(41 days)
The Integrity Spine Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The Integrity Spine Lumbar Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy. The Integrity Spine lumbar interbody fusion device(s) mav be implanted:
- bi-laterally in pairs via a posterior (PLIF) approach;
- as a single device via an oblique (OLIF) approach: a
- as a single device via a transforaminal (TLIF) approach: or -
- as as a single device via an anterior or anterolateral (ALIF) approach.
The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.
The implant components are made of polyether ether ketone (PEEK Zeniva ZA-500) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
Since the extracted text refers to a 510(k) summary for a medical device (Integrity Spine Lumbar Interbody Fusion System), the "acceptance criteria" and "device performance" would typically relate to comparisons to predicate devices based on non-clinical testing, rather than explicit numerical performance metrics like sensitivity or specificity often seen in AI/diagnostic device contexts. Also, there's no mention of a "study that proves the device meets the acceptance criteria" in terms of clinical trials or AI performance evaluations with ground truth. The summary focuses on substantiating substantial equivalence through non-clinical testing.
Here's an attempt to answer your questions based solely on the provided text, acknowledging that many of your points are not directly addressed due to the nature of this particular 510(k) summary:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the "acceptance criteria" for this device are primarily met by demonstrating substantial equivalence to predicate devices through non-clinical testing. The "reported device performance" is the successful completion of these tests with results deemed equivalent. There are no explicit numerical acceptance criteria for performance provided in the document in the way one might see for diagnostic AI (e.g., sensitivity > X%, specificity > Y%).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent static and dynamic performance to predicate devices (ASTM F2077-11) | Met: Substantially equivalent results for static and dynamic compression and torsion testing. |
| Subsidence Performance: Equivalent subsidence resistance to predicate devices (ASTM F2267-04) | Met: Substantially equivalent results for subsidence testing. |
| Expulsion Performance: Equivalent expulsion resistance to predicate devices (ASTM Draft Standard F-04.25.02.02) | Met: Substantially equivalent results for expulsion testing. |
| Material Equivalence: Use of materials compliant with recognized standards and similar to predicates | Met: Implant components made of PEEK Zeniva ZA-500 (ASTM F2026) and tantalum markers (ASTM F560), similar to predicate materials. |
| Intended Use Equivalence: Same indications for use as predicate devices | Met: Intended for intervertebral body fusion of the lumbar spine (L2-S1) in skeletally mature patients for DDD with up to Grade I spondylolisthesis, similar to predicates. |
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 describes non-clinical mechanical testing rather than testing on patient data. Therefore, the concept of "test set" in terms of patient data, data provenance, or retrospective/prospective studies does not apply here. The "samples" used were physical devices subjected to the specified ASTM tests. The sample sizes for these specific mechanical tests are not detailed in this summary.
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)
This question is not applicable to the provided document. The ground truth for this device's evaluation (substantial equivalence) is established through adherence to recognized international standards for mechanical testing (ASTM standards) and comparison to legally marketed predicate devices, not through human expert interpretation of clinical data in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to the provided document, as it pertains to clinical data interpretation and not mechanical device testing.
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
There is no mention of a multi-reader multi-case (MRMC) study. This document describes a medical device (spinal implant) and its substantial equivalence determination, not an AI or diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" is established by the specified ASTM (American Society for Testing and Materials) standards for mechanical performance (e.g., F2077-11 for static and dynamic testing, F2267-04 for subsidence, and ASTM Draft Standard F-04.25.02.02 for expulsion). The performance of the predicate devices under these same standards also serves as a comparative benchmark.
8. The sample size for the training set
This question is not applicable to the provided document. There is no concept of a "training set" for a physical medical device like a spinal implant in the context of this 510(k) summary.
9. How the ground truth for the training set was established
This question is not applicable to the provided document for the same reasons as point 8.
§ 890.5950 Powered heating unit.
(a)
Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.