(144 days)
Orthostat Bone Hemostat Matrix Applicator is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries
This submission is for Orthostat packaged in a syringe type applicator containing 3.5g of Orthostat bone hemostat. This will allow convenient discharge of the purgeon's hand, onto a surgical instrument, or directly onto bleeding bone. The tip of the applicator is tapered and made from a softer material to assist with spreading the material onto the bone.
This 510(k) submission (K102762) is for a medical device called the "Orthostat Bone Hemostat Matrix Applicator," which is intended for controlling bleeding from bone. The submission focuses on demonstrating substantial equivalence to a predicate device, the "Orthostat Bone Hemostat Matrix," rather than proving clinical effectiveness through a new clinical study. Therefore, much of the information typically associated with studies proving device performance against acceptance criteria for diagnostic AI/software devices is not directly applicable here.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This device is not an AI/software diagnostic device, so typical performance metrics like sensitivity, specificity, or AUC are not relevant. Instead, the "acceptance criteria" are related to safety, biocompatibility, and functional equivalence to the predicate device.
| In Vitro Test Description | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material Safety | Biocompatible; no extractables or plasticizers (as per predicate) | Material is biocompatible and has no extractables or plasticizers. |
| Tip Tensile Strength | Acceptable tip attachment after simulated use (as per predicate) | Tip attachment is acceptable and is acceptable after simulated use conditions. |
| Handling and Usability | Effective application of Orthostat (equivalent to predicate) | The product effectively applies Orthostat during animal and human cadaver evaluation. |
| Biocompatibility Tests | Pass criteria for each test (as per ISO 10993 standards, implied for medical devices) | Results |
| Cytotoxicity | Pass | Pass |
| Sensitization | Pass | Pass |
| Irritation/Intracutaneous Injection | Pass | Pass |
| Acute Systemic Toxicity | Pass | Pass |
| Pyrogen | Pass | Pass |
| Sterilization Method | Radiation (consistent with predicate) | Radiation |
| Sterility Assurance Level (SAL) | $10^{-6}$ (consistent with predicate) | $10^{-6}$ |
| Sterile Barrier | Foil Pouch (consistent with predicate) | Foil Pouch |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "No clinical tests were performed to determine substantial equivalence." Therefore, there is no clinical test set for performance comparison in the traditional sense for human efficacy.
For the non-clinical tests:
- Handling and Usability: This was evaluated during "animal and human cadaver evaluation." No specific sample sizes for these evaluations are provided.
- Material Safety, Tip Tensile Strength, Biocompatibility: These are typically conducted on material samples or device prototypes, not on a "test set" from a patient population. Sample sizes would be determined by relevant ASTM or ISO standards for mechanical and biocompatibility testing. The data provenance is laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As no clinical tests were performed, there was no expert-adjudicated ground truth established for a clinical test set. The non-clinical tests rely on established scientific methods and standards.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring expert adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This submission focuses on a new applicator for an existing device, not a diagnostic AI or imaging analysis tool that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical applicator, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Predicate Device Equivalence: The primary ground for substantial equivalence is the prior FDA-cleared predicate device (Orthostat Bone Hemostat Matrix, K043260, K091121).
- Non-Clinical Test Results: The "ground truth" for the non-clinical tests (material safety, tip tensile strength, handling, usability, biocompatibility) is determined by the specific pass/fail criteria defined by relevant industry standards and internal specifications, which were met. For biocompatibility, it's typically based on ISO 10993 standards.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
N/A