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510(k) Data Aggregation
(164 days)
The CD Horizon™ Astute™ Spinal System is intended to provide for posterior, supplemental fixation when used with an interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ Astute™ Spinal System consists of a variety of sizes of rods, as well as set screws, which are used with bone screws from the CD Horizon™ Solera™ Spinal System, to create a variety of rigidly locked configurations, with each construct being tailored to the individual case. The CD Horizon™ Astute™ Spinal System implant components are fabricated from medical grade titanium alloy, tantalum, or polyetheretherketone (PEEK).
This document describes the premarket notification (K191066) for the CD Horizon™ Astute™ Spinal System. However, it does not contain information related to an AI/ML powered device, nor does it present acceptance criteria or a study that proves a device meets those criteria in the context of AI/ML performance metrics.
The document is a 510(k) summary for a spinal implant system. The "Performance Data" section (VII) discusses mechanical testing of the device and reference to clinical literature and a retrospective study of the predicate device to support its clinical use.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves an AI device meets acceptance criteria, as this document is not about an AI device.
To directly answer the prompt's request given the content of this specific document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: "The subject devices met the pre-determined acceptance criteria for all tests." (Page 5)
- Reported Device Performance:
- Mechanical Testing (ASTM F1717 & F1798): The subject devices met the pre-determined acceptance criteria for static and dynamic compression bending, static torsion, static axial grip, static torsional grip, and static and dynamic flexion/extension.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified for mechanical testing. For clinical performance, it refers to data from the predicate device's unspecified "retrospective study," so the sample size is unknown.
- Data Provenance: Unspecified for mechanical testing. For clinical performance, implies data from a retrospective study, country of origin is not mentioned.
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. This is a mechanical device, not an AI diagnostic/prognostic device requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 study was not done as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical Testing: Ground truth is based on the specifications and performance limits defined by ASTM F1717 and F1798 standards.
- Clinical Performance: Ground truth for clinical claims is supported by the outcomes of the predicate device's retrospective study and clinical literature, implying patient outcomes data.
8. The sample size for the training set
- Not applicable. This is not an AI device with a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device.
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(113 days)
The Navigated Pedicle Access Kit is intended to be used in image guided surgery with the 7D Surgical System. The Navigated Pedicle Access Kit is intended for use in posterior spinal surgery to assist in the acurate placement of pedicle screws. The device is sterile and designed for single use.
The IZI Pedicle Access Kit consists of one pedicle access needle with cannula. The handle contains 4 retro-reflective Navigation Markers (Spherz K022074). The device is sterile and designed for single use. The patient-contacting components are the stainless-steel cannulas and needle. The product is used to gain access to the pedicle in image guided surgeries using the 7D Surgical System. The retro-reflective Navigation Markers (Spherz) that are attached to the handle allows the camera system of 7D Surgical System (K180352) to accurately locate where the tip of the needle is in space.
Here's a breakdown of the acceptance criteria and study information for the IZI Navigated Pedicle Access Kit, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format like typical sensitivity/specificity thresholds. Instead, it describes performance based on accuracy testing and conformance to standards. The reported device performance is demonstrated by its compliance with these tests and standards, showing that it performs as safely and effectively as the predicate device.
| Test/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Surgical Simulations on Phantom Models | The device accurately navigates and assists in pedicle screw placement in a simulated surgical environment with the 7D Surgical System, demonstrating equivalent performance to the predicate. | Performed to verify absolute accuracy, repeatability of accuracy, and navigation accuracy with the 7D Surgical System. |
| ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems | Compliance with the standard for measuring positional accuracy of computer-assisted surgical systems. | Accuracy testing performed according to this standard to verify absolute accuracy and repeatability of the device and navigation accuracy. |
| Target Registration Error (TRE) Evaluation | TRE should demonstrate acceptable clinical accuracy of the system on phantom models in a clinical simulated environment. | Used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment. |
| Biocompatibility Profile | Same biocompatibility profile as the reference device K1423244. | The IZI Pedicle Access Kit has the same biocompatibility profile as the reference device K1423244. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the "phantom models" used in the non-clinical performance surgical simulations. It mentions "phantom models" generally.
- Data Provenance: The data is based on "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models." This indicates it's retrospective simulation data from a controlled lab environment, not from human patients. The country of origin for the data is not specified, but the applicant (IZI Medical Products LLC) is based in Maryland, USA, and the predicate device manufacturer (7D Surgical Inc.) is in Ontario, Canada, suggesting a North American context for the testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide details on the number or qualifications of experts involved in establishing the ground truth for the non-clinical simulations. The "ground truth" for TRE is described as "measured physically or otherwise," implying objective physical measurements rather than expert consensus on images.
4. Adjudication Method for the Test Set:
No adjudication method is described, as the evaluation appears to be based on objective physical measurements (e.g., TRE) in a simulated environment, not subjective assessment by multiple individuals.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. This document describes a device (a physical surgical instrument) and its navigation accuracy when used with a surgical system, not an AI diagnostic algorithm that assists human readers in interpreting medical images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. Standalone Performance:
Yes, a standalone performance assessment (algorithm only, without human-in-the-loop performance) was effectively done. The performance metrics (absolute accuracy, repeatability, navigation accuracy, and TRE) are for the device (IZI Navigated Pedicle Access Kit) and its interaction with the 7D Surgical System in a simulated environment. There isn't a "human-in-the-loop" component being evaluated in these specific non-clinical tests.
7. Type of Ground Truth Used:
The ground truth used was objective physical measurements in a phantom model. For TRE, it's defined as "the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise." This implies a gold standard established by precise physical measurement to compare against the system's reported position.
8. Sample Size for the Training Set:
The document does not mention a "training set" or "training data." This submission is for a physical surgical device, not a machine learning or AI algorithm in the context of data training. The "device performance tests" are verification and validation activities, which are akin to testing, not training.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set for an AI/ML algorithm, this question is not applicable to the information provided.
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