(87 days)
The PATHWAY Interbody Fusion Device(s) is intended for spinal fusion procedure at one of two contiguous levels (L2-S1) in skeletally mature patients with degenerative Disc Diseases (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD may also have up to Grade I spondylolisthesis or retrolisthcsis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
The PATHWAY Interbody Fusion device is intended to be used with supplemental spinal fixation systems that have been cleared for lumbosacral spine (i.e. posterior pedicle screws and rod systems , anterior plate systems, and anterior screw and rod systems. The device(s) is intended to be used with autogenous bone graft.
Patients must have undergone a regiment of at least (6) months of non-operative treatment prior to being treated with the PATHWAY Device.
The PATHWAY device can be used in one of two methods:
Transforaminal Lumbar Interbody Fusion (TLIF)
Used as a TLIF, a single device is implanted in the appropriate location to provide support for a transforaminal approached surgery
Posterior Lumbar Interbody Fusion (PLIF)
Used as a PLIF, multiple devices are implanted in the appropriate locations to provide support to the spine for a posterior surgery.
The PATHWAY Interbody Fusion Device is made from Polyetheretherketone (PEEK OPTIMA TM) and contain titanium markers. The titanium markers serve a means for the end user of the device to determine the location of the implant intra-operatively and post- operatively.
The device(s) is rectangular in nature and have various widths, lengths, heights and degrees of lordosis (0 Degree and 6 Degree). The devices contain empty space for the practitioner to insert autogenous bone graft. The devices have serrated teeth on the superior and inferior sides to provide anchorage stability to the vertebrae. They are single use devices.
The 0 Degree PLIF has a width of 10 mm, a length of 23 mm, and ranges in height from 7 to 15 mm.
The 6 Degree PLIF is lordotic in nature and has a width of 8 mm, a length of 23 mm, and ranges in height from 7 to 15 mm
The TLIF is a rectangular in nature and has a width of 10 mm, a length of 28 mm, and ranges in height from 7 to 15 mm.
The implants are provided non-sterile and the instruments are provided cleaned, decontaminated and non-sterile. These devices must be sterilized by the user facility.
Here's a breakdown of the acceptance criteria and study information for the Custom Spine, Inc. PATHWAY Intervertebral Body Fusion Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Basis of Equivalence) | Reported Device Performance |
|---|---|
| Material Composition | Made from Polyetheretherketone (PEEK OPTIMA™) as per ASTM F2026 and contains Titanium (Ti-6Al-4V) as per ASTM F-136 implant grade titanium alloy. This is stated to be substantially equivalent to predicate devices. |
| Design (Dimensions and Features) | 0 Degree PLIF: Width of 10 mm, length of 23 mm, height ranges from 7 to 15 mm. |
| 6 Degree PLIF: Lordotic, width of 8 mm, length of 23 mm, height ranges from 7 to 15 mm. | |
| TLIF: Rectangular, width of 10 mm, length of 28 mm, height ranges from 7 to 15 mm. | |
| All devices have empty space for autogenous bone graft and serrated teeth for anchorage stability. | |
| This is stated to be substantially equivalent to predicate devices. | |
| Indications for Use | Intended for spinal fusion at one or two contiguous levels (L2-S1) in skeletally mature patients with Degenerative Disc Diseases (DDD), which may include up to Grade I spondylolisthesis or retrolisthesis. Patients must have undergone at least 6 months of non-operative treatment. |
| To be used with supplemental spinal fixation systems and autogenous bone graft. | |
| This is stated to be substantially equivalent to predicate devices. | |
| Mechanical Properties | Performance data per ASTM 2077 and ASTM 2267. Tested and compared to the predicate device. |
| The submission states that "The testing information and physiological data support the rational for equivalence with the predicate devices." ( implying it met the mechanical performance of the predicates). |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly mentioned. The submission relies on demonstrating substantial equivalence through material comparison, design specifications, indications for use, and mechanical testing against predicate devices. There is no mention of a clinical "test set" in the context of a prospective or retrospective patient data study for evaluation of algorithm performance.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this is a pre-market submission for a physical medical device, not an AI/software device evaluated on patient data. The "data" refers to engineering and material testing data, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission is for a physical orthopedic implant. "Ground truth" in the context of expert consensus on medical images or diagnoses is not relevant here. The ground truth for device performance is based on established engineering standards and comparison to predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication of test set results is mentioned for this type of device submission.
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/software device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is derived from:
- Established ASTM Standards: ASTM F2026 (for PEEK OPTIMA™), ASTM F-136 (for Titanium), ASTM 2077 (for mechanical performance), and ASTM 2267 (for mechanical performance).
- Performance of Predicate Devices: The device's performance and characteristics (materials, design, indications for use, mechanical properties) were compared to the cleared predicate devices: Spinal Elements Lucent (K071724) and Depuy Acromed™ Stackable Cage™ System (K990148, K001340, K030833). The equivalence to these legally marketed devices serves as the basis for demonstrating safety and effectiveness.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/software device that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an algorithm is involved.
§ 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.