(211 days)
The Steribite® Rongeur is a manually operated instrument indicated for cutting bone during surgery involving the skull or spinal column.
Steribite® is a system of disposable manual surgical Kerrison rongeurs. The instruments are offered in a 40° up configuration having shaft lengths of 8 and 11 inches and bite sizes 1mm to 5mm to accommodate variations in surgical need. The devices are sold sterile and single use only.
The document describes a 510(k) premarket notification for the "Steribite®" manual rongeur, which is a device used in surgery involving the skull or spinal column. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ||
| Cut Performance | Full profile cut in simulated use (based on Steris IMS test standard). | Demonstrated full profile cut in simulated use. |
| Cut Force | Not explicitly stated as a pass/fail criterion, but assessed against a reference device. | Assessed by applying a controlled load (10-35 pounds) in 5-pound step-wise fashion to cut a 2mm thick bone analog compared to the reference device. (Comparison results are not detailed as specific pass/fail values but implied to be acceptable for substantial equivalence). |
| Handle Strength | Force to cause failure was at least twice the required cutting force. | Applied a continuous load to failure; demonstrated that the force to cause failure was at least twice the required cutting force. |
| Sterilization | ||
| Sterilization Validation | In accordance with ISO 11137-1:2006 and ISO 11137-2006 for radiation sterilization. | Validation conducted in accordance with specified ISO standards. |
| Bacterial Endotoxin Testing | In accordance with AAMI ST72:2011/(R)2016. | Testing conducted in accordance with specified AAMI standard. |
| Packaging | ||
| Packaging Performance & Stability | In accordance with ANSI/AAMI/ISO 11607-1:2006/IR)2010. | Testing conducted in accordance with specified ANSI/AAMI/ISO standard. |
| Biocompatibility | ||
| Cytotoxicity | Not explicitly stated, but implies meeting safety standards of ISO 10993-5 Third Edition 2009-06-01. | Assessed for cytotoxicity. |
| Sensitization | Not explicitly stated, but implies meeting safety standards of ISO 10993-10 Third Edition 1020-08-01. | Assessed for sensitization. |
| Irritation/Intracutaneous Reactivity | Not explicitly stated, but implies meeting safety standards of ISO 10993-10 Third Edition 1020-08-01. | Assessed for irritation/intracutaneous reactivity. |
| Acute Systemic Toxicity | Not explicitly stated, but implies meeting safety standards for medical devices. | Assessed for acute systemic toxicity. |
| Material-Mediated Pyrogenicity | Not explicitly stated, but implies meeting safety standards for medical devices. | Assessed for material-mediated pyrogenicity. |
| Hemolysis | Not explicitly stated, but implies meeting safety standards for medical devices. | Assessed for hemolysis. |
| Residual Manufacturing Material Cleanliness | Based on ASTM F2459. | Applied ASTM F2459 to demonstrate residual manufacturing material cleanliness. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document mentions "the subject device models, 1-5 mm bite sizes and 8-11 in handles," but does not explicitly state the number of samples (individual devices) used for each mechanical test.
- Data Provenance: The data is generated from laboratory testing of the device itself. There is no mention of country of origin for data or whether it's retrospective or prospective, as it pertains to device performance testing rather than clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable to this submission. The "Steribite®" is a manual surgical instrument, and its performance and safety validation relies on non-clinical mechanical, sterilization, packaging, and biocompatibility testing against established industry standards and comparison to a predicate device. There is no mention of "ground truth" established by experts in the context of clinical outcomes or diagnostic accuracy, as would be relevant for software or diagnostic devices.
4. Adjudication Method for the Test Set
This section is not applicable for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or clinical endpoints, which are not part of this 510(k) submission for a manual surgical instrument.
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 performed. This type of study is relevant for AI/radiology devices where human readers' performance is augmented by AI. The Steribite® is a manual surgical rongeur, not an AI or diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone study was not performed. This device is a manual surgical instrument and does not incorporate an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This section is not applicable in the traditional sense. The "ground truth" for the non-clinical tests conducted is defined by established engineering principles, industry standards (e.g., ISO, AAMI, ASTM), and the expected performance characteristics of a manual rongeur compared to its predicate. For example, for "cut performance," the ground truth is a "full profile cut in simulated use" as per a specific test standard.
8. The sample size for the training set
Not Applicable. This device is a mechanical surgical instrument and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set, there is no ground truth established for one.
§ 882.4840 Manual rongeur.
(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).