(89 days)
The ChoiceSpine Stealth™ Cervical Spacer System is intended for anterior cervical spine intervertebral body fusion at one level from the C2-C3 disc space to the C7-T1 disc for the treatment of degenerative disc disease (DDD) in sketally mature patients who have had six (6) weeks of non-operative treatment. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stealth™ Cervical Spacer System is to be used with supplemental fixation and with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft to facilitate fusion.
The ChoiceSpine Stealth™ Cervical Spacer System's implants have a basic oval shape with a hollow center for placement of bone graft. The superior and inferior surfaces have angled ridges, or "teeth," for resisting migration. The spacers are available in an assortment of heights and in multiple angles of lordosis to accommodate different anatomic requirements. The implants are made from either titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Materials Class C) or polyetheretherketone (PEEK-OPTIMA® polymer, Invibio®) per ASTM F2026 with tantalum markers per ASTM F560. Both implants will be provided sterile. Instruments will be provided non-sterile but will be steam sterilized before use. The instrumentation is made from 455/465 SS per ASTM A564 and 17-4 SS per ASTM F899.
The provided text is a 510(k) summary for the ChoiceSpine Stealth™ Cervical Spacer System. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily through comparisons of material, design, and indications for use.
Crucially, this document does NOT contain information regarding clinical studies, human-in-the-loop performance, or detailed test results with acceptance criteria and reported performance metrics that would typically be found in a study proving the device meets acceptance criteria.
The 510(k) process for this type of device (intervertebral body fusion device) generally relies on bench testing for mechanical properties and biocompatibility, as well as comparison to a predicate device. It does not typically require extensive clinical trials with human subjects to demonstrate safety and effectiveness beyond what has been established for the predicate device.
Therefore, an exhaustive answer to your request, especially sections 1 through 7 which relate to clinical performance testing and ground truth establishment, cannot be provided from this document. The document primarily focuses on equivalence rather than a new standalone performance study.
However, based on the information provided, here's what can be inferred and what cannot:
Information that CANNOT be Extracted from the Provided Text:
- A table of acceptance criteria and reported device performance (for clinical outcomes/diagnostic accuracy): This document does not describe specific clinical performance tests with defined acceptance criteria or reported values related to diagnostic accuracy, sensitivity, specificity, etc. It focuses on the physical and material characteristics and intended use compared to a predicate.
- Sample size used for the test set and data provenance (for clinical performance): Not applicable for clinical performance as no such study is detailed.
- Number of experts used to establish ground truth & qualifications (for clinical performance): Not applicable.
- Adjudication method (for clinical performance): Not applicable.
- MRMC comparative effectiveness study (for AI assistance): Not applicable, as this is a medical implant, not an AI diagnostic device.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used (for clinical performance): Not applicable.
- Sample size for training set (for an AI/algorithm): Not applicable.
- How ground truth for training set was established (for an AI/algorithm): Not applicable.
Information Extracted from the Provided Text (Relevant to Device Description and Equivalence):
1. Acceptance Criteria and Reported Device Performance (as pertains to mechanical/material properties, inferred from equivalence):
While a direct table of acceptance criteria for clinical performance is not present, the document implies acceptance by demonstrating substantial equivalence to predicate devices in terms of:
| Acceptance Criterion (Inferred from Equivalence) | Reported Device Performance (as described in the document) |
|---|---|
| Material Composition | The device is made from titanium alloy (Ti-6Al-4V ELI per ASTM F3001, Class C) or PEEK-OPTIMA® polymer (Invibio®) per ASTM F2026 with tantalum markers per ASTM F560. These materials are stated to be shared with / comparable to the additional predicate device. |
| Mechanical Properties | The PEEK spacer is considered the "worst-case" mechanically, and it was previously tested and cleared under K091531 (the primary predicate). This implies the mechanical properties of both PEEK and Titanium versions meet the acceptance criteria established for the predicate, through testing. |
| Sterility Assurance Level (SAL) | For the sterile-packed device, gamma validation and distribution testing demonstrated that predetermined acceptance criteria were met. A minimum radiation dose of 25kGy was sufficient to meet a SAL of 10⁻⁶, and the package system remained intact with a hermetic barrier. |
| Indications for Use Consistency | The indications for use are similar to predicate devices, addressing anterior cervical spine intervertebral body fusion for degenerative disc disease (DDD) at one level (C2-C3 to C7-T1) in skeletally mature patients after non-operative treatment, used with supplemental fixation and bone graft. |
| Biocompatibility | Implied by the statement: "The implants proposed in this submission are similar to the predicate devices in...biocompatibility." |
| Principle of Operation | Similar to predicate devices. The implants have an oval shape, hollow center for graft, and angled ridges (teeth) for resisting migration. |
2. Sample Size and Data Provenance (for mechanical/material tests):
- The document implies that testing for mechanical properties (e.g., "PEEK spacer is the worst-case compared to the Titanium spacer which is previously tested and cleared under K091531") and sterilization validation was performed. However, specific sample sizes for these tests are not provided in this 510(k) summary.
- Data Provenance: Not specified, but standard regulatory submissions typically involve testing conducted by the manufacturer or accredited labs. The document does not mention multi-center data collection for clinical performance. The testing for substantial equivalence is generally done in a controlled, prospective manner by the manufacturer.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable as this document pertains to a medical implant and its safety/equivalence based on design, materials, and mechanical properties, not a diagnostic device requiring expert interpretation for "ground truth."
4. Adjudication Method:
- Not applicable.
5. MRMC Comparative Effectiveness Study:
- Not applicable; this is an intervertebral body fusion device, not AI software or a diagnostic tool that would typically involve human reader studies.
6. Standalone Performance:
- The "performance" discussed is related to the device's mechanical integrity, sterilization effectiveness, and biocompatibility, as compared to predicate devices. There isn't a "standalone algorithm" in this context. The device's performance is inherent to its physical properties and intended function as an implant.
7. Type of Ground Truth Used:
- For the physical device, "ground truth" relates to established standards for material properties (e.g., ASTM standards for titanium and PEEK), mechanical performance (e.g., specified load-bearing capabilities through bench testing), and biological compatibility (e.g., ISO standards for biocompatibility). The document indicates adherence to these standards (e.g., "Ti-6Al-4V ELI per ASTM F3001, Materials Class C," "PEEK-OPTIMA® polymer...per ASTM F2026").
- For sterility, the ground truth is a demonstrated Sterility Assurance Level (SAL) of 10⁻⁶, validated by testing.
8. Sample Size for the Training Set:
- Not applicable; "training set" is a concept for machine learning or AI models, which are not described here.
9. How Ground Truth for the Training Set was Established:
- Not applicable.
In summary, this 510(k) summary serves to demonstrate substantial equivalence of a medical implant to existing cleared devices, primarily through comparison of design, materials, manufacturing processes, and indications for use, supported by bench testing and validation (e.g., sterilization). It does not involve a clinical study with human "readers" or AI algorithms, and thus, many of the requested details about acceptance criteria for diagnostic performance or human-AI interaction are not present.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.