(93 days)
PISCES™-SA ALIF Spacers (Standalone Use, With Integrated Fixation)
The PISCES™ SA (Standalone) ALIF Interbody System are lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™-SA (Standalone) ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone.
PISCES™-SA Used with Screws and/or Anchors:
When used with three (3) anchors, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 level without the need for supplemental fixation.
When used with three (3) screws, interbody devices with a lordotic angle ≤20° can be used as standalone interbody fusion devices at 1 or 2 contiguous levels without the need for supplemental fixation.
Hyperlordotic interbody devices (>20° lordosis) used with screws and/or anchors must always be used with supplemental fixation and may be used at 1 or 2 contiguous levels.
PISCES™ ALIF Spacers (Without Integrated Fixation)
PISCES™ ALIF Spacers are lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. PISCES™ ALIF Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>= 20 lordosis) must be used with at least anterior supplemental fixation.
PISCES™-SA Standalone ALIF Interbody System is an interbody fusion device for the lumbar spine that may be used with three titanium alloy screws or anchors which accompany the implants. When used with screws and/or anchors, these devices are standalone interbody fusion devices. The integrated fixation anchors may not provide adequate stability for all situations. The surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation (e.g., anterior plate, posterior pedicle screws) may be needed. When used without screws and/or anchors, these devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The PISCES™ SA interbodies are manufactured from titanium alloy (Ti-6AI-4V ELI) per ASTM F3001. The spacers are available in multiple sizes. The spacers are single use devices, which are sterilized via gamma radiation and are provided to the user in sterile packages. The screws, and locking plates are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and must be sterilized prior to use. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use. The screws, anchors, locking plates, and instruments are supplied in a re-usable tray for steam sterilization.
The provided text is related to a 510(k) premarket notification for a medical device called the "PISCES™-SA STANDALONE ALIF Interbody System". This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing, rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically seen for AI/ML device evaluations. As such, many of the requested elements (like sample size for test sets, data provenance, ground truth establishment, expert qualifications, MRMC studies, standalone performance for AI, and training set details) are not applicable or available in this document because it describes a traditional hardware medical device clearance, not an AI/ML software device.
However, I can extract information related to the non-clinical testing performed to demonstrate substantial equivalence, which serves a similar purpose to meeting acceptance criteria for this type of device.
Here's a summary based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that would be directly comparable to the reported device performance in the way you might expect for an AI/ML model. Instead, it refers to a battery of non-clinical mechanical tests and cadaveric studies. The "reported device performance" is implicitly that the device performs equivalently to the predicate and meets the requirements of the standards cited.
| Criteria Category (Implied) | Specific Test/Study | Method | Performance (Implicitly Met) |
|---|---|---|---|
| Mechanical Strength & Stability | Static Compression | ASTM F2077 | Equivalent to predicate |
| Dynamic Compression | ASTM F2077 | Equivalent to predicate | |
| Static Compression Shear | ASTM F2077 | Equivalent to predicate | |
| Dynamic Compression Shear | ASTM F2077 | Equivalent to predicate | |
| Subsidence | ASTM F2267 | Equivalent to predicate | |
| Expulsion Testing | Not specified standard | Equivalent to predicate | |
| Cantilever Anchor Bending | Not specified standard | Equivalent to predicate | |
| Anchor Impaction Testing | Not specified standard | Equivalent to predicate | |
| Functional Equivalence | Cadaveric Implantation | Not specified standard | Equivalent to predicate |
| Cadaveric Range of Motion (ROM) | Not specified standard | Equivalent to predicate | |
| Cadaveric Fatigue Studies | Not specified standard | Equivalent to predicate | |
| Void Analysis | Not specified standard | Equivalent to predicate |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for each test. For cadaveric studies, the sample size (number of cadavers or specimens) is not provided. For mechanical tests, the number of samples tested is not given but would typically follow the requirements of the ASTM standards or internal protocols.
- Data Provenance: The cadaveric studies originate from cadaveric specimens. Mechanical testing data comes from laboratory experiments. There is no mention of country of origin or whether the data is retrospective or prospective, as this is typically not relevant for this type of non-clinical device testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Ground truth as typically understood for AI/ML (e.g., expert consensus) is not applicable here. The "ground truth" for this device comes from the physical and mechanical properties measured in the laboratory and cadaveric settings, compared against established standards (like ASTM) and the performance of a predicate device.
4. Adjudication method for the test set
- Adjudication methods like 2+1 or 3+1 are not applicable for this type of non-clinical testing. Performance is determined by direct physical measurement and comparison to predefined acceptance criteria within engineering and anatomical studies.
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
- A Multi Reader Multi Case (MRMC) comparative effectiveness study is not applicable as this is a physical interbody fusion device, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- "Standalone performance" in the context of an algorithm is not applicable. This is a physical implant, not an algorithm. Its performance is inherent to its design and material properties.
7. The type of ground truth used
- The "ground truth" for justifying substantial equivalence is based on engineering standards (ASTM F2077, ASTM F2267) and direct experimental measurements (mechanical tests, cadaveric studies) demonstrating that the device performs functionally and safely in a manner equivalent to its predicate device. This is a form of empirical ground truth based on physical and biomechanical properties, rather than expert consensus or pathology reports.
8. The sample size for the training set
- A "training set" as defined for AI/ML models is not applicable. This device is a physical product, not a software algorithm that undergoes a training phase.
9. How the ground truth for the training set was established
- As a training set is not applicable, the method of establishing its ground truth is also not applicable.
In conclusion, this FDA 510(k) clearance document is for a traditional medical device (an interbody fusion system). The "acceptance criteria" and "study" described are primarily non-clinical evaluations to confirm the device's mechanical and functional equivalence to a legally marketed predicate device, rather than a clinical trial or AI/ML performance study.
§ 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.