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510(k) Data Aggregation
(27 days)
IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
The IPC™ POWEREASE™ System is indicated for drilling, tapping and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.
Medtronic Reusable Instruments compatible with Medtronic's IPC™ The POWEREASE™ System are spine preparation instruments manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The instruments may be connected to the POWEREASE™ Driver or used manually. These instruments are also compatible with various Medtronic spinal implant systems.
The provided text is a 510(k) Summary for the Medtronic POWEREASE™ System. It discusses the device's substantial equivalence to a predicate device, IPC™ POWEREASE™ SYSTEM (K111520), and outlines some performance data. However, it explicitly states that no new testing was performed for the subject devices, and instead relies on a "confirmatory validation" to ensure minor modifications do not introduce new safety or effectiveness issues.
Therefore, the document does not report on a study that establishes acceptance criteria and demonstrates that the device meets those criteria through new performance testing. Instead, it asserts substantial equivalence based on the device being identical to the predicate in key aspects.
Given this, I cannot fully answer all parts of your request as there isn't a detailed study report with new acceptance criteria and performance data in the provided document. I will fill in what can be inferred from the text.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, no specific quantitative acceptance criteria or new device performance metrics are presented for the subject device. The document states that the subject instruments are "identical to the predicate devices in terms of fundamental technology, intended use and indications for use." The "confirmatory validation" is not described with numerical acceptance criteria or performance results.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition: Adherence to standards for surgical instruments. | • Manufactured from identical materials as the predicate devices. • Materials meet ASTM F899 (Standard Specification for Wrought Stainless Steels for Surgical Instruments). |
| Biocompatibility: Safe for limited contact. | • Classified as communicating devices with Tissue/Bone/Dentin (<24h external contact). • Materials have a long history of safe and effective use in predicate spinal implants. • Biocompatibility testing for the subject device was not required as materials are identical to predicate devices. |
| Functional Equivalence: No new safety or effectiveness issues introduced by minor modifications. | • A "confirmatory validation" was conducted to ensure minor modifications do not introduce new issues of safety and effectiveness and that devices function as intended. • No new testing was performed for the subject devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Non-clinical mechanical testing was not performed for the subject instruments." Therefore, there is no test set sample size mentioned in relation to new performance data. The "confirmatory validation" is not described in a way that suggests a test set or specific data provenance.
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)
Not applicable, as no new clinical or performance testing requiring expert ground truth establishment for a test set was performed or reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical or performance testing with a test set was performed or reported.
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 powered surgical system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a powered surgical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no new clinical or performance testing requiring ground truth was performed or reported for the subject device. The claim of substantial equivalence is based on the known performance and safety history of the predicate device with identical materials and technology.
8. The sample size for the training set
Not applicable, as this is a medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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