(165 days)
The CAPSTONE CONTROL™ System, including the CAPSTONE CONTROL PTC™ Spinal System, is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE CONTROL™ Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.
Additionally. the CAPSTONE CONTROL™ Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.
These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE CONTROL™ Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach.
The subject CAPSTONE CONTROL™ Spinal System adds 24-degree lordotic PEEK cages with tantalum markers to the existing CAPSTONE CONTROLTM Spinal System. Both the predicate sizes, and including the subject 24-degree lordotic cages, will also be provided with a commercially pure titanium coating (CP Ti) on the opposing, endplate-contacting sides of the implant. The titanium coated interbody cages will be branded as the CAPSTONE CONTROL PTC™ Spinal System (PTC = Pure Titanium Coating) to differentiate the coated cages from the uncoated CAPSTONE CONTROLTM Spinal System cages. The titanium coating is identical to the coating on the predicate CAPSTONE PTC™ Spinal System implants (Predicate #4).
The subject instruments include 24-degree lordotic cam spreader trials that correspond to the subject 24-degree lordotic cages. The predicate and subject cam spreader trials, and other instruments used to facilitate the implantation of the uncoated CAPSTONE CONTROL™ Spinal System cages, will also be used with the CAPSTONE CONTROL PTC™ Spinal System.
The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal Systems consist of interbody fusion cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal System cages are available in heights of 8mm to 18mm, lengths of 22mm, 27mm, and 32mm, and widths of 9mm or 10mm. The implants will be available with 0°, 6°, 12°, 18°, or 24° of lordosis. The CAPSTONE CONTROL™ / CAPSTONE CONTROL PTC™ Spinal Systems also include cam spreader trials and a variety of instruments to help facilitate the implantation of the interbody fusion cages.
This document describes the premarket notification (510(k) K171107) for the Medtronic Sofamor Danek CAPSTONE CONTROL™ Spinal System and CAPSTONE CONTROL PTC™ Spinal System. While the document outlines various tests conducted, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a study in the way a diagnostic AI/ML device would. The information provided is primarily related to mechanical and material performance testing for an intervertebral body fusion device.
Therefore, the requested information elements (especially those related to diagnostic performance like sensitivity, specificity, reader studies, ground truth establishment, training/test set sizes, and expert qualifications) are not applicable to this type of device and submission.
However, I can extract the relevant information from the provided text regarding the performance data and "acceptance criteria" as they are described within the context of a medical implant device submission.
Here's a breakdown based on the provided text, addressing elements that are applicable and noting where others are not:
1. A table of acceptance criteria and the reported device performance
The document states that "The pre-determined acceptance criteria, established using predicate test data, were met for all tests." and "The subject 24-degree lordotic CAPSTONE CONTROL PTC™ implants met the pre-determined acceptance criteria, established using predicate test data, for all tests." Specific numerical acceptance criteria and reported device performance values are not detailed in this summary document, only that the criteria were met. The tests performed are listed.
| Test Category | Specific Tests Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Commercially Pure Titanium Coating Evaluation | - ASTM F1854: Stereological evaluation of porous coatings | Predetermined, established using predicate test data | Met for all tests |
| - ASTM F1160: Shear and bending fatigue testing | Predetermined, established using predicate test data | Met for all tests | |
| - ASTM F1044: Shear testing of calcium phosphate and metallic coatings | Predetermined, established using predicate test data | Met for all tests | |
| - ASTM F1147: Tension testing of calcium phosphate & metallic coatings | Predetermined, established using predicate test data | Met for all tests | |
| - EN ISO 3274: Geometrical Product Specification (GPS) Surface Texture: Profile Method (Nominal Characteristics of Contact) | Predetermined, established using predicate test data | Met for all tests | |
| - EN ISO 4287: Geometrical Product Specification (GPS) - Surface Texture: Profile Method (Terms, Definitions, and Surface Texture Parameters) | Predetermined, established using predicate test data | Met for all tests | |
| - EN ISO 4288: Geometrical Product Specification (GPS) Surface Texture: Profile Method (Rules and Procedures for the Assessment of Surface Texture) | Predetermined, established using predicate test data | Met for all tests | |
| Mechanical Testing | - Static Compression | Predetermined, established using predicate test data | Met for all tests |
| - Compression Fatigue | Predetermined, established using predicate test data | Met for all tests | |
| - Static Compression-Shear | Predetermined, established using predicate test data | Met for all tests | |
| - Compression-Shear Fatigue | Predetermined, established using predicate test data | Met for all tests | |
| - Subsidence (ASTM F2267) | Predetermined, established using predicate test data | Met for all tests | |
| - Expulsion (Push-out) (ASTM Draft Standard F.04.25.02.02) - for both coated and uncoated 24-degree lordotic implants | Predetermined, established using predicate test data | Met for all tests | |
| - Wear Debris (ASTM F1877) | Predetermined, established using predicate test data | Met for all tests | |
| Design Validation | - Cadaver validation labs (insert and rotate 24-degree implant) | Functioned as intended; user needs met | Demonstrated success |
| MRI Safety Evaluation | - Comparison to a worst-case device for MR-safety, tested per: - ASTM F2052: Magnetically induced displacement force - ASTM F2213: Magnetically induced torque - ASTM F2119: MR image artifacts - ASTM F2182: RF induced heating | Inferred to behave in a similar (albeit reduced) manner for MRI issues compared to the worst-case system. | Passed by inference |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Mechanical and Material Testing: The document does not specify the exact sample size for each test (e.g., number of coating samples, number of implants for mechanical testing). It states "worst case subject 24-degree lordotic coated CAPSTONE CONTROL PTC™ implants" were tested and the "subject 24-degree lordotic uncoated CAPSTONE CONTROLTM implants were also tested" for expulsion.
- Cadaver Labs: The number of cadavers or surgical procedures performed is not specified.
- Data Provenance: Not specified. This type of engineering and bench testing is typically conducted in a laboratory setting. It is not patient data.
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 not an AI/ML diagnostic device; therefore, no "ground truth" in the diagnostic sense was established by experts for a test set.
- Cadaver Labs: "Independent surgeons" were involved in the design validation, but their number and specific qualifications are not detailed beyond being "surgeons."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No diagnostic test set requiring adjudication was used.
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. This is not an AI/ML diagnostic device requiring a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an AI/ML diagnostic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable (in the diagnostic sense). For the mechanical and material tests, the "ground truth" or reference for acceptance criteria was established using "predicate test data" and compliance with recognized ASTM and ISO standards. For the cadaver labs, the "ground truth" was whether the implants and instruments "functioned as intended" and "user needs were met" by independent surgeons.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML diagnostic device. However, "predicate test data" was used to establish acceptance criteria, which could be seen as a form of "training data" for defining acceptable performance ranges based on previously cleared devices. The exact sample size of this predicate data is not specified.
9. How the ground truth for the training set was established
- Not Applicable (in the diagnostic sense). The "ground truth" for defining acceptance criteria was established through data and performance characteristics of legally marketed predicate devices and compliance with relevant industry standards (ASTM, ISO).
§ 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.