(88 days)
SJM Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Swift-Lock™ anchor is intended to be an accessory to the leads component of the spinal cord stimulation (SCS) system, functioning to secure compatible St. Jude Medical™ (SJM) leads to the fascia or interspinous/supraspinous ligament.
The Swift-Lock™ Anchor is a single-use device used to attach the implanted lead to the fascia or interspinous ligament via suturing. The anchor is made up of male and female components that are partially over-molded with silicone rubber and ioined by a stainless steel pin. The Swift-Lock™ Anchor has a mechanical mechanism to secure the lead body to the anchor. This is accomplished by a rotating midsection where the male and female components align and lock into place. When properly executed, the anchor securely holds the lead into place enhancing the lead to anchor holding force. The Swift-Lock™ Anchor has several visual and tactile features such as; raised eyelets, indicating arrows, and a 1 cm depth indicator that aid the physician in inserting the anchor and securing the anchor to the lead. The Swift-Lock™ Anchor also has strain relief cuts in the distal end column for improved strain relief and increased flexibility and a thinner tapered distal tip for ease of insertion.
The provided text describes a 510(k) summary for the St. Jude Medical Swift-Lock™ Anchor, a medical device for securing spinal cord stimulation (SCS) leads. It outlines the device description, indications for use, comparison to a predicate device, and a non-clinical test summary.
However, the document does not provide specific acceptance criteria or details of a study (clinical or otherwise) that proves the device meets those criteria in the format requested. The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed performance study with quantitative results against predefined acceptance metrics.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's a breakdown of what can and cannot be extracted from the document based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. | Not specified in this document. The document only states that "Completion of all verification and validation activities demonstrated that the subject device meets the predetermined design and performance specifications." It does not list specific criteria or quantitative performance metrics. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not applicable, as the document describes non-clinical mechanical testing, not a study involving human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the document describes non-clinical mechanical testing, not a study requiring expert-established ground truth.
4. Adjudication method for the test set
- This question is not applicable as the document describes non-clinical mechanical testing, not a study requiring expert adjudication.
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 comparative effectiveness study was not done. This device is a mechanical anchor, not an AI or imaging-based diagnostic tool that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this question is not applicable. The device is a mechanical anchor and does not involve algorithms or AI.
7. The type of ground truth used
- This question is not applicable in the context of expert consensus, pathology, or outcomes data. The "ground truth" for the non-clinical mechanical testing would have been the established engineering specifications and design requirements.
8. The sample size for the training set
- This question is not applicable as the document describes mechanical testing, not a machine learning or AI-based system that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable as the document describes mechanical testing, not a machine learning or AI-based system.
Summary of the study/testing described in the document:
The document states that "Completion of all verification and validation activities demonstrated that the subject device meets the predetermined design and performance specifications. The testing included mechanical testing to confirm that the minor differences in the design do not adversely affect the safety and effectiveness of the subject device."
This indicates that a series of non-clinical mechanical tests were performed. These tests were explicitly designed to compare the new Swift-Lock™ Anchor to its predicate device (Swift-Lock ™ Anchor, K092371) and to ensure that minor design modifications did not negatively impact the device's safety and effectiveness. The conclusion reached is that the new device is substantially equivalent to the predicate device based on "device similarities in design, technological characteristics, principle of operation, indications for use and intended use."
However, the specific details of these mechanical tests, such as the number of units tested, the particular parameters measured (e.g., tensile strength, fatigue life, holding force), the quantitative results, or the acceptance thresholds for these parameters, are not provided in this 510(k) summary. These details would typically be found in a more comprehensive test report, which is usually part of the 510(k) submission but not fully disclosed in the public summary.
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).