KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105

• K Number: K062309
• Device Name: KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105
• Manufacturer: KARMA MEDICAL PRODUCTS CO., LTD.
• Date Cleared: 2006-10-10 ( 63 days)
• Product Code: IOR
• Regulation Number: 890.3850
• Type: Traditional
• Panel: PM
• Reference & Predicate Devices: K060251

Intended Use

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Device Description

The KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 are indoor / outdoor wheelchairs that have the base with four-wheeled with a seat. The devices can be disassembled for transport and it is foldable easily. Back upholstery material is also the same resistance-ignitability fabric.

AI/ML Overview

This 510(k) premarket notification for the KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105, focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria for a complex clinical outcome. The "acceptance criteria" here are the performance requirements of recognized standards, which the device is declared to meet.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Reference)	Reported Device Performance
ANSI/RESNA WC Vol. 1 Wheelchair Standard	Device meets applicable performance requirements.
ISO 7176 Wheelchair Standards	Device meets applicable performance requirements.

Note: The document does not provide specific numerical outcomes for each test within these standards. It simply states that the devices meet the applicable requirements. The core of this 510(k) is a comparison to a predicate device, not a novel clinical study for the subject device.

Study Details:

This submission is a premarket notification (510(k)) that relies on performance testing against recognized standards and comparison to a legally marketed predicate device to establish substantial equivalence. It is not a clinical study in the typical sense of evaluating a device's performance in a patient population to determine specific clinical acceptance criteria. Therefore, many of the requested study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set) are not applicable to this type of regulatory submission.

Specifically:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated as a "test set" in the context of human data. For mechanical performance testing, the sample size would typically refer to the number of wheelchairs tested to meet the ANSI/RESNA and ISO standards. This specific number is not provided in the summary.
   • Data Provenance: Not applicable for a human data test set. The performance testing was conducted by KARMA Medical Products Co., Ltd. (Taiwan, R.O.C.) against international standards for mechanical wheelchairs.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. The "ground truth" for this type of submission is the adherence to established engineering and performance standards (ANSI/RESNA, ISO 7176) for mechanical wheelchairs. There is no expert clinical review of "cases" to establish ground truth in this context.

3. Adjudication method for the test set:

   • Not Applicable. There is no clinical test set requiring adjudication in this regulatory summary.

4. 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. This is a mechanical wheelchair. MRMC studies, AI assistance, and "human readers" are not relevant to this device or its regulatory pathway.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a mechanical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" (or basis for acceptance) is the conformance to established international performance standards for wheelchairs (ANSI/RESNA WC Vol. 1 and ISO 7176) and the demonstration of substantial equivalence to a legally marketed predicate device (WH Convertible Lightweight Wheelchair, WHL100 - K060251) based on intended use, technology, and safety/effectiveness profiles.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of an algorithm or AI for this mechanical device.

8. How the ground truth for the training set was established:

   • Not Applicable. As there is no training set mentioned or implied for this device, this question is not relevant.

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).