to be extruded from the container by rotation of the base of the tube for application to bleeding bone defect. The ROP Bone Hemostasis Material is, as the predicate, a water soluble wax-like substance and is slippery when wet. The delivery tube is a barrier between the surgeon's wet gloved hand and the material, permitting application to the boney defect in the manner similar to handling a crayon. ROP Bone Hemostasis Material is sterilized by a validated gamma irradiation process. It is labeled for single surgical use and is not to be resterilized. The tube is provided in a secondary wrap to permit delivery into a sterile field. The device is a resorbable material in contact with bone tissue for less than 30 days.

The provided text describes a 510(k) premarket notification for the "ROP Resorbable Hemostasis Material" (K153095). However, the document does not present specific acceptance criteria in a quantifiable manner (e.g., a specific percentage of bleeding control or a fixed resorption rate within a certain timeframe that the device must meet).

Instead, the study aims to demonstrate substantial equivalence to a predicate device, Ostene® CT Soluble Bone Hemostasis Implant Material. The acceptance criteria for this type of submission are generally met by showing that the new device performs similarly to the legally marketed predicate device with respect to safety and effectiveness for its intended use.

Therefore, the "acceptance criteria" can be inferred as:

• Similarity in hemostatic performance to the predicate.
• Similarity in adherence to bone to the predicate.
• Similarity in resorption profile to the predicate.
• No negative impact on bone healing compared to the predicate.
• Biocompatibility according to ISO 10993 standards.
• Material and device characterization matching established specifications.
• Sterilization and shelf life validation.

Here's an attempt to structure the information based on the provided text, interpreting "acceptance criteria" as demonstrating similarity or compliance with established standards, and "reported device performance" as the study's findings regarding this similarity/compliance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • Animal Testing (In vivo performance and ISO 10993-6 study): The document specifies "ISO Bone Implantation Study in the mid shaft femur of rabbits, 48 hours, 1 and 4 weeks." While the specific number of rabbits (sample size) is not explicitly stated in the provided text, "rabbits" is mentioned, implying a multi-animal study.
  • Biocompatibility Testing: Many tests listed use animal models (e.g., "ISO Modified Intracutaneous Irritation in the Rabbit," "Guinea Pig Maximization Sensitization Test," "Mouse Peripheral Blood Micronucleus Study," "Dose Range Finding Study with a Definitive Mouse Lymphoma Assay," "Systemic Toxicity in Mice," "ISO Systemic Toxicity in the Rat," "USP Rabbit Pyrogen Study"). The exact number of animals for each test is not detailed in this summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the studies are described as "Non-clinical testing" conducted in accordance with FDA guidance and standards, indicating laboratory and animal testing. This is typically prospective.

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)

• The document does not mention the use of human experts to establish "ground truth" for the test set in the traditional sense of medical image interpretation or clinical diagnosis. The studies described are primarily non-clinical laboratory and animal studies. The "ground truth" or evaluative criteria would be based on scientific and biological endpoints (e.g., histological analysis of tissue response, observation of hemostasis, measurement of resorption) as assessed by researchers or pathologists involved in the studies, rather than subjective expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. The reported studies are non-clinical (laboratory and animal) and do not involve human reader interpretation or adjudication of results in the way a clinical imaging study would.

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

• Not applicable. The device is a "Bone Hemostasis Material," not an AI diagnostic or assistive tool. The studies focus on the intrinsic properties and performance of the material itself.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable, as this is a physical medical device, not a software algorithm. The "standalone" performance refers to the device's inherent function, which was evaluated through laboratory and animal testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The ground truth for the non-clinical studies was established through:
  • Pathology/Histology: For tissue response, bone healing, and resorption evaluation in animal studies.
  • Physical and Chemical Measurements: For material and device characterization (e.g., melting point, pH, molecular weight, formaldehyde content, stiffness).
  • Biological Endpoints/Observations: For hemostasis, adherence to bone, and biocompatibility endpoints in animal models.
  • Comparisons: Performance was assessed relative to a legally marketed predicate device (Ostene).

8. The sample size for the training set

• Not applicable. This is a physical medical device, and the described studies are non-clinical evaluations for regulatory clearance, not a machine learning study requiring training data.

9. How the ground truth for the training set was established

• Not applicable, as there is no training set mentioned or implied for this type of device submission.

Ask a specific question about this device